> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/telbivudine-5718dabe-4058-4559-b924-29d47b6e47ed
> Record changed: 2026-10-13

# Telbivudine

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

First approval year

2006

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

## Development status

**First approval year**

2006

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

**Drug name**

Telbivudine

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

**Molecular weight**

242.23

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

**Structure (SMILES)**

Cc1cn(\[C@@H\]2C\[C@@H\](O)\[C@H\](CO)O2)c(=O)\[nH\]c1=O

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

### Brand names (4)

- sebivo
- Sebivo
- tyzeka
- Tyzeka

### Other names (37)

- 2 4 1h 3h pyrimidinedione 1 2 deoxy beta l erythro pentofuranosyl 5 methyl
- 2 deoxy l thymidine
- 2,4(1H,3H)-PYRIMIDINEDIONE,1-(2-DEOXY-.BETA.-L-ERYTHRO-PENTOFURANOSYL)-5-METHYL-
- 2'-deoxy-l-thymidine
- ldt 600
- ldt telbivudine and lamivudine
- LDT-600
- ldt600
- LDT600
- LDT600 (Telbivudine)
- nv 02b
- NV-02B
- Sebivo
- telbivudina
- Telbivudina
- telbivudine
- Telbivudine
- Telbivudine (LdT)
- telbivudine (ROADMAP)
- Telbivudine (Standard of Care)
- TELBIVUDINE \[EMA EPAR\]
- telbivudine \[INN\]
- TELBIVUDINE \[MART.\]
- TELBIVUDINE \[MI\]
- TELBIVUDINE \[ORANGE BOOK\]

And 12 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- J05AF11

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

**CAS registry numbers**

- 3424-98-4

**ChEMBL ID**

CHEMBL374731

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

**InChIKey**

IQFYYKKMVGJFEH-CSMHCCOUSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL374731)

**PubChem compound IDs**

- 159269

**RxNorm IDs (RxCUI)**

- 474128

**FDA ingredient codes (UNII)**

- 2OC4HKD3SF

## Regulatory information

### United States

**Applicant**

NOVARTIS

**Approval date**

25 Oct 2006

**Application number**

NDA022011

### European Union

**Status**

Withdrawn

**Authorisation date**

24 Apr 2007

**Approved indications**

Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.

**Product number**

EMEA/H/C/000713

**Authorisation holder**

Novartis Europharm Limited

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Hepatitis B, Chronic

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/sebivo)

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

discontinued

**Boxed warning**

Yes

## Pharmacology

### Drug classification

**Drug name stem**

\-vudine

#### Administration routes

- Oral

### Mechanisms of action

- **Mechanism**  
DNA polymerase/reverse transcriptase inhibitor

**Action type**  
Inhibitor

**Target**  
DNA polymerase/reverse transcriptase

**Protein identifier**  
Q9IF40

### Open Targets mechanisms

- **Mechanism**  
DNA polymerase/reverse transcriptase inhibitor

**Action type**  
Inhibitor

**Target**  
DNA polymerase/reverse transcriptase

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
P

**Protein identifier**  
Q9IF40

**Organism**  
Hepatitis B virus

### Investigated indications (5)

- **Condition**  
Virus Diseases

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000763

**Subject identifier**  
D014777
- **Condition**  
Liver Cirrhosis

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001422

**Subject identifier**  
D008103
- **Condition**  
Hepatitis B, Chronic

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0004197

**Subject identifier**  
D019694
- **Condition**  
Hepatitis B, Chronic

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0004239

**Subject identifier**  
D019694
- **Condition**  
Hepatitis

**Highest recorded phase**  
3

**Condition identifier**  
HP:0012115

**Subject identifier**  
D006505

### Open Targets indications (13)

- **Condition identifier**  
EFO\_0000763
- **Condition identifier**  
EFO\_0001422

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004197
- **Condition identifier**  
EFO\_0004239
- **Condition identifier**  
HP\_0012115

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0001343

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005108

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005155

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005244

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005300
- **Condition identifier**  
MONDO\_0005344

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005366

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0007256

### Warnings

- **Warning**  
Black Box Warning

### Open Targets warnings

- **Warning**  
Black Box Warning

**Country**  
United States

### Reported adverse events (110)

- **Event**  
accessory auricle

**Reports**  
5

**Reporting signal score**

30.803
- **Event**  
acquired gene mutation

**Reports**  
3

**Reporting signal score**

9.06185
- **Event**  
alanine aminotransferase increased

**Reports**  
30

**Reporting signal score**

42.6785
- **Event**  
aldolase abnormal

**Reports**  
3

**Reporting signal score**

22.017
- **Event**  
alpha hydroxybutyrate dehydrogenase increased

**Reports**  
8

**Reporting signal score**

52.8581
- **Event**  
amyotrophy

**Reports**  
4

**Reporting signal score**

16.7052
- **Event**  
anuria

**Reports**  
5

**Reporting signal score**

8.98175
- **Event**  
apolipoprotein b increased

**Reports**  
2

**Reporting signal score**

13.8654
- **Event**  
areflexia

**Reports**  
4

**Reporting signal score**

10.4322
- **Event**  
ascites

**Reports**  
8

**Reporting signal score**

9.51855
- **Event**  
aspartate aminotransferase increased

**Reports**  
31

**Reporting signal score**

48.3861
- **Event**  
asthenia

**Reports**  
44

**Reporting signal score**

32.1699
- **Event**  
asymptomatic viral hepatitis

**Reports**  
5

**Reporting signal score**

39.2583
- **Event**  
base excess increased

**Reports**  
2

**Reporting signal score**

10.7072
- **Event**  
blood bilirubin increased

**Reports**  
9

**Reporting signal score**

10.4746
- **Event**  
blood creatine phosphokinase

**Reports**  
2

**Reporting signal score**

9.38392
- **Event**  
blood creatine phosphokinase abnormal

**Reports**  
3

**Reporting signal score**

11.8341
- **Event**  
blood creatine phosphokinase increased

**Reports**  
165

**Reporting signal score**

625.836
- **Event**  
blood creatine phosphokinase mb increased

**Reports**  
27

**Reporting signal score**

132.852
- **Event**  
blood creatinine increased

**Reports**  
14

**Reporting signal score**

12.5884
- **Event**  
blood lactate dehydrogenase increased

**Reports**  
26

**Reporting signal score**

69.5536
- **Event**  
blood lactic acid increased

**Reports**  
24

**Reporting signal score**

91.5591
- **Event**  
blood ph decreased

**Reports**  
5

**Reporting signal score**

16.3739
- **Event**  
blood phosphorus decreased

**Reports**  
8

**Reporting signal score**

24.1073
- **Event**  
blood uric acid increased

**Reports**  
13

**Reporting signal score**

42.3526

And 85 more, listed on the interactive page.

### Trial references (43)

- NCT00057265  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00057265)
- NCT00076336  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00076336)
- NCT00115245  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00115245)
- NCT00131742  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00131742)
- NCT00132652  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00132652)
- NCT00142298  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00142298)
- NCT00409019  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00409019)
- NCT00412529  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00412529)
- NCT00467545  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00467545)
- NCT00537537  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00537537)
- NCT00606099  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00606099)
- NCT00640588  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00640588)
- NCT00646503  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00646503)
- NCT00710216  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00710216)
- NCT00781105  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00781105)
- NCT00804622  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00804622)
- NCT00810524  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00810524)
- NCT00862706  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00862706)
- NCT00877149  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00877149)
- NCT00907894  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00907894)
- NCT00962533  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00962533)
- NCT01005238  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01005238)
- NCT01270165  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01270165)
- NCT01379508  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01379508)
- NCT01521975  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01521975)

And 18 more, listed on the interactive page.

## Chemical properties

**Hydrogen bond acceptors**

6

**Hydrogen bond donors**

3

**Polar surface area**

104.55

**Calculated partition coefficient (ALogP)**

\-1.51

**Calculated partition coefficient (XLogP)**

\-1.2

**Prodrug**

Yes

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

2

**Heavy atoms**

17

**Molecular formula**

C10H14N2O5

**Monoisotopic mass**

242.09027155

**Natural product**

Yes

## Evidence counts

**Recorded assays**

399

**Active assays**

10

### Active assay types

- Confirmatory

## Pharmacologic actions

- Antiviral Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000998.html)
- Nucleic Acid Synthesis Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D019384.html)

## Biological measurements

### Observed measurements

#### Oral bioavailability

**Median**

52

**Mean**

52

**Minimum**

52

**Maximum**

52

**Unit**

%

**Assays**

1

**Standard deviation**

0

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (633)

- " Study of the Benefit of Nebulized Amikacin in the Treatment of Gram-negative Bacillus Pneumonia Acquired During Mechanical Ventilation in Patients Receiving Extracorporeal Membrane Veno-arterial Oxygenation "
- "A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"
- 177Lu-DOTATATE for Recurrent Meningioma
- A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
- A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
- A Clinical Trial Evaluating the Safety and Efficacy of Myelin-peptide Loaded tolDC as Treatment for MS
- A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
- A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB
- A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
- A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure
- A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
- A Comparison of the Drug Telbivudine (LdT) and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.
- A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer
- A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
- A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL
- A Pharmacogenetic Study of Warfarin Dosing, "The COUMA-GEN Study"
- A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers
- A Phase 1/2/3 Study of UX701 Gene Therapy in Adults With Wilson Disease
- A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
- A Phase 2 Study to Evaluate Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec (Q203) in Covid-19 Patients

### Approved for (3)

- [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md)
- [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md)
- [Viral infectious disease](https://trialight.com/data/condition/viral-infectious-disease-43db42a3-adad-5b9d-b74c-f17df0674c21.md)

### In development for (2)

- [Cirrhosis of liver](https://trialight.com/data/condition/cirrhosis-of-liver-d90e4a84-9e82-54fc-a553-1e42086e8382.md) Phase 3
- [Hepatitis](https://trialight.com/data/condition/hepatitis-6b771058-c7ad-5a5f-aa35-ea69998a764a.md) Phase 3

---

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