Viramune(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)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
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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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nevirapine | ANDA | 2022-10-31 |
| viramune | New Drug Application | 2022-06-19 |
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
166 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 | 27 | 30 | 37 | 25 | 22 | 135 |
| Hiv | D006678 | O98.7 | 1 | 2 | 1 | 5 | 3 | 11 | |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 3 | 3 | 4 | — | 9 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 1 | 4 | 2 | 1 | 8 |
| Hiv-1 | D015497 | 1 | — | — | 1 | — | 2 | ||
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | 2 | — | 2 | |
| Hepatic insufficiency | D048550 | 1 | — | — | 1 | — | 2 | ||
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | — | — | — | 1 | — | 1 |
| Dementia | D003704 | F03 | — | — | — | 1 | — | 1 | |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | 1 | — | 1 |
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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 | — | 6 | — | 1 | 8 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | — | 1 | — | — | 2 |
| Coinfection | D060085 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Wasting syndrome | D019282 | R64 | — | — | — | — | 1 | 1 | |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | — | — | 1 | 1 | |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | — | 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 | ||
| Hepatitis c | D006526 | B19.2 | — | — | — | — | 1 | 1 | |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 1 | 1 |
| Protein-energy malnutrition | D011502 | EFO_0009563 | E41 | — | — | — | — | 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 |
Identifiers
| PDB | — |
| CAS-ID | 129618-40-2 |
| RxCUI | 53654 |
| ChEMBL ID | CHEMBL57 |
| ChEBI ID | 63613 |
| PubChem CID | 4463 |
| DrugBank | DB00238 |
| UNII ID | 99DK7FVK1H (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000029671 | CYP2B6, 516G>T, Gln172His | drug response | 2021-03-24 | 1A |
| VCV000225985 | CYP2B6, 983T>C, Ile328Thr | drug response | 2021-03-24 | 2A |
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,596 documents
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Safety
Black-box Warning
Black-box warning for: Nevirapine, Viramune
Adverse Events
Top Adverse Reactions
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315 adverse events reported
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