Corcept Therapeutics Incorporated (NASDAQ: CORT) reported on Wednesday that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for relacorilant as a treatment for hypertension secondary to hypercortisolism.

The FDA acknowledged that Corcept Therapeutics Incorporated's pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial provided confirmatory evidence. The agency concluded, however, that additional evidence of effectiveness is required to support a favourable benefit-risk assessment.

Relacorilant is an oral selective glucocorticoid receptor antagonist designed to modulate cortisol activity without interacting with other hormone receptors. Corcept Therapeutics Incorporated is also developing the drug for endogenous hypercortisolism and other serious conditions, including ovarian cancer.

Relacorilant holds orphan drug designation from both the FDA and European Commission for hypercortisolism, and from the European Commission for ovarian cancer. The FDA has set a Prescription Drug User Fee Act date of 11 July 2026 for relacorilant in platinum-resistant ovarian cancer. Corcept Therapeutics has also submitted a Marketing Authorisation Application to the European Medicines Agency for the same indication.

Corcept Therapeutics, which introduced Korlym, the first FDA-approved treatment for endogenous hypercortisolism, continues to advance a broad clinical pipeline targeting cortisol modulation across multiple serious diseases.