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# FDA Lifts Hold on Sarepta Duchenne Drug Trial
- URL: https://www.fdaweb.com/fda-lifts-hold-on-sarepta-duchenne-drug-trial/
- Published: 2022-09-06T12:00:00.000Z
- Updated: 2026-09-14T17:58:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152665

FDA has lifted its clinical hold on Sarepta’s SRP-5051 (vesleteplirsen), an investigational, next-generation peptide conjugated phosphorodiamidate morpholino oligomer indicated to treat patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping. The company [says](https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-fda-has-lifted-its-clinical-hold?ref=fdaweb.com) that as part of the lift, it will adjust the Phase 2 MOMENTUM global trial protocol to include expanded monitoring of urine biomarkers.

The hold reportedly followed a serious adverse event of hypomagnesemia. Sarepta says it provided information to FDA to assess the adequacy of the risk mitigation and safety monitoring plan.