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FOUNDAYO orforglipron 5.5 mg Tablet, Film Coated, 30-count — NDC 00002-4794-31 package photo

FOUNDAYO orforglipron 5.5 mg Tablet, Film Coated, 30-count

by Eli Lilly and Company · 1 BOTTLE in 1 CARTON (0002-4794-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4794-01)
NDC 00002-4794-31
🏷️ FDA NDC (as labeled) 0002-4794-31 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0002-4794-31
Product NDC 0002-4794
11-digit billing NDC 00002479431
NCPDP billing unit EA — each (per item)
RxCUI 2739844, 2739850, 2739852, 2739854, 2739856, 2739858, 2739860, 2739862,
UNII VI5M9OZV2X
Application # NDA220934
SPL Set ID 8ac446c5-feba-474f-a103-23facb9b5c62
Established class (EPC) GLP-1 Receptor Agonist
Mechanism of action Glucagon-like Peptide-1 (GLP-1) Agonists
Physiologic effect Decreased Gastric Motility; Increased Gastric Muscle Tone
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance ORFORGLIPRON CALCIUM
GCN Seq No 088837
GCN 59013
HICL code 051258
Ingredient (HICL) Orforglipron Calcium
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J8
Therapeutic class — intermediate (HIC2) Anti-Obesity - Anorexics
HIC3 code J8E
Therapeutic class — specific (HIC3) Anti-Obesity Glucagon-Like Peptide-1 Recep Agonist
AHFS code 68:20.06.00
AHFS class Incretin Mimetics
FDB label name FOUNDAYO 5.5 MG TABLET
FDB brand name Foundayo
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0002-4794-31 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00002-4794-31. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerEli Lilly and Company
Application holderELI LILLY AND CO
FDA applicationNDA220934 (NDA)
Labeler code00002
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio192 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FOUNDAYO 5.5 MG TABLET Ingredient Orforglipron Calcium
📖 What it is MedlinePlus · NLM

Orforglipron is used to assist with weight loss and maintenance in certain people who are obese or overweight and have weight-related medical problems. Orforglipron is in a class of medications called incretin mimetics. It works by slowing the emptying of the stomach and may decrease appetite and cause weight loss.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Foundayo contains orforglipron, which works the same way as other GLP-1 receptor agonist medicines — it activates receptors in your brain that control hunger, so you feel less hung...
  • What exactly is Foundayo, and how is it different from injectable weight-loss medicines?
  • The most common ones are stomach-related — nausea, constipation, diarrhea, and sometimes vomiting. These tend to be worst early on and after each dose increase, but they usually ea...
  • What side effects should I expect when I first start taking it?
📖 Read our full Orforglipron guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink / Yellow / Purple
ShapeOval
ImprintG6;Lilly
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $20.656 $619.69 / 30 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jun 2026 Aug 2026 $20.656 $20.649
Flat over the last 2 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Foundayo 5.5 mgthis 00002-4794-31 Eli 30 tablets $20.656 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
First FDA approval
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2037. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 1, 2026 RLD RS ⏳ ~11 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US RE50455 — drug substance (U-4474)
US RE50455 — drug substance (U-4474)
US RE50455 — drug substance (U-4474)
US RE50455 — drug substance (U-4474)
US RE50455 — drug substance (U-4474)
US RE50455 — drug substance (U-4474)
Exclusivity NCE
Exclusivity NCE
Exclusivity NCE
Exclusivity NCE
Exclusivity NCE
Exclusivity NCE
2026 2028 2030 2032 2034 2036
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US RE50455 ↗ Drug substance U-4474 Sep 26, 2037
US RE50455 ↗ Drug substance U-4474 Sep 26, 2037
US RE50455 ↗ Drug substance U-4474 Sep 26, 2037
US RE50455 ↗ Drug substance U-4474 Sep 26, 2037
US RE50455 ↗ Drug substance U-4474 Sep 26, 2037
US RE50455 ↗ Drug substance U-4474 Sep 26, 2037
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Apr 1, 2031
NCENew Chemical Entity (5-year)Apr 1, 2031
NCENew Chemical Entity (5-year)Apr 1, 2031
NCENew Chemical Entity (5-year)Apr 1, 2031
NCENew Chemical Entity (5-year)Apr 1, 2031
NCENew Chemical Entity (5-year)Apr 1, 2031
Common questions
Is there a generic version of FOUNDAYO 5.5 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for FOUNDAYO 5.5 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2037 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for FOUNDAYO (this brand).

Top reported reactions

Nausea179
Constipation81
Vomiting75
Fatigue70
Weight Increased69
Weight Loss Poor64
Diarrhoea62

Reporter sex

726 reports
Male · 19%
Female · 81%
Reports over time (by year) — tap or hover for the count & year
2025 2026 725 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00002-4794-31 You're viewing this 1 BOTTLE in 1 CARTON (0002-4794-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4794-01) 2026-04-01 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: RISK OF THYROID C-CELL TUMORS In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology ( 13.1 )] . While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] .

FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of FOUNDAYO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with FOUNDAYO [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] .

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents ( 13.1 ) .

While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined ( 5.1 , 13.1 ). FOUNDAYO is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

🎯 Indications and Usage 125 words ▾

1 INDICATIONS AND USAGE FOUNDAYO TM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.

( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Take FOUNDAYO orally once daily, with or without food. ( 2.1 ) Swallow tablets whole. Do not break, crush, or chew.

( 2.1 ) Do not take more than one tablet per day. ( 2.1 ) Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily.

( 2.1 ) After at least 30 days on the 2.5 mg dosage, increase dosage to 5.5 mg once daily. ( 2.1 ) Dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability. ( 2.1 ) Maximum dosage is 17.2 mg once daily.

( 2.1 )

2.1Recommended Dosage and Administration Recommended Administration Take FOUNDAYO orally once daily, with or without food. Swallow tablets whole. Do not break, crush, or chew.

Do not take more than one tablet per day. Recommended Dosage Escalation Follow the FOUNDAYO starting dosage and escalation described below to reduce the risk of gastrointestinal (GI) adverse reactions [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6 )] . The starting dosage is 0.8 mg orally once daily.

After at least 30 days on the 0.8 mg dosage, increase the dosage to 2.5 mg once daily. After at least 30 days on the 2.5 mg dosage, increase the dosage to 5.5 mg once daily. The dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability.

The maximum dosage of FOUNDAYO is 17.2 mg once daily.

2.2Dosage Modification for Concomitant Use with CYP3A4 Inhibitors and CYP3A4 Inducers FOUNDAYO dosage modification may be required to manage interactions with some concomitant medications [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . Strong CYP3A4 Inhibitors Avoid strong CYP3A4 inhibitors that also inhibit OATP1B when taking FOUNDAYO. The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] .

Strong and Moderate CYP3A4 Inducers Avoid strong CYP3A4 inducers when taking FOUNDAYO. Monitor FOUNDAYO effectiveness when concomitantly using moderate CYP3A4 inducers and escalate FOUNDAYO dosage as needed [see Dosage and Administration ( 2.1 , 2.3 ), Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] .

2.3Recommendations Regarding Missed Dose If a dose is missed, instruct patients to take the dose as soon as possible. Advise patients not to double up the next dose. If 7 or more consecutive doses are missed, reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6 )] .

💊 Dosage Forms and Strengths 138 words ▾

3 DOSAGE FORMS AND STRENGTHS FOUNDAYO tablets are available as orforglipron: 0.8 mg: pink round tablet debossed with “L” on one side and “G1” on the other side 2.5 mg: light yellow round tablet debossed with “L” on one side and “G2” on the other side 5.5 mg: grayish purple round tablet debossed with “L” on one side and “G3” on the other side 9 mg: pink modified oval tablet debossed with “Lilly” on one side and “G4” on the other side 14.5 mg: light yellow modified oval tablet debossed with “Lilly” on one side and “G5” on the other side 17.2 mg: grayish purple modified oval tablet debossed with “Lilly” on one side and “G6” on the other side Tablets: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, 17.2 mg of orforglipron ( 3 )

⛔ Contraindications 98 words ▾

4 CONTRAINDICATIONS FOUNDAYO is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . Known serious hypersensitivity to orforglipron or any of the excipients in FOUNDAYO. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.2 )] .

