This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

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.

Pharmacology
Reduce drug development failure rates
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Contraindications & Blackbox Warnings
Contraindications
Avoid life-threatening adverse drug events
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Pharmacodynamics

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
Adverseeffects
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Toxicity

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
  1. 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]
  2. 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]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentSurgical Blood Loss2
3CompletedTreatmentMaintenance of surgical hemostasis therapy1
3CompletedTreatmentSpinal Surgery / Vascular Surgery1
3RecruitingTreatmentMaintenance of surgical hemostasis therapy1
2CompletedTreatmentMaintenance of surgical hemostasis therapy1
1, 2CompletedTreatmentHepatectomy1

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