Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis

Phase 3 Completed 313 enrolled Ferrer Internacional S.A. Julius Clinical · collab Stichting TRICALS Foundation · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.

Timeline

Start: 2021-10-18
Primary completion: 2023-10-26
Completion: 2023-10-26

Outcome

Missed primary endpoint

release “NCT05178810) with an oral formulation of edaravone (FAB122) in patients with amyotrophic lateral sclerosis (ALS) did not meet the key primary or secondary endpoints.” ferrer.com ↗

Publications

van Wijk IF, Kraneburg L, van Eijk RPA, Veldink JH, van Es MA, Westeneng HJ, van den Berg LH. Prodromal symptoms in amyotrophic lateral sclerosis from the perspective of the patient and of the caregiver. Amyotroph Lateral Scler Frontotemporal Degener. 2026 May;27(3-4):263-273. doi: 10.1080/21678421.2025.2574687. Epub 2025 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FAB122	Unknown	100 mg	Oral