Durlobactam
Xacduro (durlobactam) is a small molecule pharmaceutical. Durlobactam was first approved as Xacduro (copackaged) on 2023-05-23.
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Commercial
Therapeutic Areas
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Trade Name
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EMA
Combinations
Xacduro
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Durlobactam sodium
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Durlobactam sodium
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Sulbactam sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XACDURO (COPACKAGED) | Entasis Therapeutics | N-216974 RX | 2023-05-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xacduro | New Drug Application | 2025-03-27 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DURLOBACTAM SODIUM / DURLOBACTAM SODIUM / SULBACTAM SODIUM, XACDURO (COPACKAGED), ENTASIS THERAP | |||
| 2033-05-23 | GAIN | ||
| 2028-05-23 | NCE | ||
ATC Codes
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HCPCS
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Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acinetobacter infections | D000151 | EFO_1000792 | — | 2 | — | 1 | — | — | 3 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | 1 | — | — | 1 |
| Iatrogenic disease | D007049 | — | — | — | — | 1 | — | — | 1 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | — | 1 |
Indications Phases 2
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 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 3 | — | — | — | — | 3 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Durlobactam |
| INN | durlobactam |
| Description | Durlobactam is a beta-lactamase inhibitor used in combination with sulbactam to treat susceptible strains of bacteria in the genus Acinetobacter It is an analog of avibactam.
|
| Classification | Small molecule |
| Drug class | beta-lactamase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1=C[C@@H]2CN(C(=O)N2OS(=O)(=O)O)[C@@H]1C(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 1467829-71-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298137 |
| ChEBI ID | — |
| PubChem CID | 89851852 |
| DrugBank | DB16704 |
| UNII ID | PSA33KO9WA (ChemIDplus, GSRS) |
Target
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Variants
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Xacduro – Innoviva
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Trends
PubMed Central
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Additional graphs summarizing 536 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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15 adverse events reported
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