Drugs / Ertapenem
Ertapenem
also known as
ertapenem sodium · MK0826 · Ertapenem sodium salt · Ertapenem sun · Invanz · Invanz(TM) · L-749345 · MK-826
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | INVANZ | — | 2005-05-18 – 2006-08-10 | fda.gov ↗ |
| Approved | EU (EMA) | Invanz | — | 2002-04-18 | europa.eu ↗ |
| Approved | US (FDA) | INVANZ | — | 2001-11-21 | fda.gov ↗ |
Trials 44 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02447224 | Mar → Oct 2015 | appendicitis | Olive View-UCLA Education & Research Institute | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT05645757 | Apr → Nov 2023 | bacterial infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01587495 | Mar 2012 → Jan 2014 | endometritis | Daniel Benjamin | Terminated | No outcome recorded |
| Phase 1 | NCT01073059 | Aug 2009 → ? | — | Chonbuk National University | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04886284 | May 2024 → Apr 2027 expected | bacterial endocarditis, bacterial infectious disease with sepsis, staphylococcus aureus infection | Todd C. Lee MD MPH FIDSA | Recruiting | No outcome recorded |
| Phase 2 | NCT05896930 | Nov 2017 → Jan 2021 | pulmonary tuberculosis | TASK Applied Science | Completed | No outcome recorded |
| Phase 2 | NCT01730664 | Jan → Jul 2017 | — | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT02159859 | Dec 2014 → Apr 2016 | end stage renal failure | Corewell Health East | Completed | No outcome recorded |
| Phase 2 | NCT00092170 | Mar 2002 → Jan 2004 | infectious disease, pelvic inflammatory disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT00451386 | Jan 2002 → Dec 2003 | bacterial pneumonia, urinary tract infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01203046 | Dec 2010 | — | Silvia M. Pinango L. | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT06739382 | Jan → Dec 2021 | ventilation pneumonitis | Beni-Suef University | Completed | No outcome recorded |
| Phase 3 | NCT03294395 | Sep 2017 → Jun 2020 | gonorrhea | Public Health Service of Amsterdam | Completed | No outcome recorded |
| Phase 3 | NCT03218800 | Jun 2017 → Feb 2021 | urinary tract infection | Brazilian National Cancer Institute | Terminated | No outcome recorded |
| Phase 3 | NCT02795949 | Oct 2016 → Jan 2020 | bacterial infectious disease | Andalusian Public Foundation for Health Research in Seville | Completed | No outcome recorded |
| Phase 3 | NCT01370616 | Sep 2011 → Dec 2013 | skin infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01254344 | Dec 2010 → Dec 2011 | infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00771316 | Dec 2008 → Jun 2009 | urinary tract infection | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT01014013 | Apr 2008 → Feb 2009 | urinary tract infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00398099 | Jul 2005 → Jan 2006 | pneumonia, urinary tract infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00379951 | Jun 2005 → May 2006 | urinary tract infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00397956 | Sep 2004 → Dec 2005 | infectious disease with sepsis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00090272 | Apr 2002 → Mar 2005 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00481702 | Dec 2001 → Jun 2003 | intestinal infectious disease | Merck Sharp & Dohme LLC | 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 | No outcome recorded |
| Phase 417 trials | ||||||
| Phase 4 | NCT07376889 | Feb 2026 → Jan 2029 expected | staphylococcus aureus infection | Intermountain Health Care, Inc. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07148960 | Sep 2025 → Jul 2027 expected | staphylococcus aureus infection | West Virginia University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06920147 | May 2025 → Mar 2027 expected | — | The University of Texas Health Science Center, Houston | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04140578 | Jan 2017 → Dec 2030 expected | cirrhosis of liver, infectious disease with sepsis | Taipei Veterans General Hospital, Taiwan | Recruiting | No outcome recorded |
| Phase 4 | NCT03859362 | Jan 2017 → Dec 2018 | — | Prince of Songkla University | Unknown | No outcome recorded |
