31 December 2025 - Corcept Therapeutics today announced that the US FDA has issued a complete response letter regarding the new drug application for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.

While the FDA acknowledged that Corcept’s pivotal GRACE trial met its primary outcome and that data from the company’s GRADIENT trial provided confirmatory evidence, the Agency concluded it could not arrive at a favourable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness.

Read Corcept Therapeutics press release