Overview
Bemiparin is an antithrombotic and belongs to the group of drugs known as the low molecular weight heparins (LMWH). Like semuloparin, bemiparin is classified as an ultra-LMH because of its low mean molecular mass of 3600 daltons, which is a unique property of this class . These heparins have lower anti-thrombin activity than the traditional low molecular weight heparins and act mainly on factor-Xa, reducing the risk of bleeding due to selectivity for this specific clotting factor. Interestingly, current research is underway for the potential benefit of bemiparin in the treatment of tumors and diabetic foot ulcers .
Indication
Bemiparin is indicated in the following cases: To prevent blood clots in the veins after general abdominal surgery in patients with a moderate risk of venous thromboembolism; in the prevention of the thromboembolic disease in non-surgical patients; prevention of clotting in the extracorporeal circuit during hemodialysis; to prevent blood clots in the veins after a major orthopedic surgery in patients with high risk of venous thromboembolism; secondary prevention of venous thromboembolism; recurrence in patients with deep vein thrombosis; transient prevention and treatment of deep vein thrombosis (DVT) .
Associated Conditions
- Extracorporeal Clotting During Hemodialysis
- Thromboembolism
Research Report
Bemiparin: A Comprehensive Pharmacological and Clinical Monograph
Section 1: Executive Summary & Drug Identification
1.1. Overview of Bemiparin as a Second-Generation Low Molecular Weight Heparin (LMWH)
Bemiparin is a potent antithrombotic agent belonging to the class of low molecular weight heparins (LMWHs).[1] It is distinguished as a second-generation, or ultra-low molecular weight heparin (ultra-LMWH), a classification defined by a unique and optimized pharmacological profile.[3] This profile is characterized by three key features that set it apart from both unfractionated heparin (UFH) and first-generation LMWHs: the lowest mean molecular weight among its peers (approximately 3,600 Daltons), the longest elimination half-life (5 to 6 hours), and the highest ratio of anti-Factor Xa to anti-Factor IIa activity (approximately 8:1).[2] These properties collectively result in a highly predictable anticoagulant response, a favorable efficacy-to-safety balance, and the clinical convenience of a once-daily subcutaneous dosing regimen for its primary indications.[8] Bemiparin is principally used for the prophylaxis and treatment of venous thromboembolism (VTE) and for the prevention of clotting in extracorporeal circuits during hemodialysis.[2]
1.2. Key Identifiers
For the purpose of unambiguous identification in clinical, regulatory, and research contexts, Bemiparin is defined by the following identifiers:
- Generic Name: Bemiparin; Bemiparin Sodium [1]
- DrugBank ID: DB09258 [4]
- CAS Number: 91449-79-5 [5]
- Type: Small Molecule [4]
- ATC Code: B01AB12 (Heparin group) [10]
- International Brand Names: Hibor, Ivor, Zibor, Badyket [3]
1.3. Primary Therapeutic Class and Distinguishing Features
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/10/06 | Not Applicable | Recruiting | |||
2020/10/27 | Phase 3 | UNKNOWN | Clinica Universidad de Navarra, Universidad de Navarra | ||
2020/06/09 | Phase 2 | Terminated | Fundación de investigación HM | ||
2018/07/26 | Early Phase 1 | Completed | |||
2016/06/16 | Phase 3 | UNKNOWN | Instituto de Investigación Marqués de Valdecilla | ||
2016/06/09 | Not Applicable | Completed | Mohamed Sayed Mohamed Abbas | ||
2015/11/18 | Phase 4 | Completed | |||
2013/06/18 | Phase 3 | Completed | Berlin-Chemie AG Menarini Group | ||
2012/06/28 | Not Applicable | Completed | |||
2012/04/30 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
HIBOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES 2,500 IU ANTI-XA/0.2 ML | SIN16463P | INJECTION, SOLUTION | 2,500 IU Anti-Xa/0.2 ml | 4/1/2022 | |
HIBOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES 3,500 IU ANTI-XA/0.2 ML | SIN16462P | INJECTION, SOLUTION | 3,500 IU Anti-Xa/0.2 ml | 4/1/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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