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 |
|---|---|
| infections | D007239 |
| skin and connective tissue diseases | D017437 |
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 |
|---|---|---|---|---|
| SIVEXTRO | Cubist Pharmaceuticals | N-205436 RX | 2014-06-20 | 1 products, RLD, RS |
| SIVEXTRO | Cubist Pharmaceuticals | N-205435 RX | 2014-06-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sivextro | New Drug Application | 2024-11-05 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TEDIZOLID PHOSPHATE, SIVEXTRO, CUBIST PHARMS LLC | |||
| 2024-06-20 | GAIN | ||
| 2019-06-20 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J3090 | Injection, tedizolid phosphate, 1 mg |
Clinical
Clinical Trials
40 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 | — | 3 | 2 | 6 | 1 | 4 | 16 |
| Communicable diseases | D003141 | — | — | 1 | 2 | 5 | 1 | 3 | 12 |
| Fibrosis | D005355 | — | — | — | — | — | 1 | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | 1 | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Bacterial endocarditis | D004697 | EFO_1000830 | — | — | — | — | 1 | — | 1 |
| Endocarditis | D004696 | HP_0100584 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | 4 | — | 3 | — | 1 | 8 |
| Bacterial skin diseases | D017192 | — | — | 1 | 1 | 3 | — | 1 | 6 |
| Skin diseases | D012871 | — | L00-L99 | 1 | 1 | 2 | — | 1 | 5 |
| Infectious skin diseases | D012874 | — | — | — | 1 | 2 | — | 1 | 4 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Healthcare-associated pneumonia | D000077299 | — | — | — | — | 1 | — | — | 1 |
| Soft tissue infections | D018461 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infectious arthritis | D001170 | EFO_1001351 | M00 | — | 1 | — | — | 1 | 2 |
| Abscess | D000038 | EFO_0003030 | — | — | 1 | — | — | — | 1 |
| 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 Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 12 | — | — | — | — | 12 |
| Gram-positive bacterial infections | D016908 | — | — | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | — | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | — | — | — | — | 1 |
| Wound infection | D014946 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycoses | D009181 | — | B35-B49 | — | — | — | — | 1 | 1 |
| Prosthesis-related infections | D016459 | EFO_1001406 | — | — | — | — | — | 1 | 1 |
| Diabetic foot | D017719 | EFO_1001459 | — | — | — | — | — | 1 | 1 |
| Foot ulcer | D016523 | — | — | — | — | — | — | 1 | 1 |
| Osteitis | D010000 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tedizolid |
| 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](CO)OC4=O)cc3F)cn2)n1 |
Identifiers
| PDB | — |
| CAS-ID | 856866-72-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1257051 |
| ChEBI ID | 82717 |
| PubChem CID | 11234049 |
| DrugBank | DB09042 |
| UNII ID | 97HLQ82NGL (ChemIDplus, GSRS) |
Target
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Trends
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Safety
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Adverse Events
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633 adverse events reported
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