Data updated: Jun 17, 2026
VIRAMUNE (nevirapine)
Infectious Disease
Approved 1996-06-21
5
Indications
--
Phase 3 Trials
2
Priority Reviews
30
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1996-06-21
- Routes
- ORAL
- Dosage Forms
- TABLET, SUSPENSION
VIRAMUNE Approval History
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 1996 to 2024 · 4 indication expansions
Apr 2016 SUPPL Priority
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Feb 2015 SUPPL
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Feb 2013 SUPPL
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Dec 2002 SUPPL
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Dec 2002 SUPPL Priority
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May 2001 SUPPL
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Feb 2001 SUPPL Priority
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Nov 2000 SUPPL
Label
Aug 2000 SUPPL
Label
Oct 1999 SUPPL
Label
Aug 1999 SUPPL Priority
Mfg
Jun 1999 SUPPL Priority
Mfg
May 1998 SUPPL
Efficacy
Jan 1998 SUPPL Priority
Mfg
Nov 1997 SUPPL Priority
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Sep 1997 SUPPL Priority
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Sep 1997 SUPPL Priority
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Jun 1996 ORIGINAL Priority
New Drug
What VIRAMUNE Treats
5 FDA approvalsOriginally approved for its first indication in 1996 . Covers 5 distinct patient populations.
- Other (5)
Boehringer Ingelheim's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02369406 EIT | U01AI114235 | Ph 2, Ph 3 | active not recruiting | Early Infant HIV Treatment in Botswana |
| NCT01789879 | 0022-14-EP 1R21HD074462-01 | Ph 2 | completed | A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy |
| NCT02712801 | 2015ZX10001001 | Ph 4 | completed | Antiretroviral Regime for Viral Eradication in Newborns |
| NCT03088410 | IRB 2019-2922 R01DK109881, HRDC 00781 | Ph 4 | completed | Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana |
| NCT00672412 | P1069 10620, IMPAACT P1069 | Ph 1, Ph 2 | completed | Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand |
| NCT02431975 LEOPARD | AAAO5011 U01HD080441 | Ph 4 | completed | Latency and Early Neonatal Provision of Antiretroviral Drugs Clinical Trial |
| NCT00661349 | A10-174 (KANELA) | Ph 4 | terminated | Trial About Hepatic Security of Antiretroviral Treatment Based on Kaletra Versus Nevirapine in Co-infected HIV/HCV Patients |
| NCT01632891 results posted | ACTG A5297 1U01AI068636 | Ph 1, Ph 2 | completed | Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
| NCT01637558 DATiC | DATiC | Ph 4 | completed | Optimal Dosing of 1st Line Antituberculosis and Antiretroviral Drugs in Children (a Pharmacokinetic Study) |
| NCT02202005 | NEVIR5U14EU 2014-002247-18 | Ph 1 | completed | Multiple Dose BE Study With Nevirapine 400mg PR Tablets |
| NCT01772940 | Lubumbashi trial | Ph 4 | completed | Nevirapine vs Ritonavir-boosted Lopinavir in ART Naive HIV-infected Adults in a Resource Limited Setting |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIRAMUNE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.