ANAVEX3-71 — Safety, Research, Risks & Legal Status

Not medical advice. ANAVEX3-71 is discussed here for informational and harm-reduction purposes only. We do not endorse use, and any dosing context is informational, not a protocol.

Also known as	AF710B; ANAVEX 3-71
Category	Research Chemical
Developer	Anavex Life Sciences Corp. (NASDAQ: AVXL), New York
Former designation	AF710B
Mechanism	Dual SIGMAR1 agonist / M1 muscarinic positive allosteric modulator
Highest development stage	Phase 2 (schizophrenia, completed Oct 2025); Phase 1 completed 2022
Regulatory designations	FDA Orphan Drug Designation granted for frontotemporal dementia (FTD)
Phase 1 half-life	Approximately 3.56 hours; linear, dose-proportional PK; food-neutral absorption
US legal status	Investigational drug in the United States; not approved by the FDA for any indication. Orphan Drug Designation granted by FDA for frontotemporal dementia (FTD). Anavex Life Sciences has initiated dialogue with the FDA regarding potential NDA pathways for early Alzheimer's disease as of early 2026. Not available for human use outside of authorized clinical trials.

What is ANAVEX3-71?

ANAVEX3-71 is a small-molecule, orally administered clinical-stage drug candidate developed by Anavex Life Sciences Corp. (NASDAQ: AVXL). It is a dual-acting agent designed to simultaneously engage the sigma-1 receptor (SIGMAR1) as an agonist and the M1 muscarinic acetylcholine receptor (CHRM1) as a positive allosteric modulator (PAM). This combined mechanism distinguishes it from compounds that target only one of these pathways. Primary development focus is on neuropsychiatric and neurodegenerative indications including schizophrenia, frontotemporal dementia, and Alzheimer's disease.

How it works

ANAVEX3-71 acts through two complementary receptor systems within a single molecule. As a SIGMAR1 agonist, it engages the sigma-1 receptor, which is implicated in neuroprotection, neuroinflammation modulation, and cellular stress response. As an M1 muscarinic positive allosteric modulator, it potentiates the activity of the M1 receptor without directly replacing the endogenous ligand (acetylcholine), which may offer selectivity advantages over direct muscarinic agonists. The combined neuromodulatory effect on both pathways is hypothesized to address cognitive, inflammatory, and synaptic synchronization deficits relevant to schizophrenia, Alzheimer's disease, and FTD. The precise molecular basis for the dual activity within a single scaffold is an active area of investigation.

Background & history

ANAVEX3-71 was developed under the earlier designation AF710B by Anavex Life Sciences. Preclinical work established activity in transgenic rodent models of Alzheimer's disease, including attenuation of cognitive deficits in 3xTg-AD mice and reversal of cognitive decline in an advanced Alzheimer's-model rat study with long-term dosing (PubMed PMID 29291374). The compound advanced into human testing with a Phase 1 study in healthy volunteers (ClinicalTrials.gov NCT04442945), with pharmacokinetic data published in 2023 (PubMed PMID 38073274). A placebo-controlled U.S. Phase 2 trial in schizophrenia (ANAVEX3-71-SZ-001, NCT06245213) initiated thereafter and reported topline results in October 2025. FDA Orphan Drug Designation for FTD has been granted. As of mid-2026, the compound remains in active clinical development.

What the research says

Human clinical data are limited but exist. Phase 1 (NCT04442945, healthy volunteers): ANAVEX3-71 was well tolerated across single doses of 5 to 200 mg. No serious adverse events were observed. Pharmacokinetics were linear and dose-proportional, with a mean half-life of approximately 3.56 hours and no clinically meaningful food effect on absorption (PubMed PMID 38073274). Phase 2 schizophrenia trial (ANAVEX3-71-SZ-001, NCT06245213, completed October 2025): Met its primary endpoint of safety and tolerability. Treatment-emergent adverse event (TEAE) rates were 39.3% in the ANAVEX3-71 60 mg group versus 48.1% in the placebo group. No serious or severe TEAEs reported; no treatment-group discontinuations due to adverse events. Importantly, clinical efficacy endpoints did not achieve statistical significance. Secondary biomarker signals - including EEG/ERP measures (40 Hz auditory steady-state response inter-trial coherence, 40 Hz ASSR ITC) and reductions in glial fibrillary acidic protein (GFAP, a neuroinflammation marker) - showed trends suggesting potential neuroinflammatory and neural synchronization benefits, but these are preliminary and require confirmatory study. Preclinical data in rodent Alzheimer's models (animal-only; not directly generalizable to humans) showed cognitive benefit with long-term dosing. No human efficacy data exist for Alzheimer's disease or FTD as of mid-2026.

