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Telbivudine

Generic Name
Telbivudine
Drug Type
Small Molecule
Chemical Formula
C10H14N2O5
CAS Number
3424-98-4
Unique Ingredient Identifier
2OC4HKD3SF

Overview

Telbivudine is a synthetic thymidine nucleoside analog with specific activity against the hepatitis B virus. Telbivudine is orally administered, with good tolerance, lack of toxicity and no dose-limiting side effects.

Indication

For the treatment of chronic hepatitis B in adult and adolescent patients ≥16 years of age with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Associated Conditions

  • Chronic Hepatitis B Infection

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2007/04/30
Phase 4
Completed
2006/12/18
Phase 3
Completed
2006/12/18
Phase 3
Terminated
2006/12/08
Phase 4
Withdrawn
2006/09/14
Phase 3
Terminated
2006/01/12
Phase 3
Completed
2005/09/02
Phase 3
Completed
2005/08/22
Phase 3
Completed
2005/08/19
Phase 3
Completed
2005/08/10
Phase 2
Completed

FDA Drug Approvals

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EMA Drug Approvals

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NMPA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Philippines FDA Drug Approvals

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UK EMC Drug Information

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