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PALSONIFY PALTUSOTINE 20 mg Tablet, Film Coated, 60-count

by Crinetics Pharmaceuticals, Inc. · 60 TABLET, FILM COATED in 1 BOTTLE (84015-920-60)
NDC 84015-0920-60
🏷️ FDA NDC (as labeled) 84015-920-60 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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) 84015-920-60
Product NDC 84015-920
11-digit billing NDC 84015092060
NCPDP billing unit EA — each (per item)
RxCUI 2724403, 2724409, 2724411, 2724413
UNII FZT5Z83JNS
UPC 0312345678906
Application # NDA219070
SPL Set ID 8a6d2ce0-a621-4ee7-983c-977cd948ff4d
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-25
Route ORAL
Dosage form TABLET, FILM COATED
Substance PALTUSOTINE HYDROCHLORIDE
GPI-14 30170073100320
GCN Seq No 088280
GCN 58389
HICL code 050910
Ingredient (HICL) Paltusotine Hcl
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1B
Therapeutic class — specific (HIC3) Somatostatic Agents
AHFS code 68:29.04.00
AHFS class Somatostatin Agonists
FDB label name PALSONIFY 20 MG TABLET
FDB brand name Palsonify
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 84015-920-60 — a 5-3-2 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 product segment → 84015-0920-60. 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.

🏷️ RxNorm drug class

This medicine belongs to the Somatostatin and analogues class.

Drug family (ATC) Somatostatin and analogues
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCrinetics Pharmaceuticals, Inc.
Application holderCRINETICS PHARMACEUTICALS INC
FDA applicationNDA219070 (NDA)
Labeler code84015
First marketedSep 2025
Product typeHuman Prescription Drug
Portfolio2 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 PALSONIFY 20 MG TABLET Ingredient Paltusotine Hcl
📖 What it is MedlinePlus · NLM

Paltusotine is used to treat certain patients with acromegaly (rare condition that causes bones, organs and tissues to grow bigger). Paltusotine is in a class of medications called somatostatin receptor agonists. It works by stopping the production of growth hormone that causes the bones and tissues to grow bigger.

Read the full MedlinePlus article ↗

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.

🧪 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026 $384.37 $23,062.36 / 60 tablets
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
Palsonify 20 mgthis 84015-0920-60 Crinetics 60 tablets — — FDA listed —
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

🏛️
2025
First FDA approval
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2044
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 Mar 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 25, 2025 RLD RS ⏳ ~17.5 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 12208092 — method of use (U-4282)
US 12208092 — method of use (U-4282)
US 11957674 — method of use (U-4283)
US 11957674 — method of use (U-4283)
US 11414397 — drug substance (U-4283)
US 11414397 — drug substance (U-4283)
US 11266641 — method of use (U-4283)
US 11266641 — method of use (U-4283)
US 10875839 — method of use (U-4283)
US 10875839 — method of use (U-4283)
US 10597377 — drug substance (U-4283)
US 10597377 — drug substance (U-4283)
US 10351547 — drug substance (U-4283)
US 10351547 — drug substance (U-4283)
US 9896432 — drug substance (U-4283)
US 9896432 — drug substance (U-4283)
US 10464918 — drug substance
US 10464918 — drug substance
Exclusivity NCE
Exclusivity ODE-537
Exclusivity NCE
Exclusivity ODE-537
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (18)
PatentTypeUse codeExpires
US 12208092 ↗ Method of use U-4282 Mar 25, 2044
US 12208092 ↗ Method of use U-4282 Mar 25, 2044
US 11957674 ↗ Method of use U-4283 Sep 7, 2041
US 11957674 ↗ Method of use U-4283 Sep 7, 2041
US 11414397 ↗ Drug substance U-4283 Jul 12, 2037
US 11414397 ↗ Drug substance U-4283 Jul 12, 2037
US 11266641 ↗ Method of use U-4283 Sep 7, 2041
US 11266641 ↗ Method of use U-4283 Sep 7, 2041
US 10875839 ↗ Method of use U-4283 Jul 12, 2037
US 10875839 ↗ Method of use U-4283 Jul 12, 2037
US 10597377 ↗ Drug substance U-4283 Jul 12, 2037
US 10597377 ↗ Drug substance U-4283 Jul 12, 2037
US 10351547 ↗ Drug substance U-4283 Jul 12, 2037
US 10351547 ↗ Drug substance U-4283 Jul 12, 2037
US 9896432 ↗ Drug substance U-4283 Jul 12, 2037
US 9896432 ↗ Drug substance U-4283 Jul 12, 2037
US 10464918 ↗ Drug substance — Jan 16, 2039
US 10464918 ↗ Drug substance — Jan 16, 2039
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Sep 25, 2030
ODE-537Orphan Drug Exclusivity (7-year)Sep 25, 2032
NCENew Chemical Entity (5-year)Sep 25, 2030
ODE-537Orphan Drug Exclusivity (7-year)Sep 25, 2032
Common questions
Is there a generic version of PALSONIFY 20 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for PALSONIFY 20 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2044 — 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Palsonify — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Palsonify. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.8M
Claims incl. refills
161
Beneficiaries
83
Spend / beneficiary
$45,731.42
Spend / claim
$23,575.82
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 PALSONIFY (this brand).

