VTGN: Post-hoc analyses reveal fasedienol benefits severe social anxiety patients, guiding new FDA pathway

The PALISADE-4 Phase 3 trial of fasedienol for social anxiety disorder did not meet primary or secondary endpoints in the overall population, but post-hoc analyses showed significant benefit in patients with very severe anxiety. Favorable safety data and pooled analyses support plans to pursue a new registrational pathway using LSAS as the primary endpoint, with FDA engagement planned.

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