Trial Profile

A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 16 Jun 2025

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At a glance

Drugs Omaveloxolone (Primary)
Indications Friedreich's ataxia
Focus Proof of concept; Registrational; Therapeutic Use
Acronyms MOXIe
Sponsors Biogen; Reata Pharmaceuticals

Most Recent Events

10 Jun 2025 Planned End Date changed from 30 Jun 2025 to 27 Jun 2025.
23 Apr 2025 According to The Medicines and Healthcare products Regulatory Agency (MHRA), omaveloxolone (Skyclarys) is approved as the first treatment for patients aged 16 and over , in the UK for a rare neurodegenerative movement disorder called Friedreichs ataxia. The new marketing authorisation was granted on 23 April to Biogen Netherlands B.V.
18 Apr 2025 Planned End Date changed from 1 Dec 2024 to 30 Jun 2025.

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