Drugs / Ertapenem
Ertapenem
also known as
ertapenem sodium · MK0826 · ERT · Ertapenem sodium salt · Ertapenem sun · Invanz · Invanz(TM) · L-749345 · +1 more
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 45
| 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 Stop: Enrollment |
| Phase 1 | NCT01073059 | Aug 2009 → ? | — | Chonbuk National University | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07840105 | Sep 2026 → Sep 2027 expected | acute pyelonephritis | Wockhardt | Not yet recruiting | No outcome recorded |
| 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 · 5 met primary | ||||||
| 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 | Mixed |
| 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 | Met primary |
| Phase 3 | NCT01370616 | Sep 2011 → Dec 2013 | skin infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01254344 | Dec 2010 → Dec 2011 | infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00771316 | Dec 2008 → Jun 2009 | urinary tract infection | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01014013 | Apr 2008 → Feb 2009 | urinary tract infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 | Met primary |
| Phase 417 trials | ||||||
| Phase 4 | NCT07376889 | Feb 2026 → Jan 2029 expected | staphylococcus aureus infection | Intermountain Health Care, Inc. | 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 | 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 Stop: Enrollment |
| Comparator or background therapy32 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 2/3 | 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 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 | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT03358576 Comparator | Sep 2018 → Oct 2019 | intestinal infectious disease | Iterum Therapeutics, International Limited | Completed | Missed primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 |
| — | NCT03234296 Comparator | Aug 2017 → Sep 2020 overdue | appendicitis | Turku University Hospital | Enrolling by invitation | Missed primary |
| — | 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 | Mixed |
| — | NCT01022567 Comparator | Nov 2009 → Jun 2012 | appendicitis | Turku University Hospital | Unknown | Missed primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-06-11 | JW Pharmaceutical | Regulatory [JW중외제약] 항생제 ‘에르타페넴’ 중국 품목허가 획득 jw-pharma.co.kr ↗
JW중외제약은 자사 기술로 합성·제조한 항생제 원료 ‘에르타페넴(Ertapenem)’을 사용한 완제품이 최근 중국 국가약품감독관리국(NMPA)으로부터 품목허가를 받았다고 11일 밝혔다. |
| 2024-10-07 | Wockhardt | Regulatory Wockhardt’s another breakthrough antibiotic: once a – day β – lactam enhancer, WCK 6777 with unique out – patient treatment advantage granted Fast Track designation by US FDA and successfully completes Phase I study conducted by National Institutes of Health, US wockhardt.com ↗
Additionally, recognizing its potential to meet significant unmet medical needs, the US FDA has recently granted Fast Track designation to WCK 6777 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI). |
All press releases naming this drug 2 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 80 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 ↗75“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 | ERT | “The aims of this study were to evaluate pharmacokinetic (PK) parameters of total and unbound ertapenem (ERT) in burns patients and to identify which covariates influence these...” PMID 23578794 ↗ Apr 2013 |
| 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” NCT00090272 ↗ “MK0826; ertapenem sodium” NCT00157898 ↗ “MK0826, ertapenem sodium” NCT00092170 ↗ |
| 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 ↗ |