Top reported reactions

Diarrhoea50
Fatigue26
Abdominal Discomfort23
Nausea23
Arthralgia19
Headache18
Abdominal Pain16

Reporter sex

223 reports
Male · 17%
Female · 83%

Serious outcomes

Hospitalization13
Reports over time (by year) — tap or hover for the count & year
2025 2026 221 2
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
84015-0920-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE (84015-920-60) 2025-09-25 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 84015-920-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84015-0920-60, written without dashes as 84015092060. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 84015-0920-60, the first segment (84015) is the labeler code FDA assigned to Crinetics Pharmaceuticals, Inc.; the middle segment (0920) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Crinetics Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Crinetics Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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.
🎯 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 📋 Description 💬 Information for Patients
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE PALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option ( 1 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Take orally once daily with water on an empty stomach (at least 6 hours after a meal) and at least 1 hour before the next meal ( 2.1 ). Recommended initial dosage is 40 mg once daily. During initiation, PALSONIFY may be temporarily reduced to 20 mg once daily if needed, based on tolerability.

Once adverse reactions have resolved, resume PALSONIFY 40 mg once daily ( 2.2 ). After 2 to 4 weeks, based on IGF-1 levels, titrate to 60 mg once daily ( 2.2 ).

2.1Important Administration Instructions Take PALSONIFY orally once daily with water on an empty stomach, at least 6 hours after a meal (e.g., after overnight fasting) and at least 1 hour before the next meal [see Clinical Pharmacology ( 12.3 )] .

2.2Recommended Dosage, Titration, and Monitoring The recommended initial dosage of PALSONIFY is 40 mg once daily. During initiation period, PALSONIFY may be temporarily reduced to 20 mg once daily if needed, based on tolerability [see Adverse Reactions ( 6.1 )] . Once adverse reactions have resolved, resume PALSONIFY 40 mg once daily.

After 2 to 4 weeks on PALSONIFY 40 mg once daily, based on IGF-1 levels, titrate to a PALSONIFY dosage of 60 mg once daily.

2.3Dosage Modifications for Drug Interactions Concomitant Use with Strong CYP3A4 Inducers Patients taking strong CYP3A4 inducers may require an increased dosage of PALSONIFY. Do not exceed three-fold the PALSONIFY dosage prior to concomitant use or 120 mg daily, whichever is less [see Drug Interactions ( 7.1 )] . Concomitant Use with Moderate CYP3A4 Inducers Patients taking moderate CYP3A4 inducers may require an increased dosage of PALSONIFY.

Do not exceed two-fold the PALSONIFY dosage prior to concomitant use or 120 mg daily, whichever is less [see Drug Interactions ( 7.1 )] . Concomitant Use with Proton Pump Inhibitors Patients taking proton pump inhibitors may require an increased dosage of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients who are already on PALSONIFY 60 mg [see Drug Interactions ( 7.1 )] .

