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clofibrate clofibrate
clofibrate clofibrate is a Fibric acid derivative (fibrate) Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development.
Clofibrate activates peroxisome proliferator-activated receptor alpha (PPAR-α) to increase lipoprotein lipase activity and reduce triglyceride levels.
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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 | clofibrate clofibrate |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | Fibric acid derivative (fibrate) |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Clofibrate is a prodrug that is hydrolyzed to clofibric acid, which activates PPAR-α nuclear receptors. This activation increases the expression of lipoprotein lipase, enhances fatty acid oxidation, and reduces hepatic triglyceride production, ultimately lowering serum triglycerides and VLDL cholesterol levels.
Approved indications
Common side effects
Key clinical trials
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:
- clofibrate clofibrate CI brief — competitive landscape report
- clofibrate clofibrate updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about clofibrate clofibrate
What is clofibrate clofibrate?
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Who makes clofibrate clofibrate?
What drug class is clofibrate clofibrate in?
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Related
- Drug class: All Fibric acid derivative (fibrate) drugs
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing