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Lifyorli Relacorilant Kit — NDC 76346-0550-03 package photo

Lifyorli Relacorilant Kit

by Corcept Therapeutics Incorporated · 1 BLISTER PACK in 1 CARTON (76346-550-03) / 1 KIT in 1 BLISTER PACK (76346-550-33) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-025-01) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-100-01)
NDC 76346-0550-03
🏷️ FDA NDC (as labeled) 76346-550-03 billing pads the product segment with a zero
This package
Contains1 kit in 1 blister pack * 1 capsule in 1 package, combination * 1 capsule in 1 package, combination Pack sizes2 compare ↓
Also comes in: 1 capsule 76346-0550-09
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) 76346-550-03
Product NDC 76346-550
11-digit billing NDC 76346055003
NCPDP billing unit EA — each (per item)
RxCUI 2739542, 2739548, 2739550, 2739552, 2739553, 2739554, 2739555, 2739556,
Application # NDA220641
SPL Set ID 6fcebfb5-19d6-4f63-b852-999d68a13729
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-25
Route ORAL
Dosage form KIT
GPI-14 2140536500B225
GCN Seq No 088808
GCN 58979
HICL code 051244
Ingredient (HICL) Relacorilant
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V5
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 2)
HIC3 code V5I
Therapeutic class — specific (HIC3) Antineoplastic - Glucocorticoid Receptor Antag.
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name LIFYORLI 150 MG DOSE PACK
FDB brand name Lifyorli
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 76346-550-03 — 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 → 76346-0550-03. 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

LabelerCorcept Therapeutics Incorporated
Application holderCORCEPT THERAPEUTICS INC
FDA applicationNDA220641 (NDA)
Labeler code76346
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio6 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 LIFYORLI 150 MG DOSE PACK Ingredient Relacorilant
📖 What it is MedlinePlus · NLM

Relacorilant is used to treat certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), or primary peritoneal (layer of tissue that lines the abdomen) cancer. Relacorilant is in a class of medications called glucocorticoid receptor antagonists. It works by blocking glucocorticoid receptors, which helps stop the spread and growth of cancer cells.

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.

💊 What it looks like

Color brown / yellow
ShapeCapsule
ImprintCR100
Size2 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 capsule
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
Lifyorlithis 76346-0550-03 Corcept 1 capsule — — FDA listed —
Lifyorli 76346-0425-01 Corcept 1 capsule — — FDA listed —
Lifyorli 76346-0450-01 Corcept 1 capsule — — FDA listed —
Lifyorli 76346-0525-03 Corcept 1 capsule — — 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

🏛️
2026
First FDA approval
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2041
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 Dec 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 25, 2026 RLD RS ⏳ ~15.3 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 11285145 — method of use (U-4458)
US 11285145 — method of use (U-4457)
US 11285145 — method of use (U-4459)
US 10456392 — method of use (U-4457)
US 9273047 — method of use (U-4457)
US 9273047 — method of use (U-4458)
US 9273047 — method of use (U-4459)
US 12589094 — method of use (U-4457)
US 12589094 — method of use (U-4458)
US 12589094 — method of use (U-4459)
US 12152028 — method of use (U-4457)
US 12152028 — method of use (U-4458)
US 12152028 — method of use (U-4459)
US 11576907 — drug substance (U-4458)
US 11576907 — drug substance (U-4457)
US 11576907 — drug substance (U-4459)
US 11464764 — drug product
US 11925626 — drug product
US 8859774 — drug substance
US 12514849 — drug product
Exclusivity NCE
2026 2028 2030 2032 2034 2036 2038 2040 2042
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 (20)
PatentTypeUse codeExpires
US 11285145 ↗ Method of use U-4458 May 26, 2041
US 11285145 ↗ Method of use U-4457 May 26, 2041
US 11285145 ↗ Method of use U-4459 May 26, 2041
US 10456392 ↗ Method of use U-4457 May 24, 2033
US 9273047 ↗ Method of use U-4457 May 24, 2033
US 9273047 ↗ Method of use U-4458 May 24, 2033
US 9273047 ↗ Method of use U-4459 May 24, 2033
US 12589094 ↗ Method of use U-4457 May 26, 2041
US 12589094 ↗ Method of use U-4458 May 26, 2041
US 12589094 ↗ Method of use U-4459 May 26, 2041
US 12152028 ↗ Method of use U-4457 Dec 22, 2041
US 12152028 ↗ Method of use U-4458 Dec 22, 2041
US 12152028 ↗ Method of use U-4459 Dec 22, 2041
US 11576907 ↗ Drug substance U-4458 May 24, 2033
US 11576907 ↗ Drug substance U-4457 May 24, 2033
US 11576907 ↗ Drug substance U-4459 May 24, 2033
US 11464764 ↗ Drug product — Apr 14, 2040
US 11925626 ↗ Drug product — Dec 18, 2039
US 8859774 ↗ Drug substance — May 24, 2033
US 12514849 ↗ Drug product — Dec 18, 2039
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Mar 25, 2031
Common questions
Is there a generic version of LIFYORLI 150 MG DOSE PACK?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LIFYORLI 150 MG DOSE PACK. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2041 — 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 Lifyorli (this brand).

