Anavex Life Sciences Corp. (Nasdaq: AVXL) reported on October 20, 2026, that the clinical conduct of two pharmacology studies for its drug candidate blarcamesine (ANAVEX 2-73) has been completed. The studies, an Absorption, Distribution, Metabolism and Excretion (ADME) study and a Drug-drug Interaction (DDI) study, were conducted in healthy volunteers and are intended to further characterize the clinical pharmacology profile of the compound.
The DDI study enrolled 65 participants who received a 30 mg dose of blarcamesine. The last participant completed the study at the end of September. The ADME study enrolled 8 participants, all of whom received the same 30 mg dose. The last participant in this study completed the trial in mid-October. According to the company's press release, preliminary observations indicate that no serious adverse events were reported in either study, though full safety and pharmacokinetic data analysis is still ongoing.
The data from these studies are expected to support the clinical pharmacology characterization across Anavex's pipeline programs, specifically for early Alzheimer's disease, Rett syndrome, and Fragile X syndrome. In addition to these study completions, the company noted that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for blarcamesine in Fragile X syndrome. Blarcamesine has also been granted Orphan Drug Designation by the FDA for this indication.
Anavex also announced that it is scheduled to meet with the FDA in November to discuss adding pediatric participants to the Phase 3 study protocol for Rett syndrome. The company stated that study start-up activities are underway for the Fragile X program.
