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

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 → Oct 2027 expected gram-negative bacterial infections Menarini Group Recruiting No outcome recorded
Phase 32 trials · 1 met primary
Phase 3 NCT03006679 Aug 2018 → Jun 2020 bacterial pneumonia Melinta Therapeutics, Inc. Withdrawn No outcome recorded Stop: Business
Phase 3 NCT02166476 Nov 2014 → Apr 2016 acute pyelonephritis Melinta Therapeutics, Inc. Completed Met primary

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2020-07-09 Menarini Group Results Menarini Ricerche Announces the Latest Findings of its Vaborem™ and Quofenix™ Clinical Studies menarini.com ↗
Menarini Ricerche, the R&D division of the Menarini Group, announces that it has published four abstracts presenting the latest findings related to its meropenem/vaborbactam (Vaborem ™ ) and delafloxacin (Quofenix ™ ) clinical studies, confirming Menarini’s commitment to fighting life-threatening bacterial infections.
2018-12-20 Menarini Group Regulatory The Menarini Group announces meropenem/vaborbactam European marketing authorization menarini.com ↗
Meropenem/vaborbactam approved on 20th November 2018 by the European Commission for clinical use in adult patients with difficult-to-treat infections.

All press releases naming this drug 2 releases

DateIssuerRelease

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

NCT06828848 ↗

NCT02166476 ↗

NCT03564158 ↗

NCT03006679 ↗

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

NCT01897779 ↗

NCT02073812 ↗

NCT02020434 ↗

NCT01772836 ↗

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 ↗