Linezolid - PharmaKB

Linezolid

Linezolid, Zyvox (linezolid) is a small molecule pharmaceutical. Linezolid was first approved as Zyvox on 2000-04-18. It is used to treat bacterial infections, bacterial pneumonia, bacterial skin diseases, soft tissue infections, and staphylococcal infections amongst others in the USA. It is known to target amine oxidase [flavin-containing] A and amine oxidase [flavin-containing] B.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
respiratory tract diseases	D012140
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Linezolid, Zyvox (discontinued: Linezolid, Zyvox)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Linezolid

Tradename	Company	Number	Date	Products
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	Hospira	N-206473 RX	2015-06-18	1 products, RLD, RS
ZYVOX	Pfizer	N-021130 RX	2000-04-18	1 products, RLD, RS
ZYVOX	Pfizer	N-021131 RX	2000-04-18	2 products, RLD, RS
ZYVOX	Pfizer	N-021132 RX	2000-04-18	1 products, RLD, RS

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Labels

FDA

EMA

Brand Name	Status	Last Update
linezolid	ANDA	2025-01-09
linezolid for oral solution	ANDA	2015-11-18
zyvox	New Drug Application	2024-09-25

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
bacterial infections	—	D001424	A49
bacterial skin diseases	—	D017192	—
soft tissue infections	—	D018461	—
streptococcal infections	EFO_1001476	D013290	—
bacterial pneumonia	EFO_1001272	D018410	J15.9
staphylococcal infections	—	D013203	A49.01

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J01: Antibacterials for systemic use

— J01X: Other antibacterials in atc

— J01XX: Other antibacterials in atc

— J01XX08: Linezolid

HCPCS

Code	Description
J2020	Injection, linezolid, 200 mg
J2021	Injection, linezolid (hospira) not therapeutically equivalent to j2020, 200 mg

Clinical

Clinical Trials

194 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	—	—	16	27	6	11	58
Tuberculosis	D014376	EFO_0000774	A15-A19	4	24	15	7	9	51
Communicable diseases	D003141	—	—	—	13	23	4	7	46
Multidrug-resistant tuberculosis	D018088	EFO_0007381	—	2	12	12	6	5	31
Bacterial infections	D001424	—	A49	2	6	13	1	3	25
Pneumonia	D011014	EFO_0003106	—	—	1	11	6	7	25
Pulmonary tuberculosis	D014397	EFO_1000049	A15	1	13	12	1	—	22
Staphylococcal infections	D013203	—	A49.01	—	—	2	4	6	12
Extensively drug-resistant tuberculosis	D054908	—	—	2	7	6	1	—	10
Gram-positive bacterial infections	D016908	—	—	1	1	5	1	2	10

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Bacterial skin diseases	D017192	—	—	—	9	10	—	2	21
Infectious skin diseases	D012874	—	—	—	4	4	—	2	10
Skin diseases	D012871	—	L00-L99	—	4	4	—	2	10
Meningitis	D008581	HP_0001287	G03	—	4	1	—	2	7
Sepsis	D018805	HP_0100806	A41.9	—	2	3	—	4	7
Meningeal tuberculosis	D014390	—	A17.0	—	4	1	—	1	6
Cellulitis	D002481	EFO_0003035	L03.90	—	3	3	—	—	6
Bacterial pneumonia	D018410	EFO_1001272	J15.9	—	1	4	—	—	5
Abscess	D000038	EFO_0003030	—	—	1	2	—	1	4
Wound infection	D014946	—	—	—	—	3	—	—	3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	—	1	—	—	2	3
Neoplasms	D009369	—	C80	—	2	—	—	—	2
Streptococcal infections	D013290	EFO_1001476	—	—	1	—	—	1	2
Fibrosis	D005355	—	—	—	1	—	—	—	1
Cystic fibrosis	D003550	EFO_0000390	E84	—	1	—	—	—	1
Staphylococcal skin infections	D013207	EFO_1001849	L00	—	1	—	—	—	1
Hematologic neoplasms	D019337	—	—	—	1	—	—	—	1
Sinusitis	D012852	EFO_0007486	J32	—	1	—	—	—	1
Hypersensitivity	D006967	HP_0012393	T78.40	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	4	—	—	—	—	4
Neurosurgical procedures	D019635	—	—	1	—	—	—	—	1
Burns	D002056	—	T30.0	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Septic shock	D012772	—	A48.3	—	—	—	—	4	4
Staphylococcus aureus	D013211	NCBITaxon_1280	—	—	—	—	—	3	3
Renal insufficiency	D051437	HP_0000083	N19	—	—	—	—	2	2
Shock	D012769	—	R57.1	—	—	—	—	2	2
Inappropriate prescribing	D057970	—	—	—	—	—	—	1	1
Bacterial meningitis	D016920	EFO_1000831	G00	—	—	—	—	1	1
Prosthesis-related infections	D016459	EFO_1001406	—	—	—	—	—	1	1
Asymptomatic infections	D058345	—	—	—	—	—	—	1	1
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	1	1
Cerebral hemorrhage	D002543	—	—	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Linezolid
INN	linezolid
Description	Linezolid is an organofluorine compound that consists of 1,3-oxazolidin-2-one bearing an N-3-fluoro-4-(morpholin-4-yl)phenyl group as well as an acetamidomethyl group at position 5. A synthetic antibacterial agent that inhibits bacterial protein synthesis by binding to a site on 23S ribosomal RNA of the 50S subunit and prevents further formation of a functional 70S initiation complex. It has a role as an antibacterial drug and a protein synthesis inhibitor. It is an oxazolidinone, a member of morpholines, an organofluorine compound and a member of acetamides.
Classification	Small molecule
Drug class	oxazolidinone antibacterials
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(=O)NC[C@H]1CN(c2ccc(N3CCOCC3)c(F)c2)C(=O)O1