HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% (heparin sodium)
Heparin Sodium is an anticoagulant indicated for the prophylaxis and treatment of venous thrombosis, pulmonary embolism, and peripheral arterial embolism. It is utilized for the prevention of postoperative deep venous thrombosis (DVT) and pulmonary embolism in patients undergoing major abdominothoracic surgery or those at high risk for thromboembolic disease. Additionally, it is indicated for atrial fibrillation with embolization and the management of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation). Heparin is also used to maintain anticoagulation during medical procedures including blood transfusions, extracorporeal circulation, dialysis, and arterial or cardiac surgery.
How HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% Works
Heparin functions by interacting with the naturally occurring plasma protein Antithrombin III (ATIII). This interaction induces a conformational change in ATIII that markedly accelerates its ability to inhibit activated coagulation factors, specifically Factor Xa and Factor IIa (thrombin). By inhibiting thrombin, heparin prevents the conversion of fibrinogen to fibrin, thereby hindering the formation of stable fibrin clots. It is important to note that heparin does not possess fibrinolytic activity and will not lyse or dissolve existing thrombi.
Details
- Status
- Prescription
- First Approved
- 1972-02-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% Approval History
What HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% Treats
6 indicationsHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% is approved for 6 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Venous Thrombosis
- Pulmonary Embolism
- Deep Venous Thrombosis
- Atrial Fibrillation
- Disseminated Intravascular Coagulation
- Peripheral Arterial Embolism
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%'s indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06646328 | FER-CIT-2016-01 2016-004361-12 | Ph 4 | terminated | Oxidative Stress and Circulating Nuclear DNA (cfDNA) in Acute Kidney Injury and Continuous Renal Replacement Therapies. |
| NCT04743011 EnHanCed results posted | UPECLIN-MB-2 | Ph 1, Ph 2 | completed | Enriched Heparin Anti COVID-19 Trial |
| NCT03707418 | IRB00176475 | Ph 1 | withdrawn | Bivalirudin vs Heparin in ECMO Patients |
| NCT02206087 | PER977-01-002 | Ph 1, Ph 2 | completed | Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% FDA Label Details
Indications & Usage
FDA Label (PDF)HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% is indicated for the treatment of Venous Thrombosis; Pulmonary Embolism; Deep Venous Thrombosis; Atrial Fibrillation; Disseminated Intravascular Coagulation; Peripheral Arterial Embolism.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.