Drugs / Tazobactam
Tazobactam
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pneumonia caused by pseudomonas aeruginosa infection 1 milestone | |||||
| Filed | US (FDA) | ZERBAXA | pneumonia caused by pseudomonas aeruginosa infection | 2019-02-05 | “a sNDA accepted for Priority Review for ZERBAXA ® (ceftolozane and tazobactam) to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia” merck.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Zerbaxa | — | 2015-09-18 | europa.eu ↗ |
| Approved | US (FDA) | ZOSYN | — | 1993-10-22 | fda.gov ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT04223752 | Apr 2020 → Sep 2024 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT03622008 | Mar → May 2018 | flucloxacilline toxicity | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT03441529 | Feb → May 2018 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02709382 | Mar → Aug 2016 | impaired renal function disease | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02387372 | Feb 2015 → Jun 2017 | pneumonia | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02266706 | Sep 2014 → Jun 2017 | gram-negative bacterial infections | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02508753 | Jun → Jul 2010 | — | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02817347 | Jun 2016 → Apr 2017 | discharging ear, otitis media | Yuhan Corporation | Terminated | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07481539 | Mar 2026 → Apr 2027 expected | bacterial infectious disease | Azienda Sanitaria Universitaria Friuli Centrale | Recruiting | No outcome recorded |
| Phase 2 | NCT05753735 | Jan → Mar 2024 | pancreas disorder | Case Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03230838 | Apr 2018 → Dec 2020 | pyelonephritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT03217136 | Apr 2018 → Mar 2020 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 39 trials · 1 met primary | ||||||
| Phase 3 | NCT03630081 | Jan 2024 → Jan 2026 | acute pyelonephritis | Wockhardt | Unknown | No outcome recorded |
| Phase 3 | NCT04238390 | Jan 2022 → Jun 2024 | gram-negative bacterial infections | The University of Queensland | Withdrawn | No outcome recorded |
| Phase 3 | NCT02728089 | Apr 2016 → Sep 2017 | pyelonephritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02739997 | Apr 2016 → Jul 2017 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01853982 | Jun → Nov 2013 | — | Merck & Co., Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00629135 | Nov 2005 → Aug 2011 | abscess | Hannover Medical School | Completed | No outcome recorded |
| Phase 3 | NCT00389987 | Sep 2001 → May 2004 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00229112 | Apr 2001 → Apr 2004 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00044759 | ? → Jan 2003 | hematopoietic and lymphoid cell neoplasm | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 412 trials · 1 missed | ||||||
| Phase 4 | NCT05981079 | Jul 2023 → Dec 2024 | neonatal sepsis | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT04673175 | Jan 2023 → Mar 2025 | Pseudomonas aeruginosa infectious disease, disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm, pneumonia | Weill Medical College of Cornell University | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT05394298 | Jul 2022 → Jul 2024 | Enterococcus infectious disease | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 4 | NCT05355350 | Jul 2022 → Jul 2025 | bacterial infectious disease | Rambam Health Care Campus | Withdrawn | No outcome recorded |
| Phase 4 | NCT04948463 | Nov 2021 → Dec 2025 | neutropenia | Murdoch Childrens Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT04233996 | Jun 2019 → Dec 2021 | neutropenia | Hospital Universitari de Bellvitge | Unknown | No outcome recorded |
| Phase 4 | NCT03002506 | Aug 2017 → Jun 2020 | — | Texas Tech University Health Sciences Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03289351 | May 2017 → Nov 2021 | appendicitis | Phoenix Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01694069 | Sep 2012 → Sep 2013 | cystic fibrosis | West Virginia University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00703144 | Jun 2008 → Aug 2012 | — | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00044928 | Jul 2002 → Feb 2004 | bacterial infectious disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT00044746 | Oct 2000 → Jan 2003 | diabetes mellitus | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06972537 | Jul 2024 → Sep 2026 overdue | pneumonia | Shandong University | Recruiting | No outcome recorded |
| — | NCT02795793 | May 2016 → May 2019 | appendicitis | Sydney Children's Hospitals Network | Unknown | No outcome recorded |
| — | NCT01923363 | Feb 2014 → Jan 2016 | obesity disorder | Loma Linda University | Completed | No outcome recorded |
| — | NCT01714570 | Nov 2012 → Mar 2014 | neutropenia | Chinese PLA General Hospital | Completed | No outcome recorded |
| — | NCT00924742 | Mar → Apr 2009 | — | Tri-Service General Hospital (TSGH) | Completed | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 2 | NCT05060419 Comparator | Oct 2021 → Apr 2022 | acute pyelonephritis | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03485950 Background | May 2018 → May 2021 | infectious disease | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03435900 Comparator | Feb → Jul 2018 | appendicitis | Herlev Hospital | Completed | Met primary |
| Phase 2/3 | NCT01796717 Comparator | Mar 2012 → Nov 2016 | bacterial pneumonia | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04042077 Comparator | Sep 2019 → Oct 2020 | — | Menarini Group | Terminated | Met primary |
| Phase 3 | NCT03687255 Comparator | Sep 2018 → Jan 2020 | urinary tract infection | Allecra | Completed | Met primary |
