Indinavir - PharmaKB

Crixivan(indinavir)

Crixivan (indinavir) is a small molecule pharmaceutical. Indinavir was first approved as Crixivan on 1996-03-13. 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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FDA approval date

EMA approval date

Patent expiration date

Study 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

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Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Indinavir sulfate

Tradename	Company	Number	Date	Products
CRIXIVAN	Merck & Co	N-020685 DISCN	1996-03-13	4 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
crixivan	New Drug Application	2012-06-14

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

— J05AE02: Indinavir

HCPCS

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Clinical

Clinical Trials

112 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	14	35	16	7	35	102
Infections	D007239	EFO_0000544	—	3	8	2	1	5	19
Hiv	D006678	—	—	—	—	1	1	1	3
Healthy volunteers/patients	—	—	—	1	—	—	1	—	2
Cardiovascular diseases	D002318	HP_0001626	—	1	—	—	1	—	2
Lipodystrophy	D008060	HP_0009125	E88.1	—	—	—	1	—	1
Hiv-associated lipodystrophy syndrome	D039682	EFO_1001348	—	—	—	—	1	—	1
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	2	5	3	—	4	13
Communicable diseases	D003141	—	—	2	3	1	—	4	10
Immunologic deficiency syndromes	D007153	HP_0002721	D84.9	1	1	1	—	1	3

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Sarcoma	D012509	—	—	—	4	—	—	—	4
Kaposi sarcoma	D012514	—	C46	—	3	—	—	—	3
Brain neoplasms	D001932	EFO_0003833	C71	—	1	—	—	—	1
Neoplasms	D009369	—	C80	—	1	—	—	—	1
Tuberculosis	D014376	EFO_0000774	A15-A19	1	1	—	—	—	1
Ewing sarcoma	D012512	EFO_0000173	—	—	1	—	—	—	1
Rhabdomyosarcoma	D012208	—	—	—	1	—	—	—	1
Mycobacterium avium-intracellulare infection	D015270	EFO_0007386	—	—	1	—	—	—	1
Mycobacterium infections	D009164	—	A31.9	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypertension	D006973	EFO_0000537	I10	1	—	—	—	—	1
Dementia	D003704	EFO_0003862	F03	1	—	—	—	—	1
Aids dementia complex	D015526	EFO_0002608	—	1	—	—	—	—	1
Pregnancy	D011247	EFO_0002950	Z33.1	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes mellitus	D003920	HP_0000819	E08-E13	—	—	—	—	1	1
Insulin resistance	D007333	HP_0000855	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Indinavir
INN	indinavir
Description	Indinavir is a N-(2-hydroxyethyl)piperazine, a piperazinecarboxamide and a dicarboxylic acid diamide. It has a role as a HIV protease inhibitor.
Classification	Small molecule
Drug class	antivirals: HIV protease inhibitors (saquinavir type)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(C)(C)NC(=O)[C@@H]1CN(Cc2cccnc2)CCN1C[C@@H](O)C[C@@H](Cc1ccccc1)C(=O)N[C@H]1c2ccccc2C[C@H]1O