Corcept Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for relacorilant, a selective cortisol modulator, for the treatment of endogenous hypercortisolism (Cushing's syndrome). This acceptance signifies a key step in the regulatory review process.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025, for the relacorilant NDA. This provides a clear timeline for a potential approval decision, which could bring a new treatment option to patients with this severe endocrinologic disorder.
The NDA submission was based on positive results from the pivotal GRACE trial, supported by confirmatory evidence from the Phase 3 GRADIENT trial, a long-term extension trial, and a Phase 2 trial. These studies demonstrated relacorilant's efficacy in improving various signs and symptoms of hypercortisolism, coupled with a favorable safety profile that avoids serious adverse events associated with other approved medications.
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