RECARBRIO (cilastatin sodium)
Recarbrio is a combination of imipenem (a penem antibacterial), cilastatin (a renal dehydropeptidase inhibitor), and relebactam (a beta-lactamase inhibitor). It is indicated for adult and pediatric patients weighing at least 2 kg for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). It is also indicated for complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in patients with limited or no alternative treatment options. Usage is restricted to infections caused by susceptible gram-negative bacteria. Recarbrio is not recommended for pediatric patients less than 37 weeks post-menstrual age or those weighing less than 30 kg with renal impairment.
How RECARBRIO Works
Recarbrio exerts its effect through the synergistic action of three components: imipenem, cilastatin, and relebactam. Imipenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell death. Cilastatin limits the renal metabolism of imipenem by inhibiting the enzyme dehydropeptidase I in the renal tubule, thereby increasing therapeutic concentrations in the urine. Relebactam protects imipenem from degradation by certain beta-lactamase enzymes (specifically Class A and Class C), extending the antibiotic's spectrum of activity against resistant gram-negative bacteria.
Details
- Status
- Prescription
- First Approved
- 2019-07-16
- Patent Cliff
- 2033
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
RECARBRIO Approval History
What RECARBRIO Treats
5 indicationsRECARBRIO is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hospital-Acquired Bacterial Pneumonia
- Ventilator-Associated Bacterial Pneumonia
- Complicated Urinary Tract Infection
- Pyelonephritis
- Complicated Intra-Abdominal Infection
RECARBRIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to RECARBRIO
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06886464 PONTiAK | NEPH24-1191 | Ph 2 | recruiting | Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin |
| NCT02493764 RESTORE-IMI 2 results posted | 7655A-014 2015-000246-34, 163240 | Ph 3 | completed | Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RECARBRIO FDA Label Details
Indications & Usage
FDA Label (PDF)RECARBRIO is indicated for the treatment of Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia; Complicated Urinary Tract Infection; Pyelonephritis; Complicated Intra-Abdominal Infection.
RECARBRIO Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for RECARBRIO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 13 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.