Drugs / nacubactam
last change May 2026 re-read 2 minutes ago

nacubactam

also known as OP0595 · RO7079901 · FPI-1459 · RG-6080

Small molecule

Developed for
acute pyelonephritis · bacterial infectious disease · bacterial pneumonia · urinary tract infection
Investigated by
Hoffmann-La Roche · Meiji Seika Pharma Co., Ltd.

Trials 7 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT03174795 Jul → Dec 2017 urinary tract infection Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT03182504 Jun → Aug 2017 gram-negative bacterial infections Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT02975388 Dec 2016 → Jul 2017 impaired renal function disease Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT02972255 Oct 2016 → Mar 2017 Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT02134834 May → Aug 2014 bacterial infectious disease Meiji Seika Pharma Co., Ltd. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT05905055 Sep 2023 → Sep 2025 acute pyelonephritis, bacterial pneumonia Meiji Seika Pharma Co., Ltd. Completed No outcome recorded
Phase 3 NCT05887908 May 2023 → Nov 2024 acute pyelonephritis Meiji Seika Pharma Co., Ltd. Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as nacubactam “A multi-center, open-label, two-part study to investigate the effect of renal function and hemodialysis on the pharmacokinetics of the novel β-lactamase inhibitor nacubactam.” PMID 42059789 Apr 2026
3

NCT05887908

NCT03182504

NCT05905055

Known as FPI-1459 ChEMBL registry synonym — accepted as the source's own label CHEMBL3989959
Known as OP0595 “Nacubactam (OP0595) is a newly developed diazabicyclooctane β-lactamase inhibitor used in combination with cefepime or aztreonam.” PMID 42134354 May 2026
1

“A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595NCT02134834

Known as RG-6080 ChEMBL registry synonym — accepted as the source's own label CHEMBL3989959
Known as RO7079901 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03174795
1

NCT02972255

Action Inhibit “novel bicyclic non-β-lactam β-lactamase inhibitor” PMID 42059789 Apr 2026
Modality Small molecule “Nacubactam is a novel bicyclic non-β-lactam β-lactamase inhibitor” PMID 42059789 Apr 2026
Route Intravenous “OP0595 Administered Intravenously” NCT02134834