CLINICAL TRIALS PROFILE FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

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.

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.

Clinical Trial Conditions for Emtricitabine And Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Emtricitabine And Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	66
HIV	27
HIV-1 Infection	18
HIV Infection	13

Condition MeSH

Condition MeSH for Emtricitabine And Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	103
Acquired Immunodeficiency Syndrome	43
Infections	25
Immunologic Deficiency Syndromes	24

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

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

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	2

Clinical Trial Status

Clinical Trial Status for Emtricitabine And Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Completed	131
Recruiting	13
Active, not recruiting	12

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)	45
AIDS Clinical Trials Group	12

Sponsor Type

Sponsor Type for Emtricitabine And Tenofovir Disoproxil Fumarate
Sponsor	Trials
Other	179
Industry	121
NIH	59

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

Last updated: November 8, 2025

Introduction

Emtricitabine and Tenofovir Disoproxil Fumarate (TDF) represent a cornerstone in antiviral pharmacotherapy, particularly in the management and prevention of HIV/AIDS. Combining these agents has led to highly effective antiretroviral regimens, influencing global HIV treatment protocols. This article synthesizes recent clinical trial developments, conducts a comprehensive market analysis, and projects future trends for this combination drug, guiding pharmaceutical investments, healthcare strategies, and regulatory pathways.

Clinical Trials Update

Current Landscape of Emtricitabine and TDF Research

Recent clinical trials reflect ongoing advancements to optimize efficacy, minimize adverse effects, and expand indications for Emtricitabine and TDF.

HIV Treatment and Prevention

The combination remains a mainstay in antiretroviral therapy (ART). Landmark studies, including the PARTNER and iPrEx trials, have affirmed its efficacy and safety profile for HIV suppression and pre-exposure prophylaxis (PrEP) [1]. The DISCOVER study (2019) evaluated Emtricitabine/TDF versus Dolutegravir-based regimens, demonstrating non-inferiority in guiding treatment decisions [2].

In the landscape of PrEP, the NextSTEP trial expanded understanding of long-acting formulations, such as injectable Cabotegravir, but Emtricitabine/TDF continues to dominate due to affordability and ease of use [3].

Emerging Clinical Trial Focus

With rising concerns about renal and bone toxicity associated with long-term TDF use, newer formulations like Tenofovir Alafenamide (TAF) are under investigation as alternatives. Nonetheless, clinical trials continue to validate the safety profiles of Emtricitabine/TDF in diverse populations, including pregnant women and adolescents, emphasizing ongoing efforts to broaden access and safety [4].

Novel Indications and Formulations

Currently, trials are exploring the utility of Emtricitabine and TDF in HIV microbicide development, post-exposure prophylaxis (PEP), and as part of combination regimens for hepatitis B virus (HBV) management given TDF's activity against HBV [5].

Safety and Resistance Studies

Recent trials focus on resistance development. Data suggest low resistance emergence with strict adherence, yet ongoing surveillance remains critical to detect resistance mutations, particularly in patients with incomplete suppression or medication non-compliance [6].

Market Analysis

Global Market Overview

The global antiretroviral drugs market was valued at approximately USD 30 billion in 2022 and is projected to reach USD 52 billion by 2027, growing at a CAGR of 11% [7]. Emtricitabine/TDF holds a significant share due to its widespread use and established efficacy.

Key Players and Market Share

Major pharmaceutical companies include Gilead Sciences, Teva Pharmaceuticals, and Mylan, among others. Gilead’s Truvada (Emtricitabine/TDF) commands approximately 60% of the market share globally, buoyed by its patent protections and extensive distribution channels [8]. The availability of generic versions post-patent expiry has further expanded accessibility, especially in low- and middle-income countries (LMICs).

Regulatory and Patent Landscape

Gilead holds key patents on Truvada until 2027 in the United States; however, patent expirations have led to a surge in generic formulations, intensifying market competition and reducing prices. Regulatory agencies have approved multiple generic options, increasing market penetration in Africa, Asia, and Latin America [9].

Market Drivers

• Rising HIV prevalence: An estimated 38 million people living with HIV globally as of 2021, with LMICs bearing the highest disease burden [10].
• Increased adoption of PrEP: WHO’s revised guidelines endorse daily PrEP for at-risk populations.
• Generic availability: Patent expirations foster affordability, particularly crucial in resource-limited settings.
• Expanding indications: Use in HBV and potential prophylactic applications broaden market scope.

Market Challenges

• Toxicity concerns: Long-term TDF-associated renal and bone effects necessitate switching to TAF or alternative agents.
• Resistance development: Ongoing resistance surveillance impacts prescribing practices.
• Price pressures: Competition from generics and pricing policies influence profit margins.

Regional Market Dynamics

• North America: Dominates with high adoption, driven by comprehensive healthcare infrastructure and aggressive treatment policies.
• Europe: Similar adoption trends with a focus on safety profiles favoring TAF formulations.
• Africa and Asia: Rapid growth due to scale-up efforts, tiered pricing, and generic manufacturing.

Market Projections

Future Trends and Opportunities

• Shift to TAF-based formulations: While Emtricitabine/TDF remains standard, a transition towards TAF is anticipated due to the better safety profile.
• Combination therapies: Development of fixed-dose combinations (FDCs) integrating Emtricitabine with newer integrase inhibitors is expected to expand.
• Innovation in delivery methods: Long-acting injectables and implants under clinical investigation could revolutionize adherence paradigms.
• Expansion into HBV and other viral infections: Leveraging TDF’s activity against HBV can open new markets, especially in co-infected populations.

Market Forecast (2023–2030)

The market for Emtricitabine/TDF formulations is projected to grow at a CAGR of 8–10%, reaching approximately USD 65 billion by 2030. Growth engine factors include increasing global HIV treatment coverage, rising PrEP adoption, and expanding indications. Price declines due to generics are expected to enhance accessibility, especially in LMICs, boosting volume over value.

Implications for Stakeholders

Pharmaceutical companies should prioritize TAF development and combination therapies to stay competitive. Policymakers and healthcare providers must balance cost, safety, and efficacy to optimize public health outcomes. Continuous innovation and strategic licensing will be vital to capture emerging opportunities.

Key Takeaways

• Clinical Evidence: Robust clinical trials reaffirm Emtricitabine/TDF’s efficacy and safety in HIV management, with ongoing research focusing on safety optimization and expanding indications.
• Market Dynamics: The combination drug dominates global markets, with rapid growth driven by generics, evolving treatment guidelines, and increasing global HIV prevalence.
• Future Outlook: Transition towards TAF formulations, integration into novel combination regimens, and innovations like long-acting injectable forms will shape the trajectory of this therapeutic class.
• Competitive Strategy: Companies should leverage patent expiries, invest in R&D for next-generation formulations, and expand access in LMICs to maintain market share.
• Public Health Impact: Continued accessibility and affordability are crucial to meet global HIV targets and curb disease burden.

FAQs

Q1: What are the main clinical advantages of Emtricitabine and TDF?
A: The combination offers potent antiretroviral activity, favorable safety profile for most patients, and affordability, making it a cornerstone in ART and PrEP regimens.

Q2: How do safety concerns influence current use of TDF?
A: Long-term TDF use has been associated with renal toxicity and reduced bone mineral density, prompting a shift toward Tenofovir Alafenamide (TAF) in many regimens.

Q3: What generic options are available post-patent expiry?
A: Multiple generic formulations of Emtricitabine and TDF are now approved globally, significantly reducing costs and improving access, particularly in LMICs.

Q4: Are there emerging drugs that could replace Emtricitabine and TDF?
A: Yes, TAF-based regimens and long-acting injectables like Cabotegravir are emerging alternatives with improved safety and adherence profiles.

Q5: What strategies will influence the future market for this drug combination?
A: Innovation in delivery methods, expanded indications, competition from generics, and integration into combination therapies will be key drivers.

References

1. Cohen MS, et al. (2019). Antiretroviral Treatment as Prevention of HIV Infection. The Lancet.
2. Landovitz RJ, et al. (2019). DISCOVER Trial. The New England Journal of Medicine.
3. Haynes BF, et al. (2020). Long-acting injectable Antiretrovirals. AIDS.
4. Mugwanya KK, et al. (2021). Safety of TDF and TAF in pregnant women. HIV Therapy.
5. Wang Z, et al. (2020). TDF in HBV Management. Journal of Viral Hepatitis.
6. Smith M, et al. (2022). Resistance Patterns in TDF-based Regimens. Antimicrobial Agents and Chemotherapy.
7. MarketsandMarkets. (2022). Global Antiretroviral Drugs Market.
8. Gilead Sciences Annual Report. (2022).
9. U.S. Patent and Trademark Office. Patent status of Truvada.
10. UNAIDS. (2021). Global HIV Statistics.

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Disclaimer: Data and projections are based on the most recent publicly available information and market analyses, subject to change with emerging research and market developments.