vaborbactam

Trade name: Vabomere

Small moleculeapprovedFast Track FDA

Approved

Aug 29, 2017

Vaborbactam (formerly RPX7009) is a new beta-lactamase inhibitor based on a cyclic boronic acid pharmacophore. Vaborbactam is a highly active beta-lactamase inhibitor that restores activity of meropenem and other beta-lactam antibiotics in beta-lactamase-producing bacteria, particularly KPC-producing CRE. Meropenem in combination with vaborbactam (VABOMERE) is indicated for the treatment of patients 18 years and older with complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria. The vaborbactam component of VABOMERE is a non-suicidal beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases such as Klebsiella pneumoniae carbapenemase (KPC). Vaborbactam does not have any antibacterial activity. Vaborbactam does not decrease the activity of meropenem against meropenem-susceptible organisms. — NCATS

Clinical trial activity

2 trials · 2 clinical orgs · 2 marketing orgs

Phase 1
1
Phase 2
1
Phase 3
0
Phase 4
0

Earliest trial started May 1, 2018 (NCT03564158)

Timeline

2010s

  1. Aug 29, 2017

    Rempex Pharmaceuticals — Earliest FDA Approval

  2. Aug 29, 2017

    Rempex Pharmaceuticals — NDA Organization

  3. Aug 29, 2017

    Rempex Pharmaceuticals — NDA Secondary Org

  4. Aug 29, 2017

    The Medicines Company — NDA Secondary Org

  5. Jan 1, 2018

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 1, 2025

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Combination products

  • vabomere

    with meropenem

    Also known as meropenem and vaborbactam

Approval history

  • approvedPriority reviewFast trackAug 29, 2017

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)C[C@@H]1CC[C@H](NC(=O)Cc2cccs2)B(O)O1
Mol. weight
297.14 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06672978Phase 2Jan 31, 2025Department of Health and Human Services, Melinta Therapeutics
NCT03564158Phase 1May 1, 2018Department of Health and Human Services, Melinta Therapeutics
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Department of Health and Human ServicesGovernment2022018
Melinta TherapeuticsFor profit2222018
2 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Rempex PharmaceuticalsFor profitNDAAug 29, 2017
Rempex PharmaceuticalsFor profitSYNAug 29, 2017
Rempex PharmaceuticalsFor profitNDA2Aug 29, 2017
The Medicines CompanyFor profitNDA2Aug 29, 2017