💊 Dosage Forms and Strengths 63 words ▾

3 DOSAGE FORMS AND STRENGTHS PALSONIFY Tablets: 20 mg: pink, biconvex oval tablets, debossed with “PAL” on one side and “20” on the other side; contains 20 mg paltusotine free base. 30 mg: yellow, biconvex oval tablets, debossed with “PAL” on one side and “30” on the other side; contains 30 mg paltusotine free base. Tablets: 20 mg, 30 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Cholelithiasis and its Complications: Monitor periodically. If complications of cholelithiasis occur, discontinue PALSONIFY and treat appropriately ( 5.1 ). Hyperglycemia and Hypoglycemia: Monitor glucose and adjust antidiabetic treatment as needed ( 5.2 ).

Cardiovascular Abnormalities: Bradycardia or conduction abnormalities may occur. Dosage adjustments of concomitantly used drugs with bradycardia effects may be necessary ( 5.3 ). Thyroid Function Abnormalities: Hypothyroidism may occur.

Assess thyroid function periodically ( 5.4 ). Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency ( 5.5 ).

Vitamin B 12 Deficiency: Monitor vitamin B 12 levels during treatment if indicated ( 5.6 ).

5.1Cholelithiasis and its Complications PALSONIFY may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder stones or sludge. Cholelithiasis was reported in participants treated with PALSONIFY in clinical trials. Complications of cholelithiasis, such as acute cholecystitis and pancreatitis, have also been reported with the use of PALSONIFY [see Adverse Reactions ( 6.1 )] .

Monitor patients periodically. If complications of cholelithiasis occur, discontinue PALSONIFY and treat appropriately.

5.2Hyperglycemia and Hypoglycemia PALSONIFY may alter the balance between the counter-regulatory hormones, insulin, glucagon, and growth hormone, which may result in hypoglycemia, hyperglycemia, or diabetes mellitus. Hyperglycemia was reported in participants treated with PALSONIFY in clinical trials [see Adverse Reactions ( 6.1 )] . Monitor blood glucose levels when PALSONIFY treatment is initiated or when the dose is altered.

Adjust antidiabetic treatment accordingly.

5.3Cardiovascular Abnormalities Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation have occurred during treatment with PALSONIFY. Bradycardia, sinus arrest, and atrioventricular block were reported in participants treated with PALSONIFY in clinical trials [see Adverse Reactions ( 6.1 )] . These ECG changes may occur in patients with acromegaly.

Dosage adjustments of concomitantly used drugs that have bradycardia effects (e.g., beta-blockers) may be necessary.

5.4Thyroid Function Abnormalities Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function (TSH, total, and/or free T 4 ) is recommended during treatment with PALSONIFY.

5.5Steatorrhea and Malabsorption of Dietary Fats New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new occurrence or worsening of these symptoms are reported in patients receiving PALSONIFY, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

5.6Vitamin B 12 Deficiency Decreased vitamin B 12 levels have been observed in patients treated with somatostatin analogs, including PALSONIFY. Monitor vitamin B 12 levels during treatment with PALSONIFY if clinically indicated.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions ( 5.5 )] Changes in Vitamin B 12 Levels [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Crinetics Pharmaceuticals, Inc. at toll-free phone 1-833-CRN-INFO 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 PALSONIFY was evaluated in adults with acromegaly in two randomized, double-blind, placebo-controlled Phase 3 studies. Study 1 was a 24-week, randomized, placebo-controlled study in 111 adults who were naive or previously treated on a somatostatin analog and biochemically uncontrolled at randomization.

Participants in Study 1 had a mean age of 47 years (range: 18 to 80 years) and were randomized to PALSONIFY (n=54) or placebo (n=57) [see Clinical Studies ( 14.1 )] . Study 2 was a 36-week, randomized, placebo-controlled study in 58 adults who were biochemically controlled on injectable depot formulations of octreotide or lanreotide. Participants in Study 2 had a mean age of 55 years (range: 29 to 84 years) and were randomized to PALSONIFY (n=30) or placebo (n=28) [see Clinical Studies ( 14.2 )] .

Adverse Reactions Adverse reactions that occurred in ≥5% of PALSONIFY-treated participants and 5% greater incidence than placebo in the randomized-controlled phase of Study 1 and Study 2 are presented in Table 1 and Table 2 , respectively. Adverse reactions presented in Table 1 and Table 2 exclude events which occurred after a participant received rescue therapy (Study 1 PALSONIFY n=1, placebo n=13; Study 2 PALSONIFY n=1, placebo n=17). Table 1.

