Relacorilant is marketed as Lifyorli and was FDA approved on March 25, 2026 in combination with nab-paclitaxel for certain platinum-resistant ovarian cancers. It is described as a selective glucocorticoid receptor antagonist that enhances chemotherapy sensitivity by blocking cortisol signaling at the glucocorticoid receptor. The approved use is for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after prior systemic therapy including bevacizumab.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
A securities class action alleges Corcept misled investors about the regulatory prospects for relacorilant. The suit cites an FDA Complete Response Letter, a 50.4% stock drop, and an April 21, 2026 lead plaintiff deadline.
The FDA has approved Lifyorli (relacorilant) plus nab-paclitaxel for platinum-resistant ovarian cancer based on trial data showing improved survival. Separately, the agency granted Breakthrough Therapy designation to Lilly's sofetabart mipitecan for the same condition, expediting development of the antibody-drug conjugate.
Corcept Therapeutics received an FDA Complete Response Letter denying approval of relacorilant for hypertension secondary to hypercortisolism, triggering a 44.76% stock decline and multiple securities class actions.
The FDA issued a Complete Response Letter for Corcept's relacorilant as a treatment for hypertension secondary to hypercortisolism, requesting additional evidence of effectiveness despite acknowledging positive trial results.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06094725 |
A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant |
COMPLETED | PHASE1 |
| NCT05726292 |
A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer |
RECRUITING | PHASE2 |
| NCT05347979 |
Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants |
COMPLETED | PHASE1 |
| NCT04795479 |
T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers |
COMPLETED | PHASE1 |
| NCT04373265 |
Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol) |
COMPLETED | PHASE1 |
| NCT04308590 |
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas |
COMPLETED | PHASE3 |
| NCT03776812 |
Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
COMPLETED | PHASE2 |
| NCT03697109 |
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome |
COMPLETED | PHASE3 |
| NCT03674814 |
Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer |
COMPLETED | PHASE1 |
| NCT03604198 |
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome |
ACTIVE_NOT_RECRUITING | PHASE2 |
