Corcept Files NDA for Cushing’s Syndrome Drug

FDA has accepted for review a Corcept Therapeutics NDA for its selective cortisol modulator relacorilant and its use in treating patients with endogenous hypercortisolism (Cushing’s syndrome). The agency has set a 12/30 user fee review action target date.

The submission is based on data from the company’s pivotal GRACE trial and confirmatory evidence from the Phase 3 GRADIENT trial. “Patients in these trials who received relacorilant experienced improvements in a wide array of hypercortisolism’s signs and symptoms,” Corcept says. Relacorilant was well tolerated, and there were “no instances of drug-induced adrenal insufficiency, hypokalemia or QT prolongation – serious adverse events that can arise in patients taking currently approved medications,” it adds.

Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors, the company says.