Adverse Reactions Occurring in ≥5% of PALSONIFY-Treated Participants and 5% Greater Incidence than Placebo-Treated Participants During the Randomized Controlled Period of Study 1 a Abdominal pain also includes abdominal discomfort. b Hyperglycemia also includes impaired fasting glucose and diabetes mellitus. Adverse Reaction PALSONIFY N=54 n (%) Placebo N=57 n (%) Diarrhea 18 (33) 8 (14) Abdominal pain a 10 (19) 3 (5) Nausea 5 (9) 1 (2) Sinus bradycardia 4 (7) 0 Hyperglycemia b 4 (7) 1 (2) Table 2. Adverse Reactions Occurring in ≥5% of PALSONIFY-Treated Participants and 5% Greater Incidence than Placebo-Treated Participants During the Randomized Controlled Period of Study 2 a Decreased appetite also includes early satiety.

Adverse Reaction PALSONIFY N=30 n (%) Placebo N=28 n (%) Diarrhea 7 (23) 3 (11) Nausea 4 (13) 1 (4) Decreased appetite a 3 (10) 0 Palpitations 2 (7) 0 Gastroenteritis 2 (7) 0 Gastrointestinal Gastrointestinal adverse reactions, including diarrhea, nausea, and abdominal pain were reported in participants from Studies 1 and 2 (see Table 1 and Table 2 ). Most gastrointestinal adverse reactions occurred within the first two months of PALSONIFY treatment initiation and had a median duration ranging between 6 to 18 days. Other Adverse Reactions from Studies 1 and 2 Cholelithiasis and its Complications Cholelithiasis and its complications were reported in 10/173 (6%) participants during Studies 1 and 2 as follows: cholelithiasis (n=8), acute cholecystitis, biliary colic, and bile duct stone (on…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inducers: may decrease paltusotine exposure. May require PALSONIFY dosage increase ( 2.3 , 7.1 ). Moderate CYP3A4 Inducers: may decrease paltusotine exposure. May require PALSONIFY dosage increase ( 2.3 , 7.1 ). Proton Pump Inhibitors: may decrease paltusotine exposure. May require PALSONIFY dosage increase ( 2.3 , 7.1 ) Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment ( 7.2 ).

7.1Effect of Other Drugs on PALSONIFY Table 3. Clinically Significant Interactions Affecting PALSONIFY Strong CYP3A4 Inducers Intervention Concomitant use of PALSONIFY with strong CYP3A4 inducers may require an increased dosage of PALSONIFY, not to exceed three-fold the dose prior to concomitant use or 120 mg daily, whichever is less. Clinical Impact Concomitant use of PALSONIFY with strong CYP3A4 inducers reduced paltusotine exposure and may affect therapeutic response [see Clinical Pharmacology ( 12.3 )].

Moderate CYP3A4 Inducers Intervention Concomitant use of PALSONIFY with moderate CYP3A4 inducers may require an increased dosage of PALSONIFY, not to exceed two-fold the dose prior to concomitant use or 120 mg daily, whichever is less. Clinical Impact Concomitant use of PALSONIFY with moderate CYP3A4 inducers resulted in a decrease in paltusotine exposure [see Clinical Pharmacology ( 12.3 )]. Proton Pump Inhibitors Intervention Concomitant use of PALSONIFY with PPIs may require an increased dosage of PALSONIFY.

Patients who are already on PALSONIFY 60 mg should avoid concomitant use with proton pump inhibitors. Clinical Impact Concomitant use of PALSONIFY with proton pump inhibitors demonstrated a dose-dependent decrease in paltusotine exposure [see Clinical Pharmacology ( 12.3 )].

7.2Effect of PALSONIFY on Other Drugs Table 4. Clinically Significant Interactions Affecting Other Drugs Cyclosporine Intervention Adjustment of cyclosporine dose to maintain therapeutic levels may be necessary. Follow recommended therapeutic drug monitoring for cyclosporine. Clinical Impact Concomitant use of PALSONIFY with cyclosporine resulted in a decrease in cyclosporine bioavailability [see Clinical Pharmacology ( 12.3 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The available data with PALSONIFY use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no malformations were observed with oral administration of paltusotine to pregnant rats and rabbits during organogenesis at exposures 11 and 3 times the human exposure at the maximum recommended human dose (MRHD) of 60 mg once daily, respectively (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats, paltusotine was administered orally at 25, 75, and 500 mg/kg/day during the period of organogenesis from gestation Day 7 to 17.

