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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
chronic hepatitis bEFO_0004239D019694B18.1
hepatitis b—D006509—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Telbivudine, Tyzeka, Novartis
75890792023-09-11DS, DPU-999
78585942023-09-11DS, DPU-999
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
No data
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544———1—1
Cystic fibrosisD003550EFO_0000390E84———1—1
ObesityD009765EFO_0001073E66.9———1—1
EndocarditisD004696EFO_0000465I33———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Infectious skin diseasesD012874——2—13
Bacterial skin diseasesD0171921—1——2
Bacterial infectionsD001424A49——1——1
PneumoniaD011014EFO_0003106J18——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19—1———1
Multidrug-resistant tuberculosisD018088EFO_0007381—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gram-positive bacterial infectionsD0169082————2
Healthy volunteers/patients—2————2
Wound infectionD0149461————1
Indications Without Phase
No data
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)
Image (chem structure or protein)
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
RxCUI474128
ChEMBL IDCHEMBL374731
ChEBI ID63624
PubChem CID159269
DrugBankDB01265
UNII ID2OC4HKD3SF (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,397 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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425 adverse events reported
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