MedPath

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

Title
Posted
Study ID
Phase
Status
Sponsor
2018/12/19
Phase 4
Completed
2018/03/19
Phase 4
Completed
Third Affiliated Hospital, Sun Yat-Sen University
2016/09/09
Phase 4
Terminated
2016/07/07
Phase 4
UNKNOWN
2016/05/17
Phase 4
UNKNOWN
Seng Gee Lim
2015/11/26
Phase 1
UNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University
2015/05/19
Phase 2
Completed
Chang Gung Memorial Hospital
2014/11/26
N/A
UNKNOWN
Beijing Ditan Hospital
2014/10/01
N/A
UNKNOWN
Beijing Ditan Hospital
2014/02/07
Phase 3
Terminated

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
No HSA approvals found for this drug.

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
SEBIVO
novartis pharmaceuticals canada inc
02288389
Tablet - Oral
600 MG
12/14/2006

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
SEBIVO 600 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
07388001
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Not Commercialized
SEBIVO 20 mg/ml SOLUCION ORAL
07388003
SOLUCIÓN ORAL
Uso Hospitalario
Not Commercialized

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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