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Sarepta Therapeutics (SRPT)
NASDAQ:SRPT
Srp-9005, Corticosteroid
Muscular Dystrophies, Limb-Girdle
Phase III
Withdrawn
A Study of SRP-9005 in Limb Girdle Muscular Dystrophy Type 2C/R5 Pediatric and Adult Participants
Apr 23, 2025
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Srp-9004
Limb Girdle Muscular Dystrophy, Limb Girdle Muscular Dystrophy Type 2D/R3
Phase I
Terminated
Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9004 Administered by Systemic Infusion in Limb Girdle Muscular Dystrophy Type 2D/R3 Participants in the United States
Dec 18, 2024
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Delandistrogene Moxeparvovec, Plasmapheresis
Duchenne Muscular Dystrophy
Phase I
Terminated
A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74
Sep 12, 2024
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Srp-9003, Glucocorticoid
Limb-Girdle Muscular Dystrophy
Phase III
Active Not Recruiting
A Trial to Learn More About an Experimental Gene Therapy Called Bidridistrogene Xeboparvovec (SRP-9003) as a Possible Treatment for Limb Girdle Muscular Dystrophy 2E/R4
Jan 30, 2024
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Delandistrogene Moxeparvovec, Imlifidase
Duchenne Muscular Dystrophy
Phase I
Enrolling By Invitation
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74)
Jan 26, 2024
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Delandistrogene Moxeparvovec
Duchenne Muscular Dystrophy
Phase II
Recruiting
A Gene Delivery Study to Evaluate the Safety and Expression of Delandistrogene Moxeparvovec in Participants Under the Age of Four With Duchenne Muscular Dystrophy (DMD)
Nov 08, 2023
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Delandistrogene Moxeparvovec
Duchenne Muscular Dystrophy
Phase III
Enrolling By Invitation
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
Jul 21, 2023
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Srp-6004
Limb Girdle Muscular Dystrophy
Phase I
Terminated
A Gene Transfer Study to Evaluate the Safety, Tolerability and Efficacy of SRP-6004 in Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2B/R2 (LGMD2B/R2, Dysferlin [DYSF] Related)
Jun 07, 2023
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Delandistrogene Moxeparvovec
Duchenne Muscular Dystrophy
Phase III
Active Not Recruiting
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
May 19, 2023
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Srp-9003
Limb Girdle Muscular Dystrophy
Phase I
Active Not Recruiting
A Gene Transfer Single Dose Study to Evaluate the Safety, Tolerability and Efficacy of SRP-9003 in Non-Ambulatory and Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2E/R4 (Beta-Sarcoglycan [β-SG] Deficiency)
May 17, 2023
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Sarepta Therapeutics (SRPT) have in its pipeline
SRPT is currently developing the following drugs: Srp-9005, Corticosteroid, Srp-9004, Delandistrogene Moxeparvovec, Plasmapheresis. These drug candidates are in various stages of clinical development as the company works toward FDA approval.