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Klexane
Klexane is a Small molecule drug developed by University of Helsinki. It is currently in Phase 3 development.
Klexane, also known as enoxaparin sodium, is an anticoagulant medication used to treat and prevent conditions such as deep vein thrombosis, pulmonary embolism, and habitual abortion. It works as an Antithrombin-III activator, a type of oligosaccharide that helps prevent blood clotting.
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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 | Klexane |
|---|---|
| Sponsor | University of Helsinki |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- : Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery (PHASE4)
- Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation (PHASE2)
- A Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment (ImmCoVA) Study (PHASE2)
- Pharmacokinetics of Enoxaparin in Intensive Care Patients (PHASE4)
- Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage (PHASE4)
- Low Molecular Weight Heparin and/or Aspirin in Prevention of Habitual Abortion (PHASE3)
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:
- Klexane CI brief — competitive landscape report
- Klexane updates RSS · CI watch RSS
- University of Helsinki portfolio CI
Frequently asked questions about Klexane
What is Klexane?
Who makes Klexane?
What development phase is Klexane in?
Related
- Manufacturer: University of Helsinki — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing