FDA Accepts Corcept Relacorilant NDA

FDA has accepted and will consider a Corcept Therapeutics NDA for relacorilant to treat patients with platinum-resistant ovarian cancer. The agency set 7/11/2026 as the PDUFA action date for the NDA.

A company statement says the NDA is based on data from its pivotal Phase 3 ROSELLA and Phase 2 trials. Patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection, the company says. It says the drug was well tolerated, consistent with its known safety profile.

Relacorilant is described as a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors.

FDA previously designated relacorilant as an orphan drug to treat hypercortisolism and gave it 12/30/2025 as the PDUFA action date for that indication.