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Phenserine
Phenserine is a Small molecule drug developed by Helse Stavanger HF. It is currently in Phase 1 development.
Phenserine is a small molecule that has been investigated as a potential treatment for Alzheimer's disease and other conditions such as amnestic mild cognitive impairment and Parkinson disease. It was initially developed by the National Institute on Aging and was investigated in clinical trials, including a phase III trial in 2006, but its development was suspended.
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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 | Phenserine |
|---|---|
| Sponsor | Helse Stavanger HF |
| 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:
- Phenserine CI brief — competitive landscape report
- Phenserine updates RSS · CI watch RSS
- Helse Stavanger HF portfolio CI
Frequently asked questions about Phenserine
What is Phenserine?
Who makes Phenserine?
What development phase is Phenserine in?
Related
- Manufacturer: Helse Stavanger HF — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing