Sivextro(tedizolid phosphate)
Sivextro (tedizolid phosphate) is a small molecule pharmaceutical. Tedizolid phosphate was first approved as Sivextro on 2014-06-20. It is used to treat bacterial infections, bacterial skin diseases, staphylococcal infections, and streptococcal infections in the USA. It has been approved in Europe to treat bacterial skin diseases and soft tissue infections.
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Commercial
Trade Name
FDA
EMA
Sivextro
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 |
---|---|---|
sivextro | New Drug Application | 2023-03-10 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
TEDIZOLID PHOSPHATE, SIVEXTRO, CUBIST PHARMS LLC | |||
2024-06-20 | GAIN | ||
2023-06-19 | NPP | ||
2019-06-20 | NCE |
HCPCS
Code | Description |
---|---|
J3090 | Injection, tedizolid phosphate, 1 mg |
Clinical
Clinical Trials
37 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 | — | 1 | |
Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
Endocarditis | D004696 | EFO_0000465 | I33 | — | — | — | 1 | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cellulitis | D002481 | EFO_0003035 | L03.90 | — | 1 | — | — | — | 1 |
Erysipelas | D004886 | A46 | — | 1 | — | — | — | 1 | |
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 1 | — | — | — | 1 |
Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | 1 | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TEDIZOLID PHOSPHATE |
INN | tedizolid |
Description | Tedizolid is a member of the class of pyridines that is pyridine which is substituted by a 2-methyl-2H-tetrazol-5-yl group at position 2 and by a 2-fluoro-4-[(5R)-5-(hydroxymethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl group at position 5. It is used as its phosphate pro-drug used for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. It has a role as an antimicrobial agent, a drug metabolite and a protein synthesis inhibitor. It is a member of pyridines, a member of tetrazoles, an organofluorine compound, an oxazolidinone, a primary alcohol and a carbamate ester. |
Classification | Small molecule |
Drug class | oxazolidinone antibacterials |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1 |
Identifiers
PDB | — |
CAS-ID | 856866-72-3 |
RxCUI | 1540825 |
ChEMBL ID | CHEMBL2105669 |
ChEBI ID | 83326 |
PubChem CID | 11234049 |
DrugBank | DB14569 |
UNII ID | 97HLQ82NGL (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 1,246 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,299 adverse events reported
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