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.
Background
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 |
|---|---|---|---|---|---|
2023/11/07 | Phase 4 | Recruiting | Aaron Cook | ||
2017/06/01 | Phase 4 | Completed | Joseph L. Kuti, PharmD | ||
2016/04/28 | Phase 1 | Completed | |||
2015/03/18 | Phase 4 | Completed | |||
2014/11/11 | N/A | Completed | Cumberland Pharmaceuticals | ||
2014/08/04 | Phase 3 | Terminated | Cumberland Pharmaceuticals | ||
2013/12/17 | Phase 1 | Terminated | Cumberland Pharmaceuticals | ||
2011/03/24 | Phase 2 | Completed | |||
2010/11/11 | Phase 1 | Completed | Cumberland Pharmaceuticals | ||
2010/05/26 | N/A | Withdrawn | Cumberland Pharmaceuticals |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Theravance, Inc. | 52118-001 | INTRAVENOUS | 15 mg in 1 mL | 3/28/2014 | |
| Cumberland Pharmaceuticals Inc. | 66220-315 | INTRAVENOUS | 15 mg in 1 mL | 11/10/2023 | |
| 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. | |||||