TRUVADA (emtricitabine)
TRUVADA is indicated for the treatment of HIV-1 Infection.
How TRUVADA Works
TRUVADA is a fixed-dose combination consisting of two antiviral drugs, emtricitabine and tenofovir disoproxil fumarate. Both active components of the medication are classified as nucleoside analog HIV-1 reverse transcriptase inhibitors. These components work as antiviral agents to target the HIV-1 virus. The product combines the therapeutic properties of the individual drugs EMTRIVA and VIREAD.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-08-02
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TRUVADA Approval History
What TRUVADA Treats
1 indicationsTRUVADA is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
TRUVADA Boxed Warning
LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals [see Warnings and Precautions (5.1) ] . TRUVADA is not appr...
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals [see Warnings and Precautions (5.1) ] . TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued TRUVADA. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.2) ] . TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.9) ] . WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning. Lactic acidosis and severe hepatomegaly with steatosis, incl
TRUVADA Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05979311 VOGUE | 219816 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
| NCT03512418 PrEPSteps results posted | 2019P000792 K23DA044874 | Ph 3 | completed | Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) |
| NCT02732730 results posted | HPTN 082 UM1AI068619, 12068 | Ph 4 | completed | Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study |
| NCT01140880 results posted | MC08-LA-710-FRI | Ph 2 | completed | Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men |
| NCT01400412 results posted | ACTG A5303 1U01AI068636 | Ph 2 | completed | Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen |
| NCT01380080 REMEMBER results posted | ACTG A5274 1U01AI068636 | Ph 4 | completed | REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment |
| NCT06631365 | 23-38355 | Ph 2 | recruiting | PrEPsmart 2-1-1 Pilot |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years |
| NCT02486133 Dualis | DUA-1463-SPI-0320-I | Ph 3 | completed | Dual Therapy With Boosted Darunavir + Dolutegravir |
| NCT02213328 results posted | CHAMPS PrEP 11931 | Ph 2 | completed | Acceptability, Safety, and Use of Daily Truvada Pre-Exposure Prophylaxis in Adolescents |
| NCT02475915 | SEARCH 019 | Ph 1, Ph 2 | completed | Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection |
| NCT03122262 ADVANCE | WRHI060 | Ph 3 | completed | ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy |
| NCT02924389 results posted | IRB00089025 K23AI124913 | Ph 4 | terminated | Dolutegravir in Reservoirs |
| NCT03842436 DigiPrEP results posted | 2019P000793 | Ph 4 | completed | Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use |
| NCT03227731 PrEP | UKwaZulu | Ph 2, Ph 3 | completed | Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women |
| NCT01505114 results posted | HPTN 069/A5305 (NEXT Prep) 11789, HPTN 069/A5305 | Ph 2 | completed | Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women |
| NCT04965662 Home PEPSE | JF006-3170 | Ph 4 | completed | The Role of Home Packs of HIV PEPSE in High Risk Individuals |
| NCT01709084 SALIF results posted | CR100875 TMC278IFD3002 | Ph 3 | completed | A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment |
| NCT04477096 | HS-10234-108 | Ph 1 | completed | Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine |
| NCT01803074 results posted | 206739 2012-004124-38, AI468-002 | Ph 2 | completed | Study to Evaluate a HIV Drug for the Treatment of HIV Infection |
| NCT01335620 results posted | RTG_60 2010-022907-23 | Ph 4 | completed | The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age |
| NCT01348763 results posted | MRV_DRV_PK 2009-014924-42 | Ph 1 | completed | The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study |
| NCT02985996 results posted | IRB00092488 | Ph 1 | completed | Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities |
| NCT02022657 DOT-DBS results posted | 13-0427 U01AI106499 | Ph 1, Ph 2 | completed | Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots |
| 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) |
| NCT00632970 results posted | GS001 | Ph 4 | terminated | Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals |
| NCT00625404 results posted | 10015 | Ph 3 | completed | FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women |
| NCT02904369 | A15-137 | Ph 1 | completed | PK and PD Study of Oral F/TAF for HIV Prevention |
| NCT02401230 results posted | IRB00077593 | Ph 4 | completed | PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV |
| NCT03074786 | MTN-034/IPM 045 | Ph 2 | withdrawn | Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH) |
| NCT01473472 IPERGAY | 2011-002645-35 IPERGAY | Ph 3 | completed | On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men |
| NCT01040091 | U01 Anderson 10817 | Ph 1 | completed | Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status |
| NCT00856323 results posted | 702632 | Ph 2 | completed | Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men |
| NCT02722343 | A15-140 | Ph 1 | completed | Exploratory Pharmacodynamic Study of Tenofovir-Based Products |
| NCT00959894 results posted | 08-2070 | Ph 2 | completed | Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection |
| NCT01214759 results posted | UT-NPEP | Ph 4 | completed | Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP) |
| NCT00869960 results posted | F080428014 1K23AI074390-01A2 | Ph 4 | completed | Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TRUVADA FDA Label Details
Indications & Usage
FDA Label (PDF)TRUVADA is indicated for the treatment of HIV-1 Infection.
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fa...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment