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# CRL for Zealand’s SBS Treatment NDA
- URL: https://www.fdaweb.com/crl-for-zealands-sbs-treatment-nda/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158372

FDA has issued a complete response letter for the Zealand Pharma NDA for glepaglutide to treat short bowel syndrome. The letter says the agency concluded that the NDA did not meet the full requirements for substantial evidence to establish the efficacy and safety of the glepaglutide dose that would be marketed.

The company [says](https://www.globenewswire.com/news-release/2024/12/19/3000220/0/en/U-S-Food-and-Drug-Administration-issues-Complete-Response-Letter-for-the-glepaglutide-New-Drug-Application-for-the-treatment-of-short-bowel-syndrome.html?ref=fdaweb.com) it will continue to talk with FDA to align on the path toward obtaining regulatory approval in the U.S.