Relacorilant FDA Approval Status
Last updated by Judith Stewart, BPharm on March 4, 2025.
FDA Approved: No
Generic name: relacorilant
Company: Corcept Therapeutics Incorporated
Treatment for: Cushing's Syndrome
Relacorilant is a selective cortisol modulator in development for the treatment of patients with endogenous hypercortisolism (Cushing’s syndrome).
- Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms can include hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common.
- 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 is 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.
Development timeline for relacorilant
Further information
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