FDA lifts clinical hold on Filana's simufilam, enabling Phase 2a trial for TSC-related epilepsy

FILANA THERAPEUTICS, INC.

FDA lifted full clinical hold on Filana's IND for simufilam on Sept 22, 2026, enabling Phase 2a trial in TSC-related epilepsy.
Phase 2a trial: 16-week, randomized, double-blind, two doses, 13 U.S. sites, target 40 subjects aged 12-55; screening expected Q1 2027.
Company completed trial-readiness during hold: engaged leading CRO, identified sites, recruiting investigators, drug supply in place.
TSC Alliance CEO Kari Luther Rosbeck praised work; simufilam reduced seizure frequency in two preclinical mouse models.

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