| Phase 3 | NCT03583333 Comparator | Sep 2018 → Jul 2022 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT03006679 Comparator | Aug 2018 → Jun 2020 | bacterial pneumonia | Melinta Therapeutics, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02493764 Comparator | Nov 2015 → Apr 2019 | bacterial pneumonia | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02166476 Comparator | Nov 2014 → Apr 2016 | acute pyelonephritis | Melinta Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02619149 Comparator | Mar 2009 → Dec 2017 | acute cholecystitis | Karolinska Institutet | Completed | No outcome recorded |
| Phase 3 | NCT00402727 Comparator | Sep 2006 → Jun 2008 | abscess, skin infection, ulcer disease | Bayer | Completed | Met primary |
| Phase 3 | NCT00253955 Comparator | Jun 2003 → May 2007 | pneumonia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00003805 Background | Nov 1997 → Jun 2000 | bone marrow disorder, cancer of unknown primary site, childhood malignant neoplasm, infectious disease +3 | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 4 | NCT07556107 Comparator | Jun 2026 → Jun 2028 expected | acute kidney injury, infectious disease with sepsis | Bassett Healthcare | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06184659 Comparator | Jun 2025 → Jun 2028 expected | infectious disease with sepsis | Scandinavian Critical Care Trials Group | Recruiting | No outcome recorded |
| Phase 4 | NCT03891433 Comparator | Apr 2019 → Dec 2024 | Klebsiella pneumonia, bacterial urinary tract infection, escherichia coli infection | Universidad del Norte | Suspended | No outcome recorded |
| Phase 4 | NCT02730624 Background | Mar 2014 → May 2016 | infectious disease with sepsis | Sutep Jaruratanasirikul | Completed | No outcome recorded |
| Phase 4 | NCT00634166 Background | Sep 2007 → Dec 2013 | — | Mylan Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00488189 Comparator | May 2007 → Feb 2008 | bacterial infectious disease | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| — | NCT04803422 Comparator | Apr 2021 → May 2024 | appendicitis | Zealand University Hospital | Completed | No outcome recorded |
| — | NCT04394182 Background | Apr → Dec 2020 | cytokine release syndrome, viral pneumonia | Fundacion GenesisCare | Suspended | No outcome recorded Stop: Enrollment |
| — | NCT03765645 Comparator | Oct 2018 → Aug 2020 | — | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT02840136 Background | Feb 2016 → Sep 2017 | cystic fibrosis | University Ghent | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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. |
| 2018-10-25 | Merck Sharp & Dohme LLC | Results Merck Announces Third-Quarter 2018 Financial Results merck.com ↗
met the pre-specified primary endpoints, demonstrating non-inferiority to meropenem, the active comparator, in day 28 all-cause mortality and in clinical cure rate at the test-of-cure visit. |
| 2018-09-11 | Merck Sharp & Dohme LLC | Results Merck’s ZERBAXA® (ceftolozane and tazobactam) Met Primary Endpoints of Non-Inferiority Compared to Meropenem in Pivotal Phase 3 Study of Adult Patients with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia merck.com ↗ |
| 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 10 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tazobactam | “'Topical Antimicrobial/Antifungal Medications' Various topical antimicrobials and antifungals include: Bacitracin; Amphotericin B; Silver Sulfadiazine; Cefazolin; Vancomycin;...” NCT00634166 ↗60“FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days” NCT03622008 ↗ “Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes” NCT01796717 ↗ “4 g piperacillin/500 mg tazobactam and 1 g metronidazole administered intravenously during surgery” NCT03435900 ↗ “Last 6 month: Intravenous Metronidazole and Intravenous Pipperacillin / Tazobactam.” NCT04803422 ↗ “4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial” NCT03583333 ↗ “Piperacillin/tazobactam (isolates sensitive to ampicillin) 4 g/8h (i.v.)” NCT05394298 ↗ “FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h)” NCT03630081 ↗ “With intravenous Piperacillin with Tazobactam (Tazocin)” NCT02795793 ↗ |
| Known as | CL 298,741 | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | CL 307,579 | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | NSC-759887 | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | TAZ | “WCK 4282 is a combination product of cefepime (FEP) and tazobactam (TAZ) in a 1:1 ratio currently under development for the treatment of multidrug-resistant Gram-negative...” PMID 31332068 ↗ Sep 2019 |
| Known as | Tazobactam (as sodium) | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | Tazobactam Sodium | “Piperacillin Sodium and Tazobactam Sodium for Injection (Bonda) 4.5g administered four times a day (QID), with each infusion lasting for 4 hours.” NCT06972537 ↗ |
| Known as | Tazobactam sodium component of zerbaxa | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | Tazobactam sodium component of zosyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | Tazobactam sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | Tazobactum sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | Tazocillin | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Known as | YTR-830H | ChEMBL registry synonym — accepted as the source's own label CHEMBL404 ↗ |
| Action | Inhibit | “beta-lactamase inhibitor” NCT02166476 ↗ |
| Modality | Small molecule | “Ceftolozane/tazobactam, a cephalosporin-β-lactamase inhibitor combination” PMID 37000942 ↗ Mar 2023 |
| Route | Intravenous | “Patients receive piperacillin/tazobactam IV over 20-30 minutes every 6 hours.” NCT00003805 ↗ |