Drugs / Relacorilant
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Cushing syndrome 2 milestones | |||||
| Filed | US (FDA) | — | Cushing syndrome | 2026-06-17 | “has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant as a treatment for patients with Cushing’s syndrome.” corcept.com ↗ |
| Rejected (CRL) | US (FDA) | — | Cushing syndrome | — | “Following issuance of its complete response letter, the FDA asked us to conduct additional analyses of our NDA data” corcept.com ↗ |
| Filed progesterone-receptor positive breast cancer 3 milestones | |||||
| Filed | EU (EMA) | — | progesterone-receptor positive breast cancer | 2025-10-14 | “Corcept also recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant...” corcept.com ↗ “Corcept also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.” corcept.com ↗ “Corcept has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.” corcept.com ↗ “Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.” corcept.com ↗ “has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.” corcept.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2025-09-10 | “the U.S. Food and Drug Administration (FDA) has accepted Corcept’s New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer” corcept.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2025-07-14 | “has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant” corcept.com ↗ |
| Rejected malignant secondary hypertension 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | malignant secondary hypertension | 2025-12-31 | “has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.” corcept.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | US (FDA) | LIFYORLI (COPACKAGED) | — | 2026-03-25 | fda.gov ↗ |
| Filed | US (FDA) | — | endogenous hypercortisolism | 2025-03-03 | “today announced that the U.S. Food and Drug Administration (FDA) filed its New Drug Application (NDA) submission for its proprietary, selective cortisol modulator, relacorilant” corcept.com ↗ “Relacorilant for patients with hypercortisolism – U.S. Food and Drug Administration (FDA) accepted NDA for filing” corcept.com ↗ |
| Filed | US (FDA) | — | endogenous hypercortisolism | 2024-12-30 | “has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant” corcept.com ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials · 1 missed | ||||||
| Phase 1 | NCT05347979 | May → Jul 2022 | Cushing syndrome, neoplasm | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04795479 | Jan → May 2021 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04373265 | Sep 2020 → Oct 2023 | adrenal cortex carcinoma | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT06094738 | Sep → Nov 2020 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT06094725 | Jan → Dec 2020 | liver disease, severe congenital | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03674814 | Oct 2018 → Jun 2024 | prostate cancer | University of Chicago | Completed | Missed primary |
| Phase 1 | NCT03540836 | May → Jul 2018 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03512548 | Apr 2018 → Jul 2019 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03457597 | Mar → Apr 2018 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03442621 | Jan → Feb 2018 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT06094790 | May → Nov 2017 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03067376 | Aug → Sep 2016 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT06094712 | Apr 2016 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03508635 | Sep 2014 → Dec 2015 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02762981 | May 2016 → May 2020 | cancer | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT07259317 | Jan 2026 → Sep 2027 expected | pancreatic ductal adenocarcinoma | Corcept Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT06906341 | Apr 2025 → Aug 2026 overdue | endometrial cancer, fallopian tube cancer, ovarian cancer, peritoneal neoplasm | Corcept Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT05726292 | Jan 2025 → Oct 2027 expected | prostate adenocarcinoma | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT03776812 | Apr 2019 → Mar 2021 | fallopian tube carcinoma, ovarian cancer, primary peritoneal carcinoma | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03604198 | May 2018 → Dec 2026 expected | Cushing syndrome | Corcept Therapeutics | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02804750 | Jun 2016 → Sep 2018 | endogenous Cushing syndrome | Corcept Therapeutics | Completed | Met primary |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT05257408 | Jun 2022 → Mar 2025 overdue | fallopian tube cancer, ovarian cancer, peritoneal carcinoma | Corcept Therapeutics | Active not recruiting | Met primary |
| Phase 3 | NCT04308590 | Jul 2020 → Sep 2024 | Cushing syndrome | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT04329949 | Jun 2020 → Aug 2021 | pancreatic ductal adenocarcinoma | Corcept Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT03697109 | Nov 2018 → Apr 2024 | Cushing syndrome | Corcept Therapeutics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Corcept Therapeutics | Regulatory Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant) corcept.com ↗
The CHMP’s positive opinion takes us a big step closer to making the benefits of glucocorticoid receptor antagonism available to patients in the EU. |
| 2026-06-17 | Corcept Therapeutics | Regulatory Corcept Resubmits New Drug Application for Relacorilant as a Treatment for Patients with Cushing’s Syndrome corcept.com ↗
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant as a treatment for patients with Cushing’s syndrome. |
| 2026-05-29 | Corcept Therapeutics | Results Corcept Presents New Data at ASCO 2026: Lifyorli™ Overall Survival Across All Subgroups of Patients with Platinum-Resistant Ovarian Cancer, Including Those with Recent Taxane Exposure corcept.com ↗
The data presented at ASCO 2026 describe the overall survival benefit in patients whose treatment included a taxane-free interval of 6 months or less (HR: 0.60) and in those who received a taxane in their most recent treatment regimen (HR: 0.67). |
| 2026-05-27 | Corcept Therapeutics | Regulatory Corcept to Resubmit its New Drug Application for Relacorilant as a Treatment for Patients with Cushing’s Syndrome corcept.com ↗
today announced it will resubmit its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant as a treatment for patients with Cushing’s syndrome. |
| 2026-04-10 | Corcept Therapeutics | Results Corcept Presents Complete Data from Pivotal ROSELLA Trial in SGO Late-Breaker with Simultaneous Publication in The Lancet: Lifyorli™ (Relacorilant) Plus Nab-Paclitaxel Improves Overall Survival in Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗ |
| 2026-03-25 | Corcept Therapeutics | Regulatory FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗ |
| 2026-03-25 | Corcept Therapeutics | Regulatory (Español) FDA Approves Corcept’s Selective Glucocorticoid Receptor Antagonist Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗
La FDA aprobó Lifyorli™ (relacorilant), el antagonista selectivo del receptor de glucocorticoides de Corcept, en combinación con nab-paclitaxel para el tratamiento de pacientes con cáncer de ovario resistente al platino |
| 2026-01-22 | Corcept Therapeutics | Results Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗
today announced that ROSELLA, the company's pivotal Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, met its overall survival (OS) primary endpoint. |
| 2025-12-31 | Corcept Therapeutics | Regulatory Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism corcept.com ↗ |
| 2025-10-19 | Corcept Therapeutics | Results Corcept Presents ESMO 2025 Late-Breaker: Relacorilant Demonstrates Benefit in Patients with Platinum-Resistant Ovarian Cancer with Prior PARP Inhibitor Treatment corcept.com ↗
The data demonstrated a progression-free survival (PFS) benefit for patients who experienced disease progression while on or after taking a PARP inhibitor (PARPi), a patient population with particularly poor prognosis. |
| 2025-10-14 | Corcept Therapeutics | Regulatory Corcept Submits Marketing Authorization Application to European Medicines Agency for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗ |
| 2025-09-10 | Corcept Therapeutics | Regulatory FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗ |
| 2025-07-14 | Corcept Therapeutics | Regulatory Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗
has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer. |
| 2025-06-02 | Corcept Therapeutics | Results Corcept Presents Pivotal Clinical Data in ASCO Late-Breaker with Simultaneous Publication in The Lancet: Relacorilant Improves Progression-Free and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗
ROSELLA met its primary endpoint of improved progression-free survival as assessed by blinded independent central review (PFS-BICR). |
| 2025-03-31 | Corcept Therapeutics | Results Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer corcept.com ↗
In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). |
| 2025-03-03 | Corcept Therapeutics | Regulatory FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism corcept.com ↗ |
| 2024-12-30 | Corcept Therapeutics | Regulatory Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism corcept.com ↗
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushing’s syndrome). |
| 2024-12-16 | Corcept Therapeutics | Results Corcept’s Phase 3 Long-Term Extension Study of Relacorilant Demonstrated Durable Cardiometabolic Improvements in Patients with Hypercortisolism corcept.com ↗
The results from this study demonstrated that patients treated with relacorilant experienced clinically meaningful and durable cardiometabolic improvements and relacorilant was well-tolerated, with a treatment duration of up to six years. |
| 2024-10-30 | Corcept Therapeutics | Results Corcept Therapeutics Announces Third Quarter Financial Results, Positive Results From Phase 3 GRADIENT Trial in Patients With Cushing’s Syndrome and Provides Corporate Update corcept.com ↗
During the study, 5 patients who received placebo compared to 1 patient who received relacorilant required rescue therapy with anti-hypertension medications. |
| 2024-05-28 | Corcept Therapeutics | Results Corcept Announces Primary Endpoint Met in Pivotal Phase 3 GRACE Trial of Relacorilant in Patients With Hypercortisolism (Cushing’s Syndrome) corcept.com ↗ |
| 2024-04-22 | Corcept Therapeutics | Results Corcept Announces Positive Results From Open-Label Portion of Pivotal Phase 3 GRACE Trial in Patients With Cushing’s Syndrome corcept.com ↗
Patients in the open-label phase exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia and other key secondary and exploratory endpoints. |
| 2023-06-27 | Corcept Therapeutics | Results Journal of Clinical Oncology Publishes Results of Corcept’s Phase 2 Trial of Relacorilant in Women With Platinum-Resistant Ovarian Cancer corcept.com ↗
