Clinical Trials

Numerous clinical trials evaluate cilastatin combination regimens for serious bacterial infections, such as complicated urinary tract infections, acute pyelonephritis, and antibiotic-resistant Gram-negative pathogens. Spanning Phase 1 through Phase 4, these studies involve academic institutions and commercial sponsors, including Evopoint Biosciences, Merck Sharp & Dohme, Pfizer, and Jiangsu HengRui Medicine. Research ranges from early-stage pharmacokinetic and safety evaluations to late-stage efficacy trials, with recruitment statuses extending from completed to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07485010 NOT_YET_RECRUITING
Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease
The University of Queensland
 2027-04 PHASE2
NCT07229040 RECRUITING
Debulking Surgery for Ovarian Cancer; Acute Kidney Injury
Hospital General Universitario Gregorio Marañon
 2025-02-21 PHASE2
NCT06886464 RECRUITING
Acute Kidney Injury
Matthew James
 2025-07-16 PHASE2
NCT07228702 ENROLLING_BY_INVITATION
Non-Tuberculous Mycobacterial (NTM) Pneumonia; Mycobacterium Abscessus Infection
Vancouver Coastal Health
 2026-01-11 PHASE1
NCT07524920 NOT_YET_RECRUITING
MDR Bacteria
Ain Shams University
 2026-04-01 PHASE2
NCT06569056 RECRUITING
Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
Jiangsu HengRui Medicine Co., Ltd.
 2024-09-25 PHASE3
NCT05204368 UNKNOWN
Complicated Urinary Tract Infection Including Acute Pyelonephritis
Evopoint Biosciences Inc.
 2023-03-30 PHASE3
NCT06059846 COMPLETED
Urinary Tract Infection; Acute Pyelonephritis
Spero Therapeutics
 2023-12-21 PHASE3
NCT05887908 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis; cUTI; AP
Meiji Seika Pharma Co., Ltd.
 2023-05-23 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
NCT06144060 UNKNOWN
Patients With Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
Jiangsu HengRui Medicine Co., Ltd.
 2023-12 PHASE2
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NCT05146154 WITHDRAWN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
NCT03583333 COMPLETED
Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia
Merck Sharp & Dohme LLC
 2018-09-18 PHASE3
NCT04801043 COMPLETED
Bacterial Infections
Evopoint Biosciences Inc.
 2021-03-02 PHASE1
NCT04787562 COMPLETED
Bacterial Infections
Evopoint Biosciences Inc.
 2021-02-25 PHASE1
NCT03894046 COMPLETED
Acinetobacter Baumannii-calcoaceticus Complex; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; Bacteremia; Colistin Resistant ABC
Entasis Therapeutics
 2019-09-05 PHASE3
NCT04802863 COMPLETED
Bacterial Infections
Evopoint Biosciences Inc.
 2021-03-25 PHASE1
NCT04802863 Completed
Bacterial Infections
Evopoint Biosciences Inc.
 2021-03-25 Phase 1
NCT04801043 Completed
Bacterial Infections
Evopoint Biosciences Inc.
 2021-03-02 Phase 1
NCT04482569 COMPLETED
Bacterial Infections
Evopoint Biosciences Inc.
 2020-07-10 PHASE1
NCT04787562 Completed
Bacterial Infections
Evopoint Biosciences Inc.
 2021-02-25 Phase 1
NCT02149329 COMPLETED
Febrile Neutropenia; Hematological Malignancy
Amsterdam UMC, location VUmc
 2014-12 PHASE4
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
NCT03595189 COMPLETED
Dose Finding Study
Spherium Biomed
 2018-06-19 PHASE1
NCT03595189 Completed
Dose Finding Study
Spherium Biomed|Hospital Universitario La Paz
 2018-06-19 Phase 1
NCT03445195 COMPLETED
Complicated Urinary Tract Infection; Acute Pyelonephritis
Entasis Therapeutics
 2018-01-17 PHASE2
NCT02474706 TERMINATED
Urinary Tract Infections
Central Hospital, Nancy, France
 2016-03 PHASE4
NCT03230916 Completed
Suspected or Documented Gram-negative Bacterial Infection
Merck Sharp & Dohme LLC
 2017-11-06 Phase 1
NCT02452047 COMPLETED
Bacterial Infections
Merck Sharp & Dohme LLC
 2015-08-21 PHASE3
NCT02971423 COMPLETED
Acinetobacter Baumannii Infection
Entasis Therapeutics
 2016-10 PHASE1
NCT02321800 COMPLETED
Urinary Tract Infections
Shionogi
 2015-02-05 PHASE2
NCT02616354 UNKNOWN
Sepsis
Southeast University, China
 2015-01 PHASE4
NCT01721408 COMPLETED
Intra-abdominal Infection
Pfizer
 2012-11 PHASE4
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
NCT01356472 UNKNOWN
Methicillin-resistant Staphylococcus Aureus; Pneumonia, Ventilator-Associated
Ruijin Hospital
 2011-06 PHASE4
NCT01381549 TERMINATED
Infections, Urinary Tract
GlaxoSmithKline
 2011-06-28 PHASE2
NCT01275170 COMPLETED
Infectious Disease
Merck Sharp & Dohme LLC
 2011-01-28 PHASE1
NCT00589693 TERMINATED
Ventilator-Associated Pneumonia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-04 PHASE3
NCT00707239 TERMINATED
Pneumonia, Bacterial
Pfizer
 2008-12 PHASE2
NCT00690378 COMPLETED
Complicated Urinary Tract Infection
Pfizer
 2008-11 PHASE2
NCT00515034 COMPLETED
Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Pneumonia; Abdominal Abscess; Bacterial Infections
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2007-10 PHASE2
NCT00445094 COMPLETED
Infection; Pneumonia
Merck Sharp & Dohme LLC
 2006-11 PHASE4
NCT00136201 COMPLETED
Abdominal Abscess
Wyeth is now a wholly owned subsidiary of Pfizer
 2005-11 PHASE3
NCT00081744 COMPLETED
Gram-Positive Bacterial Infections; Cross Infection
Wyeth is now a wholly owned subsidiary of Pfizer
 2002-11 PHASE3
NCT00619710 COMPLETED
Skin Infection; Abscess; Cellulitis
Pfizer
 2001-02 PHASE3
NCT00080496 COMPLETED
Bacterial Pneumonia
Wyeth is now a wholly owned subsidiary of Pfizer
 2003-07 PHASE3
NCT00236834 COMPLETED
Nosocomial Pneumonia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 1997-12 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-03-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cilastatin specifically binds to and inhibits renal dehydropeptidase-I and leukotriene D4 dipeptidase located on the brush border of proximal renal tubules. By blocking enzymatic hydrolysis, it prevents the renal breakdown of co-administered carbapenem antibiotics, thereby maintaining therapeutic circulating concentrations necessary to combat severe bacterial infections and complicated urinary tract infections.

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.