Imipenem/cilastatin: trials, targets and approvals

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Comparator or background therapy1 trial
Phase 2	NCT01506271 Background	Jun 2012 → Aug 2014	infectious peritonitis	Merck Sharp & Dohme LLC	Completed	Met primary

Date	Issuer	Release
2019-02-05	Merck Sharp & Dohme LLC	FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam, and Supplemental NDA (sNDA) for ZERBAXA® (Ceftolozane and Tazobactam) merck.com ↗
2018-04-22	Merck Sharp & Dohme LLC	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 ↗
2016-06-20	Merck Sharp & Dohme LLC	Results of Phase 2 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe merck.com ↗

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

Field	Value	Cited text
Known as	Imipenem/cilastatin	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01506271 ↗
Route	Intravenous	“A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval.” NCT01506271 ↗