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# Clinical Hold on Sarepta Muscular Dystrophy Trial
- URL: https://www.fdaweb.com/clinical-hold-on-sarepta-muscular-dystrophy-trial/
- Published: 2018-07-25T12:00:00.000Z
- Updated: 2026-09-15T00:21:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141964

FDA has placed a clinical hold on a Sarepta Therapeutics Phase 1/2 Duchenne muscular dystrophy micro-dystrophin gene therapy trial due to the presence of a trace amount of DNA fragment in research-grade third-party supplied plasmid. “Preliminary *in-vivo* testing performed by the research institute indicates that the trace fragment does not result in protein expression and is quickly cleared,” the company says. The company has proposed in an action plan to use GMP-s plasmid for the clinical program. “Subject to the FDA’s acceptance of the action plan, Sarepta does not anticipate any material delay in dosing patients as originally planned by year-end 2018,” it says.