Personal or family history of MTC or in patients with MEN 2 ( 4 ) Known serious hypersensitivity to orforglipron or any of the excipients in FOUNDAYO ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including FOUNDAYO. Discontinue if pancreatitis is suspected. ( 5.2 ) Severe Gastrointestinal Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe.

FOUNDAYO is not recommended in patients with severe gastroparesis. ( 5.3 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.4 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia.

Reducing the dosage of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. ( 5.5 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists.

If suspected, advise the patient to promptly seek medical attention and discontinue FOUNDAYO. ( 5.6 ) Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression.

( 5.7 ) Acute Gallbladder Disease : Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.8 ) Pulmonary Aspiration During General Anesthesia and Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures.

Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 )

5.1Risk of Thyroid C-Cell Tumors In products with GLP-1 receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology ( 13.1 )] . While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Nonclinical Toxicology ( 13.1 )] .

Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. FOUNDAYO is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of FOUNDAYO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with FOUNDAYO. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L.

If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2Acute Pancreatitis Acute pancreatitis has been reported in patients treated with FOUNDAYO. Fatal and non-fatal hemorrhagic or necrotizing pancreatitis have been observed in patients treated with GLP-1 receptor agonists [see Adverse Reactions ( 6 )] . After initiation of FOUNDAYO, obse…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Severe Gastrointestinal Reactions [see Warnings and Precautions ( 5.3 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.4 )] Hypoglycemia [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with Type 2 Diabetes [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions, reported in ≥5% of patients treated with FOUNDAYO, are nausea, constipation, diarrhea, vomiting, dyspepsia, abdominal pain, headache, abdominal distension, fatigue, eructation, gastroesophageal reflux disease, flatulence, and hair loss.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of FOUNDAYO has been established in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition based on adequate and well-controlled trials of an investigational orforglipron formulation (Trials 1 and 2), referred to in this section as FOUNDAYO [see Clinical Studies ( 14 )] .

This section of labeling presents safety data from administration of the investigational orforglipron formulation shown as equivalent dosages of once daily FOUNDAYO [see Dosage and Administration ( 2.1 )] . Adverse Reactions in Patients in Weight Management Clinical Trials Pool of Two Placebo-Controlled Clinical Trials: FOUNDAYO was evaluated for safety in a pool of two randomized, double-blind, placebo-controlled trials that included 3155 adult patients with obesity or overweight treated with FOUNDAYO once daily for up to 72 weeks and a 2-week off-drug follow-up period (Trial 1 and Trial 2) [see Clinical Studies ( 14 )] .

The mean age of patients was 49 years and 41% were male. The population was 60% White, 25% Asian, 8% Black or African American, and 0.3% American Indian or Alaska Native; 35% identified as Hispanic or Latino ethnicity. At baseline, patients had an average BMI of 36.5 kg/m 2 , 51% with a BMI ≥35 kg/m 2 , 50% with hypertension, 49% with dyslipidemia, 31% with type 2 diabetes, 11% with obstructive sleep apnea, 3% with coronary artery disease, and 3% with cerebrovascular disease.

Across both trials, 8% of patients treated with FOUNDAYO (5.5 mg, 6%; 9 mg, 9%; and 17.2 mg, 10%) once daily permanently discontinued treatment as a result of adverse reactions compared to 3% of patients receiving placebo. The majority of patients (5%) who discontinued FOUNDAYO due to adverse reactions did so due to gastrointestinal adverse reactions. Common Adverse Reactions Table 1 shows common adverse reactions associated with the use of once daily FOUNDAYO in the pool of two placebo-controlled trials for weight management (Trials 1 and 2).

