Drug Profile

Ribitol - ML Bio Solutions

Alternative Names: Adonitol; BBP 418

Latest Information Update: 04 Jun 2026

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At a glance

Originator Atrium Health
Developer ML Bio Solutions
Class Small molecules; Sugar alcohols
Mechanism of Action Glycosylation stimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Limb girdle muscular dystrophies
New Molecular Entity Yes

Highest Development Phases

Preregistration Limb girdle muscular dystrophies

Most Recent Events

27 May 2026 FDA assigns PDUFA action date of 27 November 2026 for Ribitol for Limb girdle muscular dystrophies
27 May 2026 US FDA accepts new drug application (NDA) with priority review for oral BBP 418 for limb-girdle muscular dystrophy
30 Mar 2026 Preregistration for Limb girdle muscular dystrophies (In adolescents, In adults) in USA (PO)

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