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Fibrates
Fibrates is a Small molecule drug developed by Azienda Ospedaliero, Universitaria Pisana. It is currently in Phase 1 development.
Fibrates, specifically bezafibrate, are a class of small molecule drugs that act as peroxisome proliferator-activated receptor agonists. They are used to treat various metabolic disorders, including hypertriglyceridemia, and are also being studied for other conditions such as primary sclerosing cholangitis and diabetic nephropathy.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Fibrates |
|---|---|
| Sponsor | Azienda Ospedaliero, Universitaria Pisana |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes (PHASE2)
- Adding Evolocumab to Conventional Lipid-lowering Therapy for Hypertriglyceridemia Induced Acute Pancreatitis (NA)
- Evolocumab in Patients With Multivessel Coronary Disease After Acute Myocardial Infarction: A Target Trial Emulation
- Liraglutide Effect in Atrial Fibrillation (PHASE4)
- COAST Study - Cholesterol Optimization After Stroke
- Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
- Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation (PHASE2)
- Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO) (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:
- Fibrates CI brief — competitive landscape report
- Fibrates updates RSS · CI watch RSS
- Azienda Ospedaliero, Universitaria Pisana portfolio CI
Frequently asked questions about Fibrates
What is Fibrates?
Who makes Fibrates?
What development phase is Fibrates in?
Related
- Manufacturer: Azienda Ospedaliero, Universitaria Pisana — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing