AVI-4658 (Eteplirsen) ( DrugBank: Eteplirsen )


1 disease
IDDisease name (Link within this page)Number of trials
113Muscular dystrophy3

113. Muscular dystrophy


Clinical trials : 622 Drugs : 485 - (DrugBank : 99) / Drug target genes : 59 - Drug target pathways : 168
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PhaseCountries
1NCT01540409
(ClinicalTrials.gov)
February 27, 201223/2/2012Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular DystrophyOpen-Label, Multiple-Dose, Efficacy, Safety, and Tolerability Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy Who Participated in Study 4658-US-201Duchenne Muscular Dystrophy (DMD)Drug: AVI-4658 (Eteplirsen)Sarepta Therapeutics, Inc.NULLCompleted7 Years13 YearsMale12Phase 2United States
2NCT01396239
(ClinicalTrials.gov)
July 20118/7/2011Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy PatientsA Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Efficacy, Safety, Tolerability and Pharmacokinetics Study of AVI-4658(Eteplirsen),in the Treatment of Ambulant Subjects With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: AVI-4658 (Eteplirsen);Other: PlaceboSarepta Therapeutics, Inc.NULLCompleted7 Years13 YearsMale12Phase 2United States
3EUCTR2016-005000-26-Outside-EU/EEA
(EUCTR)
16/03/2017A research study of a new investigational medicinal product for the treatment of patients with Duchenne Muscular Dystrophy.A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Efficacy, Safety, Tolerability, and Pharmacokinetics Study of AVI-4658 (Eteplirsen), a Phosphorodiamidate Morpholino Oligomer, Administered Over 28 Weeks in the Treatment of Ambulant Subjects with Duchenne Muscular Dystrophy Patients with Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
MedDRA version: 19.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Exondys 51
Product Name: Eteplirsen Injection
Product Code: AVI-4658
INN or Proposed INN: AVI-4658
Other descriptive name: ETEPLIRSEN
Sarepta Therapeutics, Inc.NULLNAFemale: no
Male: yes
12Phase 2United States