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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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Telithromycin
Tradename | Company | Number | Date | Products |
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KETEK | Sanofi | N-021144 DISCN | 2004-04-01 | 2 products |
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Brand Name | Status | Last Update |
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ketek | New Drug Application | 2012-05-02 |
Agency Specific
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HCPCS
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Clinical
Clinical Trials
66 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 3 | 3 | 10 | 22 | 4 | 40 |
Hepatitis b | D006509 | — | 2 | 4 | 1 | 2 | 9 | ||
Chronic hepatitis | D006521 | K73.9 | — | — | — | 3 | — | 3 | |
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 2 | 1 | — | 3 |
Chronic renal insufficiency | D051436 | N18 | — | — | — | 1 | — | 1 | |
Viremia | D014766 | B34.9 | — | — | — | 1 | — | 1 | |
Pregnancy complications | D011248 | — | — | — | 1 | — | 1 | ||
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hepatitis b virus | D006515 | — | — | 1 | — | 1 | 2 | ||
Hepatitis | D006505 | HP_0012115 | K75.9 | — | — | 1 | — | — | 1 |
Virus diseases | D014777 | B34 | — | 1 | 1 | — | — | 1 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Non-small-cell lung carcinoma | D002289 | — | 1 | — | — | 1 | 2 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
Esophageal neoplasms | D004938 | C15 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TELITHROMYCIN |
INN | telithromycin |
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.
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Classification | Small molecule |
Drug class | antibiotics (Streptomyces strain) |
Image (chem structure or protein) | |
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-ID | 191114-48-4 |
RxCUI | 274786 |
ChEMBL ID | CHEMBL1136 |
ChEBI ID | — |
PubChem CID | 3002190 |
DrugBank | DB00976 |
UNII ID | KI8H7H19WL (ChemIDplus, GSRS) |
Target
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Alternate
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Variants
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Trends
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Safety
Black-box Warning
Black-box warning for: Ketek
Adverse Events
Top Adverse Reactions
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1,229 adverse events reported
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