NCT03917719 (GalaxyDMD) is a Phase 3 clinical trial of Edasalonexent in Duchenne Muscular Dystrophy, sponsored by Catabasis Pharmaceuticals.

Who is sponsoring NCT03917719?

NCT03917719 is sponsored by Catabasis Pharmaceuticals.

What drugs are being tested in NCT03917719?

Interventions in NCT03917719: Edasalonexent.

What condition does NCT03917719 study?

NCT03917719 studies Duchenne Muscular Dystrophy.

Is NCT03917719 still recruiting?

NCT03917719 is currently terminated. Last updated 23 November 2020.

Last reviewed 2020-11-23 · How we verify

NCT03917719: GalaxyDMD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy

Terminated Phase 3 Last updated 23 November 2020

What this trial tests

Phase 3 trial testing Edasalonexent in Duchenne Muscular Dystrophy in 130 participants. Terminated before completion.

Timeline

14 March 2019

Primary endpoint
26 October 2020

26 October 2020

Quick facts

Lead sponsor	Catabasis Pharmaceuticals
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	130
Start date	14 March 2019
Primary completion	26 October 2020
Estimated completion	26 October 2020
Sites	23 locations across Sweden, United Kingdom, Germany, Canada, Australia, United States

Drugs / interventions tested

Edasalonexent — full drug profile →

Conditions studied

Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →

Sponsor

Catabasis Pharmaceuticals — full company profile →

Who can join

Adults 4 to 12, male only, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Patients who completed CAT-1004-201 or CAT-1004-301 or siblings of these boys from 4-12 years of age (up to 13th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is a key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Anti-Inflammatory and General Glucocorticoid Physiology in Skeletal Muscles Affected by Duchenne Muscular Dystrophy: Exploration of Steroid-Sparing Agents.
Herbelet S, Rodenbach A, Paepe B, De Bleecker JL. · · 2020 · cited 25× · PMID 32605223 · DOI 10.3390/ijms21134596

Verify or expand the search:

Other trials of Edasalonexent

Trials testing the same drug.

NCT03703882 — Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy · Phase 3 · completed

Other recruiting trials for Duchenne Muscular Dystrophy

Currently open trials in the same condition.

NCT07287189 — Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients · Phase 2 · recruiting
NCT06817382 — A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Ma · Phase 1 · recruiting
NCT06402942 — Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy · NA · recruiting
NCT06450639 — A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) · Phase 2 · active not recruiting
NCT06692426 — Trial of Cell Based Therapy for DMD · Phase 1 · recruiting

Other Catabasis Pharmaceuticals trials

Trials by the same sponsor.

NCT04543370 — Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects · Phase 1 · completed
NCT03703882 — Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03917719 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Catabasis Pharmaceuticals
Last refreshed: 23 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03917719.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing