Anavex Receives FDA Clearance of its IND Application for Blarcamesine in Fragile X Syndrome
Globe Newswire•15/10/2026•16:00 ET
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Key Highlights
- ➤FDA clears Anavex’s Fragile X syndrome IND, enabling U.S. clinical investigation
- ➤Planned Phase 2a study will enroll approximately 60 adult males with Fragile X syndrome
- ➤Study will assess blarcamesine safety, tolerability, pharmacokinetics, behavioral, and cognitive measures
- ➤Anavex now has open INDs for Alzheimer’s disease, Rett syndrome, and Fragile X syndrome
- ➤Frontiers in Pharmacology study reported dose-related EEG improvements in a Fragile X mouse model
Expert Statements
Terrie Kellmeyer, Interim Chief Executive Officer of Anavex Life Sciences Corp.
“FDA clearance of the Fragile X IND is an important milestone that gives Anavex open INDs in all three of our core indications: Alzheimer’s Disease, Rett syndrome, and Fragile X syndrome, and supports our continued momentum of working closely with the FDA as we move our programs forward”
Terrie Kellmeyer, Interim Chief Executive Officer of Anavex Life Sciences Corp.
“With an open IND, we are positioned to advance ANAVEX2-73-FXS-001, a planned Phase 2a randomized, double-blind, placebo-controlled, dose-ranging study of the safety, tolerability, and pharmacokinetics of blarcamesine oral solution in approximately 60 adult males with FXS, with behavioral (Aberrant Behavior Checklist revised for FXS “ABC(FX)”) and cognitive (NIH Toolbox) measures included as secondary endpoints.”
Terrie Kellmeyer, Interim Chief Executive Officer of Anavex Life Sciences Corp.
“We believe blarcamesine’s differentiated mechanism of action, including its targeting of sigma-1 receptors, uniquely positions Anavex with the potential to pioneer a transformative treatment approach for patients and families affected by Fragile X syndrome.”
Anavex now has open INDs in all three core indications: Alzheimer's disease, Rett syndrome, and Fragile X syndrome
Phase 2a study will evaluate the safety, tolerability and pharmacokinetics of blarcamesine oral solution in adult males with Fragile X syndrome
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