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buntanetap/posiphen
buntanetap/posiphen is a Translation inhibitor; protein synthesis modulator Small molecule drug developed by Annovis Bio Inc.. It is currently in Phase 3 development for Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage). Also known as: Posiphen Tartrate, ANVS401.
Buntanetap/posiphen inhibits translation of amyloid precursor protein (APP) and tau, reducing production of amyloid-beta and tau pathology in the brain.
Buntanetap/posiphen is a small molecule intervention being studied in clinical trials for conditions including early Alzheimer's disease, Alzheimer's disease, Parkinson's disease, and deep brain stimulation. Clinical trials are investigating the safety and efficacy of buntanetap/posiphen in these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | buntanetap/posiphen |
|---|---|
| Also known as | Posiphen Tartrate, ANVS401 |
| Sponsor | Annovis Bio Inc. |
| Drug class | Translation inhibitor; protein synthesis modulator |
| Target | APP (amyloid precursor protein) and tau mRNA translation initiation |
| Modality | Small molecule |
| Therapeutic area | Neurology; Alzheimer's disease |
| Phase | Phase 3 |
Mechanism of action
The drug works by targeting the translation initiation of APP and tau mRNA, thereby decreasing the levels of these neurotoxic proteins implicated in Alzheimer's disease pathology. By reducing both amyloid-beta and tau simultaneously, the compound addresses two hallmark pathologies of Alzheimer's disease. This dual mechanism is intended to slow cognitive decline in early symptomatic Alzheimer's disease.
Approved indications
- Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage)
Common side effects
- Gastrointestinal disturbances (nausea, diarrhea)
- Headache
- Dizziness
Key clinical trials
- A Study of Buntanetap in Participants With PD (PHASE2, PHASE3)
- A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD (PHASE3)
- A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD (PHASE2, PHASE3)
- A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- buntanetap/posiphen CI brief — competitive landscape report
- buntanetap/posiphen updates RSS · CI watch RSS
- Annovis Bio Inc. portfolio CI
Frequently asked questions about buntanetap/posiphen
What is buntanetap/posiphen?
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Is buntanetap/posiphen also known as anything else?
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Related
- Drug class: All Translation inhibitor; protein synthesis modulator drugs
- Target: All drugs targeting APP (amyloid precursor protein) and tau mRNA translation initiation
- Manufacturer: Annovis Bio Inc. — full pipeline
- Therapeutic area: All drugs in Neurology; Alzheimer's disease
- Indication: Drugs for Early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia stage)
- Also known as: Posiphen Tartrate, ANVS401
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing