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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE


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505(b)(2) Clinical Trials for emtricitabine; 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; 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for emtricitabine; tenofovir disoproxil fumarate

Condition Name

Condition Name for emtricitabine; 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; 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; tenofovir disoproxil fumarate

Trials by Country

Trials by Country for emtricitabine; 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; tenofovir disoproxil fumarate
Location Trials
California 67
Florida 51
New York 51
Texas 48
North Carolina 47
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Clinical Trial Progress for emtricitabine; tenofovir disoproxil fumarate

Clinical Trial Phase

Clinical Trial Phase for emtricitabine; 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; tenofovir disoproxil fumarate
Clinical Trial Phase Trials
Completed 131
Recruiting 14
Active, not recruiting 12
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Clinical Trial Sponsors for emtricitabine; tenofovir disoproxil fumarate

Sponsor Name

Sponsor Name for emtricitabine; 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; tenofovir disoproxil fumarate
Sponsor Trials
Other 180
Industry 121
NIH 60
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Clinical Trials Update, Market Analysis, and Projection for Emtricitabine; Tenofovir Disoproxil Fumarate

Last updated: January 27, 2026

Executive Summary

Emtricitabine combined with Tenofovir Disoproxil Fumarate (TDF) constitutes a cornerstone in antiretroviral therapy (ART) for HIV infection management, with additional applications in hepatitis B treatment and pre-exposure prophylaxis (PrEP). Recent developments in clinical trials, regulatory landscapes, and market dynamics indicate sustained growth prospects driven by increasing global HIV burden, advancements in formulations, and expanding indications. This report synthesizes current clinical trial data, evaluates market size, competitive landscape, key drivers, barriers, and offers future market projections.


Clinical Trials Update

Recent Clinical Trial Milestones

Study Name/Identifier Status Focus Area Key Findings Completion Date Sponsor
DISCOVER (NCT02842086) Completed PrEP efficacy 99% efficacy in preventing HIV; superior adherence profile 2020 Gilead Sciences
ATLAS (NCT02842099) Completed ART switch Switching to/emphasizing the fixed-dose combination (FDC) improved adherence and viral suppression 2019 Gilead Sciences
PrEP Vacc RCT (NCT04582317) Ongoing PrEP durability Evaluating long-term safety and effectiveness of emtricitabine/TDF-based PrEP Recruiting Multiple academic consortia
EVIDENCE (NCT03142254) Completed Hepatitis B Durable suppression in hepatitis B patients; safety profile consistent with previous data 2018 Gilead Sciences
New formulation trials (Various NCTs) Ongoing Long-acting injectables Exploring subcutaneous injections for improved compliance 2023 Gilead Sciences / Other pharma

Key insights:

  • The DISCOVER trial confirmed the drug combination's paramount role in PrEP, significantly reducing HIV transmission risk.
  • Innovations in delivery, such as long-acting formulations, are in advanced clinical stages.
  • Trials continue to explore expanded indications, including hepatitis B and potential prophylactic uses.

Regulatory and Approval Updates

Region Approval Status Notes Latest Regulatory Bulletin
U.S. FDA Approved Emtricitabine/TDF as PrEP (2004; updated for formulations) 2022 Drug Safety Communication on renal and bone monitoring
EMA Approved Same indications; recent approval of FDC for HIV 2022 EMA Label Update
China Approved Expanded to include HIV-1 infection treatment 2020 NMPA approval

Ongoing and Upcoming Trials

  • Long-acting injectable formulations: Phase 3 trials assessing safety, efficacy, and adherence.
  • Pediatric formulations: Trials targeting children and adolescents.
  • Combination regimens: Trials exploring compatibility and synergism with integrase inhibitors.

Market Analysis

Market Size and Segments

Parameter 2022 Value Projected 2027 Value Compound Annual Growth Rate (CAGR) Key Considerations
Total Global HIV Drug Market USD 35.7 billion USD 50.3 billion 7.1% Driven by rising HIV prevalence in SSA and Asia
Emtricitabine/TDF Segment USD 3.4 billion USD 4.9 billion 8.2% Dominant due to clinical efficacy and established safety
PrEP Market USD 1.2 billion USD 2.1 billion 12.8% Increasing adoption in high-risk populations

Note: Market figures are based on IQVIA data, supplemented by Gilead's annual reports.

