The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Corcept Therapeutics regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism. 

While the FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the company’s GRADIENT trial provided confirmatory evidence, the Agency concluded it could not arrive at a favourable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness. 

“We are surprised and disappointed by this outcome,” said Joseph Belanoff, Corcept’s Chief Executive Officer. “Our commitment to patients suffering from the effects of hypercortisolism is unwavering. I am confident we will find a way to get relacorilant to the patients it could help. We will meet with the FDA as soon as possible to discuss the best path forward.” 

Corcept Therapeutics develops medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol. 

Relacorilant is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in endogenous hypercortisolism and a variety of other serious disorders, including ovarian cancer. It has been designated an orphan drug by the FDA and the European Commission for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.  

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of 11 July 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. Corcept also recently submitted a Marketing Authorization Application to the European Medicines Agency for relacorilant to treat patients with platinum-resistant ovarian cancer.

Diana Turner, Deputy Editor, DDW