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active, not recruiting

Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy (PolarisDMD)

key information

study id #: NCT03703882

condition: Muscular Dystrophy, Duchenne

status: active, not recruiting


The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled.

Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the 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.

intervention: Edasalonexent, Placebo

mechanism of action: NF-KB inhibitor to prevent muscle damage and promote muscle regeneration

results: https://clinicaltrials.gov/ct2/show/results/NCT03703882

last updated: July 19, 2020