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Last Updated: April 26, 2024

CLINICAL TRIALS PROFILE FOR ETEPLIRSEN

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All Clinical Trials for ETEPLIRSEN

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00844597 ↗	Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients	Completed	British Medical Research Council	Phase 1/Phase 2	2009-01-01	The specific aim of this Phase I/II study is to assess the safety of intravenous administered Morpholino oligomer directed against exon 51 (AVI-4658 PMO).
NCT00844597 ↗	Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients	Completed	Sarepta Therapeutics	Phase 1/Phase 2	2009-01-01	The specific aim of this Phase I/II study is to assess the safety of intravenous administered Morpholino oligomer directed against exon 51 (AVI-4658 PMO).
NCT00844597 ↗	Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients	Completed	Sarepta Therapeutics, Inc.	Phase 1/Phase 2	2009-01-01	The specific aim of this Phase I/II study is to assess the safety of intravenous administered Morpholino oligomer directed against exon 51 (AVI-4658 PMO).
NCT01396239 ↗	Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients	Completed	Sarepta Therapeutics	Phase 2	2011-07-01	This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24 weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).
NCT01396239 ↗	Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients	Completed	Sarepta Therapeutics, Inc.	Phase 2	2011-07-01	This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24 weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).
NCT01540409 ↗	Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy	Completed	Sarepta Therapeutics	Phase 2	2012-02-27	The primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers for DMD and the clinical status of participating DMD subjects.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for ETEPLIRSEN

Condition Name

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Condition Name for ETEPLIRSEN
Intervention	Trials
Duchenne Muscular Dystrophy	5
Duchenne Muscular Dystrophy (DMD)	3
Muscular Dystrophy, Duchenne	3
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Condition MeSH

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Condition MeSH for ETEPLIRSEN
Intervention	Trials
Muscular Dystrophy, Duchenne	11
Muscular Dystrophies	11
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Clinical Trial Locations for ETEPLIRSEN

Trials by Country

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Trials by Country for ETEPLIRSEN
Location	Trials
United States	62
United Kingdom	3
Belgium	2
Italy	2
France	2
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Trials by US State

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Trials by US State for ETEPLIRSEN
Location	Trials
Ohio	6
California	5
Pennsylvania	4
Missouri	4
Florida	4
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Clinical Trial Progress for ETEPLIRSEN

Clinical Trial Phase

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Clinical Trial Phase for ETEPLIRSEN
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	7
Phase 1/Phase 2	2
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Clinical Trial Status

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Clinical Trial Status for ETEPLIRSEN
Clinical Trial Phase	Trials
Completed	8
Active, not recruiting	2
Enrolling by invitation	1
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Clinical Trial Sponsors for ETEPLIRSEN

Sponsor Name

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Sponsor Name for ETEPLIRSEN
Sponsor	Trials
Sarepta Therapeutics, Inc.	10
Sarepta Therapeutics	9
Catabasis Pharmaceuticals	1
[disabled in preview]	2
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Sponsor Type

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Sponsor Type for ETEPLIRSEN
Sponsor	Trials
Industry	20
Other	2
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