Reported effects

Sigma-1 receptor agonism with hypothesized neuroprotective and neuroinflammation-modulating properties (preclinical and biomarker-level data only)
M1 muscarinic positive allosteric modulation, potentially enhancing cholinergic neurotransmission relevant to cognition (mechanism established; clinical efficacy unproven)
Favorable tolerability profile in Phase 1 and Phase 2 human trials - adverse event rate numerically lower than placebo in the schizophrenia Phase 2
Biomarker signals suggesting possible reduction of neuroinflammation (GFAP reduction) and enhanced neural synchrony (40 Hz ASSR ITC) in schizophrenia cohort - exploratory, not confirmatory
Cognitive deficit attenuation in transgenic Alzheimer's-model rodents (animal data only, not established in humans)
No demonstrated statistically significant clinical efficacy on primary schizophrenia endpoints in completed Phase 2

Dosing & administration (informational)

Published Phase 1 data document single oral doses ranging from 5 to 200 mg in healthy volunteers, with a pharmacokinetic half-life of approximately 3.56 hours and dose-proportional exposure (PubMed PMID 38073274). The Phase 2 schizophrenia trial used a 60 mg dose. These are trial-specific doses selected under medical supervision within controlled research protocols and are presented here as literature context only. They do not constitute a dosing protocol, recommendation, or guidance of any kind. Consult a licensed clinician for any medical question related to this or any investigational compound.

This is general research/context information, not medical advice or a recommended protocol.

Safety & side effects

No serious adverse events reported in Phase 1 (healthy volunteers, doses 5-200 mg) or Phase 2 (schizophrenia cohort, 60 mg)
No QTc prolongation or serious cardiac effects documented in available published data
TEAE rate in Phase 2 treatment arm (39.3%) was numerically lower than placebo arm (48.1%); adverse events described as mild and consistent with placebo
No treatment-group discontinuations due to adverse events in the completed Phase 2 trial
Long-term safety data beyond the Phase 2 trial duration are not yet available
Safety in special populations (renal impairment, hepatic impairment, elderly, pediatric) has not been characterized in published data
This compound is not approved for human use; any use outside authorized clinical trials is without regulatory sanction

Drug & supplement interactions

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Who should avoid it

Use outside of authorized and IRB-approved clinical trials
Combining with other investigational compounds in the absence of clinical oversight
Any assumption of efficacy based on preclinical (rodent) data alone
Sourcing from any supplier other than a licensed clinical trial site - no legitimate commercial supply exists
Self-administration under any circumstances

How it is commonly combined

No data exist on combination use of ANAVEX3-71 with other compounds in humans. The preclinical Alzheimer's literature on AF710B explored single-agent effects. Combination regimens are not established and cannot be evaluated from available evidence.

Legal & regulatory. Investigational drug in the United States; not approved by the FDA for any indication. Orphan Drug Designation granted by FDA for frontotemporal dementia (FTD). Anavex Life Sciences has initiated dialogue with the FDA regarding potential NDA pathways for early Alzheimer's disease as of early 2026. Not available for human use outside of authorized clinical trials.

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Frequently asked questions

Did ANAVEX3-71 show efficacy in the Phase 2 schizophrenia trial?

The Phase 2 trial (NCT06245213, completed October 2025) met its primary endpoint of safety and tolerability, but clinical efficacy endpoints did not reach statistical significance. Secondary biomarker signals - including EEG measures of neural synchronization and reductions in GFAP (a neuroinflammation marker) - showed trends of interest, but these are exploratory and do not constitute evidence of proven clinical efficacy.

Is ANAVEX3-71 available to purchase or use outside of a clinical trial?

No. ANAVEX3-71 is an unapproved investigational drug with no commercial supply chain. It is only available within authorized, sponsor-controlled clinical trials. Any substance sold under this name outside of that context is of unknown identity and purity.

What indications is ANAVEX3-71 being developed for?

Primary active development is in schizophrenia (Phase 2 completed). FDA Orphan Drug Designation has been granted for frontotemporal dementia (FTD). Alzheimer's disease is a planned indication supported by preclinical data, with Anavex in early FDA dialogue regarding potential NDA pathways as of early 2026. None of these indications are approved.

What does the preclinical Alzheimer's data show?

Animal studies using the AF710B designation showed attenuation of cognitive deficits in 3xTg-AD transgenic mice and reversal of cognitive decline with long-term dosing in an advanced Alzheimer's-model rat study (PubMed PMID 29291374). These are animal-only findings and have not been replicated or confirmed in human Alzheimer's trials to date.

What is the safety profile based on human data?

Phase 1 data in healthy volunteers at doses from 5 to 200 mg showed no serious adverse events and no QTc concerns. The Phase 2 schizophrenia trial reported a TEAE rate of 39.3% in the treatment arm versus 48.1% in the placebo arm, with no serious or severe events and no treatment-group discontinuations. Long-term safety data are not yet available.

Can you recommend a dose or protocol for ANAVEX3-71?

No. ANAVEX3-71 is an unapproved investigational compound. Dosing information presented on this site reflects published trial literature only and is not a protocol, recommendation, or clinical guidance. Any question about this compound in the context of personal health should be directed to a licensed clinician.

References & further reading

PubMed PMID 38073274: Population-Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71 (search: ANAVEX3-71 pharmacokinetics sigma-1 muscarinic)
PubMed PMID 29291374: AF710B M1/sigma-1 receptor agonist disease-modifying properties transgenic rat Alzheimer's disease (search: AF710B sigma-1 M1 muscarinic Alzheimer rat model)
ClinicalTrials.gov NCT06245213: A Study of ANAVEX3-71 in Adults With Schizophrenia (Phase 2, ANAVEX3-71-SZ-001)
ClinicalTrials.gov NCT04442945: ANAVEX3-71 Phase 1 healthy volunteers pharmacokinetics
ClinicalTrials.gov: search ANAVEX3-71 for full trial registry