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 Sharp & Dohme | N-212819 RX | 2019-07-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
recarbrio | New Drug Application | 2021-04-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
intraabdominal infections | — | D059413 | — |
pyelonephritis | EFO_1001141 | D011704 | N10-N16 |
urinary tract infections | EFO_0003103 | D014552 | N39.0 |
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
14 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 pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 1 | 1 | — | 2 |
Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 1 | |
Gram-negative bacterial infections | D016905 | — | — | — | 1 | — | 1 | ||
Critical illness | D016638 | — | — | — | 1 | — | 1 | ||
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 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 |
---|---|---|---|---|---|---|---|---|---|
Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 1 | 1 | — | — | 2 |
Intraabdominal infections | D059413 | — | 1 | 1 | — | — | 2 | ||
Bacterial infections | D001424 | A49 | — | — | 1 | — | — | 1 | |
Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 1 | — | — | — | 1 |
Indications Without Phase
No data
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 | 2184137 |
ChEMBL ID | CHEMBL3301605 |
ChEBI ID | — |
PubChem CID | 44129647 |
DrugBank | DB12377 |
UNII ID | 1OQF7TT3PF (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,193 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,049 adverse events reported
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