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Drug

Ertapenem sodium

Approved · EMA
Emerging researchLate-stage developmentRising momentum

Also known as Ertapenem, INVanz ADD-Vantage, Invanz.

3
Research papers
5
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia (CERT)

Clinical trial2026-05-27Results expected Q2 2027 · ClinicalTrials.gov

PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) Network

Clinical trial2025-04-11Results expected Q1 2027 · ClinicalTrials.gov

Approval: Ertapenem SUN (EMA)

Regulatory2022-07-15EMA

Pharmacokinetics and investigation of optimal dose ertapenem in intermittent hemodialysis patients.

Research2019-10-01Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association

Approval: Invanz (EMA)

Regulatory2002-04-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ertapenem sodium
Aliases & brands
ErtapenemINVanz ADD-VantageInvanz
RxNorm CUI
353107
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2002-04-18
Latest approval
2022-07-15
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2022-07-15Approval
Approval: Ertapenem SUN (EMA)
Indication: Treatment Ertapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria knownShow full indication

Treatment Ertapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1): Intra-abdominal infections Community acquired pneumonia Acute gynaecological infections Diabetic foot infections of the skin and soft tissue (see section 4.4) Prevention Ertapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗
2002-04-18Approval
Approval: Invanz (EMA)
Indication: Treatment Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required:Show full indication

Treatment Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required: intra-abdominal infections; community-acquired pneumonia; acute gynaecological infections; diabetic foot infections of the skin and soft tissue. Prevention Invanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

49 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
49
registered trials across all phases
LATEST COMPLETION 2025
5
Active studies
4
Recruiting
40
Late-stage (III+)
31
Completed
13
Discontinued
PHASE DISTRIBUTIONn = 49
Phase 12Phase 27Phase 2 / 33Phase 314Phase 419Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132019
Most influential

Pharmacokinetics and investigation of optimal dose ertapenem in intermittent hemodialysis patients.

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2019 · 8 cites
Recent papers

Pharmacokinetics and investigation of optimal dose ertapenem in intermittent hemodialysis patients.

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2019 · 8 cites
Journals, researchers & institutions
Top journals
  • International journal of antimicrobial agents1
  • Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association1
  • The Journal of antimicrobial chemotherapy1
Leading researchers
  • Alder J1
  • Arvis P1
  • Cha R1
  • De Waele JJ1
  • Desai NH1
  • Gan WJ1
  • Hampel B1
  • Hsaiky LM1
Leading institutions
free-text, unnormalised
  • Affiliated Hospital of Jiangsu University1
  • Beaumont Hospital - Dearborn1
  • Eugene Applebaum College of Pharmacy and Health Sciences1
  • Ghent University Hospital1
  • Sichuan Academy of Medical Sciences1
  • The 306th Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.