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 that 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. The FDA has assigned a PDUFA date of July 11, 2026 for the application.
Corcept’s NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. 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, consistent with its known safety profile. Importantly, relacorilant 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.
“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.”
About Relacorilant
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. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism.
https://en.wikipedia.org/wiki/Relacorilant