Relacorilant plus nab-paclitaxel improved progression-free survival (PFS), duration of response (DoR) and overall survival (OS), without increasing side effects, compared to nab-paclitaxel monotherapy |
| 2022-03-30 | Corcept Therapeutics | Results Relacorilant Plus Nab-Paclitaxel Extends Survival in Women with Recurrent, Platinum-resistant Ovarian Cancer corcept.com ↗
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial stage company engaged in the discovery, development and sale of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the hormone cortisol, today announced overall survival (“OS”) data from its 178-patient, randomized, controlled, Phase 2 study of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. |
| 2021-09-17 | Corcept Therapeutics | Results Positive Results Presented at ESMO 2021 From Randomized, Controlled, Phase 2 Trial of Relacorilant in Patients with Recurrent Platinum-Resistant Ovarian Cancer corcept.com ↗
The results presented at ESMO today clearly demonstrate the benefit experienced by the women who received relacorilant – delayed disease progression without increased side effect burden. |
| 2021-06-22 | Corcept Therapeutics | Results Preliminary Results From RELIANT Trial of Relacorilant Plus Nab-Paclitaxel in Patients with Metastatic Pancreatic Cancer corcept.com ↗
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced preliminary results from its Phase 3 RELIANT trial of relacorilant combined with nab-paclitaxel in patients with metastatic pancreatic cancer. |
| 2021-05-06 | Corcept Therapeutics | Results Corcept Therapeutics Provides Clinical Update and Announces First Quarter 2021 Financial Results corcept.com ↗
In a 178-patient, controlled, Phase 2 trial, women with platinum-resistant ovarian cancer who received relacorilant plus nab-paclitaxel experienced improved progression free survival (PFS) compared to women who received nab-paclitaxel alone, with comparable safety and tolerability |
| 2021-05-06 | Corcept Therapeutics | Results Addition of Relacorilant to Nab-Paclitaxel Improves Progression Free Survival (PFS) in Controlled, Phase 2 trial of 178 Patients with Platinum Resistant Ovarian Cancer corcept.com ↗
today announced positive results from its 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer. |
| 2019-05-02 | Corcept Therapeutics | Regulatory European Medicines Agency Recommends Orphan Drug Designation for Relacorilant to Treat Patients with Cushing’s Syndrome corcept.com ↗ |
| 2019-03-20 | Corcept Therapeutics | Results Corcept Therapeutics Announces Poster Presentations at the 2019 Annual Meeting of the Endocrine Society Meeting corcept.com ↗
Tumor Shrinkage with Preoperative Relacorilant Therapy in Two Patients with Cushing Disease Due to Pituitary Macroadenomas |
| 2019-02-25 | Corcept Therapeutics | Results Corcept Therapeutics Announces Fourth Quarter And Full-Year 2018 Audited Financial Results And Provides Update corcept.com ↗
Fifty percent of patients with hyperglycemia achieved improved glucose control, as shown by (i) a 0.5 percent or greater reduction in HbA1c |
| 2018-10-01 | Corcept Therapeutics | Regulatory Corcept Therapeutics Receives Orphan Designation for Relacorilant as Treatment for Pancreatic Cancer corcept.com ↗
today announced that the Food and Drug Administration (FDA) has granted orphan drug status to Corcept’s selective cortisol modulator relacorilant to treat patients with pancreatic cancer. |
| 2018-08-09 | Corcept Therapeutics | Results Corcept Therapeutics Announces Second Quarter 2018 Financial Results and Stock Repurchase Program; Provides Clinical Update corcept.com ↗
Applying these endpoints to the High-Dose cohort at eight weeks of treatment (conclusion of the 300 mg dose level) produces the following results: |
| 2018-06-04 | Corcept Therapeutics | Results Corcept Therapeutics Announces Positive Relacorilant Data at the 2018 American Society of Clinical Oncology Meeting corcept.com ↗
Nonetheless, of the patients who received at least 100 mg of relacorilant and 80 mg/m2 of nab-paclitaxel, four of nine with pancreatic cancer exhibited durable disease control, as did four of seven with ovarian cancer. |
| 2018-02-22 | Corcept Therapeutics | Results Corcept Therapeutics Announces 2017 Financial Results and Positive Interim Results of Relacorilant Phase 2 Trial corcept.com ↗
Statistically significant, dose-dependent improvements in glucose tolerance and serum osteocalcin (a marker of bone growth suppressed by excess cortisol activity) |
| 2016-04-28 | Corcept Therapeutics | Results Promising Pre-Clinical and Phase 1 Data Support Advance of Selective Cortisol Modulator CORT125134 as Potential Treatment for Cushing’s Syndrome and Solid-Tumor Cancers corcept.com ↗
With respect to all parameters, CORT125134 was as potent a modulator of prednisone’s activity as Korlym (see Figure 1; p value < 0.0003). |
All press releases naming this drug 50 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Relacorilant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06094738 ↗ |
| Known as | CORT125134 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06094712 ↗ |
| Action | Inhibit | “a novel glucocorticoid receptor (GR) antagonist” NCT02762981 ↗1“Glucocorticoid receptor antagonist” CHEMBL4068611 ↗ |
| Modality | Small molecule | “Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR).” NCT03776812 ↗ |
| Route | Oral | “oral relacorilant lead-in once-daily” NCT02762981 ↗ |
| Target | NR3C1 | “Glucocorticoid receptor antagonist” CHEMBL4068611 ↗ |