Corcept FDA Complete Response Letter Rejects Relacorilant
Corcept FDA Complete Response Letter highlighted insufficient evidence for relacorilant despite trial data, creating approval delay and market uncertainty.
KEY TAKEAWAYS
- FDA issued a Complete Response Letter requiring additional effectiveness evidence despite GRACE and GRADIENT trial data.
- Corcept said it will meet with the FDA to discuss the path forward for relacorilant.
- A separate PDUFA date remains for relacorilant in platinum-resistant ovarian cancer on July 11, 2026.
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Corcept Therapeutics said in a Dec. 31 press release that the FDA issued a Complete Response Letter for relacorilant, citing insufficient evidence of effectiveness despite positive data from the GRACE and GRADIENT trials. The company plans to meet with the agency to discuss next steps.
FDA Decision and Trial Findings
The FDA’s Complete Response Letter said additional evidence of effectiveness is needed to support a favorable benefit-risk assessment for relacorilant, a treatment for hypercortisolism secondary to endogenous Cushing's syndrome. The agency acknowledged that the pivotal GRACE trial met its primary endpoint, the upper hypertension response rate, and that the GRADIENT trial provided confirmatory data. However, the FDA concluded these results were insufficient for approval.
Regulatory Path and Company Response
Relacorilant is an oral selective glucocorticoid receptor antagonist that modulates cortisol activity. It holds FDA orphan drug designation for hypercortisolism and European Commission orphan designation for hypercortisolism and ovarian cancer. Corcept has submitted a marketing-authorization application to the European Medicines Agency for relacorilant in platinum-resistant ovarian cancer.
The company said additional clinical data analyses or regulatory steps may be required before approval for hypercortisolism. Chief Executive Joseph K. Belanoff, MD, said, "We are surprised and disappointed by this outcome."
Relacorilant’s regulatory timeline for platinum-resistant ovarian cancer remains separate, with a Prescription Drug User Fee Act (PDUFA) date set for July 11, 2026.
