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Ketek (TELITHROMYCIN)
Ketek (Telithromycin) is a ketolide antibacterial drug developed by Sanofi Aventis US, targeting the potassium voltage-gated channel subfamily H member 2. It was approved by the FDA in 2004 for various bacterial infections, including pneumonia and tonsillitis. As a small molecule, Ketek works by inhibiting bacterial protein synthesis, making it difficult for bacteria to multiply. Currently, Ketek is off-patent with no active Orange Book patents, but it is still owned by Sanofi Aventis US. Key safety considerations include its potential to cause liver damage and interact with other medications.
At a glance
| Generic name | TELITHROMYCIN |
|---|---|
| Sponsor | Sanofi |
| Drug class | Ketolide Antibacterial |
| Target | Potassium voltage-gated channel subfamily H member 2 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2004 |
Approved indications
- Chlamydial pneumonia
- Haemophilus influenzae pneumonia
- Moraxella Catarrhalis Pneumonia
- Pneumococcal pneumonia
- Pneumonia due to Mycoplasma pneumoniae
- Streptococcus pyogenes infection
- Tonsillitis due to Streptococcus Pyogenes
Common side effects
- Diarrhea
- Nausea
- ALT elevations above 3x ULN
- Blurred vision
- Diplopia
- Difficulty focusing
- Abdominal distension
- Dyspepsia
- Gastrointestinal upset
- Flatulence
- Constipation
- Gastroenteritis
Serious adverse events
- Hepatotoxicity (severe/fatal)
- Fulminant hepatitis
- Hepatic necrosis
- Hepatic failure
- Hepatitis
- Anaphylaxis
- Angioedema
- Pancreatitis
- Atrial arrhythmias
- Erythema multiforme
Drug interactions
- CYP3A4 Substrates
- High Risk QT Prolonging Agents
- alfentanil
- alfuzosin
- conivaptan
- dasatinib
- diltiazem
- fentanyl
- isradipine
- itraconazole
- ketoconazole
- nicardipine
Key clinical trials
- CCR5 Inhibitor Treatment Intensification on CD4+ T-cell Recovery (PHASE4)
- Controlled Trial: 5-day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus (PHASE3)
- Outpatient Registry Trial of Respiratory Tract Infections in Adults (PHASE4)
- Risk of Acute Liver Injury in Users of Antimicrobials
- AMS VS MOXI Ketek vs Avelox in AMS (PHASE3)
- Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD (PHASE4)
- Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas (PHASE4)
- PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ketek CI brief — competitive landscape report
- Ketek updates RSS · CI watch RSS
- Sanofi portfolio CI