Nevirapine - PharmaKB

Viramune(nevirapine)

Nevirapine, Viramune (nevirapine) is a small molecule pharmaceutical. Nevirapine was first approved as Viramune on 1996-06-21. 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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Therapeutic Areas

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

Trade Name

FDA

EMA

Viramune (generic drugs available since 2012-05-22)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Lamivudine

Nevirapine

Zidovudine

Tradename	Company	Number	Date	Products
LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE	Micro Laboratories	N-205626 DISCN	2018-08-13	1 products, RLD

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Nevirapine

Tradename	Company	Number	Date	Products
VIRAMUNE	Boehringer Ingelheim	N-020933 RX	1998-09-11	1 products, RLD, RS
VIRAMUNE XR	Boehringer Ingelheim	N-201152 RX	2011-03-25	2 products, RLD, RS

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Labels

FDA

EMA

No data

Indications

FDA

EMA

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

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Nevirapine, Viramune Xr, Boehringer Ingelheim
8460704	2029-03-12		U-1409

ATC Codes

J: Antiinfectives for systemic use

— J05: Antivirals for systemic use

— J05A: Direct acting antivirals

— J05AG: Non-nucleoside reverse transcriptase inhibitors

— J05AG01: Nevirapine

— J05AR: Antivirals for treatment of hiv infections, combinations

— J05AR05: Zidovudine, lamivudine and nevirapine

— J05AR07: Stavudine, lamivudine and nevirapine

HCPCS

No data

Clinical

Clinical Trials

235 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	28	39	50	32	36	175
Hiv	D006678	—	O98.7	3	6	4	13	11	33
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	1	2	6	4	2	13
Tuberculosis	D014376	EFO_0000774	A15-A19	—	3	3	4	1	10
Malaria	D008288	EFO_0001068	B54	1	—	1	2	1	5
Hiv-1	D015497	—	—	1	1	1	1	—	3
Hepatitis c	D006526	—	B19.2	—	—	—	1	1	2
Contraception	D003267	—	—	—	1	—	1	—	2
Hiv-associated lipodystrophy syndrome	D039682	EFO_1001348	—	—	—	—	2	—	2
Hepatic insufficiency	D048550	—	—	1	—	—	1	—	2

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pregnancy	D011247	EFO_0002950	Z33.1	1	2	6	—	1	10
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	1	1	—	2	3
Coinfection	D060085	—	—	—	—	1	—	1	2

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lipodystrophy	D008060	HP_0009125	E88.1	—	1	—	—	1	2
Parasitemia	D018512	—	—	1	1	—	—	—	1
Hiv seropositivity	D006679	—	—	—	1	—	—	—	1
Neutropenia	D009503	—	D70	—	1	—	—	—	1
Anemia	D000740	HP_0001903	D64.9	—	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
Renal insufficiency	D051437	HP_0000083	N19	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chronic hepatitis c	D019698	EFO_0004220	B18.2	—	—	—	—	1	1
Chronic hepatitis b	D019694	EFO_0004239	B18.1	—	—	—	—	1	1
Wasting syndrome	D019282	—	—	—	—	—	—	1	1
Mycobacterium avium-intracellulare infection	D015270	EFO_0007386	—	—	—	—	—	1	1
Neurobehavioral manifestations	D019954	EFO_0004364	—	—	—	—	—	1	1
Medication adherence	D055118	EFO_0006344	—	—	—	—	—	1	1
Child behavior	D002652	—	—	—	—	—	—	1	1
Breast feeding	D001942	—	—	—	—	—	—	1	1
Cd4 lymphocyte count	D018791	—	—	—	—	—	—	1	1
Hypersensitivity	D006967	HP_0012393	T78.40	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Nevirapine
INN	nevirapine
Description	Nevirapine is a dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection. It has a role as an antiviral drug and a HIV-1 reverse transcriptase inhibitor. It is a dipyridodiazepine and a member of cyclopropanes.
Classification	Small molecule
Drug class	tricyclic compounds; antivirals
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	Cc1ccnc2c1NC(=O)c1cccnc1N2C1CC1