Drug Approval
FDA delays Corcept’s hypertension drug, seeks more evidence
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
- By IPP Bureau
| January 05, 2026
Global pharma powerhouse Corcept Therapeutics has hit a setback as the US FDA issued a Complete Response Letter (CRL) for its New Drug Application (NDA) seeking approval of relacorilant to treat hypertension secondary to hypercortisolism.
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence. Still, the agency concluded it could not determine a favorable benefit-risk profile without additional proof of effectiveness.
“We are surprised and disappointed by this outcome,” said Joseph K. 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.”
Relacorilant is an oral therapy and a selective glucocorticoid receptor (GR) antagonist, designed to modulate cortisol activity by binding only to the GR and avoiding the body’s other hormone receptors.
