Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
High dose ANAVEX2-73 · 3 trials · 2 indications
To continue assessing the safety and tolerability of ANAVEX2-73
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL)
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | ANAVEX2-73 |
| High dose ANAVEX2-73 | EXPERIMENTAL | High dose ANAVEX2-73 |
| Mid dose ANAVEX2-73 | EXPERIMENTAL | Mid dose ANAVEX2-73 |
| Placebo oral capsule | PLACEBO_COMPARATOR | Placebo oral capsule |
| Name | Type | Description |
|---|---|---|
| ANAVEX2-73 | DRUG | Oral capsules |
| High dose ANAVEX2-73 | DRUG | Active oral capsule |
| Mid dose ANAVEX2-73 | DRUG | Active oral capsule |
| Placebo oral capsule | DRUG | Placebo oral capsule |
Inclusion Criteria: * Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study. * Participants may be either outpatients, or residents of an assisted-living facility. * Participants must have a designated study partner, who spends at least 10hrs per week with the participant...
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ANAVEX2-73 is an investigational small molecule being developed for neurological conditions including Rett Syndrome, Parkinson's Disease With Dementia, and Alzheimer's Disease. It is in Phase 2 clinical development and has not been approved by the FDA.
ANAVEX2-73 is being developed by Anavex Life Sciences Corp., a biopharmaceutical company traded on NASDAQ under the ticker AVXL. The company is conducting clinical trials for this drug in multiple countries.
ANAVEX2-73 is in Phase 2 clinical development. It has completed two Phase 2 trials and two open-label extension studies, with a total enrollment of 809 participants across all studies. The drug is investigational and not yet FDA approved.
ANAVEX2-73 has completed several clinical trials, including NCT03774459 for Parkinson's Disease Dementia, NCT03790709 for early Alzheimer's Disease, and open-label extensions NCT04314934 and NCT04575259. All trials were Phase 2 and are now completed.
Yes, ANAVEX2-73 has received Fast Track designation, Orphan Drug designation, and Rare Pediatric Disease designation from the FDA. These designations are intended to expedite development and review of the drug for serious conditions.
ANAVEX2-73 is also known as blarcamesine, though this alternative name is not provided in the available data. The drug is being studied under the name ANAVEX2-73 in clinical trials for Alzheimer's disease and Parkinson's disease dementia.