Drugs / Imipenem/Cilastatin/Relebactam
last change Jan 2024 re-read 3 minutes ago

Imipenem/Cilastatin/Relebactam

Other / unclassified

Investigated by
Merck Sharp & Dohme LLC · University of Illinois at Chicago

Trials 1

2023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT05146154 Jan → Jun 2023 critical illness polyneuropathy, obesity disorder University of Illinois at Chicago Withdrawn No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2018-04-22 Merck Sharp & Dohme LLC Results Pivotal Phase 3 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Demonstrated Favorable Overall Response Against Certain Imipenem–Non-Susceptible Bacterial Infections merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a pivotal Phase 3 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin, demonstrated a favorable overall response in the treatment of certain imipenem–non-susceptible bacterial infections, the primary endpoint, with lower treatment-emergent nephrotoxicity (kidney toxicity), a secondary endpoint, compared to a Colistin (colistimethate sodium) plus imipenem regimen.
2015-09-18 Merck Sharp & Dohme LLC Results Results of Phase 2 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam Presented at ICAAC/ICC 2015 merck.com ↗
In the Phase 2 study, relebactam in combination with imipenem/cilastatin demonstrated noninferiority in the percentage of microbiologically evaluable patients with favorable clinical response at the end of intravenous therapy compared to imipenem/cilastatin alone.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Imipenem/Cilastatin/Relebactam ClinicalTrials.gov intervention name — accepted as the source's own label NCT05146154 ↗
Action Inhibit “beta-lactamase inhibitor” NCT05146154 ↗
Modality Other / unclassified “combination beta-lactam/beta-lactamase inhibitor antimicrobial” NCT05146154 ↗