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: 26 Nov 2025

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At a glance

Drugs Ribitol (Primary)
Indications Limb girdle muscular dystrophies
Focus Adverse reactions; Registrational; Therapeutic Use
Acronyms Fortify
Sponsors ML Bio Solutions

Most Recent Events

29 Oct 2025 According to a BridgeBio Pharma media release, the company intends to file a New Drug Application (NDA) for approval with the FDA in the first half of 2026.
29 Oct 2025 Interim Results presented in the BridgeBio Pharma media release.
27 Oct 2025 According to a BridgeBio Pharma media release, the company plans to engage the FDA later this year to discuss data form this study for submission of NDA in 1H 2026.

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