Top reported reactions

Nausea4
Angioedema2
Atrial Fibrillation2
Death2
Dehydration2
Diarrhoea2
Dysarthria2

Age at onset

Adult1

Reporter sex

24 reports
Male · 40%
Female · 60%

Serious outcomes

Hospitalization17
Death2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 21 0
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
76346-0550-03 You're viewing this 1 BLISTER PACK in 1 CARTON (76346-550-03) / 1 KIT in 1 BLISTER PACK (76346-550-33) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-025-01) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-100-01) 2026-03-25 Active
76346-0550-09 3 CARTON in 1 CARTON (76346-550-09) / 1 BLISTER PACK in 1 CARTON (76346-550-03) / 1 KIT in 1 BLISTER PACK (76346-550-33) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-025-01) * 1 CAPSULE in 1 PACKAGE, COMBINATION (76346-100-01) 2026-03-25 Active

Pack size FAQ

What quantity is in NDC 76346-0550-03?
NDC 76346-0550-03 is listed by the FDA — 1 blister pack in 1 carton / 1 kit in 1 blister pack * 1 capsule in 1 package, combination * 1 capsule in 1 package, combination.
What NDC number is used to bill for this package of Lifyorli Relacorilant Kit?
Bill NDC 76346-0550-03 — the 11-digit billing format is 76346055003. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 76346-550-03, 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: 76346-0550-03, written without dashes as 76346055003. 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 76346-0550-03, the first segment (76346) is the labeler code FDA assigned to Corcept Therapeutics Incorporated; the middle segment (0550) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Corcept Therapeutics Incorporated. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 capsule (76346-0550-09). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Corcept Therapeutics Incorporated 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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 98 words ▾

1 INDICATIONS AND USAGE LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.

( 1 , 14 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of LIFYORLI is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion. ( 2 )

2.1Important Dosage and Administration Information LIFYORLI Follow LIFYORLI dosing instructions provided on the blister card. Take LIFYORLI with food. Swallow capsules whole.

Do not crush, chew, dissolve, or split the capsules. If a dose of LIFYORLI is missed by less than 12 hours, take the missed dose. If a dose of LIFYORLI is missed by 12 hours or more, skip the missed dose and take the next dose at the regularly scheduled time.

Do not take 2 doses at the same time to make up for a missed dose. If vomiting occurs after taking LIFYORLI, do not take an additional dose. Nab-Paclitaxel The recommended dosage and dosage modifications for nab-paclitaxel when administered in combination with LIFYORLI differ from those for other nab-paclitaxel indications [see Dosage and Administration ( 2.2 and 2.3 ) and Clinical Studies ( 14 )] .

Do not substitute with other paclitaxel formulations.

2.2Recommended Dosage and Administration The recommended dosage of LIFYORLI is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity. The recommended dosage for nab-paclitaxel is 80 mg/m 2 administered as an intravenous infusion on Days 1, 8 and 15 of each 28-day cycle until disease progression or unacceptable toxicity [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14 )]. Refer to the Prescribing Information for nab-paclitaxel for administration.

2.3Dosage Modifications for Adverse Reactions Dose reduction levels are summarized in Table 1 and Table 2 . Table 1: Recommended Dosage Reductions for Adverse Reactions for Nab-Paclitaxel Dose Reduction Nab-Paclitaxel First 60 mg/m 2 on Days 1, 8 and 15 of each 28-day cycle Second 60 mg/m 2 on Days 1 and 15 of each 28-day cycle Third Permanently discontinue nab-paclitaxel if unable to tolerate after two dose reductions. Table 2: Recommended Dosage Reductions for Adverse Reactions for LIFYORLI Dose Reduction LIFYORLI First 125 mg once the day before, the day of and the day after the nab-paclitaxel infusion Second Permanently discontinue LIFYORLI in patients unable to tolerate after one dose reduction.

The recommended dosage modifications for adverse reactions are provided in Tables 3 and 4 . Interrupt or discontinue LIFYORLI whenever nab-paclitaxel is interrupted or discontinued. Table 3: Dosage Modifications for Hematologic Adverse Reactions Adverse Reaction Severity a Dosage Modification a Unless otherwise specified, Grade per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. b Supportive short acting G-CSF administered 24 hours after nab-paclitaxel for 2 days in accordance with clinical practice. c If the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose.

Neutropenia Day 1 [see Warnings and Precautions ( 5.1 )] ANC 1,000 to < 1,500/mm 3 Nab-paclitaxel: Withhold until ≥ 1,500/mm 3 ; resume at same dose LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes ANC < 1,000/mm 3 Nab-paclitaxel: Withhold until ≥ 1,500/mm 3 ; resume at reduced dose LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes Neutropenia Day 8 or 15 [see Warnings and Precautions ( 5.1 )] ANC < 1,000/mm 3 Nab-paclitaxel: Omit dose; resume at reduced dose or continue at the same dose with short acting G-CSF b,c LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes Febrile neutropenia [see Warnings and Precautions ( 5.1 )] Grade 3 or 4 Nab-paclitaxel: Withhold until fever resolves and ANC ≥ 1,500/mm 3 ; resume at reduced dose c LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes Thrombocytopenia Day 1 [see Adverse Reactions ( 6.1 )] Platelets < 100,000/mm 3 Nab-paclitaxel: Withhold until ≥ 100,000/mm 3 ; resume at the same dose L…

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 25 mg: opaque dark brown, oval soft gelatin capsules with “CR25” printed in black. 100 mg: opaque yellow, oblong soft gelatin capsules with “CR100” printed in black. Capsules: 25 mg, 100 mg ( 3 )

⛔ Contraindications 44 words ▾

4 CONTRAINDICATIONS LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids [see Warnings and Precautions ( 5.3 )] . Concurrent systemic glucocorticoid therapy for a lifesaving indication. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Neutropenia and Severe Infections : Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Withhold, reduce the dose, or permanently discontinue LIFYORLI based on severity. ( 2.3 , 5.1 ) Adrenal insufficiency: Monitor for signs and symptoms of adrenal insufficiency.

( 5.2 ) Exacerbation of Conditions Treated with Glucocorticoids: LIFYORLI makes systemic glucocorticoids less effective in patients who have an ongoing requirement for systemic glucocorticoids. ( 5.3 ) Embryo-Fetal Toxicity : LIFYORLI can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use effective contraception.

( 5.4 )

5.1Neutropenia and Severe Infections LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. In ROSELLA, decreased neutrophil count occurred in 74% of patients treated with LIFYORLI in combination with nab-paclitaxel, 30% Grade 3, 15% Grade 4, and 3.7% febrile neutropenia. The median time to onset of neutropenia was 15 days (range: 8 to 329).

Instances of neutropenia were temporally associated with infection in 16% of patients. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.

Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable [see Dosage and Administration ( 2.3 )] .

Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection [see Warnings and Precautions ( 5.2 )] . Inform patients to promptly report any episodes of fever to their healthcare provider.

5.2Adrenal Insufficiency LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery.

Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Serum cortisol levels do not provide an accurate assessment of adrenal insufficiency in patients receiving LIFYORLI.

Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. When deciding on the duration of glucocorticoid treatment, consider the long half-life of relacorilant (27.5 hours) and that glucocorticoid receptor antagonism may occur for up to 6 days after the last dose of LIFYORLI [see Clinical Pharmacology ( 12.3 )] .

After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity [see Dosage and Administration ( 2.3 )] . Educate patients on the symptoms associated with adrenal insufficiency and advise them to contact a healthcare provider if they occur.

5.3Exacerbation of Conditions Treated with Glucocorticoids Use of LIFYORLI in patients who are taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist which may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective.

Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patie…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Neutropenia and Severe Infections [see Warnings and Precautions ( 5.1 )] . Adrenal Insufficiency [see Warnings and Precautions ( 5.2 )] Exacerbation of Conditions Treated with Glucocorticoids [see Warnings and Precautions ( 5.3 )]. Most common adverse reactions (incidence > 20%), including laboratory abnormalities, that occurred in patients treated with LIFYORLI in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Corcept Therapeutics at 1-855-844-3270 or the 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 LIFYORLI in combination with nab-paclitaxel was evaluated in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in ROSELLA [see Clinical Studies ( 14 )] . Patients received LIFYORLI (150 mg orally on the day before, the day of, and the day after each administration of nab-paclitaxel 80 mg/m 2 intravenous infusion on Days 1, 8 and 15 of each 28-day cycle (n=188) or nab-paclitaxel 100 mg/m 2 intravenous infusion (n=190) until disease progression or unacceptable toxicity.

LIFYORLI dosing was interrupted whenever nab-paclitaxel was interrupted. The median duration of LIFYORLI treatment was 4.7 months (range: 0.2 to 24). Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel.

Serious adverse reactions in ≥2% of patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions occurred in 2.1% of patients who received LIFYORLI in combination with nab-paclitaxel including septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%). Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients.

The adverse reaction which resulted in permanent discontinuation of LIFYORLI in >2% of patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions which required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in ≥5% of patients included neutropenia (44%), anemia (12%), and fatigue (7%).

Dose reductions of LIFYORLI due to an adverse reaction occurred in 7.4% of patients and dose reductions of nab-paclitaxel occurred in 48% of patients. Adverse reactions which required dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). The most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Table 5 and 6 summarize adverse reactions and laboratory abnormalities, respectively, occurring in ≥10% of patients who received LIFYORLI in combination with nab-paclitaxel in ROSELLA. Table 5: Adverse Reactions Occurring in ≥10% of Patients Who Received LIFYORLI in Combination with Nab-Paclitaxel in ROSELLA a Includes multiple related terms Adverse Reaction LIFYORLI + Nab-Paclitaxel (n=188) Nab-Paclitaxel (n=190) All Grades (%) Grades 3 or 4 (%) All Grades (%) Grades 3 or 4 (%) General disorders Fatigue a 54 9 45

1.6Edema a 19 1.1 12

0.5Pyrexia a 14 0.5 9 0 Gastrointestinal disorders Nausea 44 4 35 3 Diarrhea a 40 3.7 27

1.6Stomatitis a 19 3.2 9 1.1…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong CYP3A Inducers : Avoid coadministration with LIFYORLI in combination with nab-paclitaxel. ( 7.1 ) CYP2C8 Inducers and Moderate CYP3A Inducers : Monitor for reduced effectiveness for LIFYORLI in combination with nab-paclitaxel. ( 7.1 ) CYP2C8 Inhibitors : Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended.

( 7.1 ) CYP3A Substrates : Avoid coadministration unless otherwise recommended. ( 7.2 ) Certain CYP2C8 Substrates : Avoid coadministration unless otherwise recommended. ( 7.2 )

7.1Effect of Other Drugs on LIFYORLI in Combination with Nab-Paclitaxel Strong CYP3A Inducers Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness [see Clinical Pharmacology ( 12.3 )] .

CYP2C8 Inducers and Moderate CYP3A Inducers Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 inducers and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.

CYP2C8 Inhibitors Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended [see Dosage and Administration ( 2.3 )] . Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.

7.2Effect of LIFYORLI on Other Drugs CYP3A Substrates Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates [see Clinical Pharmacology ( 12.3 )], which may increase the risk for adverse reactions related to these substrates.

Certain CYP2C8 Substrates Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates [see Clinical Pharmacology ( 12.3 )] , which may decrease the effectiveness related to these substrates.

7.3Potential for Reduced Effectiveness of Glucocorticoids or LIFYORLI with Coadministration LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression in organ transplantation) [see Contraindications ( 4 )]. Avoid coadministration in patients with other medical conditions requiring systemic glucocorticoids when possible. If coadministration cannot be avoided, monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids.

LIFYORLI is a glucocorticoid receptor antagonist, which may make systemic glucocorticoids less effective. Coadministration of systemic glucocorticoids may make LIFYORLI less effective.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 ) Hepatic Impairment : Avoid use in patients with moderate or severe hepatic impairment. ( 8.6 )

8.1Pregnancy Risk Summary LIFYORLI is used in combination with nab-paclitaxel. Refer to the Prescribing Information of nab-paclitaxel for pregnancy information. Based on findings in animals, LIFYORLI can cause fetal harm when administered to a pregnant woman.

There are no available data on relacorilant use in pregnant women to inform drug-associated risk. In animal embryo-fetal development studies, oral administration of relacorilant to pregnant rabbits during the period of organogenesis resulted in embryo-fetal mortality and structural abnormalities at maternal doses of ≥ 10 mg/kg/day (0.6 times the human exposure based on area under the curve (AUC) at the recommended dose). Oral administration of relacorilant to pregnant rats during the period of organogenesis did not result in fetal malformations [see Data ] .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is between 2 to 4% and 15 to 20%, respectively. Data Animal Data Relacorilant is a partial agonist of the glucocorticoid receptor in rats.

In an embryo-fetal development study, relacorilant was administered to pregnant rats at oral doses of 1, 2.5, and 10 mg/kg/day during the period of organogenesis. Maternal toxicity (decreased body weight and food consumption) was observed at a dose of 10 mg/kg/day (3.8 times the human exposure based on AUC at the recommended dose). No developmental toxicity was noted at doses up to 10 mg/kg/day.

In an embryo-fetal development study, relacorilant administered to pregnant rabbits at oral doses of 1, 3, and 10 mg/kg/day during the period of organogenesis resulted in embryo-fetal mortality (increased post-implantation loss, fetal resorptions, and a decrease in litter size) at 10 mg/kg/day (0.6 times the human exposure based on AUC at the recommended dose). Fetal malformations (abnormal flexure of the forepaw, microcephaly, malrotated hindlimbs, absent interparietal bone, and fused sternebra in sternum) were observed at a dose of 10 mg/kg/day (0.6 times the human exposure based on AUC at the recommended dose).

Additional adverse effects included skeletal variations of bipartite interparietal bone of the skull observed at doses ≥ 1 mg/kg/day (lower than the human exposure based on AUC at the recommended dose).

8.2Lactation Risk Summary LIFYORLI is used in combination with nab-paclitaxel. Refer to the Prescribing Information of nab-paclitaxel for lactation information. There are no data on the presence of relacorilant or its metabolites in animal or human milk, the effects on the breastfed child, or the effects on milk production.

Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with LIFYORLI and for one week after the last dose.

8.3Females and Males of Reproductive Potential LIFYORLI is used in combination with nab-paclitaxel. Refer to the Prescribing Information of nab-paclitaxel for contraception and infertility information. LIFYORLI can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] .

Pregnancy Testing Verify pregnancy status in women of reproductive potential prior to initiating LIFYORLI. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose. Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.

8.4Pediatric Use The safety and effectiveness of LIFYORLI in pediatric patients has not been established.

8.5 Geriatric Use Of the 188 patients with…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary LIFYORLI is used in combination with nab-paclitaxel. Refer to the Prescribing Information of nab-paclitaxel for pregnancy information. Based on findings in animals, LIFYORLI can cause fetal harm when administered to a pregnant woman.

There are no available data on relacorilant use in pregnant women to inform drug-associated risk. In animal embryo-fetal development studies, oral administration of relacorilant to pregnant rabbits during the period of organogenesis resulted in embryo-fetal mortality and structural abnormalities at maternal doses of ≥ 10 mg/kg/day (0.6 times the human exposure based on area under the curve (AUC) at the recommended dose). Oral administration of relacorilant to pregnant rats during the period of organogenesis did not result in fetal malformations [see Data ] .

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is between 2 to 4% and 15 to 20%, respectively. Data Animal Data Relacorilant is a partial agonist of the glucocorticoid receptor in rats.

In an embryo-fetal development study, relacorilant was administered to pregnant rats at oral doses of 1, 2.5, and 10 mg/kg/day during the period of organogenesis. Maternal toxicity (decreased body weight and food consumption) was observed at a dose of 10 mg/kg/day (3.8 times the human exposure based on AUC at the recommended dose). No developmental toxicity was noted at doses up to 10 mg/kg/day.

In an embryo-fetal development study, relacorilant administered to pregnant rabbits at oral doses of 1, 3, and 10 mg/kg/day during the period of organogenesis resulted in embryo-fetal mortality (increased post-implantation loss, fetal resorptions, and a decrease in litter size) at 10 mg/kg/day (0.6 times the human exposure based on AUC at the recommended dose). Fetal malformations (abnormal flexure of the forepaw, microcephaly, malrotated hindlimbs, absent interparietal bone, and fused sternebra in sternum) were observed at a dose of 10 mg/kg/day (0.6 times the human exposure based on AUC at the recommended dose).

Additional adverse effects included skeletal variations of bipartite interparietal bone of the skull observed at doses ≥ 1 mg/kg/day (lower than the human exposure based on AUC at the recommended dose).

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of LIFYORLI in pediatric patients has not been established.

🧓 Geriatric Use 69 words ▾

8.5Geriatric Use Of the 188 patients with platinum-resistant epithelial ovarian cancer who received LIFYORLI, 38% were 65 years or older and 9.6% were 75 years or older. A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients 65 years or older when compared to younger adult patients. No overall differences in effectiveness were observed between patients in ≥65 years of age and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Relacorilant is a reversible glucocorticoid receptor (GR) antagonist. In functional in vitro assays with the mineralocorticoid receptor, relacorilant showed no agonist or antagonist activity. In human cell-line derived xenograft models, relacorilant enhanced apoptosis and antitumor activity when administered with paclitaxel.

Cortisol binding to the GR is immunosuppressive, decreasing secretion of pro‑inflammatory cytokines. GR antagonism may indirectly activate the immune system; relacorilant inhibited the cortisol-induced reduction of tumor necrosis factor alpha and interferon gamma in stimulated peripheral blood mononuclear cells.

12.2Pharmacodynamics Exposure-Response Relationships Relacorilant exposure-response relationships and the time course of pharmacodynamic response have not been fully characterized. Cardiac Electrophysiology At 3.8 times the mean maximal relacorilant concentration of the recommended dosage, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics Relacorilant pharmacokinetics were observed in adult patients at the approved recommended dosage and are presented as mean (CV%), unless otherwise specified. Relacorilant maximum concentration (C max ) is 720 (68%) ng/mL and systemic exposure (AUC) is 5,686 (84%) ng*h/mL following the third consecutive daily dose. Absorption Relacorilant median (min, max) time to maximum plasma concentration (T max ) is 2.5 hours (1.2, 5.5).

Effect of Food Relacorilant C max increased 1.7-fold, AUC increased 2-fold, and T max was delayed 0.5 hours following administration with a low-fat meal (approximately 400 to 500 calories, 25% fat content). Relacorilant C max increased 1.9-fold, AUC increased 2.4-fold, and T max was delayed 0.25 hours following administration with a high-fat meal (approximately 800 to 1,000 calories, 50% fat content). Distribution Relacorilant apparent volume of distribution (V z /F) is 2490 (54%) L after a single 150 mg dose under fasted conditions.

Protein binding of relacorilant in human plasma is >99% in vitro . Elimination Relacorilant terminal half-life is 27 (30%) hours with an apparent total clearance of 52 (69%) L/h under fasted conditions. Metabolism Relacorilant is primarily metabolized by cytosolic reductases and CYP3A.

An active metabolite, CORT125295, with functional activity approximately 5-fold lower than relacorilant, represents 75% of the parent AUC. Excretion After a single oral dose of radiolabeled relacorilant 250 mg to healthy participants, about 73% (< 1% unchanged) of the dose was recovered in feces and 17% (< 2% unchanged) in urine. Specific Populations No clinically significant differences in the pharmacokinetics of relacorilant were observed based on age (26 to 85 years), body weight (35 to 128 kg), race (White [81%], Asian [9%]), ethnicity (Non-Hispanic [93%], Hispanic [7%]), CLcr 30 to <90 mL/min, or mild hepatic impairment (total bilirubin > ULN to ≤ 1.5 × ULN or AST > ULN and total bilirubin ≤ ULN).

The effect of CLcr <30 mL/min or end-stage renal disease undergoing hemodialysis or severe hepatic impairment (total bilirubin > 3 to 10 × ULN and any AST) on the pharmacokinetics of relacorilant is unknown. Patients with Hepatic Impairment Relacorilant AUC increased 1.3-fold in participants with moderate hepatic impairment (Child-Pugh Class B). Drug Interaction Studies Clinical Studies Nab-paclitaxel : Dose-normalized paclitaxel (CYP2C8 and CYP3A4 substrate) C max increased 2-fold and dose-normalized AUC increased 1.7-fold following coadministration of nab-paclitaxel with LIFYORLI 150 mg.

No clinically significant differences in the pharmacokinetics of relacorilant were observed when given in combination with nab-paclitaxel. Strong CYP3A Inhibitors : Relacorilant (300 mg once daily for 10 days under fasted conditions) steady state C max increased 1.2-fold and steady state AUC increased 1.5-fold following coadministration of itraconazole (strong…

🧬 Mechanism of Action 83 words ▾

12.1Mechanism of Action Relacorilant is a reversible glucocorticoid receptor (GR) antagonist. In functional in vitro assays with the mineralocorticoid receptor, relacorilant showed no agonist or antagonist activity. In human cell-line derived xenograft models, relacorilant enhanced apoptosis and antitumor activity when administered with paclitaxel.

Cortisol binding to the GR is immunosuppressive, decreasing secretion of pro‑inflammatory cytokines. GR antagonism may indirectly activate the immune system; relacorilant inhibited the cortisol-induced reduction of tumor necrosis factor alpha and interferon gamma in stimulated peripheral blood mononuclear cells.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LIFYORLI is available as soft gelatin capsules containing 25 mg or 100 mg of relacorilant. LIFYORLI 25 mg are opaque dark brown, oval soft gelatin capsules with “CR25” printed in black. LIFYORLI 100 mg are opaque yellow, oblong soft gelatin capsules with “CR100” printed in black.

LIFYORLI capsules are supplied as follows: Dose Each Carton Contains Each Blister Card Contains NDC 150 mg One blister card of 3 capsules. One 100 mg capsule, and Two 25 mg capsules. NDC 76346-450-01 One blister card of 9 capsules.

Three 100 mg capsules, and Six 25 mg capsules. NDC 76346-550-03 Three cartons each containing one blister card of 9 capsules. (27 capsules total).

Three 100 mg capsules, and Six 25 mg capsules. NDC 76346-550-09 125 mg One blister card of 2 capsules. One 100 mg capsule, and One 25 mg capsule.

NDC 76346-425-01 One blister card of 6 capsules. Three 100 mg capsules, and Three 25 mg capsules. NDC 76346-525-03 Three cartons each containing one blister card of 6 capsules.

(18 capsules total). Three 100 mg capsules, and Three 25 mg capsules. NDC 76346-525-09 Storage and Handling Store and dispense LIFYORLI in their original carton.

Store LIFYORLI at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature ].

📦 Storage and Handling 36 words ▾

Storage and Handling Store and dispense LIFYORLI in their original carton. Store LIFYORLI at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature ].

📋 Description 176 words ▾

11 DESCRIPTION LIFYORLI (relacorilant) is a glucocorticoid receptor antagonist antineoplastic agent. Relacorilant chemical names: (R)-(1-(4-fluorophenyl)-6-((1-methyl-1H-pyrazol-4-yl)sulfonyl)-4,4a,5,6,7,8-hexahydro-1H-pyrazolo[3,4-g]isoquinolin-4a-yl)(4-trifluoromethyl)(pyridin-2-yl)methanone [(4a R )-1-(4-fluorophenyl)-6-(1-methyl-1 H -pyrazole-4-sulfonyl)-1,4,5,6,7,8-hexahydro-4a H -pyrazolo[3,4-g]isoquinolin-4a-yl][4-(trifluoromethyl)pyridin-2-yl]methanone The molecular formula is C 27 H 22 F 4 N 6 O 3 S and the molecular weight is 586.57 g/mol.

The chemical structure of relacorilant is: Relacorilant is an off-white to light yellow solid that is practically insoluble in aqueous media. LIFYORLI capsules for oral use are supplied as immediate release, printed, soft gelatin capsules containing 25 mg or 100 mg of relacorilant. Each capsule contains the following excipients: butylated hydroxytoluene, lauroyl polyoxyl-32 glycerides, and propylene glycol caprylate.

The capsule shell for the 25 mg strength contains black iron oxide, gelatin, red iron oxide, sorbitol special glycerin blend, titanium dioxide, and yellow iron oxide. The capsule shell for the 100 mg strength contains gelatin, sorbitol special glycerin blend, titanium dioxide, and yellow iron oxide. The printing ink contains ammonium hydroxide, black iron oxide, ethanol, ethyl acetate, isopropyl alcohol, macrogol/polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, and purified water.

Chemical Structure of Relacorilant

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Patient Information). Neutropenia and Severe Infections Inform patients about the risk of neutropenia and infection. Instruct patients to immediately report any fever or symptoms of infection to their healthcare provider [see Warnings and Precautions ( 5.1 )].

Adrenal Insufficiency Inform patients that LIFYORLI can cause adrenal insufficiency, a potentially life-threatening condition. Advise patients to immediately report signs or symptoms of adrenal insufficiency to their healthcare provider [see Warnings and Precautions ( 5.2 )]. Exacerbation of Conditions Treated with Glucocorticoids Advise patients who require chronic or frequent use of glucocorticoids that glucocorticoids may be less effective and to contact their healthcare provider for any worsening symptoms during concomitant use [see Warnings and Precautions ( 5.3 )] .

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose [see Warnings and Precautions ( 5.4 ) and Use in Specific Population ( 8.1 , 8.3 )]. Lactation Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose [see Use in Specific Populations ( 8.2 )] . Administration Advise patients to follow the LIFYORLI dosing instructions on the blister card.

Advise patients to take LIFYORLI with food, how to make up a missed dose, and to swallow capsules whole and to not crush, chew, dissolve or split the capsules [see Dosage and Administration ( 2.1 , 2.2 )]. Manufactured for: Corcept Therapeutics Incorporated Redwood City, CA 94065 LIFYORLI TM is a trademark of Corcept Therapeutics Incorporated. Copyright 2026 Corcept Therapeutics Incorporated.

All rights reserved. USPI-220641-v01 03/2026

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76346-0525-03 · Corcept 76346-0654-03 · Corcept →
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.