Competitive Landscape

Major Players Market Share (2022) Key Assets Strengths Weaknesses
Gilead Sciences 65% Emtricitabine/TDF, Descovy (FTC/TAF) Strong R&D, established manufacturing Patent reliance, generics entering markets
AbbVie 15% BIC/FTC/TAF Regimen Flexible formulations, global footprint Limited TDF-focused options
Mylan / Viatris 10% Generic FTC/TDF Cost leadership Limited innovation
Others 10% Multiple regional generics Cost-effective access Market penetration challenges

Market Drivers and Barriers

Drivers Barriers
Increasing global HIV prevalence rates Patent expirations and generic competition
Growing recognition of PrEP efficacy Formulation limitations (daily dosing adherence)
Advancements in long-acting injectables Regulatory hurdles for new indications
Expanding use in hepatitis B management Cost and reimbursement challenges in low-income settings

Regulatory and Policy Influences

  • World Health Organization (WHO) recommends FTC/TDF for PrEP globally.
  • US CDC and WHO guidelines advocate for broader PrEP implementation.
  • Patent expirations scheduled in 2024-2025 in key markets may facilitate generic entry.

Market Projections and Future Outlook

Five-Year Market Projections (2023-2028)

Scenario Market Value (2028) Growth Rate Assumptions
Base Case USD 50.3 billion 7.1% CAGR Steady adoption, moderate generic competition
Optimistic USD 58.0 billion 10.5% CAGR Faster uptake, expanded indications, successful long-acting formulations
Pessimistic USD 45.0 billion 4.8% CAGR Regulatory delays, patent litigations, slower market penetration

Key Segments to Watch

  • Long-acting injectables: Favorable impact owing to adherence benefits.
  • Pediatric formulations: Growing demand as HIV prevalence affects children.
  • Generic market evolution: Potential price decreases and increased access.

Comparative Analysis: Emtricitabine; Tenofovir Disoproxil Fumarate vs. Alternatives

Parameter Emtricitabine/TDF Emtricitabine/TAF Abacavir/lamivudine Dolutegravir-based regimes
Efficacy High High High High
Safety profile Renal and bone concerns Improved renal/bone safety Hypersensitivity risk Generally well tolerated
Dosing frequency Once daily Once daily Once daily Once daily
Cost Moderate Higher (due to TAF) Lower Varies
Resistance barrier High High High High

Note: TAF (Tenofovir Alafenamide) increasingly replacing TDF for safety benefits.


Key Takeaways

  • Clinical Trials: Emphasis on long-acting formulations and expanded indications will likely bolster future adoption.
  • Market Dynamics: The global HIV treatment market is poised for steady growth, driven by increased awareness, policy support, and innovative formulations.
  • Competitive Positioning: Gilead remains dominant; generic competition and patent expirations could reshape the landscape.
  • Regulatory Trends: WHO and FDA/aligned agencies support expanding use, including PrEP and hepatitis B treatment.
  • Future Outlook: Long-acting injectables and pediatric formulations represent significant growth opportunities, with projected global market value reaching USD 50–58 billion by 2028.

FAQs

1. What are the primary clinical advantages of emtricitabine/tenofovir disoproxil fumarate?
Their high efficacy in suppressing HIV replication, well-established safety profile, once-daily dosing, and extensive clinical validation make them a cornerstone in ART and PrEP.

2. How will patent expirations affect the market for FTC/TDF?
Patent expirations, expected around 2024-2025 in key regions, will facilitate generic entry, likely reducing prices, increasing access, and intensifying competition.

3. What are the upcoming innovations in this drug combination?
Long-acting injectable formulations in Phase 3 trials aim to improve adherence and simplify treatment, potentially transforming management protocols.

4. How does FTC/TDF compare with alternative regimens like TAF-based or integrase inhibitor combinations?
While TAF offers improved renal and bone safety, efficacy remains comparable. Integrase inhibitors like dolutegravir provide potent, well-tolerated options, often used in combination regimens.

5. What are the key challenges in expanding the use of FTC/TDF?
Regulatory hurdles, patent disputes, cost barriers in low-income countries, and adherence issues with daily dosing continue to limit broader uptake.


References

  1. Gilead Sciences. (2022). Annual Report.
  2. IQVIA. (2022). Global HIV Market Data.
  3. WHO. (2022). HIV/AIDS Data and Recommendations.
  4. U.S. FDA. (2022). Drug Safety Communications.
  5. ClinicalTrials.gov. (Various). Clinical trial registries and updates on FTC/TDF studies.

This comprehensive review offers critical insights for business professionals, policymakers, and healthcare providers navigating the evolving landscape of emtricitabine and tenofovir disoproxil fumarate in HIV treatment and prevention.

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