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FDA lifts clinical hold on Filana's simufilam, enabling Phase 2a epilepsy study
FLNAFilana Therapeutics, Inc.
On September 22, 2026, Filana Therapeutics announced that the U.S. Food and Drug Administration lifted the clinical hold on its investigational new drug application for simufilam. This regulatory clearance enables the company to initiate a planned Phase 2a proof-of-concept study in patients with tuberous sclerosis complex-related epilepsy. The trial is designed as a 16-week, multicenter, randomized, double-blind study evaluating two doses of simufilam at 13 U.S. sites, targeting an enrollment of 40 subjects aged 12 to 55. Patient screening is expected to begin in the first quarter of 2027. Filana Therapeutics operates as a biotechnology company focused on developing novel therapies for central nervous system disorders.