The NOAEL for maternal and embryo-fetal developmental toxicity was 500 mg/kg/day, as no paltusotine-related effects were observed on any ovarian, uterine or litter parameters (approximately 11 times the MRHD based on AUC). In an embryo-fetal development study in pregnant rabbits, paltusotine was administered orally at 10, 25, and 75 mg/kg/day during the period of organogenesis from gestation Day 7 to 19. Maternal findings included an increased incidence of spontaneous abortions at 75 mg/kg/day, with decreased body weight gain, body weights, and food consumption.

No fetal abnormalities were observed at any dose. Lower fetal body weight was noted at 75 mg/kg/day. The NOAEL for maternal and embryo-fetal developmental toxicity was 25 mg/kg/day (approximately 3 times the MRHD based on AUC).

In a pre- and postnatal development study, pregnant rats were given paltusotine orally at the doses of 25, 75, and 500 mg/kg/day from gestation Day 6 to lactation Day 20. Paltusotine had no effect on the growth and development of offspring up to the highest tested dose of 500 mg/kg (5 times MRHD based on AUC). In a single dose pharmacokinetic study, oral administration of paltusotine at 25 mg/kg or 500 mg/kg paltusotine to pregnant rats showed measurable paltusotine concentrations in embryos and fetuses, demonstrating placental transfer.

Overall, the embryo and fetal concentrations were generally low when compared to maternal concentrations.

8.2Lactation Risk Summary There is no information available on the presence of paltusotine in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Paltusotine is present in animal milk (see Data ). When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PALSONIFY and any potential adverse effects on the breastfed infant from PALSONIFY or from the underlying maternal condition. Data Paltusotine concentrations were elevated 2.4- to 3.8-fold in rat milk compared to plasma during animal studies. Paltusotine concentrations in plasma and maternal milk suggest that rat pups were likely exposed in utero and/or via lactational transfer.

The concentration of paltusotine in animal milk does not necessarily predict the concentration of paltusotine in human milk.

8.4Pediatric Use The safety and efficacy of PALSONIFY have not been established in pediatric patients.

8.5Geriatric Use In the Phase 3 studies 17/84 (20.2%) PALSONIFY-treated participants were ≥65 years of age. No overall differences in safety or effectiveness of PALSONIFY have been observed between participants 65 years of age and older and younger adult participants. No dose adjustments are required based on age [see Clinical Pharmacology ( 12.3 )] .

8.6 Hepatic Impairm…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The available data with PALSONIFY use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no malformations were observed with oral administration of paltusotine to pregnant rats and rabbits during organogenesis at exposures 11 and 3 times the human exposure at the maximum recommended human dose (MRHD) of 60 mg once daily, respectively (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats, paltusotine was administered orally at 25, 75, and 500 mg/kg/day during the period of organogenesis from gestation Day 7 to 17.

The NOAEL for maternal and embryo-fetal developmental toxicity was 500 mg/kg/day, as no paltusotine-related effects were observed on any ovarian, uterine or litter parameters (approximately 11 times the MRHD based on AUC). In an embryo-fetal development study in pregnant rabbits, paltusotine was administered orally at 10, 25, and 75 mg/kg/day during the period of organogenesis from gestation Day 7 to 19. Maternal findings included an increased incidence of spontaneous abortions at 75 mg/kg/day, with decreased body weight gain, body weights, and food consumption.

No fetal abnormalities were observed at any dose. Lower fetal body weight was noted at 75 mg/kg/day. The NOAEL for maternal and embryo-fetal developmental toxicity was 25 mg/kg/day (approximately 3 times the MRHD based on AUC).

In a pre- and postnatal development study, pregnant rats were given paltusotine orally at the doses of 25, 75, and 500 mg/kg/day from gestation Day 6 to lactation Day 20. Paltusotine had no effect on the growth and development of offspring up to the highest tested dose of 500 mg/kg (5 times MRHD based on AUC). In a single dose pharmacokinetic study, oral administration of paltusotine at 25 mg/kg or 500 mg/kg paltusotine to pregnant rats showed measurable paltusotine concentrations in embryos and fetuses, demonstrating placental transfer.

Overall, the embryo and fetal concentrations were generally low when compared to maternal concentrations.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and efficacy of PALSONIFY have not been established in pediatric patients.

🧓 Geriatric Use 56 words ▾

8.5Geriatric Use In the Phase 3 studies 17/84 (20.2%) PALSONIFY-treated participants were ≥65 years of age. No overall differences in safety or effectiveness of PALSONIFY have been observed between participants 65 years of age and older and younger adult participants. No dose adjustments are required based on age [see Clinical Pharmacology ( 12.3 )] .

🆘 Overdosage 33 words ▾

10 OVERDOSAGE Overdose with somatostatin analogs may result in hyperglycemia or hypoglycemia, bradycardia, arrhythmia, diarrhea, vomiting, and other gastrointestinal symptoms. If overdose is suspected, initiate supportive treatment as dictated by patient's clinical status.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Similar to the natural hormone somatostatin, paltusotine suppresses growth hormone (GH) and insulin-like growth factor-1 (IGF-1) secretion. Paltusotine exerts its pharmacological activity via selective agonism (>4000-fold) at somatostatin receptor 2 (SSTR2) and exhibits little or no affinity for other SST receptor subtypes. Paltusotine inhibited cyclic adenosine monophosphate accumulation via human SSTR2 activation with an average drug (agonist) concentration that results in half-maximal response (EC 50 ) of 0.25 nM.

12.2Pharmacodynamics In patients with acromegaly, there was a dose-dependent reduction in IGF-1 levels over the therapeutic dose range of 20 to 60 mg. Paltusotine may inhibit gallbladder contractility and decrease bile secretion, which may lead to gallbladder stones or sludge [see Warnings and Precautions ( 5.1 )] . Cardiac Electrophysiology At 4.6 times the maximum recommended dose of PALSONIFY, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics Paltusotine exhibited dose-proportional increases in exposures for doses ranging from 20 mg (lowest approved recommended dosage) to 120 mg (2 times the highest approved recommended dosage) in healthy participants. Apparent dose proportional increase was observed for mean steady-state trough concentrations up to 60 mg once daily in participants with acromegaly. Following once daily administration, paltusotine reaches steady-state exposure within one week.

Absorption Following oral administration of paltusotine, the median time to maximum plasma concentration (t max ) is 1 to 4 hours regardless of post dose fasting duration. Effect of Food Relative to administration in the fasted state, administration of paltusotine with a high-fat meal (800 to 1000 calories, 50% to 60% fat) reduced the AUC by 85% and the C max by 81%. Administration of paltusotine with a low-fat meal (400 to 500 calories, 25% fat) reduced AUC by 72% and the C max by 68%.

Distribution The volume of distribution (V z ) of paltusotine is 220 L. Paltusotine is highly plasma protein bound (99%). Elimination After maximal concentrations were attained, paltusotine concentration declined with apparent terminal half-life (t ½ ) of 28 hours.

Metabolism Paltusotine is metabolized primarily in the liver via glucuronidation and oxidation. In vitro, glucuronidation was the major metabolic pathway and is primarily mediated by UGT1A1 and UGT1A9. Oxidation was a secondary pathway and was primarily catalyzed by CYP3A4/5 with a minor contribution from CYP2D6.

Excretion Following oral administration of radiolabeled paltusotine, fecal excretion was the predominant route of elimination with observed mean recovery of total administered radioactivity being 90% in feces and 3.9% in urine. Unchanged paltusotine was a major component in excreta. Specific Populations Effects of Age, Body Weight, Sex, Race , Renal Function , and UGT1A1 Polymorphism Based on population pharmacokinetics data, no clinically significant difference in the pharmacokinetics of paltusotine was observed based on age (18 to 84 years), body weight (45 to 138 kg), sex, race (White, Asian, Other), renal function (52 to 148 mL/min/1.73 m 2 ; eGFR), or UGT1A1 polymorphism.

Hepatic Impairment Paltusotine AUC did not change in participants with mild hepatic impairment (Child-Pugh A) compared to participants with normal hepatic function. Paltusotine AUC decreased by 25% in moderate (Child-Pugh B) and 10% in severe (Child-Pugh C) hepatic impairment. Drug Interaction Clinical Studies and Model-Informed Approaches Effects of Other Drugs on PALSONIFY Strong CYP3A4 Inducers: Paltusotine C max and AUC decreased by approximately 44% and 70%, respectively, following concomitant administration of carbamazepine (a strong inducer of multiple enzymes and transporters [CYP3A4, UGT1A1, and P-gp]).

Moderate CYP3A4 Inducers: Drugs such as efavirenz are predicted to decrease C max and AUC of paltus…

🧬 Mechanism of Action 73 words ▾

12.1Mechanism of Action Similar to the natural hormone somatostatin, paltusotine suppresses growth hormone (GH) and insulin-like growth factor-1 (IGF-1) secretion. Paltusotine exerts its pharmacological activity via selective agonism (>4000-fold) at somatostatin receptor 2 (SSTR2) and exhibits little or no affinity for other SST receptor subtypes. Paltusotine inhibited cyclic adenosine monophosphate accumulation via human SSTR2 activation with an average drug (agonist) concentration that results in half-maximal response (EC 50 ) of 0.25 nM.

📦 How Supplied / Storage and Handling 120 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied PALSONIFY is provided in two strengths: 20 mg and 30 mg. Table 8. PALSONIFY Configurations and NDC Numbers Strength Tablet Color/Shape Imprint NDC Package Size 20 mg Pink; biconvex oval shape “PAL” on one side; “20” on other side 84015-920-60 Bottle of 60 tablets 30 mg Yellow; biconvex oval shape “PAL” on one side; “30” on other side 84015-930-60 Bottle of 60 tablets Storage and Handling PALSONIFY tablets are packaged in a child-resistant container; keep out of reach of children.

Store tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Excursions permitted 15°C to 30°C (59°F to 86°F). Store and dispense in original container or USP equivalent tight container.

📋 Description 121 words ▾

11 DESCRIPTION PALSONIFY tablets contain paltusotine hydrochloride, a somatostatin receptor agonist. Paltusotine is known chemically as 3-[4-(4-Amino-1-piperidinyl)-3-(3,5-difluorophenyl)-6-quinolinyl]-2-hydroxybenzonitrile hydrochloride. The molecular weight of paltusotine hydrochloride is 492.95 g/mol (C 27 H 22 F 2 N 4 O·HCl).

PALSONIFY tablets for oral administration contain 20 mg of paltusotine (equivalent to 21.6 mg of paltusotine hydrochloride) or 30 mg of paltusotine (equivalent to 32.4 mg of paltusotine hydrochloride). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose. Additionally, the 20 mg tablets contain Opadry pink coating (hypromellose, iron oxide red, iron oxide yellow, titanium dioxide, and triacetin) and the 30 mg tablets contain Opadry yellow coating (hypromellose, iron oxide yellow, titanium dioxide, and triacetin).

Figure

💬 Information for Patients 212 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Cholelithiasis and its Complications Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis, cholangitis, and pancreatitis) [see Warnings and Precautions ( 5.1 )] . Hyperglycemia and Hypoglycemia Advise patients to contact their healthcare provider if they have problems with blood sugar levels, either hyperglycemia or hypoglycemia [see Warnings and Precautions ( 5.2 )] .

Cardiovascular Abnormalities Advise patients to contact their healthcare provider if they notice irregular heartbeat [see Warnings and Precautions ( 5.3 )] . Thyroid Function Abnormalities Advise patients that their thyroid function may be assessed periodically [see Warnings and Precautions ( 5.4 )] . Steatorrhea and Malabsorption of Dietary Fats Advise patients to contact their healthcare provider if they experience new or worsening symptoms of steatorrhea, loose stools, abdominal bloating, weight loss [see Warnings and Precautions ( 5.5 )] .

Vitamin B 12 Deficiency Advise patients that Vitamin B 12 levels may be monitored during treatment [see Warnings and Precautions ( 5.6 )] . PALSONIFY is a trademark of Crinetics Pharmaceuticals, Inc. ©2025 Crinetics Pharmaceuticals, Inc. All rights reserved.

Manufactured for: Crinetics Pharmaceuticals, Inc. San Diego, CA 92121 USA

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84012-0001-01 · Interparfums 84015-0930-60 · Crinetics →
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