Saturday, July 11, 2026

Drug profile · INN

telbivudine

telbivudine (SEBIVO) is a dna polymerase/reverse transcriptase inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: withdrawn NMPA: clinical trials Antiinfectives for systemic use (J05) J05AF11
US status approved
Patents linked 0
Pipeline programs 6
News articles 0
Drug details — telbivudine
US status
approved
Class
Antiinfectives for systemic use (J05)
Route
ORAL
Patents
0
Programs
6
Data quality
0.84

Quick answer

telbivudine (SEBIVO) is a dna polymerase/reverse transcriptase inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN telbivudine
Brand SEBIVO
Mechanism DNA polymerase/reverse transcriptase inhibitor
Target DNA polymerase/reverse transcriptase
Therapeutic class Antiinfectives for systemic use (J05)
Route ORAL
Formulation SOLUTION
ATC code J05AF11

Mechanism of action

DNA polymerase/reverse transcriptase inhibitor

Primary target: DNA polymerase/reverse transcriptase

Approval history

Authority Status Date
FDA approved
EMA withdrawn
NMPA clinical trials

Pipeline programs

  1. Telbivudine Phase 3 · Novartis India · Hepatitis
  2. telbivudine or lamivudine Phase 3 · Novartis India · Chronic Hepatitis B
  3. LDT600 (Telbivudine) Phase 1 · Novartis India · Chronic Hepatitis B
  4. Telbivudine treatment Approved · Chinese Academy of · Chronic Hepatitis B
  5. telbivudine (ROADMAP) Approved · Chinese Academy of · Hepatitis B, Chronic
  6. Telbivudine Unknown · Chinese University of · Chronic Hepatitis B

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. colistimethate sodium Antiinfectives for systemic use (J01)
  3. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  4. daptomycin Antiinfectives for systemic use (J01)
  5. darunavir Antiinfectives for systemic use (J05)
  6. dengue tetravalent vaccine (live, attenuated) Antiinfectives for systemic use (J07)

Frequently asked questions

What is telbivudine?

telbivudine (SEBIVO) is a dna polymerase/reverse transcriptase inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for telbivudine?

SEBIVO is a marketed brand name for telbivudine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of telbivudine?

telbivudine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.