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Posiphen
Posiphen is a Small molecule drug developed by Annovis Bio Inc.. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Posiphen |
|---|---|
| Sponsor | Annovis Bio Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
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)
- Phenserine on the Alzheimer's Treatment Horizon, Study 1 (PHASE1)
- Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease (PHASE1, PHASE2)
- Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients (PHASE1, PHASE2)
- Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment (PHASE1)
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:
- Posiphen CI brief — competitive landscape report
- Posiphen updates RSS · CI watch RSS
- Annovis Bio Inc. portfolio CI
Frequently asked questions about Posiphen
What is Posiphen?
Who makes Posiphen?
What development phase is Posiphen in?
Related
- Manufacturer: Annovis Bio Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing