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Telithromycin (HMR3647)

Phase 3
Sanofi (SNY)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape
Drug Information

Target Indication

Pneumonia

Clinical Trial

NCT00638859

Last updated: 12/19/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA7/9/2001

Levviax

When prescribing Levviax consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).Levviax is indicated for the treatment of the following infections:In patients of 18 years and older:-Community-acquired pneumonia, mild or moderate (see section 4.4).- When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):- Acute exacerbation of chronic bronchitis,- Acute sinusitisIn patients of 12 years and older:- Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).

View on EMA
EMA7/9/2001

Ketek

When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance. Ketek is indicated for the treatment of the following infections: In patients of 18 years and older community-acquired pneumonia, mild or moderate. when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin: acute exacerbation of chronic bronchitis; acute sinusitis; In patients of 12 years and older tonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA.

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Drug Science
Mechanism of action & safety profile
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