FDA Rejects Relacorilant for Cushing’s Syndrome High Blood Pressure
The FDA declined to approve relacorilant, Corcept Therapeutics' oral therapy targeting cortisol receptors, for patients with endogenous Cushing's syndrome experiencing high blood pressure.
The rejection was detailed in a complete response letter, stating that current data from Phase 3 trials GRACE and GRADIENT do not conclusively show benefits outweigh risks, despite meeting main goals.
Corcept plans to meet with the FDA to discuss additional evidence or trials needed.
Relacorilant showed reductions in blood pressure, blood sugar, and weight in trials, with common side effects like pain, headache, swelling, and nausea.
The application was submitted in late 2024 and is also under review for platinum-resistant ovarian cancer.