Last reviewed · How we verify
Polypill
Polypill is a Small molecule drug developed by Isfahan University of Medical Sciences. It is currently in Phase 3 development. Also known as: Polypill-S, Red Heart Pill, PolyPill-E, Polypill-V, PolyPill 4-2.
-
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).
| 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 | Polypill |
|---|---|
| Also known as | Polypill-S, Red Heart Pill, PolyPill-E, Polypill-V, PolyPill 4-2, PolyPill 4-1 |
| Sponsor | Isfahan University of Medical Sciences |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease (PHASE3)
- A Polypill for Acute Coronary Syndrome (PHASE2)
- Heart Failure Polypill at a Safety Net Hospital (PHASE2)
- Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II) (PHASE3)
- Polypill Strategy for Heart Failure With Reduced Ejection Fraction (PHASE2)
- Phase 2 Estimation Study of Fixed Dose Drugs Combination Type of Polypill (PHASE2)
- Cross-over Study of Coronary Risk Factors With a Polypill (PHASE4)
- Polypill for Prevention of Cardiomyopathy (PHASE1, 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:
- Polypill CI brief — competitive landscape report
- Polypill updates RSS · CI watch RSS
- Isfahan University of Medical Sciences portfolio CI
Frequently asked questions about Polypill
What is Polypill?
Who makes Polypill?
Is Polypill also known as anything else?
What development phase is Polypill in?
Related
- Manufacturer: Isfahan University of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Polypill-S, Red Heart Pill, PolyPill-E, Polypill-V, PolyPill 4-2, PolyPill 4-1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing