Tedizolid - PharmaKB

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

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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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)

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	2025-04-04

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
bacterial infections	—	D001424	A49
bacterial skin diseases	—	D017192	—
streptococcal infections	EFO_1001476	D013290	—
staphylococcal infections	—	D013203	A49.01

Agency Specific

FDA

EMA

Expiration	Code
TEDIZOLID PHOSPHATE, SIVEXTRO, CUBIST PHARMS LLC
2024-06-20	GAIN
2019-06-20	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
Tedizolid Phosphate, Sivextro, Cubist Pharms Llc
8426389	2030-12-31	DS, DP	U-282
9624250	2030-02-03	DS, DP	U-2507
9988406	2030-02-03	DP
10065947	2030-02-03	DP
10442829	2030-02-03	DP
7816379	2028-06-20	DS, DP	U-2507
8420676	2028-02-23	DS, DP	U-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

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	—	2	2	6	1	4	15
Communicable diseases	D003141	—	—	—	2	5	1	3	11
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	EFO_0000465	I33	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bacterial infections	D001424	—	A49	3	—	3	—	1	7
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	J18	—	—	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	—	—	—	13	—	—	—	—	13
Gram-positive bacterial infections	D016908	—	—	2	—	—	—	—	2
Renal insufficiency	D051437	—	N19	1	—	—	—	—	1
Diabetes mellitus	D003920	EFO_0000400	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
Peripheral nervous system diseases	D010523	—	G64	—	—	—	—	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