Corcept Therapeutics' Relacorilant NDA for Ovarian Cancer Accepted by FDA

Corcept Therapeutics announced that the FDA has accepted the new drug application (NDA) for its lead pipeline candidate, relacorilant, for treating platinum-resistant ovarian cancer. The FDA is expected to make a decision on July 11, 2026. The NDA was based on positive data from the ROSELLA study and phase II studies, which evaluated relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer.

Redwood City, Calif. — Corcept Therapeutics Incorporated (NASDAQ: CORT) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 for the application FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[1].

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body's other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. The NDA is based on positive data from the pivotal Phase 3 ROSELLA and Phase 2 trials, which evaluated relacorilant in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[2].

In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated and conferred its benefit without increasing the safety burden of the patients who received it. The type, frequency, and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[1].

"The FDA's acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated" FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[1].

Corcept Therapeutics, established in 1997, has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders. The company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. In February 2012, Corcept introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[2].

Platinum-resistant ovarian cancer is a significant health challenge, with a median overall survival of approximately 12 months following recurrence. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[2].

The FDA's decision is expected on July 11, 2026, and if approved, relacorilant could provide a new treatment option for patients with platinum-resistant ovarian cancer. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS, and liver disease FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[2].

Forward-looking statements in this press release include statements concerning: relacorilant’s potential to receive regulatory approval as a treatment for patients with platinum-resistant ovarian cancer; the timing of FDA review, including the FDA-assigned PDUFA date; and relacorilant’s potential to redefine how platinum-resistant ovarian cancer is treated. Corcept disclaims any intention or duty to update forward-looking statements made in this press release FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[1].

References:
FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[1] FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer. (2025, September 10). Morningstar. Retrieved from https://www.morningstar.com/news/business-wire/20250910770269/fda-files-corcepts-new-drug-application-for-relacorilant-as-a-treatment-for-patients-with-platinum-resistant-ovarian-cancer
FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer^[2] FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer. (2025, September 10). Biospace. Retrieved from https://www.biospace.com/press-releases/fda-files-corcepts-new-drug-application-for-relacorilant-as-a-treatment-for-patients-with-platinum-resistant-ovarian-cancer