Product
Delandistrogene Moxeparvovec
Aliases
delandistrogene moxeparvovec, delandistrogene moxeparvovec-rokl, ELEVIDYS, SRP-9001
7 clinical trials
3 indications
Indication
Duchenne muscular dystrophyIndication
Muscular DystrophyIndication
DuchenneClinical trial
An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in Association With Imlifidase in Subjects With Duchenne Muscular Dystrophy With Pre-existing Antibodies to rAAVrh74Status: Active (not recruiting), Estimated PCD: 2025-01-31
Clinical trial
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP- 9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION)Status: Recruiting, Estimated PCD: 2026-01-31
Clinical trial
A Long-term Multicenter Prospective Observational Study Evaluating the Comparative Effectiveness and Safety of Sarepta Gene Transfer Therapy vs. Standard of Care in Participants With Duchenne Muscular Dystrophy Under Conditions of Routine Clinical PracticeStatus: Recruiting, Estimated PCD: 2029-12-31
Clinical trial
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial for Duchenne Muscular Dystrophy Using SRP-9001Status: Completed, Estimated PCD: 2020-12-08
Clinical trial
Systemic Gene Delivery Phase I/IIa Clinical Trial for Duchenne Muscular Dystrophy Using rAAVrh74.MHCK7.Micro-dystrophin (microDys-IV-001)Status: Completed, Estimated PCD: 2023-04-25
Clinical trial
A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)Status: Active (not recruiting), Estimated PCD: 2023-10-04
Clinical trial
A Phase 3, Multinational, Long-term Follow-up Study to Evaluate Safety and Efficacy in Subjects Who Have Previously Received SRP-9001 in a Clinical StudyStatus: , Estimated PCD: 2030-11-30