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.

Download report

Favorite

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

Mock data
Subscribe for the real data

Commercial

Therapeutic Areas

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

Trade Name

FDA

EMA

Nevirapine (discontinued: Nevirapine, Viramune)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Nevirapine

Tradename	Company	Number	Date	Products
VIRAMUNE	Boehringer Ingelheim	N-020636 DISCN	1996-06-21	1 products, RLD
VIRAMUNE	Boehringer Ingelheim	N-020933 DISCN	1998-09-11	1 products, RLD
VIRAMUNE XR	Boehringer Ingelheim	N-201152 DISCN	2011-03-25	2 products, RLD

Hide discontinued

Lamivudine

Nevirapine

Zidovudine

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

Hide discontinued

Labels

FDA

EMA

Brand Name	Status	Last Update
nevirapine	ANDA	2025-07-28
nevirapine oral	ANDA	2012-05-23
viramune	New Drug Application	2010-05-21

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20
acquired immunodeficiency syndrome	EFO_0000765	D000163	B20
hepatitis b	—	D006509	—

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

238 clinical trials

View more details

Mock data
Subscribe for the real data

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	51	38	41	187
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	5	7	14	10	12	46
Hiv	D006678	—	O98.7	3	6	4	13	11	33
Infections	D007239	EFO_0000544	—	3	2	6	1	8	20
Tuberculosis	D014376	EFO_0000774	A15-A19	—	3	3	4	1	10
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	2	1	1	2	5
Malaria	D008288	EFO_0001068	B54	1	—	1	2	1	5
Hepatitis c	D006526	—	B19.2	—	—	—	1	3	4
Lipodystrophy	D008060	—	E88.1	—	1	—	2	1	4
Hiv-1	D015497	—	—	1	1	1	1	—	3

Show 24 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Communicable diseases	D003141	—	—	1	—	3	—	7	11
Pregnancy	D011247	EFO_0002950	Z33.1	1	2	6	—	1	10
Breast feeding	D001942	—	—	—	1	1	—	1	3
Coinfection	D060085	—	—	—	—	1	—	1	2
Anemia	D000740	EFO_0004272	D64.9	—	2	1	—	—	2
Chorioamnionitis	D002821	—	O41.12	—	—	1	—	—	1
Infectious pregnancy complications	D011251	—	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Aids-related complex	D000386	EFO_0007137	B20	2	3	—	—	1	6
Renal insufficiency	D051437	—	N19	1	1	—	—	—	2
Viremia	D014766	—	B34.9	—	1	—	—	—	1
Inflammation	D007249	MP_0001845	—	1	1	—	—	—	1
Parasitemia	D018512	—	—	1	1	—	—	—	1
Hiv seropositivity	D006679	—	—	—	1	—	—	—	1
Neutropenia	D009503	—	D70	—	1	—	—	—	1
Infant death	D066088	—	—	—	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

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hepatitis b	D006509	—	—	—	—	—	—	2	2
Hepatitis a	D006506	EFO_0007305	B15	—	—	—	—	2	2
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
Cachexia	D002100	—	R64	—	—	—	—	1	1
Mycobacterium avium-intracellulare infection	D015270	EFO_0007386	—	—	—	—	—	1	1
Mycobacterium infections	D009164	—	A31.9	—	—	—	—	1	1
Opportunistic infections	D009894	—	—	—	—	—	—	1	1
Neurobehavioral manifestations	D019954	EFO_0004364	—	—	—	—	—	1	1

Show 13 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

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