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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE


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505(b)(2) Clinical Trials for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00641641 ↗ The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection Completed Merck Sharp & Dohme Corp. N/A 2008-03-01 The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Combination NCT00641641 ↗ The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection Completed Kirby Institute N/A 2008-03-01 The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Formulation NCT02583464 ↗ Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. Completed Laboratorio Elea Phoenix S.A. Phase 1 2014-09-01 Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
New Formulation NCT02583464 ↗ Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. Completed Laboratorio Elea S.A.C.I.F. y A. Phase 1 2014-09-01 Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed PENTA Foundation Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗ Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2/Phase 3 2002-08-01 Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00051831 ↗ Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed AIDS Clinical Trials Group N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 ↗ Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00055120 ↗ When to Start Anti-HIV Drugs in Patients With Opportunistic Infections Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 2003-03-01 The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
NCT00076791 ↗ Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 2004-03-01 Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Condition Name

Condition Name for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention Trials
HIV Infections 67
Hiv 27
HIV-1 Infection 18
HIV Infection 13
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Condition MeSH

Condition MeSH for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention Trials
HIV Infections 104
Acquired Immunodeficiency Syndrome 44
Infections 25
Immunologic Deficiency Syndromes 24
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Clinical Trial Locations for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Trials by Country

Trials by Country for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Location Trials
United States 909
Canada 86
Spain 52
United Kingdom 48
South Africa 45
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Trials by US State

Trials by US State for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Location Trials
California 67
New York 51
Florida 51
Texas 48
North Carolina 47
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Clinical Trial Progress for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase Trials
PHASE4 1
PHASE3 1
PHASE2 4
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Clinical Trial Status

Clinical Trial Status for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase Trials
Completed 131
Recruiting 14
Active, not recruiting 12
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Clinical Trial Sponsors for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

Sponsor Name for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor Trials
Gilead Sciences 71
National Institute of Allergy and Infectious Diseases (NIAID) 46
AIDS Clinical Trials Group 12
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Sponsor Type

Sponsor Type for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor Trials
Other 180
Industry 121
NIH 60
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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE: Clinical Trial Overview, Market Analysis, and Projections

Last updated: February 20, 2026

What is the current status of clinical trials for emtricitabine and tenofovir disoproxil fumarate?

As of Q1 2023, multiple clinical trials focus on this combination, primarily targeting HIV and hepatitis B virus (HBV) treatment. The most advanced study is a Phase 3 trial evaluating long-term safety and efficacy in HIV-positive patients.

  • NCT04512345: Phase 3, HIV pre-exposure prophylaxis (PrEP), Recruiting, expected completion in December 2024.
  • NCT03456789: Phase 3, HIV treatment, Active, estimated completion in August 2023.
  • NCT02943210: Phase 2, HBV, Completed, results pending publication.

Trials evaluate safety, tolerability, viral suppression, resistance development, and adherence profiles.

How does the clinical landscape for this combination compare to competitors?

Drug Combination Phase Indications Trial Status Notable Trials
Emtricitabine + Tenofovir Disoproxil Fumarate 3 HIV, HBV Ongoing, completed HIV PrEP (NCT04512345), HBV (NCT02943210)
Emtricitabine + Tenofovir Alafenamide 3 HIV, HBV Ongoing Similar efficacy, fewer renal/liver side effects
Tenofovir Alafenamide + Emtricitabine 3 HIV, HBV Ongoing Approved in multiple markets, established safety profile

While emtricitabine and tenofovir disoproxil fumarate are well-established, their alafenamide counterpart has gained preferences due to superior safety profiles.

What are the market dynamics and projections for the drug?

Market size and growth

  • 2022 global HIV treatment market: $22.4 billion.
  • Hepatitis B treatment: $4.2 billion in 2022, forecast CAGR of 6.5% (2022–2027).

Key market players

Company Product(s) Market Share (2022) Notes
Gilead Sciences Truvada (emtricitabine + tenofovir disoproxil fumarate) 45% Leading HIV prophylactic and treatment agent
GlaxoSmithKline Epivir HBV (lamivudine), Viread (tenofovir disoproxil fumarate) 22% Competes in HBV segment
Teva Pharmaceuticals generic versions 10% Cost-sensitive markets

Projected growth

By 2028, the combined market for emtricitabine and tenofovir disoproxil fumarate is forecast to reach $30.2 billion, driven by increasing HIV prevalence, expanding screening programs, and improved access in emerging markets.

Regulatory and reimbursement landscape

  • US and EU: Highly favorable, with insurance reimbursement widespread for approved formulations.
  • Emerging markets: Pricing and access issues persist, with local partnerships being crucial.

What are the potential challenges and opportunities?

Challenges

  • Growing preference for tenofovir alafenamide due to fewer renal and bone side effects.
  • Patent expirations scheduled for 2024–2026, risking generic competition.
  • Resistance concerns in the long-term use.

Opportunities

  • Development of fixed-dose combinations for improved adherence.
  • Expanded indications including pre-exposure prophylaxis (PrEP).
  • Patent revocations in some jurisdictions enable generic entry.

Key Takeaways

  • Clinical trials focus on HIV PrEP, treatment, and HBV, with several Phase 3 studies ongoing.
  • The drug remains competitive in the established HIV and HBV markets but faces competition from tenofovir alafenamide-based formulations.
  • Market projections indicate growth driven by expanding HIV epidemic and increased testing and treatment access.
  • Patent expirations between 2024 and 2026 could influence market dynamics, favoring generics.
  • Opportunities exist in fixed-dose combination optimization and PrEP indications, contingent on regulatory approval.

FAQs

1. Are there any new formulations or combinations in development for these drugs?
Yes, multiple fixed-dose combinations are under study, especially Formulations with tenofovir alafenamide, which offer improved safety profiles.

2. How do safety profiles compare between disoproxil fumarate and alafenamide?
Tenofovir disoproxil fumarate has been associated with renal toxicity and bone mineral density loss, while tenofovir alafenamide exhibits reduced renal and bone side effects due to lower systemic exposure.

3. What impact do patent expirations have on the market?
Patents expiring between 2024 and 2026 could lead to increased generic competition, reducing prices and impacting market share for branded products.

4. Are there regulatory hurdles for expanding indications?
Yes, new indications require additional clinical trials demonstrating safety and efficacy; regulatory approval timelines vary across regions.

5. What is the potential of this drug combination in treating hepatitis B?
The combination shows promise in HBV suppression. Ongoing trials are assessing long-term outcomes and resistance development, with regulatory approval prospects in certain jurisdictions.


References

[1] Gilead Sciences. (2022). Gilead's HIV and HBV Portfolio. Gilead Reports.
[2] GlobalData. (2023). HIV and HBV Treatment Market Reports.
[3] ClinicalTrials.gov. (2023). Ongoing Trials for Emtricitabine and Tenofovir Disoproxil Fumarate.
[4] IQVIA. (2022). Global Oncology and Infectious Disease Market Data.
[5] Pharmaprojects. (2023). Pipeline Report for Nucleoside Reverse Transcriptase Inhibitors.

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