USFDAJun 17, 2026, 04:42 PM
Corcept Resubmits Relacorilant NDA to FDA for Cushing's Syndrome
AI Summary
Corcept Therapeutics announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant, intended to treat patients with Cushing syndrome. The resubmission includes additional data analyses as requested by the FDA, and the company anticipates a six-month review period. This action is based on positive data from multiple clinical trials, aiming to make relacorilant available as quickly as possible.
Key Highlights
- Corcept resubmitted its New Drug Application (NDA) for relacorilant to the FDA for Cushing syndrome.
- The resubmission includes additional data analyses as requested by the FDA.
- Corcept expects the FDA to complete its review within six months.
- The NDA is supported by positive data from the pivotal GRACE trial and Phase III GRADIENT trial.
- Relacorilant is a selective glucocorticoid receptor (GR) antagonist.
- Relacorilant has orphan drug designation from the FDA and EC for hypercortisolism.
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