Trial Profile

A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of BBP-418 (Ribitol) in Patients With Limb Girdle Muscular Dystrophy 2I (LGMD2I)

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 09 Apr 2026

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At a glance

30 Mar 2026 According to a BridgeBio Pharma media release, based on interim results from this study, the company has announced submission of its New Drug Application (NDA) to the FDA for oral BBP-418 for the treatment of individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The anticipates approval with a U.S. launch anticipated in late 2026/early 2027.
11 Mar 2026 According to a BridgeBio Pharma media release, company presented additional positive data from the interim analysis at the MDA Clinical and Scientific Conference in a late-breaking oral presentation.
11 Mar 2026 Results published in the BridgeBio Pharma Media Release

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