Anavex gets FDA clearance of Fragile X IND for blarcamesine; Phase 2a in ~60 adults planned

ANAVEX LIFE SCIENCES CORP.

• FDA notified Anavex on Oct 15, 2026 that it may proceed with its blarcamesine IND for Fragile X syndrome; the IND is now open for U.S. clinical study.
• Planned Phase 2a trial ANAVEX2-73-FXS-001: randomized, double-blind, placebo-controlled, dose-ranging oral solution in ~60 adult males with FXS.
• Primary endpoints are safety, tolerability and pharmacokinetics; secondary endpoints include Aberrant Behavior Checklist-FXS (ABC-FXS) and NIH Toolbox cognition.
• Anavex now holds open INDs in all three core indications: Alzheimer's disease, Rett syndrome and Fragile X syndrome; blarcamesine has FDA Orphan Drug Designation in FXS.
• Sept 2026 Frontiers in Pharmacology study reported 14 days of oral blarcamesine produced dose-related EEG biomarker improvements in Fmr1 knockout mice; no FDA-approved FXS treatment exists.