Telavancin

Overview

Telavancin is a semi-synthetic derivative of vanocymycin that has bactericidal activity against Methicillin-resistant Staphylococcus aureus (MRSA) and other gram-positive bacteria. MRSA is an important pathogen capable of causing hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and skin and subcutaneous tissue infections among others.

Indication

用于治疗革兰阳性菌耐甲氧西林金黄色葡萄球菌（MRSA）与甲氧西林敏感金黄色葡萄球菌引起的成人复杂性皮肤和皮肤结构感染，以及医院获得性和呼吸机相关细菌性肺炎(HABP/VABP)。

Associated Conditions

Bacterial Infections
Nosocomial Pneumonia
Ventilator Associated Bacterial Pneumonia (VABP)
Complicated Skin and subcutaneous tissue bacterial infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage	2023/11/07	NCT06119061	Phase 4	Recruiting	Aaron Cook
Telavancin Pharmacokinetics in Cystic Fibrosis Patients	2017/06/01	NCT03172793	Phase 4	Completed	Joseph L. Kuti, PharmD
Pharmacokinetics of Telavancin in Normal and Obese Subjects	2016/04/28	NCT02753855	Phase 1	Completed	University of Illinois at Chicago
Effect of Dialysis on the Pharmacokinetics of Telavancin in Patients With Chronic Kidney Disease Stage 5	2015/03/18	NCT02392208	Phase 4	Completed	University of Michigan
Telavancin Observational Use Registry (TOUR)	2014/11/11	NCT02288234	N/A	Completed	Cumberland Pharmaceuticals
A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial	2014/08/04	NCT02208063	Phase 3	Terminated	Cumberland Pharmaceuticals
Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)	2013/12/17	NCT02013141	Phase 1	Terminated	Cumberland Pharmaceuticals
Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients	2011/03/24	NCT01321879	Phase 2	Completed	M.D. Anderson Cancer Center
A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin	2010/11/11	NCT01238796	Phase 1	Completed	Cumberland Pharmaceuticals
VIBATIV Pregnancy Registry	2010/05/26	NCT01130324	N/A	Withdrawn	Cumberland Pharmaceuticals

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Vibativ	Theravance, Inc.	52118-001	INTRAVENOUS	15 mg in 1 mL	3/28/2014
VIBATIV	Cumberland Pharmaceuticals Inc.	66220-315	INTRAVENOUS	15 mg in 1 mL	11/10/2023
Vibativ	Theravance, Inc.	52118-002	INTRAVENOUS	15 mg in 1 mL	3/28/2014

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
Vibativ 250 mg polvo para concentrado para solucion para perfusion	Theravance Biopharma Ireland Limited	111705001	POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
Vibativ 750 mg polvo para concentrado para solucion para perfusion	Theravance Biopharma Ireland Limited	111705002	POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Tabuk Launches Vibativ Antibiotic in Saudi Arabia to Combat Multidrug-Resistant Infections

17 days ago

Tabuk Pharmaceutical Manufacturing Company has launched Vibativ (telavancin) injection in Saudi Arabia through an exclusive partnership with Cumberland Pharmaceuticals, targeting hospital-acquired pneumonia and serious skin infections.

FDA Approves Simplified Dosing Regimen for Acetadote to Enhance Acetaminophen Overdose Treatment

6 months ago

Cumberland Pharmaceuticals announced FDA approval of a simplified dosing regimen for Acetadote (N-acetylcysteine), combining the first two bags of the standard regimen into a single, slower infusion.

Cumberland Pharmaceuticals Reports Breakthrough in DMD Treatment and 11.6% Q4 Revenue Growth

7 months ago

Cumberland Pharmaceuticals achieved positive Phase II results for ifetroban in treating cardiac complications of Duchenne muscular dystrophy, marking the first successful study of its kind.

Cumberland's Vibativ Antibiotic Secures Chinese NMPA Approval for Severe Bacterial Infections

8 months ago

• China's NMPA has approved Cumberland Pharmaceuticals' Vibativ (telavancin) injection for treating severe bacterial infections, with market launch planned for 2025 through partnership with SciClone Pharmaceuticals. • Vibativ demonstrates effectiveness against ventilator-associated and hospital-acquired pneumonia caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). • The once-daily antibiotic injection requires no therapeutic drug monitoring, offering healthcare providers a streamlined treatment option for managing serious bacterial infections.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access