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Drug ReportsTelbivudine
Tyzeka, Sebivo(telbivudine)
Sebivo, Tyzeka (telbivudine) is a small molecule pharmaceutical. Telbivudine was first approved as Tyzeka on 2006-10-25. It is used to treat chronic hepatitis b and hepatitis b in the USA. It has been approved in Europe to treat chronic hepatitis b.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Telbivudine
Tradename
Company
Number
Date
Products
TYZEKANovartisN-022011 DISCN2006-10-25
1 products, RLD
TYZEKANovartisN-022154 DISCN2009-04-28
1 products
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatitis b—D006509—
chronic hepatitis bEFO_0004239D019694B18.1
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
— J05AF11: Telbivudine
HCPCS
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Clinical
Clinical Trials
95 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis bD006509——41016321674
HepatitisD006505HP_0012115K75.941016321472
Chronic hepatitis bD019694EFO_0004239B18.14913301163
Hepatitis aD006506EFO_0007305B153815271262
Chronic hepatitisD006521—K73.935919740
Liver cirrhosisD008103EFO_0001422K74.0—12328
FibrosisD005355———124—7
CarcinomaD002277—C80.01——1—2
Hepatocellular carcinomaD006528—C22.01——1—2
Biliary liver cirrhosisD008105—K74.3———2—2
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis b virusD006515————1—12
Virus diseasesD014777—B34—12——2
Herpesviridae infectionsD006566EFO_0007309B00.4——1——1
Breast neoplasmsD001943EFO_0003869C50——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289———2——13
NeoplasmsD009369—C8021———2
Lung neoplasmsD008175HP_0100526C34.90—1——12
Colorectal neoplasmsD015179——11———1
Neoplasm metastasisD009362EFO_0009708—11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal neoplasmsD012004——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————22
Portal hypertensionD006975EFO_0000666K76.6————22
Hiv infectionsD015658EFO_0000764B20————11
Sustained virologic responseD000072230——————11
Esophageal and gastric varicesD004932EFO_0009545I85————11
Essential thrombocythemiaD013920—D47.3————11
Primary myelofibrosisD055728—D47.4————11
ThrombocytosisD013922HP_0001894D75.83————11
Brain neoplasmsD001932EFO_0003833C71————11
GlioblastomaD005909EFO_0000515—————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTelbivudine
INNtelbivudine
Description
Telbivudine is a pyrimidine 2'-deoxyribonucleoside that is the L-enantiomer of thymine. A synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase. It has a role as an antiviral drug and an EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor. It is functionally related to a thymine. It is an enantiomer of a thymidine.
Classification
Small molecule
Drug classantineoplastics; antivirals (zidovudine group) (exception: edoxudine)
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Structure (InChI/SMILES or Protein Sequence)
Cc1cn([C@@H]2C[C@@H](O)[C@H](CO)O2)c(=O)[nH]c1=O
Identifiers
PDB—
CAS-ID3424-98-4
RxCUI—
ChEMBL IDCHEMBL374731
ChEBI ID63624
PubChem CID159269
DrugBankDB01265
UNII ID2OC4HKD3SF (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,337 adverse events reported
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