Identification
- Generic Name
- rhThrombin
- DrugBank Accession Number
- DB04923
- Background
rhThrombin (recombinant human thrombin) is being developed by ZymoGenetics, Inc. as a general aid to achieving hemostasis during surgery. ZymoGenetics is developing rhThrombin, a recombinant form of human thrombin that is not derived from animal or human blood, as an aid to controlling bleeding during surgery. Thrombin is used in more than 1 million surgeries each year in the United States. Currently, only thrombin derived from bovine blood is available in the U.S. as a stand-alone thrombin product. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins and in some cases these antibodies appear to be related to serious bleeding complications. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Recombinant thrombin
- Recothrom
- rhThrombin
- rThrombin
Pharmacology
- Indication
Investigated for use/treatment in blood (blood forming organ disorders, unspecified) and hemorrhage.
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Plasma-derived bovine thrombin is used as a topical agent to improve surgical hemostasis, but development of antibodies to bovine hemostatic proteins has been associated with increased bleeding and thrombotic complications. rhThrombin has a superior immunogenicity profile compared with bovine thrombin (1.5% versus 22%, respectively, p<0.0001; antibodies developed to the products, as defined by seroconversion or significant change in titer units). Characterization of the binding antibodies demonstrated none of the anti-rhThrombin antibodies neutralized human plasma thrombin.
- Mechanism of action
The potent hemostatic properties of thrombin derive from its ability to activate platelets directly to aggregate and adhere to damaged vessels and to catalyze the formation simultaneously of a fibrin matrix. Application of exogenous thrombin bypasses the physiological process of generating a thrombin burst by directly initiating the terminal reactions of blood clot formation. rhThrombin rapidly binds to endogenous inhibitors following either i.v. or s.c. administration.
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Approximately 15 hours (measured in non-human primates).
- Clearance
Not Available
- Adverse Effects
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Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- Not Available
Categories
- Drug Categories
- Not Available
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- Not Available
- CAS number
- 1270043-60-1
References
- General References
- Chapman WC, Singla N, Genyk Y, McNeil JW, Renkens KL Jr, Reynolds TC, Murphy A, Weaver FA: A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007 Aug;205(2):256-65. Epub 2007 Jun 27. [Article]
- Heffernan JK, Ponce RA, Zuckerman LA, Volpone JP, Visich J, Giste EE, Jenkins N, Boster D, Pederson S, Knitter G, Palmer T, Wills M, Early RJ, Rogge MC: Preclinical safety of recombinant human thrombin. Regul Toxicol Pharmacol. 2007 Feb;47(1):48-58. Epub 2006 Sep 12. [Article]
- External Links
- Not Available
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Blood Loss During Surgery 2 3 Completed Treatment Maintenance of surgical hemostasis therapy 2 3 Completed Treatment Spinal Surgery / Vascular Surgery 1 2 Completed Treatment Maintenance of surgical hemostasis therapy 1 1, 2 Completed Treatment Hepatectomy 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
- Not Available
- Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Drug created at October 21, 2007 22:23 / Updated at June 12, 2020 16:52