Corcept Therapeutics has received a complete response letter (CRL) from the FDA in response to its NDA for relacorilant, an oral therapy to treat hypertension secondary to hypercortisolism.
Relacorilant is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity. It met its primary endpoint in the pivital GRACE clinical trial, and Corcept provided confirmatory evidence through its GRADIENT trial. However, the FDA has said it will need additional evidence of effectiveness for a favorable benefit–risk assessment.
Corcept is a commercial-stage company that works in the discovery and development of drugs to treat diseases through cortisol modulation. It is also developing relacorilant for other serious disorders, such as ovarian cancer. The FDA has set a PDUFA date of July 11, 2026 for the drug as treatment for platinum-resistant ovarian cancer.