Telbivudine
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Also known as 2'-deoxy-l-thymidineLDT-600LDT600NV-02BSebivoTelbivudinaTyzekaTELBIVUDINE (SEBIVO, TYZEKA)Telbivudine (SebivoTyzeka)
Summary
Telbivudine (CHEMBL374731) is an approved small-molecule antiviral drug (ATC J05AF11); indicated across 5 conditions including hepatitis b virus infection and chronic hepatitis b virus infection.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: J05AF11
- Indications: 5 conditions
- Clinical trials: 60
- Chemistry: 242.23 Da · C10H14N2O5
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL374731 |
| Name | Telbivudine |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | no |
| PubChem CID | 159269 |
| ChEBI | CHEBI:63624 |
| ATC | J05AF11 |
| Molecular formula | C10H14N2O5 |
| Molecular weight | 242.23 |
| InChIKey | IQFYYKKMVGJFEH-CSMHCCOUSA-N |
SMILES: CC1=CN(C(=O)NC1=O)[C@@H]2C[C@H]([C@@H](O2)CO)O
IUPAC name: 1-[(2S,4R,5S)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione
ChEBI definition: A pyrimidine 2’-deoxyribonucleoside that is the L-enantiomer of thymine. A synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase.
Pharmacological roles (ChEBI): antiviral drug, EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor.
Also known as: 2’-deoxy-l-thymidine, LDT-600, LDT600, NV-02B, Sebivo, Telbivudina, Telbivudine, Tyzeka, telbivudine, TELBIVUDINE, TELBIVUDINE (SEBIVO, TYZEKA), Telbivudine (Sebivo; Tyzeka)
Patent coverage: 2,578 distinct patent families (8,984 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
5 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| hepatitis B virus infection | 4 | MONDO:0005344 | EFO:0004197 |
| chronic hepatitis B virus infection | 4 | MONDO:0005366 | EFO:0004239 |
| viral infectious disease | 4 | MONDO:0005108 | EFO:0000763 |
| hepatitis | 3 | MONDO:0002251 | HP:0012115 |
| cirrhosis of liver | 3 | MONDO:0005155 | EFO:0001422 |
Clinical trials
Total trials: 60.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE4 | 31 |
| PHASE3 | 13 |
| Not specified | 9 |
| PHASE2 | 3 |
| PHASE1/PHASE2 | 2 |
| PHASE2/PHASE3 | 1 |
| PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00409019 | PHASE4 | WITHDRAWN | Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy |
| NCT00467545 | PHASE4 | COMPLETED | An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B |
| NCT00537537 | PHASE4 | COMPLETED | To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB) |
| NCT00606099 | PHASE4 | WITHDRAWN | Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B |
| NCT00646503 | PHASE4 | COMPLETED | Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B |
| NCT00710216 | PHASE4 | WITHDRAWN | Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B |
| NCT00781105 | PHASE4 | COMPLETED | Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B |
| NCT00810524 | PHASE4 | UNKNOWN | Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection |
| NCT00862706 | PHASE4 | WITHDRAWN | Efficacy of Telbivudine in Blacks/African Americans and Hispanics/Latinos With Compensated Chronic Hepatitis B During 52 Weeks |
| NCT00877149 | PHASE4 | COMPLETED | Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B |
| NCT00939068 | PHASE4 | UNKNOWN | Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission |
| NCT00962533 | PHASE4 | COMPLETED | EFFicacy Optimization Research of Telbivudine Therapy |
| NCT01005238 | PHASE4 | TERMINATED | Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine |
| NCT01102335 | PHASE4 | UNKNOWN | Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy |
| NCT01337791 | PHASE4 | COMPLETED | Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels |
| NCT01379508 | PHASE4 | COMPLETED | Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept |
| NCT01380951 | PHASE4 | UNKNOWN | Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB) |
| NCT01521975 | PHASE4 | COMPLETED | A Two-year Study of Telbivudine in HBeAg Negative Hepatitis |
| NCT01529255 | PHASE4 | UNKNOWN | EFFORT Extension Study |
| NCT01588912 | PHASE4 | UNKNOWN | Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir |
| NCT01597934 | PHASE4 | UNKNOWN | Antiviral Efficacy of Switching to ETV Plus TDF |
| NCT01637844 | PHASE4 | COMPLETED | Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV |
| NCT01693679 | PHASE4 | UNKNOWN | Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis |
| NCT01743079 | PHASE4 | COMPLETED | Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B |
| NCT01788371 | PHASE4 | COMPLETED | Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus |
| NCT01799486 | PHASE4 | UNKNOWN | Telbivudine Renoprotective Effect in Patients With the HBV-related Liver Cirrhosis: a Randomized Controlled Trial |
| NCT02774837 | PHASE4 | UNKNOWN | Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B |
| NCT02826070 | PHASE4 | UNKNOWN | EFFORT Further Extension Study |
| NCT02894554 | PHASE4 | TERMINATED | Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment. |
| NCT03468907 | PHASE4 | COMPLETED | The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation |
| NCT03778567 | PHASE4 | COMPLETED | Renoprotective Effects of Telbivudine in Chronic Hepatitis B |
| NCT00076336 | PHASE3 | COMPLETED | Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis |
| NCT00115245 | PHASE3 | COMPLETED | Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B |
| NCT00131742 | PHASE3 | COMPLETED | Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B |
| NCT00132652 | PHASE3 | COMPLETED | Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B |
| NCT00142298 | PHASE3 | COMPLETED | Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies |
| NCT00376259 | PHASE3 | TERMINATED | Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone |
| NCT00412529 | PHASE3 | COMPLETED | Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B |
| NCT00412750 | PHASE3 | TERMINATED | Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) |
| NCT00640588 | PHASE3 | COMPLETED | Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline, but PharmGKB curates 0 clinical and 3 variant annotation(s) for this drug (gene-keyed; see PharmGKB).
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).