Drugs / Telavancin
Telavancin
also known as
ARBELIC · TD-6424 · Telavancin hcl · TELAVANCIN HYDROCHLORIDE · Telavancina · Telavancine · Televancin · Televancin hydrochloride · +1 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VIBATIV | — | 2016-05-06 | fda.gov ↗ |
| Approved | EU (EMA) | Vibativ | — | 2011-09-02 | europa.eu ↗ |
| Approved | US (FDA) | VIBATIV | — | 2009-09-11 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02753855 | Apr → Oct 2016 | — | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 1 | NCT02013141 | Dec 2014 → Mar 2021 | gram-positive bacterial infections | Cumberland Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT01238796 | Dec 2010 → Feb 2011 | end stage renal failure | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01321879 | Mar 2011 → Dec 2016 | bacterial infectious disease | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00077675 | Feb → Sep 2004 | gram-positive bacterial infections | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00062647 | Aug 2003 → Aug 2006 | gram-positive bacterial infections | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00061633 | Jun 2003 → Jan 2004 | abscess, cellulitis, gram-positive bacterial infections, ulcer disease | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT02208063 | Dec 2014 → Apr 2018 | bacterial infectious disease | Cumberland Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00107978 | Feb 2005 → May 2006 | staphylococcal infection | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00107952 | Feb 2005 → Jul 2007 | bacterial pneumonia | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00091819 | Jan 2005 → Jun 2006 | staphylococcal infection | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00124020 | Jan 2005 → May 2007 | bacterial pneumonia | Cumberland Pharmaceuticals | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06119061 | Jul 2024 → Dec 2026 expected | acquired aneurysmal subarachnoid hemorrhage | Aaron Cook | Recruiting | No outcome recorded |
| Phase 4 | NCT03172793 | Aug 2017 → Apr 2019 | cystic fibrosis | Joseph L. Kuti, PharmD | Completed | No outcome recorded |
| Phase 4 | NCT02392208 | Jul 2015 → Mar 2016 | end stage renal failure | University of Michigan | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Telavancin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03172793 ↗ |
| Known as | ARBELIC | “The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is...” NCT00062647 ↗ |
| Known as | TD-6424 | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Known as | Telavancin hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Known as | TELAVANCIN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Known as | Telavancina | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Known as | Telavancine | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Known as | Televancin | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Known as | Televancin hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Known as | Vibativ | ChEMBL registry synonym — accepted as the source's own label CHEMBL507870 ↗ |
| Modality | Other / unclassified | “Telavancin is an investigational, rapidly bactericidal lipoglycopeptide with a multifunctional mechanism of action.” PMID 18444791 ↗ Jun 2008 |
| Route | Intravenous | “Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days” NCT00061633 ↗ |