Linezolid
Linezolid, Zyvox (linezolid) is a small molecule pharmaceutical. Linezolid was first approved as Zyvox on 2000-04-18. It is used to treat bacterial infections, bacterial pneumonia, bacterial skin diseases, soft tissue infections, and staphylococcal infections amongst others in the USA. It is known to target amine oxidase [flavin-containing] A and amine oxidase [flavin-containing] B.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Linezolid, Zyvox (discontinued: Linezolid, Zyvox)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| linezolid | ANDA | 2025-12-23 |
| linezolid for oral solution | ANDA | 2015-11-18 |
| zyvox | New Drug Application | 2026-01-23 |
Indications
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EMA
Agency Specific
FDA
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Patent Expiration
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Clinical
Clinical Trials
216 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 1 | 5 | 2 | 1 | 9 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | 3 | 4 | 8 |
| Bacterial infections | D001424 | — | A49 | 1 | — | 4 | 1 | 1 | 7 |
| Gram-positive bacterial infections | D016908 | — | — | 1 | — | 3 | 1 | 1 | 6 |
| Communicable diseases | D003141 | — | — | — | — | 5 | 1 | — | 6 |
| Methicillin-resistant staphylococcus aureus | D055624 | — | — | — | — | — | 3 | 1 | 4 |
| Staphylococcal infections | D013203 | — | A49.01 | — | — | — | 2 | 2 | 4 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | — | — | 2 | 1 | 3 |
| Healthcare-associated pneumonia | D000077299 | — | — | — | — | — | 1 | 2 | 3 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | 1 | — | 1 | 2 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 2 | — | — | 2 |
| Neutropenia | D009503 | — | D70 | — | — | 1 | — | — | 1 |
| Fever | D005334 | — | R50.9 | — | — | 1 | — | — | 1 |
| Febrile neutropenia | D064147 | — | — | — | — | 1 | — | — | 1 |
| Hyperthermia | D000084462 | — | — | — | — | 1 | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 1 | — | — | 1 |
| Optic nerve diseases | D009901 | EFO_1001330 | H47.14 | — | — | 1 | — | — | 1 |
| Cross infection | D003428 | — | — | — | — | 1 | — | — | 1 |
| Pneumococcal pneumonia | D011018 | EFO_1001474 | J13 | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 1 | — | — | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | — | — | — | 1 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Burns | D002056 | — | T30.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial skin diseases | D017192 | — | — | — | — | — | — | 1 | 1 |
| Abscess | D000038 | EFO_0003030 | — | — | — | — | — | 1 | 1 |
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | — | 1 | 1 |
| Vancomycin-resistant enterococci | D065507 | — | — | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Linezolid |
| INN | linezolid |
| Description | Linezolid is an organofluorine compound that consists of 1,3-oxazolidin-2-one bearing an N-3-fluoro-4-(morpholin-4-yl)phenyl group as well as an acetamidomethyl group at position 5. A synthetic antibacterial agent that inhibits bacterial protein synthesis by binding to a site on 23S ribosomal RNA of the 50S subunit and prevents further formation of a functional 70S initiation complex. It has a role as an antibacterial drug and a protein synthesis inhibitor. It is an oxazolidinone, a member of morpholines, an organofluorine compound and a member of acetamides. |
| Classification | Small molecule |
| Drug class | oxazolidinone antibacterials |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)NC[C@H]1CN(c2ccc(N3CCOCC3)c(F)c2)C(=O)O1 |
Identifiers
| PDB | — |
| CAS-ID | 165800-03-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL126 |
| ChEBI ID | 63607 |
| PubChem CID | 441401 |
| DrugBank | DB00601 |
| UNII ID | ISQ9I6J12J (ChemIDplus, GSRS) |
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Zyvox – Pfizer
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Estimated US medical usage
Linezolid
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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25,354 adverse events reported
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