These adverse reactions occurred more commonly with once daily FOUNDAYO than with placebo and occurred in at least 5% of patients treated with FOUNDAYO. Table 1: Adverse Reactions Reported in ≥5% of FOUNDAYO-treated Adult Patients with Obesity or Overweight (With or Without Type 2 Diabetes) in Pool of Placebo-Controlled Trials…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors that also inhibit OATP1B. ( 7.1 ) CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers.

Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers. ( 7.1 ) Simvastatin: Do not exceed simvastatin 20 mg once daily when used concomitantly with FOUNDAYO. ( 7.2 ) FOUNDAYO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.

( 7.3 )

7.1Effect of Other Drugs on FOUNDAYO Table 2 includes clinically relevant interactions where concomitant use of other drugs affects FOUNDAYO. Table 2: Clinically Relevant Effects of Other Drugs on FOUNDAYO Strong CYP3A4 Inhibitors Intervention The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use of FOUNDAYO with strong CYP3A4 inhibitors that also inhibit OATP1B (e.g., ritonavir) [see Dosage and Administration ( 2.2 )] .

Clinical Impact CYP3A4 inhibitors increase FOUNDAYO exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of FOUNDAYO-associated adverse reactions. Strong CYP3A4 inhibitors that also clinically inhibit OATP1B are expected to significantly increase plasma concentrations of FOUNDAYO, which may increase the risk of FOUNDAYO-associated adverse reactions [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . Strong CYP3A4 Inducers Intervention Avoid concomitant use of FOUNDAYO with strong CYP3A4 inducers.

Clinical Impact Induction of CYP3A4 decreases FOUNDAYO exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce the effectiveness of FOUNDAYO. Moderate CYP3A4 Inducers Intervention Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers [see Dosage and Administration ( 2.1 )] . Clinical Impact Induction of CYP3A4 decreases FOUNDAYO exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce the effectiveness of FOUNDAYO.

7.2Effect of FOUNDAYO on Other Drugs Table 3 includes clinically relevant interactions where concomitant use of FOUNDAYO affects other drugs. Table 3: Clinically Relevant Effects of FOUNDAYO on Other Drugs Simvastatin Intervention Do not exceed simvastatin 20 mg once daily when concomitantly used with FOUNDAYO. Clinical Impact Use of FOUNDAYO with simvastatin increased exposure of the active metabolite simvastatin acid two-fold [see Clinical Pharmacology ( 12.3 )] .

A two-fold increase in simvastatin acid exposure at the highest simvastatin dose could be clinically meaningful. Insulin or Insulin Secretagogue (e.g., Sulfonylurea) Intervention When initiating FOUNDAYO, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) [see Warnings and Precautions ( 5.5 )] . Clinical Impact FOUNDAYO stimulates insulin release in the presence of elevated blood glucose concentrations which could increase the risk for hypoglycemia when used in combination with insulin or insulin secretagogues.

7.3Effect of FOUNDAYO on Oral Medications FOUNDAYO delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications [see Clinical Pharmacology ( 12.3 )] . Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 30 days after initiation with FOUNDAYO and for 30 days after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue FOUNDAYO. ( 8.1 ) Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 30 days after initiation and for 30 days after each dose escalation.

( 8.3 ) Hepatic impairment: Not recommended for use in patients with severe hepatic impairment. ( 8.6 )

8.1Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FOUNDAYO (orforglipron) during pregnancy. Pregnant patients exposed to FOUNDAYO and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Risk Summary Weight loss offers no benefit to a pregnant patient and may cause fetal harm.

When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus and discontinue FOUNDAYO. There are no adequate and well-controlled studies of FOUNDAYO during pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to orforglipron during pregnancy.

Imbalances in malformations have been reported in rats and rabbits at low multiples of clinical exposure with GLP-1 receptor agonists active in those species. Orforglipron is not pharmacologically active in rats and rabbits. In animal reproduction studies, oral administration of orforglipron to pregnant monkeys during organogenesis at doses lower than the maximum recommended human dose (MRHD) did not result in embryofetal effects.

