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Drug ReportsTedizolid phosphate
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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Events Timeline
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3M
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
sivextroNew Drug Application2025-04-04
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
TEDIZOLID PHOSPHATE, SIVEXTRO, CUBIST PHARMS LLC
2024-06-20GAIN
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
43 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD005355—————1—1
Cystic fibrosisD003550EFO_0000390E84———1—1
ObesityD009765EFO_0001073E66.9———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—2—2——4
Communicable diseasesD003141————2——2
Bacterial skin diseasesD017192——1—1——2
Bacterial infectionsD001424—A491—1——2
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/patients———3————3
Gram-positive bacterial infectionsD016908——2————2
Skin diseasesD012871—L00-L991————1
Diabetes mellitusD003920EFO_0000400E08-E131————1
Wound infectionD014946——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTedizolid phosphate
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
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Structure (InChI/SMILES or Protein Sequence)
Cn1nnc(-c2ccc(-c3ccc(N4C[C@H](COP(=O)(O)O)OC4=O)cc3F)cn2)n1
Identifiers
PDB—
CAS-ID856867-55-5
RxCUI—
ChEMBL IDCHEMBL2105669
ChEBI ID83326
PubChem CID11234049
DrugBankDB09042
UNII ID97HLQ82NGL (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 492 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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657 adverse events reported
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