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POLICOSANOL
POLICOSANOL is a drug. It is currently in Phase 3 development.
Policosanol is thought to work by inhibiting the enzyme HMG-CoA reductase, which plays a key role in cholesterol synthesis.
Policosanol is a nutraceutical that has been studied in clinical trials for various conditions, including coronary artery disease, hypercholesterolemia, diabetes mellitus, type 2, dyslipidemia, and atherosclerosis. It has been compared to ezetimibe in a clinical trial for statin-intolerant patients, but the results of this comparison are not specified in the provided information.
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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 | POLICOSANOL |
|---|---|
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Mechanism of action
Imagine your body's cells are like factories that produce cholesterol. Policosanol is like a brake that slows down this production process, which can help lower cholesterol levels in the blood. This can be beneficial for people at risk of heart disease.
Approved indications
Common side effects
Key clinical trials
- Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia (PHASE4)
- Policosanol for the Treatment of Hypercholesterolemia (NA)
- Multifactorial Intervention on Diabetes (MIDiab Study) (PHASE4)
- NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients (PHASE4)
- Study of the Cardiovascular Vitamin, CardioLife (NA)
- The Role of a Combination of Nutraceuticals in the Control of Cardiovascular Risk
- Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI) (PHASE4)
- Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy (NA)
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:
- POLICOSANOL CI brief — competitive landscape report
- POLICOSANOL updates RSS · CI watch RSS
Frequently asked questions about POLICOSANOL
What is POLICOSANOL?
How does POLICOSANOL work?
What development phase is POLICOSANOL in?
Related
- Therapeutic area: All drugs in Metabolic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing