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Fragmin (dalteparin)
Fragmin (dalteparin) is a Low-molecular-weight heparin (LMWH) Small molecule drug developed by Ottawa Hospital Research Institute. It is currently in Phase 3 development for Venous thromboembolism prophylaxis in surgical patients, Treatment of acute deep vein thrombosis, Treatment of acute pulmonary embolism. Also known as: Fragmin.
Dalteparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factor Xa and thrombin.
Dalteparin is a low-molecular-weight heparin that inhibits blood clotting by enhancing the activity of antithrombin III against factor Xa and thrombin. Used for Venous thromboembolism prophylaxis in surgical patients, Treatment of acute deep vein thrombosis, Treatment of acute pulmonary embolism.
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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.
| 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 | Fragmin (dalteparin) |
|---|---|
| Also known as | Fragmin |
| Sponsor | Ottawa Hospital Research Institute |
| Drug class | Low-molecular-weight heparin (LMWH) |
| Target | Antithrombin III (indirect); Coagulation Factor Xa and Factor IIa (thrombin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Dalteparin binds to and potentiates antithrombin III, a natural anticoagulant, leading to inactivation of coagulation factors Xa and IIa (thrombin). This prevents thrombus formation and propagation. Low-molecular-weight heparins like dalteparin have more predictable pharmacokinetics and longer half-lives than unfractionated heparin, allowing for subcutaneous dosing.
Approved indications
- Venous thromboembolism prophylaxis in surgical patients
- Treatment of acute deep vein thrombosis
- Treatment of acute pulmonary embolism
- Unstable angina and non-ST elevation myocardial infarction
Common side effects
- Bleeding
- Thrombocytopenia
- Injection site hematoma
- Elevated liver enzymes
Key clinical trials
- Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility
- Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism (PHASE4)
- Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma
- Timing of Venous Thromboembolism Prophylaxis in Patients With Hypertensive Intracerebral Hemorrhage (NA)
- Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS (NA)
- Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients (OPTI-TREX) (PHASE4)
- Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia (PHASE4)
- The Intensive Care Platform Trial (PHASE4)
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:
- Fragmin (dalteparin) CI brief — competitive landscape report
- Fragmin (dalteparin) updates RSS · CI watch RSS
- Ottawa Hospital Research Institute portfolio CI
Frequently asked questions about Fragmin (dalteparin)
What is Fragmin (dalteparin)?
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What is Fragmin (dalteparin) used for?
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Is Fragmin (dalteparin) also known as anything else?
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Related
- Drug class: All Low-molecular-weight heparin (LMWH) drugs
- Target: All drugs targeting Antithrombin III (indirect); Coagulation Factor Xa and Factor IIa (thrombin)
- Manufacturer: Ottawa Hospital Research Institute — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Venous thromboembolism prophylaxis in surgical patients
- Indication: Drugs for Treatment of acute deep vein thrombosis
- Indication: Drugs for Treatment of acute pulmonary embolism
- Also known as: Fragmin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing