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Drug ReportsTelithromycin
Ketek(telithromycin)
Ketek, Levviax (telithromycin) is a small molecule pharmaceutical. Telithromycin was first approved as Ketek on 2001-07-09. It is used to treat bacterial infections in the USA. It has been approved in Europe to treat bacterial pneumonia, chronic bronchitis, community-acquired infections, pharyngitis, and pneumonia amongst others.
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Events Timeline
5D
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3M
6M
YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
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)
Telithromycin
Tradename
Company
Number
Date
Products
KETEKSanofiN-021144 DISCN2004-04-01
2 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
ketekNew Drug Application2012-05-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01F: Macrolides, lincosamides and streptogramins
— J01FA: Macrolides
— J01FA15: Telithromycin
HCPCS
No data
Clinical
Clinical Trials
26 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumoniaD011014EFO_0003106J18—115—7
Chronic bronchitisD029481—J42———6—6
BronchitisD001991—J40———6—6
Acute diseaseD000208—————3—3
Respiratory tract infectionsD012141—J06.9———3—3
SinusitisD012852EFO_0007486J32——12—3
InfectionsD007239EFO_0000544———12—3
Healthy volunteers/patients——————2—2
Maxillary sinusitisD015523EFO_0007361J32.0——11—2
Communicable diseasesD003141————11—2
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Otitis mediaD010033EFO_0004992H66.9——3——3
OtitisD010031————3——3
PharyngitisD010612—R07.0——2——2
TonsillitisD014069————2——2
Suppurative otitis mediaD010035EFO_0007503H66——1——1
SuppurationD013492————1——1
Scrub typhusD012612EFO_0007480A75.3——1——1
Epidemic louse-borne typhusD014438EFO_0007182A75——1——1
AsthmaD001249EFO_0000270J45——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Wounds and injuriesD014947—T14.8————11
Chemical and drug induced liver injuryD056486EFO_0004228—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTelithromycin
INNtelithromycin
Description
Telithromycin is the first ketolide antibiotic to enter clinical use and is sold under the brand name of Ketek. It is used to treat community acquired pneumonia of mild to moderate severity. After significant safety concerns, the US Food and Drug Administration sharply curtailed the approved uses of the drug in early 2007.
Classification
Small molecule
Drug classantibiotics (Streptomyces strain)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC[C@H]1OC(=O)[C@H](C)C(=O)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@H]2N(CCCCn3cnc(-c4cccnc4)c3)C(=O)O[C@]12C
Identifiers
PDB—
CAS-ID191114-48-4
RxCUI—
ChEMBL IDCHEMBL1136
ChEBI ID—
PubChem CID5462516
DrugBankDB00976
UNII IDKI8H7H19WL (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Telithromycin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,259 documents
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Safety
Black-box Warning
Black-box warning for: Ketek
Adverse Events
Top Adverse Reactions
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4,471 adverse events reported
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