Telbivudine
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2006
- First approval year
- 2006
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Telbivudine
- Molecular weight
- 242.23
- Structure (SMILES)
- Cc1cn([C@@H]2C[C@@H](O)[C@H](CO)O2)c(=O)[nH]c1=O
- sebivo
- Sebivo
- tyzeka
- Tyzeka
- 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.
- ATC classification codes
- J05AF11
Sources for recorded values
- CAS registry numbers
- 3424-98-4
- ChEMBL ID
- CHEMBL374731
- InChIKey
- IQFYYKKMVGJFEH-CSMHCCOUSA-N
- PubChem compound IDs
- 159269
- RxNorm IDs (RxCUI)
- 474128
- FDA ingredient codes (UNII)
- 2OC4HKD3SF
- Applicant
- NOVARTIS
- Approval date
- 25 Oct 2006
- Application number
- NDA022011
- 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- Withdrawn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
- First in class
- No
- Orphan designation
- No
- Availability
- discontinued
- Boxed warning
- Yes
- 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
- 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
- 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
- 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.
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And 18 more, listed on the interactive page.
- 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
- Recorded assays
- 399
- Active assays
- 10
Active assay types
- Confirmatory
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
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
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Approved for (3)
In development for (2)
- Cirrhosis of liver Phase 3
- Hepatitis Phase 3