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BP1.3656 low dose
BP1.3656 low dose is a ACE inhibitor Small molecule drug developed by Bioprojet. It is currently in Phase 2 development for Hypertension.
BP1.3656 low dose is a medication that lowers blood pressure by acting on the renin-angiotensin system.
BP1.3656 low dose is a medication that lowers blood pressure by acting on the renin-angiotensin system. Used for Hypertension.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | BP1.3656 low dose |
|---|---|
| Sponsor | Bioprojet |
| Drug class | ACE inhibitor |
| Target | Angiotensin-converting enzyme (ACE) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
BP1.3656 low dose works by inhibiting the angiotensin-converting enzyme (ACE), which is involved in the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This leads to vasodilation and a decrease in blood pressure. The exact mechanism of action is not fully understood, but it is believed to involve the blockade of the renin-angiotensin-aldosterone system (RAAS).
Approved indications
- Hypertension
Common side effects
- Cough
- Dizziness
- Headache
Key clinical trials
- Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment (PHASE2)
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:
- BP1.3656 low dose CI brief — competitive landscape report
- BP1.3656 low dose updates RSS · CI watch RSS
- Bioprojet portfolio CI
Frequently asked questions about BP1.3656 low dose
What is BP1.3656 low dose?
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Related
- Drug class: All ACE inhibitor drugs
- Target: All drugs targeting Angiotensin-converting enzyme (ACE)
- Manufacturer: Bioprojet — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing