Lifyorli (copackaged)

(Relacorilant)

Phase 3Small molecule

Lifyorli (copackaged) is a small molecule that works as a Glucocorticoid Receptor Antagonist.[2] It is being investigated across 5 indications, with its most advanced program in Phase 3.[1]

Lifyorli (copackaged) is one of 131 small molecule programs targeting Cushing syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

130

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cushing SyndromeCompleted

Alcohol DependenceActive, not recruiting

Prostate CancerRecruiting

Ovarian CancerRecruiting

Recurrent or Metastatic Cervical CancerNot yet recruiting

Cushing SyndromePhase 3

Completed

Alcohol DependencePreclinical

Active, not recruiting

Prostate CancerPhase 2

Recruiting

Ovarian CancerPhase 2

Recruiting

Recurrent or Metastatic Cervical CancerPhase 2

Not yet recruiting

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

21 2

Yervoy

Bristol-Myers Squibb

Phase 3

20 3

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

7 4

Lifyorli (copackaged)

CCorcept Therapeutics

Phase 3

2 5

LHRH Agonist

Roche

Phase 3

10 6

Lutetium Lu-177 PNT2002

JJonsson Comprehensive Cancer Center

Phase 3

4 7

Semaglutide Pen Injector

UUniversitaire Ziekenhuizen KU Leuven

Phase 3

1 8

Rhpsma-7.3 (18f)

BBlue Earth Diagnostics

Phase 3

4 9

Trexall

Jazz Pharmaceuticals

Preclinical

—10

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Cushing Syndrome

NCT03604198

Phase 3Active, not recruiting

Ovarian Neoplasm

NCT05257408

Phase 2Recruiting

Ovarian Cancer

NCT06906341

Q1 2027

Phase 1Active, not recruiting

Prostate Cancer

NCT03674814

Q3 2027

Phase 2Recruiting

Adenocarcinoma

NCT07259317

Q2 2028

Phase 2Recruiting

Prostate Cancer

NCT05726292

Clinical

Trials by Indication[1]

Cushing syndrome2 trials

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

Completed·CCorcept Therapeutics·Phase 3·NCT03697109·152 enrolled

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Active, not recruiting·CCorcept Therapeutics·Phase 2·NCT03604198·125 enrolled

Prostate Cancer2 trials

Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer

Active, not recruiting·UUniversity of Chicago·Phase 1·NCT03674814·35 enrolled

A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer

Recruiting·UUniversity of Chicago·Phase 2·NCT05726292·90 enrolled

Cardiac Repolarization1 trial

T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers

Completed·CCorcept Therapeutics·Phase 1·NCT04795479·36 enrolled

Oral1 trial

A Study to Evaluate the Effect of Food on the Oral Bioavailability of Relacorilant in Healthy Subjects

Completed·CCorcept Therapeutics·Phase 1·NCT06094738·30 enrolled

Nab-paclitaxel1 trial

Study to Evaluate Relacorilant (CORT125134) in Combination With Nab-paclitaxel in Participants With Solid Tumors

Completed·CCorcept Therapeutics·Phase 1/2·NCT02762981·85 enrolled

10 more indications

Adenoma1 trial

A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

Completed·CCorcept Therapeutics·Phase 3·NCT04308590·137 enrolled

Tics1 trial

Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants

Completed·CCorcept Therapeutics·Phase 1·NCT05347979·30 enrolled

Primary Peritoneal Cancer1 trial

Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed·CCorcept Therapeutics·Phase 2·NCT03776812·178 enrolled

Hepatic Impairment1 trial

A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant

Completed·CCorcept Therapeutics·Phase 1·NCT06094725·30 enrolled

Adrenocortical Carcinoma1 trial

Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)

Completed·CCorcept Therapeutics·Phase 1·NCT04373265·15 enrolled

Adenocarcinoma1 trial

A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)

Recruiting·CCorcept Therapeutics·Phase 2·NCT07259317·80 enrolled

Ovarian Neoplasm1 trial

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

Active, not recruiting·CCorcept Therapeutics·Phase 3·NCT05257408·381 enrolled

Recurrent or Metastatic Cervical Cancer1 trial

Second Line Therapy and Beyond With Relacorilant and Nab-Paclitaxel for Cervical Cancer With Loss of Benefit From Immune Checkpoint and Platinum Exposure

Not yet recruiting·AARCAGY/ GINECO GROUP·Phase 2·NCT07763496·63 enrolled

Ovarian Cancer1 trial

An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)

Recruiting·CCorcept Therapeutics·Phase 2·NCT06906341·270 enrolled

Unspecified4 trials

Relacorilant Food Effect Study in Healthy Subjects

Completed·CCorcept Therapeutics·Phase 1·NCT03442621·30 enrolled

A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants

Completed·CCorcept Therapeutics·Phase 1·NCT03540836·30 enrolled

Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites

Completed·CCorcept Therapeutics·Phase 1·NCT03512548·52 enrolled

Show 1 more trial

Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s

Completed·CCorcept Therapeutics·Phase 1·NCT03457597·27 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 25, 2026

LIFYORLI (COPACKAGED)

NDA NDA220641

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Relacorilant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Relacorilant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Relacorilant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220641). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lifyorli (copackaged). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Corcept Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucocorticoid Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCorcept Therapeutics

Patent Landscape[5]

Patent Cliff

May 24, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11576907May 24, 2033

10456392May 24, 2033

9273047May 24, 2033

8859774May 24, 2033

12514849Dec 18, 2039

5 more patents

11925626Dec 18, 2039

11464764Apr 14, 2040

11285145May 26, 2041

12589094May 26, 2041

12152028Dec 22, 2041

Lifyorli (copackaged)

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q2 2028

Trials by Indication[1]

Cushing syndrome2 trials

Prostate Cancer2 trials

Cardiac Repolarization1 trial

Oral1 trial

Nab-paclitaxel1 trial

Adenoma1 trial

Tics1 trial

Primary Peritoneal Cancer1 trial

Hepatic Impairment1 trial

Adrenocortical Carcinoma1 trial

Adenocarcinoma1 trial

Ovarian Neoplasm1 trial

Recurrent or Metastatic Cervical Cancer1 trial

Ovarian Cancer1 trial

Unspecified4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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