Overview
Dalbavancin is a second-generation lipoglycopeptide antibiotic that was designed to improve on the natural glycopeptides currently available, such as vancomycin and teicoplanin . Modifications from these older glycoprotein classes facilitated a similar mechanism of action for dalbavancin but with increased activity and once-weekly dosing . Its use is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), S. pyogenes, S. agalactiae, S. dysgalactiae, the S. anginosus group (including S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin susceptible strains) . Dalbavancin acts by interfering with bacterial cell wall synthesis by binding to the D-alanyl-D-alanine terminus of nascent cell wall peptidoglycan and preventing cross-linking .
Indication
适用于治疗由革兰氏阳性菌（包括耐甲氧西林金黄色葡萄球菌，MRSA）导致的急性细菌性皮肤和皮肤结构感染（ABSSSI）。
Associated Conditions
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/05 | Phase 1 | Recruiting | |||
2024/02/20 | Phase 4 | Recruiting | |||
2023/10/18 | N/A | Completed | Tourcoing Hospital | ||
2021/11/11 | Phase 3 | Recruiting | |||
2021/09/16 | Not Applicable | Recruiting | |||
2021/07/13 | N/A | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A | ||
2021/04/19 | Phase 2 | Terminated | |||
2021/03/01 | Phase 2 | Completed | |||
2020/11/10 | N/A | Terminated | |||
2020/03/06 | N/A | Completed | Aziende Chimiche Riunite Angelini Francesco S.p.A |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Allergan, Inc. | 57970-100 | INTRAVENOUS | 500 mg in 25 mL | 2/16/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/19/2015 | ||
Authorised | 2/19/2015 |
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 |
|---|---|---|---|---|---|
| DALBAVANCINA SALA 500 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | Laboratorio Reig Jofre, S.A. | 89545 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| DALBAVANCINA BAXTER 500 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 90291 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| XYDALBA 500 MG DE POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 114986001 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| DALBAVANCINA ACCORD 500 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 89574 | 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. | |||||
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