Relacorilant FDA Approval Status

Last updated by Judith Stewart, BPharm on July 16, 2025.

FDA Approved: No
Generic name: relacorilant
Company: Corcept Therapeutics Incorporated
Treatment for: Cushing's Syndrome, Ovarian Cancer

Relacorilant is a selective cortisol modulator in development for the treatment of patients with endogenous hypercortisolism (Cushing’s syndrome), and for the combination treatment patients with platinum-resistant ovarian cancer.

Hypercortisolism is caused by excessive activity of the hormone cortisol. Cortisol also plays a role in tumor growth through several mechanisms.
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors.
A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for relacorilant to treat patients with endogenous hypercortisolism. The NDA was based on positive results from the pivotal GRACE trial and confirmatory evidence from the Phase 3 GRADIENT and long-term extension studies and a Phase 2 study in hypercortisolism. Patients in these studies who received relacorilant experienced improvements in symptoms with an acceptable safety burden.
An NDA has also been submitted to the FDA for relacorilant to treat patients with platinum-resistant ovarian cancer. The NDA was based based on positive data from the 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. The type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.

Development timeline for relacorilant

Date	Article
Jul 14, 2025	Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer
Mar 3, 2025	FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism
Dec 30, 2024	Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism
Jul 28, 2020	Corcept Therapeutics Initiates Phase 3 Trial of Relacorilant in Patients with Cushing’s Syndrome of Adrenal Origin

Further information

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