telavancin
Trade name: vibativ
Approved
Sep 11, 2009
TELAVANCIN (VIBATIV®) is a lipoglycopeptide antibacterial that is a synthetic derivative of vancomycin. It exerts concentration-dependent, bactericidal activity against Gram-positive organisms in vitro. TELAVANCIN (VIBATIV®) inhibits cell wall biosynthesis by binding to late-stage peptidoglycan precursors, including lipid II. It also binds to the bacterial membrane and disrupts membrane barrier function. TELAVANCIN (VIBATIV®) is indicated for the treatment of adult patients with complicated skin and skin structure infections caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only). It is also indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (both methicillin-susceptible and -resistant isolates). It should be reserved for use when alternative treatments are not suitable. — NCATS
Clinical trial activity
15 trials · 10 clinical orgs · 2 marketing orgs
Earliest trial started Jun 1, 2003 (NCT00061633)
Timeline
2000s
- May 25, 2002
Theravance — IND Organization
- May 25, 2002
Theravance — IND Organization
- Jan 1, 2003
Theravance — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
Theravance — Earliest Phase 3 Sponsor(trial)
- Sep 11, 2009
Theravance — Earliest FDA Approval
- Sep 11, 2009
Cumberland Pharmaceuticals — NDA Secondary Org
- Sep 11, 2009
Theravance — NDA Organization
2010s
- Jan 1, 2010
Theravance — Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Abscess · Phase 2
- Bacteremia · Phase 3
- Burns · Phase 2
- Cellulitis · Phase 2
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Cystic Fibrosis · Phase 4
- Gram-Positive Bacterial Infections · Phase 4
- Healthy Volunteers · Phase 1
- Infections · Phase 2
- Kidney Diseases · Phase 1
- Kidney Failure, Chronic · Phase 4
- Pneumonia, Bacterial · Phase 3
- Staphylococcal Infections · Phase 3
- Subarachnoid Hemorrhage · Phase 4
- Ulcer · Phase 2
- Wound Infection · Phase 2
Mechanism of action
- Cell outer membraneINHIBITOR
Cell outer membrane inhibitor
Approval history
- approvedSep 11, 2009
Chemistry & pharmacology
SMILES
CCCCCCCCCCNCCN[C@@]1(C)C[C@H](O[C@H]2[C@H](Oc3c4cc5cc3Oc3ccc(cc3Cl)[C@@H](O)[C@@H](NC(=O)[C@@H](CC(C)C)NC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]5C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c5cc(O)c(CNCP(=O)(O)O)c(O)c5-c5cc3ccc5O)[C@H](O)c3ccc(c(Cl)c3)O4)O[C@H](CO)[C@@H](O)[C@@H]2O)O[C@@H](C)[C@H]1O- Mol. weight
- 1755.66 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL507870 ↗
- WikipediaTelavancin ↗
- NCATSXK134822Z0 ↗
- ChEMBLCHEMBL3301680 ↗
Also known as
- arbelic
- td6424
- td 6424
- td-6424
- td-6424
- td-6424
- telavancin
- telavancin
- telavancin
- telavancin
- telavancin
- telavancin
- telavancin
- telavancin
- telavancin
- telavancin
- telavancin
- telavancina
- telavancina
- télavancine
- télavancine
- telavancin hcl
- telavancin hcl
- telavancin hcl
- telavancin hydrochloride
- telavancin hydrochloride
- telavancin hydrochloride
- telavancin hydrochloride
- telavancin hydrochloride
- telavancinum
- telavancinum
- vibativ
- vibativ
- vibativ
- vibativ
- vibativ
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06119061 | Phase 4 | Nov 30, 2023 | Cumberland Pharmaceuticals, University of Kentucky |
| NCT03172793 | Phase 4 | Jul 1, 2017 | Hartford Hospital, Theravance, University of Connecticut |
| NCT02753855 | Phase 1 | Apr 1, 2016 | Theravance, University of Illinois at Chicago |
| NCT02392208 | Phase 4 | Jul 1, 2015 | Theravance, University of Michigan |
| NCT02208063 | Phase 3 | Dec 1, 2014 | Theravance |
| NCT02013141 | Phase 4 | Dec 1, 2014 | Theravance |
| NCT01321879 | Phase 2 | Mar 1, 2011 | Theravance, University of Texas at Houston |
| NCT01238796 | Phase 1 | Dec 1, 2010 | Astellas, Theravance |
| NCT00107952 | Phase 3 | Feb 1, 2005 | Duke University, Theravance |
| NCT00107978 | Phase 3 | Feb 1, 2005 | Duke University, Theravance |
| NCT00091819 | Phase 3 | Jan 1, 2005 | Duke University, Theravance |
| NCT00124020 | Phase 3 | Jan 1, 2005 | Duke University, Theravance |
| NCT00077675 | Phase 2 | Feb 1, 2004 | Duke University, Theravance |
| NCT00062647 | Phase 2 | Aug 1, 2003 | Duke University, Theravance |
| NCT00061633 | Phase 2 | Jun 1, 2003 | Duke University, Theravance |
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Theravance | For profit | 14 | 10 | 4 | 2003 |
| Duke University | Academic/Hospital | 7 | 0 | 2 | 2003 |
| Astellas | For profit | 1 | 0 | 1 | 2010 |
| Cumberland Pharmaceuticals | For profit | 1 | 0 | 1 | 2023 |
| Hartford Hospital | Academic/Hospital | 1 | 1 | 1 | 2017 |
| University of Connecticut | Academic/Hospital | 1 | 0 | 1 | 2017 |
| University of Illinois at Chicago | Academic/Hospital | 1 | 1 | 1 | 2016 |
| University of Kentucky | Academic/Hospital | 1 | 1 | 1 | 2023 |
| University of Michigan | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2011 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Cumberland Pharmaceuticals | For profit | NDA2 | Sep 11, 2009 |
| Theravance | For profit | NDA | Sep 11, 2009 |
| Theravance | For profit | IND | May 25, 2002 |