Clinical Trials

Relebactam (MK-7655) has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to assess its efficacy and pharmacokinetics in treating bacterial pneumonia, complicated urinary tract infections, intra-abdominal infections, sepsis, and carbapenem-resistant Gram-negative infections. Sponsored by industry entities such as Merck Sharp & Dohme LLC alongside academic medical centers like Hartford Hospital, these active, recruiting, and completed protocols aim to optimize treatment regimens for patients with severe antibiotic-resistant infections and critical illnesses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07759453 NOT_YET_RECRUITING
Liver Transplant; Carbapenem-resistant Enterobacterales; CRE Colonization
IRCCS Azienda Ospedaliero-Universitaria di Bologna
 2026-10-01 PHASE3
NCT05561764 TERMINATED
Cystic Fibrosis; Pneumonia, Bacterial
Hartford Hospital
 2023-01-03 PHASE4
NCT05204563 COMPLETED
Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
Evopoint Biosciences Inc.
 2022-07-31 PHASE3
NCT04983901 COMPLETED
Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2021-09-14 PHASE2
NCT05146154 WITHDRAWN
Obesity; Critical Illness
University of Illinois at Chicago
 2023-01-01 PHASE4
NCT04493151 COMPLETED
Sepsis
Joseph L. Kuti, PharmD
 2021-01-01 PHASE1
NCT04785924 WITHDRAWN
Carbapenem-Resistant Enterobacteriaceae Infection; KPC; Gram-Negative Bacterial Infections; Antibiotic Resistant Infection
Wake Forest University Health Sciences
 2021-06-07 PHASE4
NCT05561764 Recruiting
Cystic Fibrosis|Pneumonia Bacterial
Hartford Hospital|Merck Sharp & Dohme LLC|Q2 Solutions|Connecticut Children''s Medical Center|St. Christopher''s Hospital for Children|University of Texas Southwestern Medical Center|University of Pittsburgh Medical Center|Indiana University Health Methodist Hospital|James Whitcomb Riley Hospital for Children
 2023-01-03 Phase 4
NCT05146154 Enrolling by invitation
Obesity|Critical Illness
University of Illinois at Chicago|Merck Sharp & Dohme LLC
 2023-01-01 Phase 4
NCT03583333 COMPLETED
Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia
Merck Sharp & Dohme LLC
 2018-09-18 PHASE3
NCT05285046 Unknown status
Bacterial Infections|Antibiotic Resistant Infection
D''Or Institute for Research and Education
 2022-04-01 --
NCT04147221 COMPLETED
Sepsis
Hartford Hospital
 2020-02-10 PHASE1
NCT04493151 Completed
Sepsis
Joseph L. Kuti PharmD|Merck Sharp & Dohme LLC|Hartford Hospital
 2021-01-01 Phase 1
NCT04147221 Completed
Sepsis
Hartford Hospital|Merck Sharp & Dohme LLC
 2020-02-10 Phase 1
NCT03969901 Active not recruiting
Suspected or Documented Gram-negative Bacterial Infection
Merck Sharp & Dohme LLC
 2019-10-08 Phase 2|Phase 3
NCT02493764 COMPLETED
Bacterial Pneumonia
Merck Sharp & Dohme LLC
 2015-11-24 PHASE3
NCT03293485 COMPLETED
Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection
Merck Sharp & Dohme LLC
 2017-10-04 PHASE3
NCT02452047 COMPLETED
Bacterial Infections
Merck Sharp & Dohme LLC
 2015-08-21 PHASE3
NCT01505634 COMPLETED
Urinary Tract Infections; Pyelonephritis
Merck Sharp & Dohme LLC
 2012-05-16 PHASE2
NCT01506271 COMPLETED
Intra-abdominal Infections
Merck Sharp & Dohme LLC
 2012-06-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-12)

Check the Relebactam product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Relebactam acts as a potent inhibitor of class A and class C β-lactamases, including KPC-2, binding to these bacterial enzymes to block the degradation of co-administered β-lactam antibiotics. By restoring bacterial susceptibility to antimicrobial therapy, this target inhibition effectively combats resistant Gram-negative pathogens in clinical settings such as bacterial pneumonia, complicated urinary tract infections, and sepsis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.