Sarepta Therapeutics Inc. — Sponsor Intelligence | 9 EU Trials

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9 Registered trials

3 Recruiting

4 Completed trials

17 Countries active

11 Unique IMPs

100% Results reported

Phase III

Phase II

Phase I (Other)

Phase I (FiH)

Phase III: 5 Phase II: 1 Phase I (Other): 1 Phase I (FiH): 2

Oversight events:

1 serious breach 7 temporary halts 2 corrective measures across 3 trials

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100%

4 of 4 completed trials have published summary results (EU CTR Article 37 — 12-month obligation).

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Top indications

Duchenne muscular dystrophy 4 Duchenne muscular dystrophy gene carrier 4 Facioscapulohumeral muscular dystrophy 1

Top IMPs

DELANDISTROGENE MOXEPARVOVEC 3 ADS-010 1 ADS-019 1 BIDRIDISTROGENE XEBOPARVOVEC 1 CASIMERSEN 1 ETEPLIRSEN 1 GOLODIRSEN 1 IMLIFIDASE 1 VESLETEPLIRSEN 1

All trials

9 total

A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-DM1 in Subjects With … Pending

2024-513579-42-00 Phase I (FiH) 4 countries ADS-019
Open-label, Phase 3 Gene Delivery Study with SRP-9003 in LGMD 2E/R4 Subjects Recruiting

2022-503112-17-00 Phase III 4 countries BIDRIDISTROGENE XEBOPARVOVEC
Study of ARO-DUX4 in Adult Patients With Facioscapulohumeral Muscular Dystrophy Type 1 Recruiting

2023-509748-89-00 Phase I (FiH) 4 countries ADS-010
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study (EXPEDITION) Recruiting

2023-505043-39-00 Phase III 4 countries DELANDISTROGENE MOXEPARVOVEC
A research study to compare different doses of a new investigational medicinal product for treatment of certain patients with Duchenne muscu… Ended

2024-511492-15-00 Phase III 13 countries ETEPLIRSEN
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulator… Halted

2024-512626-28-00 Phase III 6 countries DELANDISTROGENE MOXEPARVOVEC
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion … Ended

2024-512624-11-00 Phase I (Other) 1 country DELANDISTROGENE MOXEPARVOVEC; IMLIFIDASE
Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Efficacy (Part B) in Participants With Duchenne Muscu… Ended

2023-509935-23-00 Phase II 5 countries VESLETEPLIRSEN
A research study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients Ended

2024-514698-23-00 Phase III 9 countries CASIMERSEN; GOLODIRSEN

Showing 1–9 of 9 trials

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