LIFYORLI (COPACKAGED) (relacorilant)
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 ] .
Development Insights
Details
- Status
- Prescription
- First Approved
- 2026-03-25
- PDUFA Date
- 2026-07-11 (46d)
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LIFYORLI (COPACKAGED) Approval History
What LIFYORLI (COPACKAGED) Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2026) NewLetter
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03604198 | CORT125134-452 | Ph 2 | active not recruiting | Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome |
| NCT03674814 | IRB18-0152 P50CA180995 | Ph 1 | completed | Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer |
| NCT05726292 | IRB22-1318 | Ph 2 | recruiting | A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer |
| NCT03776812 results posted | CORT125134-552 | Ph 2 | completed | Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| NCT04308590 GRADIENT results posted | CORT125134-456 | Ph 3 | completed | A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas |
| NCT03697109 GRACE results posted | CORT125134-455 | Ph 3 | completed | A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome |
| NCT04373265 | CORT125134-551 | Ph 1 | completed | Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol) |
| NCT06094725 | CORT125134-128 | Ph 1 | completed | A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant |
| NCT05347979 | CORT125134-132 | Ph 1 | completed | Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-glycoprotein Substrate Dabigatran Etexilate in Healthy Participants |
| NCT04795479 | CORT125134-130 | Ph 1 | completed | T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers |
| NCT03457597 | CORT125134-126 | Ph 1 | completed | Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIFYORLI (COPACKAGED) FDA Label Details
Indications & 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 ] . 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 o...
LIFYORLI (COPACKAGED) Patents & Exclusivity
Patents (10 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LIFYORLI (COPACKAGED)
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 20 active patents
Trial Analysis
- • 11 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment