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Fraxiparine
Fraxiparine is a Small molecule drug developed by Leiden University Medical Center. It is currently in Phase 1 development for Deep venous thrombosis. Also known as: LMWH.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | Fraxiparine |
|---|---|
| Also known as | LMWH |
| Sponsor | Leiden University Medical Center |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 1 |
Approved indications
- Deep venous thrombosis
Common side effects
Key clinical trials
- Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis (PHASE3)
- Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk (PHASE4)
- Reduced Anticoagulation Targets in ECLS (RATE) (PHASE3)
- Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT） (PHASE4)
- Leiden Trial in Prevention of Post-Operative ThromboEmbolic Events (NA)
- The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity (PHASE3)
- Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine (PHASE2)
- Kinetics of Extracellular Vesicles in Hemodialysis
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:
- Fraxiparine CI brief — competitive landscape report
- Fraxiparine updates RSS · CI watch RSS
- Leiden University Medical Center portfolio CI
Frequently asked questions about Fraxiparine
What is Fraxiparine?
What is Fraxiparine used for?
Who makes Fraxiparine?
Is Fraxiparine also known as anything else?
What development phase is Fraxiparine in?
Related
- Manufacturer: Leiden University Medical Center — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Deep venous thrombosis
- Also known as: LMWH
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing