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telithromycin

Phase 4FDA approved

Asthma | Small molecule | Respiratory |Sanofi|Trials Updated: Feb 17, 2012

telithromycin development status

FDA approval on record Apr 1, 2004 as Ketek
Approval holderSanofi Aventis Us
ApplicationNDA021144
Highest phase Phase 4 (NCT00132938)
Phase scored for SNYPhase 3
Registered trials 15 across 3 sponsors since Aug 2005

telithromycin target and mechanism

ModalitySmall molecule

Also known as telithromycin (HMR3647)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment574

FDA Designations

No designations recorded

telithromycin clinical trials

telithromycin · 5 trials · 6 indications

Phase 3 5
NCT00408135Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With InfectionsInfections
COMPLETED111 Analytics
NCT00638859Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired PneumoniaPneumonia
COMPLETED56 Analytics
NCT00638534Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis MediaOtitis Media
COMPLETED56 Analytics
NCT00273520TELICAST : Telithromycin in Acute Exacerbations of AsthmaAsthma
COMPLETED- Analytics
NCT00537563AMS VS MOXI Ketek vs Avelox in AMSMaxillary Sinusitis
COMPLETED351 Analytics
PHASE3COMPLETED
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
InfectionsUnlock trial analytics
PHASE3COMPLETED
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
PneumoniaUnlock trial analytics
PHASE3COMPLETED
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Otitis MediaUnlock trial analytics
PHASE3COMPLETED
TELICAST : Telithromycin in Acute Exacerbations of Asthma
AsthmaUnlock trial analytics
PHASE3COMPLETED
AMS VS MOXI Ketek vs Avelox in AMS
Maxillary SinusitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Patient's daily diary summary symptom scores/Morning diary PEFR
During the Study Conduct
To demonstrate equivalence in clinical efficacy between telithromycin and moxifloxacin at the post-therapy/test of cure (TOC) visit.
Days 17 to 24

Secondary Endpoints

Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit
Clinical efficacy: change in the symptoms and signs
Acceptability: compliance and willingness to take medication
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
telithromycin (HMR3647)DRUG -
TelithromycinDRUG -
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Eligibility Criteria

Age Range6 Months to 16 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Outpatients of weight from 7.0 kg. * For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings. * For de...

Countries:JapanUnited States
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Frequently asked questions about telithromycin

What is telithromycin used for?

Telithromycin is a small molecule antibacterial studied for respiratory and related infections, including community-acquired pneumonia, acute otitis media, maxillary sinusitis, and other infections in children and adults. It has also been studied in asthma. Development has focused on these infectious and respiratory indications.

Who makes telithromycin?

Telithromycin is developed by Sanofi, which trades under the ticker SNY. The company has sponsored Phase 3 clinical studies of the drug in Japan and the United States across pneumonia, otitis media, maxillary sinusitis, and pediatric infections.

What phase is telithromycin in?

Telithromycin is in Phase 3 clinical development. It is investigational and is not described as approved. The Phase 3 program includes completed trials in community-acquired pneumonia, acute otitis media, maxillary sinusitis, and infections in children.

What clinical trials is telithromycin in?

Completed Phase 3 trials include NCT00638859 in children with community-acquired pneumonia, NCT00638534 in children with acute otitis media, NCT00537563 comparing telithromycin with moxifloxacin in maxillary sinusitis, and NCT00408135 evaluating safety, efficacy, and acceptability in children with infections.

Is telithromycin the same as HMR3647?

Yes. Telithromycin is also known as HMR3647, so the two names refer to the same compound. Searches for either name lead to the same Sanofi Phase 3 small molecule program in respiratory and infectious disease indications.

What is telithromycin used for in children?

In children, telithromycin has been studied in Phase 3 trials for community-acquired pneumonia, acute otitis media, and other infections. These Japanese studies enrolled children from 6 months of age, and all of them have been completed.