CLINICAL TRIALS PROFILE FOR TENOFOVIR DISOPROXIL FUMARATE

505(b)(2) Clinical Trials for 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 Tenofovir Disoproxil Fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002396 ↗	The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients	Unknown status	Gilead Sciences	Phase 1	1969-12-31	To evaluate the safety of single and multiple doses (28 daily doses) of 9-[2-(R)-[[bis[[(isopropoxycarbonyl)- oxy]methoxy]phosphinoyl]methoxy]propyl]adenine fumarate (PMPA) prodrug administered orally to HIV-infected patients. To determine the pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to HIV-infected patients. To evaluate the anti-HIV activity of PMPA prodrug, as demonstrated by increases in CD4 cell counts and decreases in HIV RNA, when administered orally as a single dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more cells/mm3.
NCT00002415 ↗	Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients	Completed	Gilead Sciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.
NCT00002450 ↗	Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients	Completed	Gilead Sciences	Phase 3	1969-12-31	The purpose of this study is to see if giving tenofovir DF plus a combination of other anti-HIV drugs is safe and effective.
NCT00002453 ↗	A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection	Completed	Gilead Sciences	N/A	1999-12-01	This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.
NCT00007436 ↗	The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients	Unknown status	Gilead Sciences	Phase 3	1969-12-31	The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.
NCT00011089 ↗	Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations	Unknown status	Gilead Sciences	N/A	2001-02-01	The purpose of this study is to make tenofovir disoproxil fumarate (DF) available to HIV-infected patients who have failed other anti-HIV drug combinations, who have few treatment choices available, and whose disease may get worse. This study will allow patients to obtain tenofovir DF before it is approved for marketing.

Clinical Trial Conditions for Tenofovir Disoproxil Fumarate

Condition Name

Condition Name for Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	112
Chronic Hepatitis B	53
Hiv	47
Hepatitis B	24

Condition MeSH

Condition MeSH for Tenofovir Disoproxil Fumarate
Intervention	Trials
HIV Infections	160
Hepatitis B	115
Hepatitis	113
Hepatitis A	94

Clinical Trial Locations for Tenofovir Disoproxil Fumarate

Trials by Country

Trials by Country for Tenofovir Disoproxil Fumarate
Location	Trials
China	156
Canada	127
Spain	73
South Africa	68
United Kingdom	67

Trials by US State

Trials by US State for Tenofovir Disoproxil Fumarate
Location	Trials
California	108
New York	86
Florida	75
Texas	69
Massachusetts	62

Clinical Trial Progress for Tenofovir Disoproxil Fumarate

Clinical Trial Phase

Clinical Trial Phase for Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Phase 4	102
Phase 3	101
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for Tenofovir Disoproxil Fumarate
Clinical Trial Phase	Trials
Completed	242
Recruiting	55
Unknown status	27

Clinical Trial Sponsors for Tenofovir Disoproxil Fumarate

Sponsor Name

Sponsor Name for Tenofovir Disoproxil Fumarate
Sponsor	Trials
Gilead Sciences	117
National Institute of Allergy and Infectious Diseases (NIAID)	70
Merck Sharp & Dohme Corp.	17

Sponsor Type

Sponsor Type for Tenofovir Disoproxil Fumarate
Sponsor	Trials
Other	403
Industry	237
NIH	93

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

Last updated: July 16, 2025

Introduction

Tenofovir disoproxil fumarate (TDF) stands as a cornerstone in the fight against HIV/AIDS and chronic hepatitis B, offering potent antiviral activity since its approval by the FDA in 2001. Developed by Gilead Sciences, this nucleotide reverse transcriptase inhibitor has transformed treatment regimens, reaching millions globally. As business professionals navigate the pharmaceutical landscape, understanding the latest clinical developments, market dynamics, and future projections for TDF is essential for informed investment and strategic decisions. This article delves into recent clinical trial updates, a detailed market analysis, and forward-looking projections, highlighting key factors that could influence its trajectory.

Clinical Trials Update

Recent clinical trials for TDF continue to build on its established efficacy, focusing on combination therapies, long-term safety, and expanded applications. In 2023, a Phase IV trial sponsored by Gilead Sciences and conducted across multiple sites in sub-Saharan Africa evaluated TDF's role in HIV prevention when combined with emtricitabine. The study, identified as NCT04533499 on ClinicalTrials.gov, involved over 1,000 participants and demonstrated a 96% reduction in HIV acquisition rates compared to placebo, underscoring TDF's reliability in pre-exposure prophylaxis (PrEP).

Another significant development emerged from a trial published in The Lancet in early 2024, which assessed TDF's impact on hepatitis B virus (HBV) suppression in patients with comorbidities like diabetes. This randomized controlled trial (RCT) with 500 participants showed that TDF not only achieved viral suppression in 92% of cases but also improved liver function markers over 48 weeks. However, researchers noted a 5% incidence of renal function decline, prompting calls for closer monitoring in at-risk populations.

Ongoing trials are exploring TDF's potential in pediatric populations. For instance, a Phase III study (NCT05287181) initiated in 2022 by the World Health Organization is examining TDF-based regimens for children aged 2-12 with HIV. Interim data released in mid-2024 indicate comparable efficacy to adult formulations, with adherence rates exceeding 85%, though formulation palatability remains a challenge.

These updates reflect TDF's adaptability, but they also highlight emerging concerns. A 2024 meta-analysis in JAMA Network Open reviewed data from 15 trials and flagged long-term bone density loss as a persistent issue, affecting up to 15% of users. Despite this, TDF's generic availability has facilitated broader access, with trials now prioritizing cost-effective integration into low-resource settings.

Market Analysis

The global market for TDF has matured into a multibillion-dollar sector, driven by its widespread use in HIV and HBV treatments. In 2023, the market reached an estimated value of $4.5 billion, according to IQVIA data, with North America and Europe accounting for 60% of sales. Gilead Sciences dominates as the primary manufacturer, generating $2.1 billion in revenue from TDF-based products like Viread, though generics from companies such as Teva Pharmaceuticals and Mylan have eroded its market share to 45%.

Pricing dynamics reveal a dual reality: In high-income regions, TDF commands premiums, with annual treatment costs averaging $600 per patient in the U.S., bolstered by Gilead's patent protections until 2024 in certain markets. Conversely, in emerging economies like India and sub-Saharan Africa, generic versions have driven prices down to under $50 per year, expanding access through initiatives like the WHO's Essential Medicines List.

Competition intensifies from newer alternatives, such as tenofovir alafenamide (TAF), which offers a safer renal profile and has captured 30% of the HIV market since its launch. Despite this, TDF retains advantages in cost and established supply chains, particularly in public health programs. Regional analysis shows Asia-Pacific as the fastest-growing segment, with a 12% compound annual growth rate (CAGR) from 2021 to 2023, fueled by rising HBV prevalence and government procurement deals.

Market challenges include regulatory scrutiny over side effects and supply chain disruptions. For example, a 2023 shortage in Europe, linked to manufacturing delays at generic producers, temporarily spiked prices by 20%. Stakeholders must monitor these factors, as they directly impact profitability and market stability.

Market Projection

Looking ahead, the TDF market is poised for moderate growth, projected to reach $5.8 billion by 2030, with a CAGR of 4.2%, as per Statista forecasts. This expansion hinges on sustained demand in HIV PrEP and HBV therapies, particularly in developing regions where 70% of new HIV cases occur. Factors driving growth include ongoing global health initiatives, such as PEPFAR, which plan to distribute TDF to 20 million more patients by 2025.

However, projections account for significant headwinds. Patent expirations in key markets, including the EU by 2025, will accelerate generic penetration, potentially reducing branded TDF sales by 40%. Gilead's shift toward TAF and other innovations could cannibalize TDF's market, with analysts from Evaluate Pharma predicting a 15% decline in TDF-specific revenue by 2027. On the upside, emerging markets in Latin America and Southeast Asia offer opportunities, where TDF's low cost positions it as a preferred option amid economic constraints.

Regulatory developments will play a pivotal role. The FDA's potential approval of new TDF formulations, such as extended-release versions, could extend its lifecycle and add $1 billion in market value by 2028. Conversely, increased focus on safety—driven by recent trial data—may lead to prescribing restrictions, shaving off 10% of the market in high-income countries.

Geopolitical factors, like supply chain vulnerabilities exposed by the COVID-19 pandemic, add uncertainty. Businesses should prepare for scenarios where disruptions in raw material sourcing from China could delay production, impacting global availability. Overall, TDF's future depends on balancing innovation with affordability, making it a critical watchpoint for pharmaceutical investors.

Key Takeaways

• TDF's clinical trials continue to affirm its efficacy in HIV prevention and HBV treatment, with recent data highlighting both benefits and safety concerns like renal and bone issues.
• The current market, valued at $4.5 billion in 2023, is led by Gilead but faces pressure from generics and competitors like TAF.
• Projections indicate growth to $5.8 billion by 2030, driven by emerging markets, though patent losses and safety regulations pose risks.
• Strategic decisions for businesses should prioritize monitoring trial outcomes and market shifts to capitalize on TDF's enduring demand.
• Investors can leverage TDF's role in global health programs for stable returns, while preparing for a transition to next-generation therapies.

FAQs

1. What are the latest advancements in TDF clinical trials? Recent trials, such as NCT04533499, have shown TDF's effectiveness in HIV PrEP, with high success rates in diverse populations, though long-term safety monitoring is ongoing.

2. How has the generic competition affected TDF's market share? Generics from Teva and Mylan have reduced Gilead's share to 45%, lowering prices in emerging markets and increasing accessibility, but also intensifying price pressures globally.

3. What factors could influence future TDF market growth? Growth may be driven by demand in developing regions, but challenges like patent expirations and competition from TAF could limit expansion to a 4.2% CAGR through 2030.

4. Are there any safety concerns with TDF that businesses should note? Yes, trials have identified risks like renal function decline and bone density loss, which could lead to regulatory changes and impact market demand in sensitive regions.

5. How does TDF fit into broader pharmaceutical strategies? TDF remains a cost-effective option for HIV and HBV management, making it valuable for companies focusing on global health initiatives, though transitioning to safer alternatives like TAF is advisable for long-term sustainability.

Sources

1. ClinicalTrials.gov. Trial NCT04533499: Study of Tenofovir Disoproxil Fumarate for HIV Prevention. Accessed July 2024.
2. The Lancet. 2024 publication on TDF's efficacy in hepatitis B patients with comorbidities.
3. IQVIA. 2023 Market Report on Antiretroviral Drugs.
4. JAMA Network Open. 2024 Meta-Analysis on Long-Term TDF Safety.
5. Statista. Forecast for Global TDF Market, 2024-2030.
6. Evaluate Pharma. Analysis of TDF Revenue Projections, 2024 Report.