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Dalcetrapib (RO4607381)
Dalcetrapib (RO4607381) is a CETP inhibitor Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Cardiovascular risk reduction in patients with coronary heart disease or high cardiovascular risk (Phase 3 development).
Dalcetrapib inhibits cholesteryl ester transfer protein (CETP) to increase HDL cholesterol and reduce LDL cholesterol levels.
Dalcetrapib inhibits cholesteryl ester transfer protein (CETP) to increase HDL cholesterol and reduce LDL cholesterol levels. Used for Cardiovascular risk reduction in patients with coronary heart disease or high cardiovascular risk (Phase 3 development).
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care. -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Dalcetrapib (RO4607381) |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | CETP inhibitor |
| Target | CETP (Cholesteryl ester transfer protein) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
CETP is responsible for transferring cholesteryl esters from HDL to apoB-containing lipoproteins. By blocking this enzyme, dalcetrapib increases HDL-C levels and decreases LDL-C and triglycerides, potentially improving the lipid profile and reducing cardiovascular risk. This mechanism was intended to provide additional cardiovascular benefit beyond standard statin therapy.
Approved indications
- Cardiovascular risk reduction in patients with coronary heart disease or high cardiovascular risk (Phase 3 development)
Common side effects
- Increased uric acid levels
- Hyperuricemia
- Gout
- Headache
Key clinical trials
- A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent. (PHASE2)
- A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome (PHASE3)
- A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381 (PHASE2)
- A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease (PHASE2)
- A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients (PHASE2)
- A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C) (PHASE2)
- A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers (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:
- Dalcetrapib (RO4607381) CI brief — competitive landscape report
- Dalcetrapib (RO4607381) updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about Dalcetrapib (RO4607381)
What is Dalcetrapib (RO4607381)?
How does Dalcetrapib (RO4607381) work?
What is Dalcetrapib (RO4607381) used for?
Who makes Dalcetrapib (RO4607381)?
What drug class is Dalcetrapib (RO4607381) in?
What development phase is Dalcetrapib (RO4607381) in?
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What does Dalcetrapib (RO4607381) target?
Related
- Drug class: All CETP inhibitor drugs
- Target: All drugs targeting CETP (Cholesteryl ester transfer protein)
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Cardiovascular risk reduction in patients with coronary heart disease or high cardiovascular risk (Phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing