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Imipenem and Cilastatin Sodium
Imipenem and Cilastatin Sodium is a Beta-lactam antibiotic (carbapenem) with dehydropeptidase inhibitor Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently FDA-approved for Serious bacterial infections including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, gynecological infections, and septicemia, Polymicrobial infections and infections caused by gram-positive and gram-negative aerobic and anaerobic bacteria.
Imipenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, while cilastatin prevents imipenem degradation by inhibiting renal dehydropeptidase I.
Imipenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, while cilastatin prevents imipenem degradation by inhibiting renal dehydropeptidase I. Used for Serious bacterial infections including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, gynecological infections, and septicemia, Polymicrobial infections and infections caused by gram-positive and gram-negative aerobic and anaerobic bacteria.
At a glance
| Generic name | Imipenem and Cilastatin Sodium |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Beta-lactam antibiotic (carbapenem) with dehydropeptidase inhibitor |
| Target | Penicillin-binding proteins (PBPs); bacterial cell wall peptidoglycan; renal dehydropeptidase I |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Imipenem is a broad-spectrum beta-lactam antibiotic that disrupts peptidoglycan cross-linking in bacterial cell walls, leading to cell lysis and death. Cilastatin sodium is a dehydropeptidase inhibitor that protects imipenem from renal metabolism, allowing higher urinary concentrations and reducing nephrotoxicity while maintaining systemic antibiotic efficacy.
Approved indications
- Serious bacterial infections including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, gynecological infections, and septicemia
- Polymicrobial infections and infections caused by gram-positive and gram-negative aerobic and anaerobic bacteria
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Phlebitis at injection site
- Seizures
- Hypersensitivity reactions
- Elevated liver enzymes
Key clinical trials
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PHASE3)
- Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021) (PHASE2, PHASE3)
- Percutaneous Transcatheter Genicular Embolization in Osteoarthritis (NA)
- Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis (PHASE3)
- Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain. (NA)
- Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2) (PHASE3)
- Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Imipenem and Cilastatin Sodium CI brief — competitive landscape report
- Imipenem and Cilastatin Sodium updates RSS · CI watch RSS
- Jiangsu HengRui Medicine Co., Ltd. portfolio CI
Frequently asked questions about Imipenem and Cilastatin Sodium
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Related
- Drug class: All Beta-lactam antibiotic (carbapenem) with dehydropeptidase inhibitor drugs
- Target: All drugs targeting Penicillin-binding proteins (PBPs); bacterial cell wall peptidoglycan; renal dehydropeptidase I
- Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Serious bacterial infections including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, gynecological infections, and septicemia
- Indication: Drugs for Polymicrobial infections and infections caused by gram-positive and gram-negative aerobic and anaerobic bacteria
- Compare: Imipenem and Cilastatin Sodium vs similar drugs
- Pricing: Imipenem and Cilastatin Sodium cost, discount & access