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# Intercept to Resubmit Obeticholic Acid NDA
- URL: https://www.fdaweb.com/intercept-to-resubmit-obeticholic-acid-nda/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152246

Intercept Pharmaceuticals says that based on results from the Phase 3 REGENERATE trial of its obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis, it will resubmit an NDA to FDA. The company received a 2020 complete response letter to its original NDA submission.

An Intercept [announcement](https://ir.interceptpharma.com/news-releases/news-release-details/intercept-announces-positive-data-fibrosis-due-nash-new-analysis?ref=fdaweb.com) says that in the newest interim analysis of the intent-to-treat population in Regenerate, 22.4% of subjects receiving once-daily OCA 25 mg met the primary endpoint.