Higher dose levels and exposures could not be evaluated in monkeys due to dose limiting effects on body weight (see Data) . In a rabbit dose-range finding study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures 14 times the clinical exposure at the MRHD resulted in external malformations and decreases in fetal and placental weights in the absence of maternal toxicity (see Data) . In the definitive rabbit study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures up to 6 times the clinical exposure at the MRHD did not result in embryofetal effects (see Data) .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is increased when compared to the general population. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Appropriate weight gain relative to pre-pregnancy weight is currently recommended for all pregnant patients, including those with obesity or overweight, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.

Data Animal Data Embryofetal development was evaluated in pregnant monkeys administered orforglipron orally during organogenesis (gestation days 20 to 50) at doses of 0.15 and 0.7 mg/kg/day resulting in systemic exposures lower than the human exposure at the MRHD of 17.2 mg FOUNDAYO, based on AUC. No effects on pregnancy outcome, placental weight, fetal viability, fetal body weight, fetal measurements or external, visceral or skeletal evaluations were observed. Exposure in monkeys was lower than exposure at the MRHD.

Higher dose levels and exposures cannot be achieved in pregnant monkeys due to on-target body weight effects. Orforglipron is not pharmacologically active in rabbits. In a rabbit dose-range finding study, orforglipron was administered orally once daily during organogenesis (gestation days 7 to 19) at dose levels of 2, 20, and 200 mg/kg/day.

These doses resulted in exposures that were approximately 0.03, 0.8 and 14 times, respectively, the clinical exposure at the MRHD, based on AUC. Statistically significant decreases in fetal and placental weights and external malf…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FOUNDAYO (orforglipron) during pregnancy. Pregnant patients exposed to FOUNDAYO and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Risk Summary Weight loss offers no benefit to a pregnant patient and may cause fetal harm.

When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus and discontinue FOUNDAYO. There are no adequate and well-controlled studies of FOUNDAYO during pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to orforglipron during pregnancy.

Imbalances in malformations have been reported in rats and rabbits at low multiples of clinical exposure with GLP-1 receptor agonists active in those species. Orforglipron is not pharmacologically active in rats and rabbits. In animal reproduction studies, oral administration of orforglipron to pregnant monkeys during organogenesis at doses lower than the maximum recommended human dose (MRHD) did not result in embryofetal effects.

Higher dose levels and exposures could not be evaluated in monkeys due to dose limiting effects on body weight (see Data) . In a rabbit dose-range finding study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures 14 times the clinical exposure at the MRHD resulted in external malformations and decreases in fetal and placental weights in the absence of maternal toxicity (see Data) . In the definitive rabbit study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures up to 6 times the clinical exposure at the MRHD did not result in embryofetal effects (see Data) .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is increased when compared to the general population. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Appropriate weight gain relative to pre-pregnancy weight is currently recommended for all pregnant patients, including those with obesity or overweight, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.

Data Animal Data Embryofetal development was evaluated in pregnant monkeys administered orforglipron orally during organogenesis (gestation days 20 to 50) at doses of 0.15 and 0.7 mg/kg/day resulting in systemic exposures lower than the human exposure at the MRHD of 17.2 mg FOUNDAYO, based on AUC. No effects on pregnancy outcome, placental weight, fetal viability, fetal body weight, fetal measurements or external, visceral or skeletal evaluations were observed. Exposure in monkeys was lower than exposure at the MRHD.

Higher dose levels and exposures cannot be achieved in pregnant monkeys due to on-target body weight effects. Orforglipron is not pharmacologically active in rabbits. In a rabbit dose-range finding study, orforglipron was administered orally once daily during organogenesis (gestation days 7 to 19) at dose levels of 2, 20, and 200 mg/kg/day.

