FAB122

FAB122 is an investigational oral formulation of edaravone, developed as granules in sachets (100 mg per dose) by Treeway and licensed to Ferrer for clinical testing in Europe and parts of Asia. It was tested in the Phase 3 ADORE trial for the treatment of Amyotrophic Lateral Sclerosis (ALS). However, in January 2024, the trial failed to meet its primary and key secondary efficacy endpoints, showing no significant benefit over placebo in slowing ALS progression (measured by ALSFRS-R) after 48 weeks. The drug was reported to be safe and well-tolerated. Following the negative results, the open-label extension study (ADOREXT) was also concluded. FAB122 is distinct from other edaravone formulations like RADICAVA IV and RADICAVA ORS, with differences in trial design and dosing.

Other names

edaravoneoral edaravone