| Phase 4 | NCT02505386 | Aug 2014 → Aug 2016 | bacterial infectious disease | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 4 | NCT02041767 | Dec 2013 → Jan 2015 | benign prostatic hyperplasia | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT01421901 | Aug 2011 → Dec 2014 | appendicitis | A.O. Ospedale Papa Giovanni XXIII | Unknown | No outcome recorded |
| Phase 4 | NCT01297842 | May 2011 → Apr 2013 | — | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT01159379 | Jan → Sep 2011 | allergic disease | Catholic University of the Sacred Heart | Unknown | No outcome recorded |
| Phase 4 | NCT01497990 | Jan 2010 → Sep 2011 | — | Nantes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00877370 | Feb 2009 → Mar 2011 | acute kidney injury | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT00630513 | Jan 2008 → Jun 2010 | infectious peritonitis | University of Bologna | Completed | No outcome recorded |
| Phase 4 | NCT00535652 | Sep 2007 → Dec 2009 | colonic neoplasm, rectal neoplasm | University of Ulm | Completed | No outcome recorded |
| Phase 4 | NCT00489138 | Apr 2007 → Apr 2009 | — | Assistance Publique Hopitaux De Marseille | Terminated | No outcome recorded |
| Phase 4 | NCT00097734 | Jul 2004 → Jun 2007 | diverticulitis of colon | Klinikum Hanover-Siloah Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00157898 | Jan → Aug 2004 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00392028 | Nov 2006 → Jul 2007 | — | HaEmek Medical Center, Israel | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 32 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials | ||||||
| Phase 2 | NCT07318584 Comparator | Mar 2026 → Feb 2028 expected | escherichia coli discitis | Oregon Health and Science University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02789865 Comparator | May 2016 → Apr 2018 | appendicitis | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 2 | NCT02537847 Comparator | Nov 2012 → Sep 2015 | acute pyelonephritis, escherichia coli infection | Mahidol University | Unknown | No outcome recorded |
| Phase 2 | NCT01886053 Comparator | Apr 2011 → Jul 2012 | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01265784 Comparator | Jan 2011 → May 2012 | — | Tetraphase Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT04879030 Background | Jan → Aug 2020 | chronic obstructive pulmonary disease | Haiphong University of Medicine and Pharmacy | Completed | No outcome recorded |
| Phase 2/3 | NCT04505683 Comparator | Dec 2018 → May 2020 | acute pyelonephritis | Sihuan Pharmaceutical Holdings Group Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT02729116 Comparator | Jul 2016 → Dec 2023 | Klebsiella infectious disease, escherichia coli infection, urinary tract infection | Khon Kaen University | Unknown | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT05224401 Comparator | May 2023 → Sep 2027 expected | bacterial urinary tract infection | Lund University | Recruiting | No outcome recorded |
| Phase 3 | NCT03788967 Comparator | Jun 2019 → May 2020 | acute pyelonephritis | Spero Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT03582007 Background | Oct 2018 → Jul 2019 | pneumonia | Polyphor Ltd. | Terminated | No outcome recorded |
| Phase 3 | NCT03357614 Comparator | Sep 2018 → Dec 2019 | urinary tract infection | Iterum Therapeutics, International Limited | Completed | No outcome recorded |
| Phase 3 | NCT03358576 Comparator | Sep 2018 → Oct 2019 | intestinal infectious disease | Iterum Therapeutics, International Limited | Completed | No outcome recorded |
| Phase 3 | NCT03032510 Comparator | Jan → Dec 2017 | urinary tract infection | Tetraphase Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT01937832 Comparator | Oct 2013 → Oct 2015 | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT01844856 Comparator | Aug 2013 → Aug 2014 | — | Tetraphase Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 3 | NCT01069900 Comparator | Jul 2010 → Jan 2015 | infectious peritonitis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00366249 Comparator | Jan 2007 → Mar 2009 | bacterial infectious disease, osteomyelitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00492726 Comparator | Jul 2006 → Feb 2009 | infectious disease | Bayer | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT04502095 Background | Sep 2020 → Mar 2025 | urinary bladder carcinoma, urinary tract infection | Roswell Park Cancer Institute | Completed | 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 | NCT01723150 Comparator | Nov 2013 → Jan 2018 | liver abscess (disease) | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 4 | NCT01148771 Comparator | Aug → Oct 2010 | — | Hartford Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00939952 Comparator | Jun 2009 → May 2010 | end stage renal failure | Albany College of Pharmacy and Health Sciences | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT03234296 Comparator | Aug 2017 → Sep 2020 overdue | appendicitis | Turku University Hospital | Enrolling by invitation | No outcome recorded |
| — | NCT03257423 Comparator | Apr 2017 → Dec 2022 | appendicitis | Turku University Hospital | Unknown | No outcome recorded |
| — | NCT03236961 Comparator | Apr 2017 → Nov 2018 overdue | appendicitis | Turku University Hospital | Active not recruiting | No outcome recorded |
| — | NCT02800785 Comparator | May 2016 → Mar 2020 | appendicitis | University of Washington | Completed | No outcome recorded |
| — | NCT02724410 Comparator | Jan 2011 → Nov 2013 | appendicitis | Wake Forest University Health Sciences | Completed | No outcome recorded |
| — | NCT01022567 Comparator | Nov 2009 → Jun 2012 | appendicitis | Turku University Hospital | Unknown | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 78 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ertapenem | “The beta-lactam antibiotics with activity against gram-negative bacilli in this study included piperacillin-tazobactam, ticarcillin-clavulanate, imipenem-cilastin, meropenem,...” NCT04879030 ↗74“Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) and no contraindications will receive an anti-staphylococcal beta-lactam, either cefazolin or nafcillin, plus ertapenem” NCT07376889 ↗ “A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)” NCT00481702 ↗ “Preferred antibiotic for ESBL E. coli infections: ertapenem. Minimum 1 dose within 24 hours of randomization.” NCT07318584 ↗ “Participant given IV cefazolin plus ertapenem dosing per standard of care.” NCT07148960 ↗ “3) carbapenems; ertapenem, imipenem, meropenem” NCT07236944 ↗ “Murepavadin + ertapenem” NCT03582007 ↗ “Ertapenem 1-2g/24h” NCT02795949 ↗ |
| Known as | ertapenem sodium | “Combined IV and oral antibiotics consisted of IV ertapenem sodium, 1 g/d, for 2 days plus oral levofloxacin, 500 mg/d, and metronidazole, 500 mg 3 times/d, for 5 days.” PMID 38630471 ↗ Jul 20249“Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days” NCT01370616 ↗ “MK0826, ertapenem sodium / Duration of Treatment - 24 weeks” NCT00229112 ↗ “MK0826, ertapenem sodium / Duration of Treatment: 14 Days” NCT00397956 ↗ “MK0826, ertapenem sodium / Duration of Treatment: 14 Days” NCT00398099 ↗ “MK0826, ertapenem sodium /Duration of Treatment: 14 Days” NCT00451386 ↗ “ertapenem sodium (MK0826)” NCT01014013 ↗ “MK0826, ertapenem sodium” NCT00092170 ↗ “MK0826, ertapenem sodium” NCT00090272 ↗ “MK0826; ertapenem sodium” NCT00157898 ↗ |
| Known as | Ertapenem sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1359 ↗ |
| Known as | Ertapenem sun | ChEMBL registry synonym — accepted as the source's own label CHEMBL1359 ↗ |
| Known as | Invanz | ChEMBL registry synonym — accepted as the source's own label CHEMBL1359 ↗ |
| Known as | Invanz(TM) | “Invanz(TM) (Ertapenem Sodium)” NCT00397956 ↗ |
| Known as | L-749345 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1359 ↗ |
| Known as | MK-826 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1359 ↗ |
| Known as | MK0826 | “MK0826, ertapenem sodium / Duration of Treatment - 24 weeks” NCT00229112 ↗7“MK0826, ertapenem sodium / Duration of Treatment: 14 Days” NCT00397956 ↗ “MK0826, ertapenem sodium / Duration of Treatment: 14 Days” NCT00398099 ↗ “MK0826, ertapenem sodium /Duration of Treatment: 14 Days” NCT00451386 ↗ “MK0826, ertapenem sodium” NCT00090272 ↗ “MK0826, ertapenem sodium” NCT00092170 ↗ “MK0826 (ertapenem)” NCT00771316 ↗ |
| Modality | Small molecule | “Ertapenem is a new carbapenem” NCT01159379 ↗ |
| Route | Intravenous | “intravenous marketed drug” NCT00090272 ↗ |