> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts Corcept Relacorilant NDA
- URL: https://www.fdaweb.com/fda-accepts-corcept-relacorilant-nda/
- Published: 2025-09-10T12:00:00.000Z
- Updated: 2026-09-14T15:21:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159846

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](https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0?ref=fdaweb.com) 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.