Corcept Therapeutics will resubmit its NDA for relacorilant in Cushing’s syndrome after an FDA Complete Response Letter. The selective cortisol modulator could be positioned for potential approval in 2027 under a six‑month PDUFA review.
Written By: Disha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Corcept Therapeutics said it will resubmit its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant in patients with endogenous hypercortisolism (Cushing’s syndrome), following receipt of a Complete Response Letter (CRL) to its original filing in the month of December 2025. The FDA requested additional analyses of existing data instead of new clinical studies, and Corcept said the findings supported renewed regulatory discussions.
The company expects to file the resubmission in the coming weeks. Under the Prescription Drug User Fee Act (PDUFA), the FDA has indicated the application will be subject to a six-month review period. If accepted, the timeline could position relacorilant for potential approval in 2027.
Relacorilant is a selective cortisol modulator that blocks the glucocorticoid receptor without targeting the progesterone receptor, differentiating it from currently approved therapies such as Korlym® (mifepristone). Relacorilant previously showed improvements in hypertension and hyperglycemia in Phase 3 studies of endogenous hypercortisolism.
Beyond endocrinology, Corcept is also advancing relacorilant in oncology. Earlier this year, the company reported an overall survival benefit in the Phase 3 ROSELLA trial evaluating relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, further expanding the drug’s clinical profile across cortisol-driven diseases.
Excess cortisol exposure drives the metabolic, cardiovascular, and neuropsychiatric complications of Cushing’s syndrome, where cardiovascular disease remains the leading cause of death. Emerging evidence suggests the condition may be underdiagnosed in patients with resistant hypertension and uncontrolled diabetes.
Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer, said the additional analyses advanced discussions with regulators and reinforced confidence in the program. He added that the FDA continues to engage with the development strategy as Corcept works toward bringing relacorilant to patients with hypercortisolism.
The resubmission marks a key regulatory milestone for Corcept and could also help define FDA expectations for future therapies in endogenous hypercortisolism, where treatment options remain limited.
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About the Writer
Disha Sanjay Jadhav (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.