Fosamprenavir - PharmaKB

Lexiva, Telzir(fosamprenavir)

Fosamprenavir, Telzir (fosamprenavir) is a small molecule pharmaceutical. Fosamprenavir was first approved as Lexiva on 2003-10-20. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat HIV infections.

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Events Timeline

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

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Completion date

Results first post date

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Therapeutic Areas

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

Trade Name

FDA

EMA

Fosamprenavir (discontinued: Lexiva)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Fosamprenavir calcium

Tradename	Company	Number	Date	Products
LEXIVA	ViiV Healthcare	N-021548 DISCN	2003-10-20	1 products, RLD
LEXIVA	ViiV Healthcare	N-022116 DISCN	2007-06-14	1 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
fosamprenavir calcium	ANDA	2024-07-02
lexiva	New Drug Application	2020-10-01

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AE: Protease inhibitors, direct acting antivirals

— J05AE07: Fosamprenavir

HCPCS

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Clinical

Clinical Trials

67 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	1	3	4	2	3	13
Infections	D007239	EFO_0000544	—	1	2	4	2	3	12
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	2	4	1	3	11
Hiv	D006678	—	O98.7	—	—	—	1	—	1
Coinfection	D060085	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Communicable diseases	D003141	—	—	—	1	2	—	1	4

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	—	—	—	2	—	—	—	—	2

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Immunologic deficiency syndromes	D007153	—	D84.9	—	—	—	—	2	2
Bone fractures	D050723	EFO_0003931	T14.8	—	—	—	—	1	1
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	—	—	1	1
Myocardial infarction	D009203	EFO_0000612	I21	—	—	—	—	1	1
Infarction	D007238	EFO_0009463	—	—	—	—	—	1	1
Inferior wall myocardial infarction	D056989	EFO_1000983	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Fosamprenavir
INN	fosamprenavir
Description	Fosamprenavir is a sulfonamide with a structure based on that of sulfanilamide substituted on the sulfonamide nitrogen by a (2R,3S)-4-phenyl-2-(phosphonooxy)-3-({[(3S)-tetrahydrofuran-3-yloxy]carbonyl}amino)butyl group. It is a pro-drug of the HIV protease inhibitor and antiretroviral drug amprenavir. It has a role as a prodrug. It is functionally related to a sulfanilamide.
Classification	Small molecule
Drug class	phosphoro-derivatives; antivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)CN(C[C@@H](OP(=O)(O)O)[C@H](Cc1ccccc1)NC(=O)O[C@H]1CCOC1)S(=O)(=O)c1ccc(N)cc1