Overview
Vaborbactam is a β-lactamase inhibitor based on a cyclic boronic acid pharmacophore. It has been used in trials investigating the treatment of bacterial infections in subjects with varying degrees of renal insufficiency. In August 2017, a combination antibacterial therapy under the market name Vabomere was approved by the FDA for the treatment of adult patients with complicated urinary tract infections (cUTI). Vabomere consists of vaborbactam and Meropenem for intravenous administration. Vaborbactam is added to the therapy to reduce the extent meropenem degradation by inhibiting the serine beta-lactamases expressed by the microorganism of target. The treatment aims to resolve infection-related symptoms of cUTI and achieve negative urine culture, when the infections are proven or strongly suspected to be caused by susceptible bacteria.
Indication
Indicated in combination with meropenem for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
Associated Conditions
- Complicated Urinary Tract Infection caused by Enterobacter cloacae
- Complicated Urinary Tract Infection caused by Escherichia Coli
- Complicated Urinary tract infection caused by klebsiella pneumoniae
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/02/22 | Phase 1 | Active, not recruiting | Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC) | ||
2014/06/20 | Phase 3 | Completed | Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) | ||
2013/07/12 | Phase 1 | Completed | Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) | ||
2013/01/21 | Phase 1 | Completed | Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) | ||
2012/12/17 | Phase 1 | Completed | Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Melinta Therapeutics, LLC | 70842-120 | INTRAVENOUS | 1 g in 2 g | 9/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/20/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VABOREM POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/1G | SIN17224P | INJECTION, POWDER, FOR SOLUTION | 1 g | 4/25/2025 |
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 |
|---|---|---|---|---|---|
| VABOREM POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/1G | N/A | N/A | N/A | 4/30/2024 |
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 |
|---|---|---|---|---|---|
| VABOMERE | xediton pharmaceuticals inc | 02554151 | Powder For Solution - Intravenous | 1 G / VIAL | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| VABOREM 1 G/1 G POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 1181334001 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | 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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.