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Last Updated: June 28, 2022

CLINICAL TRIALS PROFILE FOR ETEPLIRSEN


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All Clinical Trials for Eteplirsen

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.
NCT01540409 ↗ Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy Completed Sarepta Therapeutics, Inc. 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 >Phase >Start Date >Summary

Clinical Trial Conditions for Eteplirsen

Condition Name

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

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

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

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

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

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

Sponsor Name for Eteplirsen
Sponsor Trials
Sarepta Therapeutics, Inc. 10
Sarepta Therapeutics 9
Catabasis Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Eteplirsen
Sponsor Trials
Industry 20
Other 2
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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
AstraZeneca
McKesson
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Express Scripts

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