Corcept Therapeutics has received a complete response letter from the FDA for its new drug application for relacorilant, a treatment for hypertension caused by hypercortisolism.
In the Dec. 31 letter, the FDA acknowledged that Corcept’s GRACE trial met its primary endpoint and that its GRADIENT trial provided supporting evidence; however, additional data is needed to support a favorable benefit-risk assessment, the agency said.
Relacorilant is a selective glucocorticoid receptor antagonist that modulates cortisol activity. The drug has received orphan drug designation in both the U.S. and Europe for the treatment of hypercortisolism.
The FDA has set a separate Prescription Drug User Fee Act action date of July 11, 2026, for relacorilant as a treatment for platinum-resistant ovarian cancer.
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