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telbivudine (ROADMAP)
Telbivudine is a nucleoside reverse transcriptase inhibitor that blocks viral reverse transcriptase to inhibit hepatitis B virus replication.
Telbivudine is a nucleoside reverse transcriptase inhibitor that blocks viral reverse transcriptase to inhibit hepatitis B virus replication. Used for Chronic hepatitis B infection.
At a glance
| Generic name | telbivudine (ROADMAP) |
|---|---|
| Sponsor | Nanfang Hospital, Southern Medical University |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) |
| Target | Hepatitis B virus reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Telbivudine is a thymidine nucleoside analog that is phosphorylated intracellularly and incorporated into viral DNA, causing chain termination and inhibiting HBV reverse transcriptase. This prevents the synthesis of viral DNA and reduces viral load in patients with chronic hepatitis B infection.
Approved indications
- Chronic hepatitis B infection
Common side effects
- Myopathy
- Elevated creatine kinase
- Lactic acidosis
- Hepatitis flare
- Nausea
- Fatigue
Key clinical trials
- Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept (PHASE4)
- A Two-year Study of Telbivudine in HBeAg Negative Hepatitis (PHASE4)
- EFFORT Extension Study (PHASE4)
- A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB) (PHASE4)
- EFFicacy Optimization Research of Telbivudine Therapy (PHASE4)
- Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- telbivudine (ROADMAP) CI brief — competitive landscape report
- telbivudine (ROADMAP) updates RSS · CI watch RSS
- Nanfang Hospital, Southern Medical University portfolio CI