These doses resulted in exposures that were approximately 0.03, 0.8 and 14 times, respectively, the clinical exposure at the MRHD, based on AUC. Statistically significant decreases in fetal and placental weights and external malformations in 2 fetuses from 2 dams were observed at 200 mg/kg/day. In the definitive rabbit study, orforglipron was given orally once daily during organogenesis (gestation days 7 to 19) at dose levels of 4, 40, and 200 mg/kg/day resulting in exposures approximately 0.06, 1.4, and 6.2 times the clinical exposure at the MRHD, respectively, based on AUC.

No embryofetal effects were observed in the definitive rabbit study at any dose level. Orforglipron is not p…

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of FOUNDAYO have not been established in pediatric patients.

🧓 Geriatric Use 67 words ▾

8.5Geriatric Use In a pool of Trials 1 and 2, 399 (13%) FOUNDAYO-treated patients were 65 years of age or older, and 33 (1%) FOUNDAYO-treated patients were 75 years of age or older at baseline [see Clinical Studies ( 14 )] . No overall differences in safety or effectiveness of FOUNDAYO have been observed between patients 65 years of age or older and younger adult patients.

🆘 Overdosage 56 words ▾

10 OVERDOSAGE In the event of an overdose, consider contacting Poison Control (1-800-222-1222) or a medical toxicologist for latest recommendations. Initiate appropriate supportive treatment according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, considering the half-life of orforglipron [see Clinical Pharmacology ( 12.3 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action FOUNDAYO is a GLP-1 receptor agonist that binds to and activates the human GLP-1 receptor. GLP-1 is a physiological regulator of appetite and caloric intake. GLP-1 receptors are present in brain regions that regulate appetite. In animal studies, orforglipron distributed to and activated neurons in brain regions that regulate appetite and food intake.

12.2Pharmacodynamics FOUNDAYO reduces body weight, with greater fat mass loss than lean mass loss. FOUNDAYO decreases food intake. This effect is likely mediated by decreased appetite.

FOUNDAYO delays gastric emptying. The delay is largest after the first dose and diminishes over time. Cardiac Electrophysiology At 1.4 times the mean of maximum concentrations provided by the maximum recommended FOUNDAYO dose (17.2 mg) once daily, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics The pharmacokinetics of orforglipron is similar between healthy subjects and patients with overweight (BMI ≥27 kg/m 2 ) or obesity. Steady state exposure is achieved after approximately 1 week of once daily administration. The data below refer to FOUNDAYO dosages [see Dosage and Administration ( 2.1 )] .

Except in the food effect study, data were generated with the corresponding orforglipron investigational formulation [see Adverse Reactions ( 6.1 )] . Absorption Maximum concentration of orforglipron is reached 4 to 8 hours post dose. Orforglipron tablet exposure increases in a dose-proportional manner.

The geometric mean absolute bioavailability of orforglipron was 77% after a 0.8 mg dose. Effect of food No clinically relevant food effect on orforglipron exposure was observed. Following multiple doses of an investigational 37.5 mg orforglipron tablet, the AUC (0-24h) decreased by 19%, and C max decreased by 26% with food compared to fasted state.

The t max and t 1/2 were unchanged. Distribution The mean steady-state volume of distribution of orforglipron is approximately 285 L, following intravenous dosing in healthy subjects. Orforglipron plasma protein binding is greater than 99%.

FOUNDAYO is only for oral use. Elimination The mean systemic clearance of orforglipron is

7.15L/hour. The elimination half-life is approximately 29 to 49 hours after an oral dose. Metabolism Orforglipron is metabolized primarily via hepatic CYP3A4 to several oxidative metabolites.

These oxidative metabolites are excreted into the intestinal lumen. Excretion After administration of a single oral dose of 2.5 mg orforglipron, 87% of the dose was recovered in feces (all metabolites) and less than 1% of the dose was recovered in urine. Special Populations The intrinsic factors of age (18 to 92 years), sex, race (White, Asian, Black or African American, American Indian, Multiracial, or Hawaiian Pacific Islander), ethnicity (Hispanic, Non-Hispanic), body weight (56.4 to 227 kg), and renal impairment (eGFR 27.8 to 156 mL/min/1.73 m 2 ) do not have a clinically relevant effect on the pharmacokinetics of orforglipron.

Patients with Hepatic Impairment The pharmacokinetics of orforglipron after a single oral 0.8 mg dose was evaluated in patients with mild, moderate, and severe hepatic impairment (Child-Pugh Class A, B, and C, respectively) and in subjects with normal hepatic function. Orforglipron exposure was similar in patients with mild hepatic impairment and normal hepatic function. Orforglipron AUC (0-∞) increased by 1.7-fold and 4.6-fold in patients with moderate and severe hepatic impairment, respectively, compared to subjects with normal hepatic function.

C max in patients with moderate and severe hepatic impairment was similar to C max in subjects with normal hepatic function [see Use in Specific Populations ( 8.6 )] . Patients with Renal Impairment Renal impairment does not impact the pharmacokinetics of orforglipron. The pharmacokinetics of orforglipron after a single oral 0.8 mg dose were evaluated in patients with severe renal impairment…

🧬 Mechanism of Action 57 words ▾

12.1Mechanism of Action FOUNDAYO is a GLP-1 receptor agonist that binds to and activates the human GLP-1 receptor. GLP-1 is a physiological regulator of appetite and caloric intake. GLP-1 receptors are present in brain regions that regulate appetite. In animal studies, orforglipron distributed to and activated neurons in brain regions that regulate appetite and food intake.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied FOUNDAYO (orforglipron) tablets are supplied in bottles with desiccant and child-resistant closure in cartons as follows: Tablet Strength of Orforglipron Description Package Configuration NDC Number 0.8 mg Pink round tablet debossed with “L” on one side and “G1” on the other side Bottles of 30 tablets 0002-4178-31 2.5 mg Light yellow round tablet debossed with “L” on one side and “G2” on the other side Bottles of 30 tablets 0002-4503-31 5.5 mg Grayish purple round tablet debossed with “L” on one side and “G3” on the other side Bottles of 30 tablets 0002-4794-31 9 mg Pink modified oval tablet debossed with “Lilly” on one side and “G4” on the other side Bottles of 30 tablets 0002-4803-31 14.5 mg Light yellow modified oval tablet debossed with “Lilly” on one side and “G5” on the other side Bottles of 30 tablets 0002-4839-31 17.2 mg Grayish purple modified oval tablet debossed with “Lilly” on one side and “G6” on the other side Bottles of 30 tablets 0002-4953-31

16.2Storage and Handling Store FOUNDAYO at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

16.1How Supplied FOUNDAYO (orforglipron) tablets are supplied in bottles with desiccant and child-resistant closure in cartons as follows: Tablet Strength of Orforglipron Description Package Configuration NDC Number 0.8 mg Pink round tablet debossed with “L” on one side and “G1” on the other side Bottles of 30 tablets 0002-4178-31 2.5 mg Light yellow round tablet debossed with “L” on one side and “G2” on the other side Bottles of 30 tablets 0002-4503-31 5.5 mg Grayish purple round tablet debossed with “L” on one side and “G3” on the other side Bottles of 30 tablets 0002-4794-31 9 mg Pink modified oval tablet debossed with “Lilly” on one side and “G4” on the other side Bottles of 30 tablets 0002-4803-31 14.5 mg Light yellow modified oval tablet debossed with “Lilly” on one side and “G5” on the other side Bottles of 30 tablets 0002-4839-31 17.2 mg Grayish purple modified oval tablet debossed with “Lilly” on one side and “G6” on the other side Bottles of 30 tablets 0002-4953-31

📦 Storage and Handling 29 words ▾

16.2Storage and Handling Store FOUNDAYO at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

📋 Description 214 words ▾

11 DESCRIPTION FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C 48 H 47 F 2 N 10 O 5 .[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1 S ,2 S )-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1 H -indazol-5-yl)-2-oxo-2,3-dihydro-1 H -imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5 H -pyrazolo[4,3- c ]pyridine-5-yl}carbonyl)-5-[(4 S )-2,2-dimethyloxan-4-yl]-1 H -indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5 H )-ide}.

Orforglipron calcium has the following chemical structure: Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use.

Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow 2.5 mg and 14.5 mg tablets contain ferric oxide yellow 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red.

Each tablet contains 10 mg or less of sodium. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Thyroid C-Cell Tumors Inform patients that in studies with rodents, medicines that work like FOUNDAYO caused thyroid C-cell tumors and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their healthcare provider [see Boxed Warning , Warnings and Precautions ( 5.1 )] .

Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue FOUNDAYO promptly and contact their healthcare provider if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )] . Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions.

Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.3 )] . Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration and volume depletion associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion.

Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.4 )] . Hypoglycemia Inform patients of the risk of hypoglycemia and educate patients on the signs and symptoms of hypoglycemia. Advise patients taking insulin or insulin secretagogue therapy such as a sulfonylurea that they may have an increased risk of hypoglycemia when using FOUNDAYO and to report signs and/or symptoms of hypoglycemia to their healthcare provider [see Warnings and Precautions ( 5.5 )] .

Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported with use of FOUNDAYO. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking FOUNDAYO and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.6 )] . Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Inform patients with type 2 diabetes to contact their healthcare provider if they experience changes in vision during treatment with FOUNDAYO [see Warnings and Precautions ( 5.7 )] .

Acute Gallbladder Disease Inform patients of the risk of acute gallbladder disease. Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected [see Warnings and Precautions ( 5.8 )] . Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that FOUNDAYO may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures.

Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking FOUNDAYO [see Warnings and Precautions ( 5.9 )] . Pregnancy Advise a pregnant patient of the potential risk to a fetus. Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with FOUNDAYO.

Advise women of childbearing potential to use effective contraception during treatment with FOUNDAYO [see Use in Specific Populations ( 8.1 , 8.3 )]. Advise patients that there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FOUNDAYO during pregnancy [see Use in Specific Populations ( 8.1 )] . Contraception Use of FOUNDAYO may reduce the efficacy of oral hormonal contraceptives.

Advise patients using o…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 07/2026 OFG-0002-MG-20260729 Medication Guide FOUNDAYO™ [fown-DAY-oh] (orforglipron) tablets, for oral use What is the most important information I should know about FOUNDAYO?

FOUNDAYO may cause serious side effects including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

In studies with rodents, medicines that work like FOUNDAYO caused thyroid tumors, including thyroid cancer. It is not known if FOUNDAYO will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not take FOUNDAYO if you or any of your family have ever had a type of thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is FOUNDAYO? FOUNDAYO is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. FOUNDAYO should not be used with other GLP-1 receptor agonist medicines.

It is not known if FOUNDAYO is safe and effective for use in children. Do not use FOUNDAYO if: you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN 2. you have had a serious allergic reaction to orforglipron or any of the ingredients in FOUNDAYO. See the end of this Medication Guide for a complete list of ingredients in FOUNDAYO.

See “What are the possible side effects of FOUNDAYO?” for symptoms of a serious allergic reaction. Before taking FOUNDAYO, tell your healthcare provider about all of your medical conditions, including if you: have or have had problems with your pancreas or kidneys. have severe problems with your liver. have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food. have a history of diabetic retinopathy. are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). are pregnant or plan to become pregnant.

FOUNDAYO may harm your unborn baby. Tell your healthcare provider if you become pregnant while taking FOUNDAYO. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken FOUNDAYO during pregnancy.

The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Birth control pills by mouth may not work as well while taking FOUNDAYO.

If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 30 days after you start FOUNDAYO and for 30 days after each increase in your dose of FOUNDAYO. Talk to your healthcare provider about birth control methods that may be right for you while using FOUNDAYO. are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with FOUNDAYO.

Talk to your healthcare provider about the best way to feed your baby while using FOUNDAYO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FOUNDAYO may affect the way some medicines work, and some medicines may affect the way FOUNDAYO works.

Before using FOUNDAYO, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharm…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.