Stavudine - PharmaKB

Zerit(stavudine)

Zerit (stavudine) is a small molecule pharmaceutical. Stavudine was first approved as Zerit on 1994-06-24. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA. It has been approved in Europe to treat HIV infections.

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Events

FDA approval date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
urogenital diseases	D000091642
immune system diseases	D007154

Trade Name

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EMA

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Drug Products

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EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Stavudine

Tradename	Company	Number	Date	Products
ZERIT	Bristol Myers Squibb	N-020412 DISCN	1994-06-24	5 products, RLD
ZERIT	Bristol Myers Squibb	N-020413 DISCN	1996-09-06	1 products, RLD
ZERIT XR	Bristol Myers Squibb	N-021453 DISCN	2002-12-31	4 products

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FDA

EMA

Brand Name	Status	Last Update
stavudine	ANDA	2019-01-16
zerit	New Drug Application	2010-08-12

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20

Agency Specific

FDA

EMA

No data

Patent Expiration

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ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors

— J05AF04: Stavudine

— J05AR: Antivirals for treatment of hiv infections, combinations

— J05AR07: Stavudine, lamivudine and nevirapine

HCPCS

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Clinical

Clinical Trials

173 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	3	6	8	2	9	28
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	—	1	2	1	5	9
Hiv	D006678	—	O98.7	—	—	1	1	—	2

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Dementia	D003704	EFO_0003862	F03	—	—	1	—	—	1
Aids dementia complex	D015526	EFO_0002608	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infections	D007239	EFO_0000544	—	—	3	—	—	5	8
Communicable diseases	D003141	—	—	—	1	—	—	3	4

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Aids-related complex	D000386	EFO_0007137	B20	2	—	—	—	—	2

Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Stavudine
INN	stavudine
Description	Stavudine is a nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase It has a role as an antimetabolite, an EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor and an antiviral agent. It is an organic molecular entity, a nucleoside analogue and a dihydrofuran. It is functionally related to a thymine.
Classification	Small molecule
Drug class	antineoplastics; antivirals (zidovudine group) (exception: edoxudine)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1cn([C@H]2C=C[C@@H](CO)O2)c(=O)[nH]c1=O