Recarbrio(relebactam)
Recarbrio (relebactam) is a small molecule pharmaceutical. Relebactam was first approved as Recarbrio on 2019-07-16. It is used to treat intraabdominal infections, pyelonephritis, and urinary tract infections in the USA. It has been approved in Europe to treat gram-negative bacterial infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Combinations
Recarbrio
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cilastatin sodium
+
Imipenem
+
Relebactam
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RECARBRIO | Merck & Co | N-212819 RX | 2019-07-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| recarbrio | New Drug Application | 2025-12-09 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CILASTATIN SODIUM / IMIPENEM / RELEBACTAM, RECARBRIO, MSD MERCK CO | |||
| 2029-07-16 | GAIN | ||
| 2024-07-16 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cilastatin Sodium / Imipenem / Relebactam, Recarbrio, Msd Merck Co | |||
| 8487093 | 2029-11-19 | DS, DP | U-2586, U-2587, U-2840 |
HCPCS
Code | Description |
|---|---|
| J0742 | Injection, imipenem 4 mg, cilastatin 4 mg and relebactam 2 mg |
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | 1 | 1 | 2 | 1 | — | 4 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | 1 | 1 | — | 4 |
| Communicable diseases | D003141 | — | — | 2 | — | 1 | 1 | — | 4 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 2 | 1 | — | 3 |
| Gram-negative bacterial infections | D016905 | — | — | 1 | — | — | 1 | — | 2 |
| Enterobacteriaceae infections | D004756 | EFO_1001313 | — | — | — | — | 1 | — | 1 |
| Critical illness | D016638 | — | — | — | — | — | 1 | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 2 | — | — | 2 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 1 | 1 | — | — | 2 |
| Intraabdominal infections | D059413 | — | — | — | 1 | 1 | — | — | 2 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | 1 | — | — | 1 |
| Iatrogenic disease | D007049 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic diseases | D014570 | — | N39.9 | — | 1 | — | — | — | 1 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 1 | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | EFO_0001420 | A41.9 | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Relebactam |
| INN | relebactam |
| Description | Relebactam is a chemical compound used in combination with antibiotics to improve their efficacy. As a beta-lactamase inhibitor, it blocks the ability of bacteria to break down a beta-lactam antibiotic. In the United States, relebactam is approved for use in the combination imipenem/cilastatin/relebactam (Recarbrio).
|
| Classification | Small molecule |
| Drug class | beta-lactamase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O.O=C(NC1CCNCC1)[C@@H]1CC[C@@H]2CN1C(=O)N2OS(=O)(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 1174018-99-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301605 |
| ChEBI ID | — |
| PubChem CID | 44129647 |
| DrugBank | DB12377 |
| UNII ID | 1OQF7TT3PF (ChemIDplus, GSRS) |
Target
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Safety
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Adverse Events
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115 adverse events reported
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