Drugs / Vaborbactam

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Vaborem 2018-11-20 europa.eu
Approved US (FDA) VABOMERE 2017-08-29 fda.gov

Trials 9 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT03564158 May → Nov 2018 Melinta Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02073812 Feb → Apr 2014 Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) Completed No outcome recorded
Phase 1 NCT02020434 Jan → Sep 2014 Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) Completed No outcome recorded
Phase 1 NCT01897779 Jul 2013 → Feb 2014 bacterial infectious disease Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) Completed No outcome recorded
Phase 1 NCT01772836 Mar 2013 bacterial infectious disease Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) Completed No outcome recorded
Phase 1 NCT01751269 Dec 2012 → Jul 2013 bacterial infectious disease Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) Completed No outcome recorded
Phase 21 trial
Phase 2 NCT06828848 Feb 2025 → Jul 2026 overdue gram-negative bacterial infections Menarini Group Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT03006679 Aug 2018 → Jun 2020 bacterial pneumonia Melinta Therapeutics, Inc. Withdrawn No outcome recorded
Phase 3 NCT02166476 Nov 2014 → Apr 2016 acute pyelonephritis Melinta Therapeutics, Inc. Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as vaborbactam “Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of the β-Lactamase Inhibitor Vaborbactam (RPX7009) in Healthy Adult Subjects.” PMID 27527080 Sep 2016
4

NCT03564158

NCT02166476

NCT03006679

NCT06828848

Known as RPX7009 “Vaborbactam (formerly RPX7009) is a member of a new class of β-lactamase inhibitor with pharmacokinetic properties similar to those of many β-lactams, including carbapenems.” PMID 27527080 Sep 2016
4

NCT01772836

NCT02073812

NCT01897779

NCT02020434

Known as Vaborbactam component of carbavance ChEMBL registry synonym — accepted as the source's own label CHEMBL3317857
Known as Vaborbactam component of vabomere ChEMBL registry synonym — accepted as the source's own label CHEMBL3317857
Action Inhibit “Vaborbactam (formerly RPX7009) is a member of a new class of β-lactamase inhibitor with pharmacokinetic properties similar to those of many β-lactams, including carbapenems.” PMID 27527080 Sep 2016
Modality Small molecule CHEMBL3317857
Route Intravenous Intravenous Biapenem and RPX7009, administered alone and in combination” NCT01772836