Drugs / Telithromycin
Telithromycin
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Ketek | — | 2019-06-07 | europa.eu ↗ |
| Label expansion | US (FDA) | KETEK | — | 2005-02-09 | fda.gov ↗ |
| Approved | US (FDA) | KETEK | — | 2004-04-01 | fda.gov ↗ |
| Approved | EU (EMA) | Ketek | — | 2001-07-09 | europa.eu ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00270517 | Dec 2005 → Jul 2007 | — | Enanta Pharmaceuticals, Inc | Unknown | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT00315042 | Mar → Aug 2006 | pharyngitis, tonsillitis | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT00315549 | Feb → Sep 2006 | pharyngitis, tonsillitis | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT00315003 | Jan → Jul 2006 | purulent acute otitis media | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT00351182 | Sep → Dec 2005 | scrub typhus | Dong-Min Kim | Completed | No outcome recorded |
| Phase 3 | NCT00174811 | Jun 2005 → Jun 2006 | otitis media | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT00408135 | Aug 2004 → May 2005 | infectious disease | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00638859 | Mar → Oct 2004 | pneumonia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00638534 | Feb → Oct 2004 | otitis media | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00273520 | Jan 2003 → Apr 2004 | asthma | Sanofi | Completed | Mixed |
| Phase 3 | NCT00537563 | Dec 2002 → Sep 2003 | maxillary sinusitis | Sanofi | Completed | No outcome recorded |
| Phase 411 trials · 1 met primary | ||||||
| Phase 4 | NCT00315601 | Jan → Nov 2006 | — | University of Illinois at Chicago | Terminated | No outcome recorded |
| Phase 4 | NCT00288223 | Jan 2006 → Jan 2007 | chronic bronchitis | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT00237445 | Nov 2005 → Sep 2006 | pneumonia | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT00261105 | Feb → Oct 2005 | respiratory tract infectious disorder | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00174694 | Nov 2004 → Dec 2005 | sinusitis | Sanofi | Completed | Met primary |
| Phase 4 | NCT00164112 | Nov 2004 → Jun 2005 | — | Bassett Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT00132951 | Oct 2004 → Sep 2006 | chronic bronchitis, pneumonia | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT00546676 | May → Dec 2004 | chronic bronchitis, pneumonia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00132938 | Jan 2004 → May 2006 | chronic bronchitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00538018 | Jan 2003 → Jun 2004 | pneumonia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00538148 | Nov 2002 → Sep 2004 | chronic bronchitis | Sanofi | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT00245440 Comparator | Dec 2005 → Jul 2006 | maxillary sinusitis | CPL Associates | Terminated | No outcome recorded |
| Phase 4 | NCT00245453 Comparator | Oct 2005 → Jul 2006 | bacterial pneumonia, chronic bronchitis | CPL Associates | Withdrawn | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Telithromycin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00538018 ↗ |
| Known as | HMR3647 | “Telithromycin (HMR3647)” NCT00638534 ↗4“telithromycin (HMR3647)” NCT00174811 ↗ “telithromycin (HMR3647)” NCT00408135 ↗ “Telithromycin (HMR3647)” NCT00638859 ↗ “Telithromycin (HMR3647)” NCT00315042 ↗ |
| Known as | Ketek | “Comparing the Clinical Efficacy of Telithromycin (KETEK®) 800 mg Once a Day for 5 Days Versus Amoxicillin-clavulanic Acid (AUGMENTIN®) 875/125 mg Twice a Day for 10 Days” NCT00174694 ↗2“treated with either Ketek® Telithromycin Once Daily for 7 Days, or Zithromax® Azithromycin Once Daily for 5 Days” NCT00237445 ↗ “Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections” NCT00261105 ↗ |
| Known as | Levviax | ChEMBL registry synonym — accepted as the source's own label CHEMBL1136 ↗ |
| Known as | NSC-758940 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1136 ↗ |
| Known as | Telithromycine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1136 ↗ |
| Known as | Telitromicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1136 ↗ |
| Modality | Small molecule | — CHEMBL1136 ↗ |
| Route | Oral | “The purpose of this study is to evaluate the effects of three Food and Drug Administration (FDA) approved oral antibiotics (azithromycin, telithromycin, and levofloxacin) on...” NCT00164112 ↗ |