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Unfractioned heparin
Unfractioned heparin is a Anticoagulant Small molecule drug developed by Universidad de Antioquia. It is currently in Phase 3 development for Prophylaxis and treatment of deep vein thrombosis, Prophylaxis and treatment of pulmonary embolism, Prophylaxis and treatment of atrial fibrillation for stroke prevention. Also known as: standard heparin, Sodic Heparin.
Unfractionated heparin works by activating antithrombin, a protein that inhibits the coagulation cascade.
Unfractionated heparin is used to prevent venous thromboembolism and is studied in conditions such as pulmonary embolism and acute kidney injury. It works by activating Antithrombin-III, a protein that inhibits blood clot formation.
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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 | Unfractioned heparin |
|---|---|
| Also known as | standard heparin, Sodic Heparin |
| Sponsor | Universidad de Antioquia |
| Drug class | Anticoagulant |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
This leads to the inhibition of thrombin and factor Xa, resulting in a decrease in blood clot formation. Unfractionated heparin also has a direct effect on the coagulation cascade by binding to and activating antithrombin, which in turn inhibits the conversion of prothrombin to thrombin.
Approved indications
- Prophylaxis and treatment of deep vein thrombosis
- Prophylaxis and treatment of pulmonary embolism
- Prophylaxis and treatment of atrial fibrillation for stroke prevention
- Prophylaxis and treatment of myocardial infarction
Common side effects
- Bleeding
- Thrombocytopenia
- Hypersensitivity reactions
- Osteoporosis
Key clinical trials
- A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229 (PHASE1)
- Unfractioned Heparin for Treatment of Sepsis Caused by Abdominal Infection (PHASE3)
- HEParin Antagonisation in Transcatheter Aortic Valve Implantation
- CoV-Hep Study: Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19 (NA)
- Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure (PHASE4)
- Low Dose Catheter Directed Thrombolysis for Acute Pulmonary Embolism (PHASE2)
- Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers (PHASE4)
- Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (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:
- Unfractioned heparin CI brief — competitive landscape report
- Unfractioned heparin updates RSS · CI watch RSS
- Universidad de Antioquia portfolio CI
Frequently asked questions about Unfractioned heparin
What is Unfractioned heparin?
How does Unfractioned heparin work?
What is Unfractioned heparin used for?
Who makes Unfractioned heparin?
Is Unfractioned heparin also known as anything else?
What drug class is Unfractioned heparin in?
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What are the side effects of Unfractioned heparin?
Related
- Drug class: All Anticoagulant drugs
- Manufacturer: Universidad de Antioquia — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Prophylaxis and treatment of deep vein thrombosis
- Indication: Drugs for Prophylaxis and treatment of pulmonary embolism
- Indication: Drugs for Prophylaxis and treatment of atrial fibrillation for stroke prevention
- Also known as: standard heparin, Sodic Heparin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing