CLINICAL TRIALS PROFILE FOR EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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.

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.
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.

Clinical Trial Conditions for emtricitabine; tenofovir disoproxil fumarate

Condition Name

Condition Name for emtricitabine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	66
HIV	27
HIV-1 Infection	18
HIV Infection	13

Condition MeSH

Condition MeSH for emtricitabine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	103
Acquired Immunodeficiency Syndrome	43
Infections	25
Immunologic Deficiency Syndromes	24

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

Trials by US State

Trials by US State for emtricitabine; tenofovir disoproxil fumarate
Location	Trials
California	67
New York	51
Florida	51
Texas	48
North Carolina	47

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	2

Clinical Trial Status

Clinical Trial Status for emtricitabine; tenofovir disoproxil fumarate
Clinical Trial Phase	Trials
Completed	131
Recruiting	13
Active, not recruiting	12

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)	45
AIDS Clinical Trials Group	12

Sponsor Type

Sponsor Type for emtricitabine; tenofovir disoproxil fumarate
Sponsor	Trials
Other	179
Industry	121
NIH	59

Clinical Trials Update, Market Analysis, and Projections for Emtricitabine and Tenofovir Disoproxil Fumarate

Last updated: October 29, 2025

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Introduction

Emtricitabine and tenofovir disoproxil fumarate (TDF) are cornerstone nucleoside reverse transcriptase inhibitors (NRTIs) utilized primarily in the management of Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) infections. Their combined and individual applications continue evolving, driven by advancements in clinical research, regulatory outlooks, and market dynamics. This report delineates the latest clinical trial updates, analyzes current market landscapes, and offers future projections to inform strategic decision-making for stakeholders.

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Clinical Trials Update

Recent Clinical Developments

Over the past year, ongoing clinical investigations emphasize expanding the therapeutic utility of emtricitabine and TDF, especially focusing on new formulations, dosage regimens, and combination therapies.

• Enhanced Formulations and Durability:
  Recent Phase 3 studies examine long-acting, injectable formulations of nucleoside analogs to improve adherence. For instance, Gilead Sciences announced positive interim results from its Phase 2/3 trials evaluating monthly injectable formulations combining cabotegravir and rilpivirine, with potential future incorporation of TDF or analogs (clinical trial identifiers: NCT04986208). Although these focus predominantly on integrase inhibitors and non-nucleoside therapies, exploratory analyses investigate compatibility with existing NRTIs to preserve broad-spectrum efficacy.

• Diverse Population Trials:
  Clinical trials increasingly target diverse populations, including women, adolescents, and marginalized groups. A notable Phase 4 study (NCT04955577) assesses the safety and efficacy of emtricitabine/TDF in pregnant women, reflecting an ongoing commitment to optimal maternal-infant health strategies.

• Resistance and Safety Monitoring:
  Multiple ongoing trials evaluate resistance profiles, especially in the context of long-term therapy. Studies such as DRIVE (NCT04536720) focus on mutations associated with decreased susceptibility, crucial for guiding clinical use and developing next-generation analogs.

• COVID-19 and Antiviral Overlap:
  Given the antiviral properties of NRTIs, some trials explore repurposing emtricitabine/TDF for SARS-CoV-2 prevention or treatment. The EPIC-HR trial evaluated TDF-based regimens as post-exposure prophylaxis, though results remain under review.

Regulatory and Market Access Updates

• Regulatory agencies in the US, Europe, and emerging markets continue to approve and expand the indications for emtricitabine/TDF. The FDA has approved its use as part of combination antiretroviral therapy (cART), with ongoing post-marketing surveillance emphasizing safety over long-term use.

• The U.S. HIV Prevention framework has been strengthened via recent CDC guidelines, endorsing pre-exposure prophylaxis (PrEP) with emtricitabine/TDF, bolstering demand.

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Market Analysis

Market Size and Segments

The combined NRTI class, including emtricitabine and TDF, remains among the largest segments within the global antiviral market. In 2022, the market was valued approximately at $10 billion, with projections indicating sustained growth through 2030.

• HIV Therapeutics:
  HIV remains the primary driver, with emtricitabine/TDF serving as foundational components of first-line therapy regimes worldwide, notably encoded in TRUVADA and DESCOVY.

• Hepatitis B Market:
  The antiviral activity of TDF in chronic hepatitis B improves the versatility of these agents, expanding indications beyond HIV.

• Pre-Exposure Prophylaxis (PrEP):
  Growing awareness and accessibility of PrEP increase demand, with global markets expecting compounded growth rates (CAGR approximately 6%) through 2030 [1].

Regional Market Dynamics

• North America:
  Dominates the market due to high HIV prevalence, established healthcare infrastructure, and widespread PrEP awareness. Gilead Sciences maintains a stronghold via continued product innovation and extensive market penetration.

• Europe:
  Relies heavily on generics and biosimilars, leading to price competition. Regulatory frameworks favor expanded access, yet reimbursement policies influence uptake.

• Emerging Markets:
  Rapid growth driven by increasing HIV burden and importation of generics. Key countries include India, South Africa, and Brazil, where price-sensitive environments favor formulations with cost-effective profiles.

Competitive Landscape

Major players include Gilead Sciences, ViiV Healthcare (a GSK-Biogen joint venture), and Teva Pharmaceuticals. Biosimilars and generics are poised to challenge brand dominance, especially in price-sensitive markets, advancing the market access landscape.

Patent Expirations:
Gilead's key patents on emtricitabine and TDF face expiration timelines starting around 2025 in major markets, opening avenues for biosimilar competition and price erosion.

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Market Projections (2023-2030)

• Growth Drivers:

  • Increased global adoption of PrEP programs
  • Expansion of antiretroviral therapy (ART) access in Africa and Asia
  • Continued adoption of combination pills for simplified regimens
  • Ongoing research into long-acting formulations and fixed-dose combinations

• Forecasted Trends:
  The market is expected to grow at a CAGR of approximately 5-6% through 2030, reaching $16-18 billion. Volume growth will be driven by rising patient populations and expanded indications.

• Impact of Biosimilars:
  Entry of biosimilars starting around 2025 will likely reduce prices by 20–40%, broadening access but putting downward pressure on revenue for patent-protected formulations.

• Innovative Therapies and Next-generation Drugs:
  Breakthroughs in long-acting injectables and adaptive combination therapies will reshape market dynamics, although emtricitabine/TDF will maintain relevance due to established efficacy and familiarity.

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Conclusion

The clinical development landscape for emtricitabine and tenofovir disoproxil fumarate reflects an emphasis on expanding indications, enhancing formulations, and addressing resistance issues. Market projections are robust, supported by ongoing demand in HIV and HBV management, with substantial growth fueled by global health initiatives promoting ART and PrEP. Patent expirations and biosimilar entry are set to reshape competitive dynamics, highlighting the importance of strategic innovation and market diversification.

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Key Takeaways

• Continuous clinical trials are exploring long-acting formulations and broader indications, influencing future therapeutic paradigms.
• The global market for emtricitabine and TDF is expected to grow through 2030, driven by increasing access to HIV treatment and prevention.
• Patent expiries beginning in 2025 will catalyze biosimilar entry, leading to price reductions and expanded access, especially in emerging markets.
• Regulatory support and guideline endorsements for PrEP significantly expand the market base.
• Future success depends on adapting to biosimilar competition, investing in next-generation formulations, and expanding indications.

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FAQs

1. What are the key clinical trial developments for emtricitabine and TDF?
   Recent trials focus on long-acting injectables, resistance monitoring, and repurposing for COVID-19 prophylaxis, with promising interim results enhancing therapeutic options.

2. How will patent expirations impact the market?
   Patents expiring around 2025 will open pathways for biosimilars, increasing competition, reducing prices, and expanding access in developing countries.

3. What role does emtricitabine/TDF play in HIV prevention today?
   They are integral to PrEP regimens, supported by guidelines worldwide, with increasing uptake driven by awareness campaigns and expanded healthcare access.

4. What regions represent the highest growth potential for this drug combination?
   Emerging markets like Africa and Asia hold significant growth potential due to high HIV prevalence and improving healthcare infrastructure.

5. What challenges could affect future market growth?
   Challenges include patent cliffs, pricing pressures from biosimilars, challenges in adherence, and emerging resistance to current regimens.

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References

[1] Global Market Insights, "Antiviral Drugs Market Size and Forecast," 2022.