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Also known as ANAVEX2-73, ANAVEX2-73 Oral
High dose ANAVEX2-73 · 8 trials · 5 indications
Drug exposure-dependent response of the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score
To continue assessing the safety and tolerability of ANAVEX2-73
PK of ANAVEX2-73 and metabolite
PK of ANAVEX2-73 and metabolite
Significant laboratory findings
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 arm | EXPERIMENTAL | ANAVEX2-73 liquid oral solution |
| Placebo arm | PLACEBO_COMPARATOR | Placebo liquid oral solution |
| Active | EXPERIMENTAL | ANAVEX2-73 |
| ANAVEX2-73 Active | EXPERIMENTAL | Oral capsules |
| 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 |
| ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 | EXPERIMENTAL | - |
| Anavex2-73 oral then the Anavex2-73 intravenous formulation | EXPERIMENTAL | Participants first receive Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days. After a washout period of 11 days they then receive the Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days. |
| Anavex2-73 intravenous then the Anavex2-73 oral formulation | EXPERIMENTAL | Participants first receive Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days. After a washout period of 11 days then they receive the Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days. |
| Anavex2-73 30 mg oral formulation | EXPERIMENTAL | Participants will receive the 30 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks. |
| Anavex2-73 50 mg oral formulation | EXPERIMENTAL | Participants will receive the 50 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| ANAVEX2-73 | DRUG | Liquid oral solution |
| Placebo | DRUG | Liquid oral solution |
| High dose ANAVEX2-73 | DRUG | Active oral capsule |
| Mid dose ANAVEX2-73 | DRUG | Active oral capsule |
| Placebo oral capsule | DRUG | Placebo oral capsule |
| ANAVEX2-73 Oral | DRUG | - |
| ANAVEX2-73 Intravenous | DRUG | - |
Inclusion Criteria: * Aged ≥ 18 years, inclusive. * Diagnosis of classic RTT, according to 2010 criteria (Neul et al., 2010), and a MECP2 mutation. * Current pharmacological treatment regimen, including supplements, has been stable for at least 4 weeks. * If on antiepileptic drugs (AEDs), 1-4 AEDs ...
Top 2 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Vadadustat |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE2 | Fostamatinib |
High dose ANAVEX2-73 is an investigational small molecule developed by Anavex Life Sciences Corp. (AVXL) for neurological conditions. It is being studied in Alzheimer disease, Parkinson disease dementia, Parkinson's disease with dementia, and Rett syndrome. It is a Phase 2 clinical-stage candidate and has not been approved by the FDA.
High dose ANAVEX2-73 is being evaluated for Alzheimer disease, Parkinson disease dementia, Parkinson's disease with dementia, and Rett syndrome. These are the indications studied in its clinical program. It remains investigational and is not approved for any use.
High dose ANAVEX2-73 is developed by Anavex Life Sciences Corp., which trades under the ticker AVXL. The company is the sponsor of the clinical trials evaluating this small molecule in neurological indications.
High dose ANAVEX2-73 is in Phase 2 development overall. Its clinical program includes four completed trials, one of which was a Phase 3 study in Rett syndrome. The drug is investigational and has not received FDA approval.
High dose ANAVEX2-73 has been studied in four completed trials: NCT04575259, an open-label extension in Parkinson disease dementia; NCT04314934, an open-label extension in Alzheimer disease; NCT03941444, a Phase 3 trial in Rett syndrome; and NCT03790709, a Phase 2 trial in early Alzheimer's disease. Total enrollment across these trials was 862 participants.
Yes, high dose ANAVEX2-73 refers to the same investigational compound as ANAVEX2-73, also written as ANAVEX2-73 Oral. These names describe the same small molecule developed by Anavex Life Sciences Corp. for neurological indications.