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
| 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 · 2 met primary | ||||||
| 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 | Met primary |
| 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 | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-02-19 | Cumberland Pharmaceuticals | Regulatory Cumberland's Vibativ Gains China's NMPA Approval cumberlandpharma.com ↗
Cumberland Pharmaceuticals’ antibiotic Vibativ (telavancin) injection has gained approval from China’s National Medical Products Administration (NMPA), offering a new treatment option for patients with severe bacterial infections. |
| 2020-11-06 | Cumberland Pharmaceuticals | Results Infectious Disease Special Edition (IDSE) – Vibativ Sustained Activity Confirmed in Two Surveillance Studies cumberlandpharma.com ↗
Telavancin maintained excellent antimicrobial activity against multidrug-resistant subsets of these pathogen groups and ceftaroline-nonsusceptible (telavancin minimum inhibitory concentration (MIC)90 value, 0.06 mcg/mL; 100% susceptible) and ceftaroline-resistant (telavancin MIC90 value, 0.12 mcg/mL; 100% susceptible) S. aureus isolates. |
| 2018-10-08 | Theravance Biopharma | Results Theravance Biopharma Reports Positive New Data from Multiple Studies of VIBATIV® (telavancin) at IDWeek™ 2018 theravance.com ↗
Presented findings from one study reported a positive clinical response following VIBATIV treatment in 77.1% of registry patients diagnosed with monomicrobial infections caused by Staphylococcus aureus (S. aureus) with vancomycin minimum inhibitory concentration (MIC) ≥ 1 µg/mL. |
| 2018-04-23 | Theravance Biopharma | Results Theravance Biopharma Reports Positive New Data from Multiple Studies of VIBATIV® (telavancin) at 2018 ECCMID™ Conference theravance.com ↗
The presented findings, which focus on data from registry patients classified as elderly or obese, report positive clinical responses for VIBATIV treatment ranging from 76.5% to 78.8% in these patient subgroups. |
| 2018-02-27 | Theravance Biopharma | Results Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update theravance.com ↗
Phase 3 bacteremia study of VIBATIV ® (telavancin) discontinued following recent interim analysis conducted by independent review committee and company-wide review of investment priorities |
| 2017-10-31 | Theravance Biopharma | Results Theravance Biopharma Reports Positive New VIBATIV® (telavancin) Data from TOUR™ Observational Patient Registry at 2017 CHEST Annual Meeting theravance.com ↗
The presented findings, which focus on a preliminary review of data from registry patients with diagnoses of lower respiratory tract infections (LRTIs), report positive clinical responses for VIBATIV treatment of 67.1% in this infection type. |
| 2017-10-09 | Theravance Biopharma | Results Theravance Biopharma Reports Positive New Data from Multiple Studies of VIBATIV® (telavancin) at IDWeek™ 2017 theravance.com ↗
The presented findings, which focus on data from registry patients with diagnoses of bone and joint infections, bacteremia and/or infective endocarditis, report positive clinical responses for VIBATIV treatment ranging from 64.9% to 72.6% in each of these infection types. |
| 2017-06-05 | Theravance Biopharma | Results New Data Highlighting in vitro Potency Advantages for VIBATIV® (telavancin) Against Difficult-to-Treat MRSA and MSSA Pathogens Reported at ASM Microbe 2017 theravance.com ↗
Study results highlighted greater in vitro potency for VIBATIV against difficult-to-treat Staphylococcus aureus (S. aureus) pathogens, including those considered to be multidrug resistant (MDR), as compared to other commercialized antibiotics. |
| 2017-04-25 | Theravance Biopharma | Results New Data for VIBATIV® (telavancin) Reported in Several Presentations at ECCMID 2017 theravance.com ↗
Study results highlighted greater in vivo and in vitro potency for VIBATIV against difficult-to-treat Staphylococcus aureus (S. aureus) pathogens as compared to other commercialized antibiotics. |
| 2017-04-24 | Theravance Biopharma | Results Theravance Biopharma Reports Positive Clinical Response Rates for Patients in TOUR™ Observational Patient Registry in Several Presentations at ECCMID 2017 theravance.com ↗ |
| 2017-02-27 | Theravance Biopharma | Results Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Business Update theravance.com ↗
Initial data show positive clinical responses in patients with bacteremia, endocarditis, osteomyelitis, skin and respiratory infections. |
| 2017-01-23 | Theravance Biopharma | Results Theravance Biopharma Reports New Data from Ongoing TOUR™ Observational Patient Registry in Oral Presentation at SCCM Critical Care Congress theravance.com ↗
The presented findings, which focused on a subset of registry patients with diagnoses of bacteremia or infective endocarditis (IE) (n=45), demonstrated positive clinical responses in 64.4% of patients, with 6.7% of patients failing treatment and 28.9% considered non-evaluable. |
| 2016-11-01 | Theravance Biopharma | Results New Data for VIBATIV® (telavancin) Reported in Presentations at IDWeek™ 2016 theravance.com ↗
At three months following treatment, the percentage of patients considered cured or improved increased to 91.3%. |
| 2016-10-31 | Theravance Biopharma | Results Theravance Biopharma Presents Interim Data from Ongoing Telavancin Observational Use Registry (TOUR™) at IDWeek™ 2016 theravance.com ↗
Results show 17% of all patients were considered non-evaluable with 9% deemed to have failed treatment. |
All press releases naming this drug 20 releases
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 NCT02013141 ↗ |
| 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 ↗ |