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# Corcept Files NDA for Cushing’s Syndrome Drug
- URL: https://www.fdaweb.com/corcept-files-nda-for-cushings-syndrome-drug/
- Published: 2025-03-03T12:00:00.000Z
- Updated: 2026-09-14T14:54:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158753

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.