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Recarbrio (RELEBACTAM)
Recarbrio works by inhibiting the beta-lactamase enzymes produced by certain bacteria, allowing carbapenem antibiotics to effectively target and kill the bacteria.
Recarbrio, a combination of meropenem and relebactam, is a marketed antibiotic by Merck & Co. designed to treat hospital-acquired and ventilator-associated bacterial pneumonia, positioning it in a critical segment of the healthcare market. Its key strength lies in its mechanism of action, which inhibits beta-lactamase enzymes, thereby enhancing the efficacy of carbapenem antibiotics against resistant bacteria. The primary risk is the competition from off-patent generics such as meropenem and ertapenem, which may erode market share and pricing power.
At a glance
| Generic name | RELEBACTAM |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Renal Dehydropeptidase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2019 |
Mechanism of action
Think of it like a lock and key. Carbapenem antibiotics are the key, but some bacteria have a special lock that prevents the key from working. Recarbrio is like a special tool that helps to open the lock, allowing the carbapenem antibiotics to do their job and kill the bacteria.
Approved indications
- Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)
- Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
- Complicated Intra-abdominal Infections (cIAI)
Common side effects
- Serious adverse reactions
- Adverse reactions leading to death
Serious adverse events
- Serious adverse reactions
- Adverse reactions leading to death
Drug interactions
- Ganciclovir
- Valproic Acid or Divalproex Sodium
Key clinical trials
- Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021) (PHASE2,PHASE3)
- 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)
- Imipenem/Cilastatin/Relebactam Pharmacokinetics, Safety, and Outcomes in Adults and Adolescents With Cystic Fibrosis (PHASE4)
- Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients (PHASE4)
- PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN (PHASE2)
- Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections (PHASE4)
- Imipenem/Cilastatin/Relebactam PK in ECMO (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Recarbrio CI brief — competitive landscape report
- Recarbrio updates RSS · CI watch RSS
- Merck & Co. portfolio CI