Drugs / Cilastatin
Cilastatin
also known as
CIL · cilastatin sodium · Cilastatin sodium component of mk-7655a · Cilastatin sodium component of primaxin · Cilastatin sodium component of recarbrio · Cilastatin sodium salt · Cilastatina · cilastatine · +2 more
Small molecule targets DPEP1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Recarbrio | — | 2020-02-13 | europa.eu ↗ |
| Filed | US (FDA) | RECARBRIO | hospital-acquired and ventilator-associated bacterial pneumonia | 2020-02-03 | “accepted for review a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) to treat adult patients with hospital-acquired bacterial pneumonia” merck.com ↗ |
| Approved | US (FDA) | PRIMAXIN | — | 1985-11-26 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT04802863 | Mar → May 2021 | bacterial infectious disease | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04801043 | Mar → Oct 2021 | bacterial infectious disease | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04787562 | Feb → Oct 2021 | bacterial infectious disease | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04493151 | Jan 2021 → May 2023 | infectious disease with sepsis | Joseph L. Kuti, PharmD | Completed | No outcome recorded |
| Phase 1 | NCT03595189 | Jun → Aug 2018 | — | Spherium Biomed | Completed | No outcome recorded |
| Phase 1 | NCT03230916 | Nov 2017 → Jul 2020 | gram-negative bacterial infections | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02971423 | Oct 2016 → Jun 2017 | Acinetobacter infectious disease | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01275170 | Jan 2011 → Mar 2012 | infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06886464 | Jul 2025 → Dec 2027 expected | acute kidney injury | Matthew James | Recruiting | No outcome recorded |
| Phase 2 | NCT07229040 | Feb 2025 → Oct 2028 expected | acute kidney injury | Hospital General Universitario Gregorio Marañon | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03969901 | Oct 2019 → May 2024 | gram-negative bacterial infections | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT05204368 | Mar 2023 → Jun 2025 | acute pyelonephritis | Evopoint Biosciences Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT05204563 | Jul 2022 → Sep 2024 | bacterial pneumonia | Evopoint Biosciences Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03583333 | Sep 2018 → Jul 2022 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03293485 | Oct 2017 → Sep 2018 | urinary tract infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02493764 | Nov 2015 → Apr 2019 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02452047 | Aug 2015 → Sep 2017 | bacterial infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00080496 | Jul 2003 → Dec 2006 | bacterial pneumonia | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
| Phase 1/2 | NCT04764058 Background | Sep 2017 → Sep 2019 | bacterial infectious disease, infectious disease with sepsis | Ain Shams University | Unknown | No outcome recorded |
| Phase 2 | NCT02321800 Comparator | Feb 2015 → Jul 2016 | urinary tract infection | Shionogi | Completed | Met primary |
| Phase 2 | NCT01381549 Comparator | Jun 2011 → Mar 2012 | urinary tract infection | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT00515034 Comparator | Oct 2007 → Nov 2008 | abscess, bacterial pneumonia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT05887908 Comparator | May 2023 → Nov 2024 | acute pyelonephritis | Meiji Seika Pharma Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03894046 Background | Sep 2019 → Jul 2021 | Acinetobacter infectious disease, bacterial pneumonia | Entasis Therapeutics | Completed | Met primary |
| Phase 4 | NCT01721408 Comparator | Nov 2012 → Oct 2015 | intestinal infectious disease | Pfizer | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2020-06-05 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) merck.com ↗ |
| 2020-05-06 | Merck Sharp & Dohme LLC | Results Results of Phase 3 Trial Evaluating the Efficacy and Safety of Merck’s RECARBRIO™ (Imipenem, Cilastatin, and Relebactam) Versus Piperacillin and Tazobactam in Adult Patients with HABP/VABP Now Available merck.com ↗
RECARBRIO met its primary and key secondary endpoints, demonstrating non-inferiority compared to PIP/TAZ. |
| 2020-02-03 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts For Review Supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms. |
| 2019-12-16 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Infections Due to Aerobic Gram-Negative Organisms in Adults with Limited Treatment Options merck.com ↗
The CHMP positive opinion will now be considered by the European Commission. |
| 2019-09-30 | Merck Sharp & Dohme LLC | Results Pivotal RESTORE-IMI 2 Phase 3 Study of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 RECARBRIO™ (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) RESTORE-IMI 2 trial met its primary endpoint. |
| 2019-07-17 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial. |
| 2019-02-05 | Merck Sharp & Dohme LLC | Regulatory 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 ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review regulatory filings for two antibacterial agents. |
| 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 ↗ |
| 2016-06-20 | Merck Sharp & Dohme LLC | Results Results of Phase 2 Study of Merck’s Investigational Beta-Lactamase Inhibitor Relebactam in Combination with Imipenem/Cilastatin Presented at ASM Microbe merck.com ↗
today announced that a Phase 2 study of relebactam, the company’s investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin (an approved carbapenem antibiotic), in patients with complicated urinary tract infections, met its primary endpoint. |
| 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. |
All press releases naming this drug 14 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cilastatin | “Healthy young females participants, ≥ 18 to ≤ 45 years of age, randomized to receive a single dose of XNW4107 250mg IV co-administered with imipenem 500mg /cilastatin 500mg.” NCT04801043 ↗23“Imipenem/cilastatin/relebactam (IMI/REL), a fixed-dose combination of imipenem/cilastatin with the β-lactamase inhibitor relebactam, has broad gram-negative coverage.” PMID 42400209 ↗ Jul 2026 “Imipenem/cilastatin/relebactam is approved for the treatment of serious gram-negative bacterial infections in adults.” PMID 37562063 ↗ Sep 2023 “500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial” NCT03583333 ↗ |
| Known as | CIL | “plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose” NCT03230916 ↗ |
| Known as | cilastatin sodium | “Imipenem and cilastatin sodium” NCT04764058 ↗ |
| Known as | Cilastatin sodium component of mk-7655a | ChEMBL registry synonym — accepted as the source's own label CHEMBL766 ↗ |
| Known as | Cilastatin sodium component of primaxin | ChEMBL registry synonym — accepted as the source's own label CHEMBL766 ↗ |
| Known as | Cilastatin sodium component of recarbrio | ChEMBL registry synonym — accepted as the source's own label CHEMBL766 ↗ |
| Known as | Cilastatin sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL766 ↗ |
| Known as | Cilastatina | ChEMBL registry synonym — accepted as the source's own label CHEMBL766 ↗ |
| Known as | cilastatine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07229040 ↗ |
| Known as | MK-791 | ChEMBL registry synonym — accepted as the source's own label CHEMBL766 ↗ |
| Known as | Primaxin | ChEMBL registry synonym — accepted as the source's own label CHEMBL766 ↗ |
| Action | Inhibit | “Renal dipeptidase inhibitor” CHEMBL766 ↗ |
| Modality | Small molecule | “Cilastatin is a small molecule” NCT06886464 ↗ |
| Route | Intravenous | “250 mg IV over 30 minutes as a single dose” NCT01275170 ↗ |
| Target | DPEP1 | “Renal dipeptidase inhibitor” CHEMBL766 ↗ |