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Sivextro(tedizolid)
Sivextro (tedizolid) is a small molecule pharmaceutical. Tedizolid 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
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
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)
Tedizolid phosphate
Tradename
Company
Number
Date
Products
SIVEXTROCubist PharmaceuticalsN-205435 RX2014-06-20
1 products, RLD, RS
SIVEXTROCubist PharmaceuticalsN-205436 RX2014-06-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
sivextroNew Drug Application2023-03-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infectionsD001424A49
bacterial skin diseasesD017192
staphylococcal infectionsD013203A49.01
streptococcal infectionsEFO_1001476D013290
Agency Specific
FDA
EMA
Expiration
Code
TEDIZOLID PHOSPHATE, SIVEXTRO, CUBIST PHARMS LLC
2024-06-20GAIN
2023-06-19NPP
2019-06-20NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Tedizolid Phosphate, Sivextro, Cubist Pharms Llc
84263892030-12-31DS, DPU-282
96242502030-02-03DS, DPU-2507
99884062030-02-03DP
100659472030-02-03DP
104428292030-02-03DP
78163792028-06-20DS, DPU-2507
84206762028-02-23DS, DPU-282
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01X: Other antibacterials in atc
J01XX: Other antibacterials in atc
J01XX11: Tedizolid
HCPCS
Code
Description
J3090
Injection, tedizolid phosphate, 1 mg
Clinical
Clinical Trials
16 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SmallpoxD012899B03112228
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MonkeypoxD045908B0411316
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
VacciniaD01461511
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTEDIZOLID
INNtedizolid
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 classoxazolidinone antibacterials
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](CO)OC4=O)cc3F)cn2)n1
Identifiers
PDB
CAS-ID856866-72-3
RxCUI1540825
ChEMBL IDCHEMBL1257051
ChEBI ID82717
PubChem CID11234049
DrugBankDB14569
UNII ID97HLQ82NGL (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:
Mock data
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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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6 adverse events reported
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