Data updated: May 26, 2026
DARUNAVIR
HIV Protease Inhibitors
Infectious Disease
Approved 2017-11-21
Darunavir treats HIV-1 infection in adults and children who are at least 3 years old. It is used for managing the virus when taken alongside ritonavir and other antiretroviral medications. This drug helps patients with HIV-1 by serving as a core component of a multi-drug regimen.
Source: FDA Label • Teva • Protease Inhibitor
How DARUNAVIR Works
This medication works by acting as a protease inhibitor to target HIV-1. As an antiviral drug, it functions to help manage the virus in the body.
Source: FDA Label
8
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2017-11-21
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Teva Cipla Aurobindo Pharma MSN HETERO LABS LTD III Dr. Reddy's AMNEAL ANNORA PHARMA ZYDUS LIFESCIENCES Viatris Lupin
Active Ingredient: DARUNAVIR
Website: ↗
DARUNAVIR Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
58 FDA actions from 2017 to 2025
Jul 2025 ORIGINAL
Update
Dec 2023 SUPPL
Label · Labeling
Dec 2023 ORIGINAL
Update
Nov 2023 SUPPL
Label
Sep 2023 ORIGINAL
Update
What DARUNAVIR Treats
1 indicationsDARUNAVIR is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus
Source: FDA Label
DARUNAVIR Competitive Set
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Clinical Trial Registry
53 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02384967 DARULIGHT | ANRS 165 DARULIGHT 2014-001505-40 | Ph 2 | completed | Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients |
| NCT02470650 | Cost-Effect-Clinic 2014-004820-24 | Ph 4 | withdrawn | Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive |
| NCT04718805 | CR108955 TMC114IFD1004, 2020-003397-43 | Ph 1 | completed | A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions |
| NCT04661397 | CR108922 2020-003396-18, TMC114FD2HTX1007 | Ph 1 | completed | A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents |
| NCT04208061 | CR108697 2019-003328-19, TMC114FD1HTX1002 | Ph 1 | completed | A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants |
| NCT02578550 | CR107887 TMC114FD2HTX1001, 2015-001264-18 | Ph 1 | completed | A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants |
| NCT01400412 results posted | ACTG A5303 1U01AI068636 | Ph 2 | completed | Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen |
| NCT02275780 DRIVE-FORWARD results posted | 1439-018 MK-1439-018, 2014-001127-69 | Ph 3 | completed | Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018) |
| NCT02437110 results posted | 150126 15-N-0126 | Ph 1 | completed | HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) |
| NCT01605084 SUPPRESS | AI424-493 2011-006186-18 | Ph 3 | withdrawn | Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone |
| NCT02475915 | SEARCH 019 | Ph 1, Ph 2 | completed | Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection |
| NCT01281813 results posted | CR017230 TMC114IFD3001, 2017-000285-30 | Ph 3 | completed | TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV |
| NCT00537394 results posted | A5241 10395, ACTG A5241 | Ph 3 | completed | Optimizing Treatment for Treatment-Experienced, HIV-Infected People |
| NCT04183738 i2-D²EFT | 2019-10-i2-DEFT 18Q065 | Ph 4 | withdrawn | Inflammation and Co-Infections in D²EFT |
| NCT01695954 results posted | 11-01787 | Ph 1 | completed | Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz |
| NCT04236453 | CR108649 2019-002245-37, TMC114FD2HTX1005 | Ph 1 | terminated | A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents |
| NCT01348763 results posted | MRV_DRV_PK 2009-014924-42 | Ph 1 | completed | The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study |
| NCT02155101 MANET results posted | ChantalIRCB | Ph 3 | completed | Efficacy and Safety Study of Darunavir for the Treatment of HIV/AIDS |
| NCT03101644 | UCL-LB-02 | Ph 4 | completed | Optimization of Darunavir Therapy and Dosage Recommendations |
| NCT01138605 | CR016768 TMC114-TiDP29-C232, 2009-017013-29 | Ph 2 | completed | TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV |
| 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) |
| NCT01641367 MULTI-OCTAVE results posted | ACTG A5288 1U01AI068636 | Ph 4 | completed | A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure |
| NCT02489487 | VM-1500-002 | Ph 1 | completed | Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500 |
| NCT00855335 results posted | CR015442 TMC114HIV3015 | Ph 3 | completed | A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women |
| NCT02671383 DRV | WRHI052 | Ph 3 | completed | Evaluation of Low-dose Darunavir in a Switch Study |
| NCT02277600 | 206285 AI438-044 | Ph 1 | completed | A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI) |
| NCT01928407 DATA | IMEA 040-DATA | Ph 4 | completed | Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts |
| NCT01448707 PROTEA results posted | CR018370 TMC114IFD3003, 2011-001635-23 | Ph 3 | completed | A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment |
| NCT02475135 | CR107430 2015-001213-27, TMC114FD2HTX1002 | Ph 1 | completed | Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination |
| NCT00855413 results posted | CID 0821 | Ph 4 | terminated | HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine |
| NCT00936793 | 090186 09-CC-0186 | Ph 1 | completed | Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers |
| NCT02503462 | DRVCOBI | Ph 4 | terminated | Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals |
| NCT01519336 | NP28089 | Ph 1 | completed | A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers |
| NCT00757783 results posted | CR015439 TMC114HIV4023 | Ph 4 | completed | Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment |
| NCT02159352 results posted | AI444-093 | Ph 1 | completed | Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants |
| NCT01374802 results posted | 1220.49 2011-000505-41 | Ph 1 | completed | Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers |
| NCT00677300 RADAR | Merck 072-00 | Ph 4 | completed | Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients |
| NCT00811954 results posted | ACTG A5257 1U01AI068636 | Ph 3 | completed | Comparative Study of Three NNRTI-Sparing HAART Regimens |
| NCT00993148 MIDAS results posted | MIDAS | Ph 2 | completed | Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 |
| NCT00630734 results posted | 07-0272 TMC114HIV4003 | Ph 4 | completed | Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin |
| NCT00919854 results posted | CR012553 TMC114-TiDP29-C228 | Ph 2 | completed | A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children |
| NCT00849160 RADAR | CREPATS 001 | Ph 3 | completed | Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection. |
| NCT01199939 INROADS results posted | CR017149 TMC125HIV4007 | Ph 2 | completed | A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients |
| NCT01810887 | CR100323 JNS011-JPN-01 | Ph 4 | completed | A Phase 4 Study to Evaluate Pharmacokinetics and Safety of Darunavir Along With Ritonavir in Healthy Male Japanese Participants |
| NCT01619527 | CR100699 TMC114IFD1003, 2012-000273-23 | Ph 1 | completed | A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions |
| NCT01323257 | CR018010 TMC435-TiDP16-C115 | Ph 1 | completed | TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r) |
| NCT00915655 DIONE results posted | CR016312 TMC114-TiDP29-C230, 2008-004631-37 | Ph 2 | completed | A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents |
| NCT00867152 | 112934 | Ph 1 | completed | GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir |
| NCT00744887 | CR015421 | Ph 1 | completed | TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers. |
| NCT00752310 | CR012565 | Ph 1 | completed | TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet |
Showing 50 of 53 trials
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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.
DARUNAVIR FDA Label Details
Indications & Usage
DARUNAVIR is indicated for the treatment of Human Immunodeficiency Virus.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.