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Bryostatin
Bryostatin is a Small molecule drug developed by Neurotrope Bioscience, Inc.. It is currently in Phase 2 development.
Bryostatin 1 is a small molecule modulator of protein kinase C, studied in clinical trials for various conditions including Head and Neck Cancer, Alzheimer's Disease, and Kidney Cancer. It has been investigated as a potential treatment in these conditions, with clinical trials comparing its efficacy to a placebo.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Bryostatin |
|---|---|
| Sponsor | Neurotrope Bioscience, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Safety of Bryostatin in Patients With MS (PHASE1)
- Bryostatin Treatment of Moderately Severe Alzheimer's Disease (PHASE2)
- Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer (PHASE2)
- A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine (PHASE2)
- Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer (PHASE2)
- A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease (PHASE2)
- Study to Evaluate the Preliminary Safety, Efficacy, PK and PD of Bryostatin 1 in Patients With Alzheimer's Disease (PHASE1, PHASE2)
- Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment (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:
- Bryostatin CI brief — competitive landscape report
- Bryostatin updates RSS · CI watch RSS
- Neurotrope Bioscience, Inc. portfolio CI
Frequently asked questions about Bryostatin
What is Bryostatin?
Who makes Bryostatin?
What development phase is Bryostatin in?
Related
- Manufacturer: Neurotrope Bioscience, Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing