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	54
HIV	51
Hepatitis B	25

Condition MeSH

Condition MeSH for TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	160
Hepatitis B	120
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	166
Canada	128
Spain	73
United Kingdom	69
South Africa	68

Trials by US State

Trials by US State for TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
California	109
New York	87
Florida	76
Texas	69
Massachusetts	63

Clinical Trial Progress for TENOFOVIR DISOPROXIL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	2
PHASE2	6

Clinical Trial Status

Clinical Trial Status for TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
Completed	244
Recruiting	62
Unknown status	27

Clinical Trial Sponsors for TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

Sponsor Name for TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Gilead Sciences	118
National Institute of Allergy and Infectious Diseases (NIAID)	71
Merck Sharp & Dohme Corp.	17

Sponsor Type

Sponsor Type for TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Other	413
Industry	243
NIH	95

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

Last updated: October 28, 2025

Introduction

Tenofovir Disoproxil Fumarate (TDF) remains a cornerstone in antiviral pharmacotherapy, especially within the management of HIV/AIDS and chronic hepatitis B virus (HBV) infections. As researchers and pharmaceutical companies advance clinical trials and formulations, understanding the current landscape, market trends, and future projections for TDF is crucial for stakeholders. This report synthesizes recent clinical developments, evaluates market drivers, and projects the economic outlook for TDF over the next five years.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen dynamic research initiatives targeting TDF's safety profile, new formulations, and expanded therapeutic uses. As of early 2023, over 40 active clinical trials investigate various aspects of TDF and its derivatives, conducted across multiple regions including North America, Europe, and Asia.

• Discontinuation and Safety Studies: Several Phase IV studies focus on long-term safety in diverse populations. Notably, trials such as NCT04372989 explore renal toxicity and bone mineral density impacts associated with prolonged TDF use. Preliminary data underscore manageable side-effect profiles with consistent monitoring protocols.

• Combination Therapy Trials: Current studies, including NCT04549832, are testing TDF in combination with integrase inhibitors to optimize HIV suppression while minimizing toxicity. Early results suggest promising synergistic effects.

• New Formulation Development: Trials such as NCT04656789 assess tenofovir alafenamide (TAF), a prodrug with enhanced tissue targeting and reduced toxicity, as an alternative to TDF. These investigations aim to improve patient adherence and safety.

Regulatory Decisions and Approvals

While TDF has been off-patent since 2020, regulatory agencies like the FDA and EMA continue to evaluate novel formulations and combination therapies incorporating TDF. Recently, the FDA approved a fixed-dose combination pill including TDF, cobicistat, elvitegravir, and emtricitabine for HIV management, reflecting ongoing endorsement of its efficacy.

Research Gaps and Opportunities

Despite comprehensive research, ongoing gaps include understanding TDF's long-term renal and bone health effects, particularly among vulnerable populations such as pregnant women and children. Researchers are also exploring the potential for TDF in treating emerging viral infections, including as a prophylactic agent against new strains of hepatitis and HIV variants.

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Market Analysis

Current Market Landscape

The global antiviral drugs market was valued at approximately USD 30 billion in 2022, with TDF constituting a significant share, especially in the HIV and HBV segments. The drug’s widespread adoption is attributable to its proven efficacy, established safety profile, and inclusion in first-line treatment guidelines.

• Market Penetration: TDF holds over 60% market share in HIV therapy due to its robustness, cost-effectiveness, and global availability. It is marketed under various brand names such as Viread (original), and as a generic by multiple manufacturers.

• Key Players: Major pharmaceutical companies include Gilead Sciences (original patent holder), Teva Pharmaceuticals, Mylan, and Cipla. Gilead maintains a competitive edge with its proprietary formulations and combination therapies.

• Geographical Trends: North America and Europe dominate the market with high healthcare spending and established treatment guidelines. However, LMICs (low- and middle-income countries) in Africa and Asia are rapidly increasing adoption, driven by generic formulations and global health initiatives.

Market Drivers

1. Rising HIV Prevalence: Despite advancements, the global HIV population remains over 36 million, sustaining the demand for potent antiretrovirals like TDF.

2. HBV Endemicity: Chronic hepatitis B infects over 290 million people worldwide, with TDF recognized as a first-line antiviral.

3. Treatment Guidelines: The WHO and CDC endorse TDF-containing regimens, cementing its position in standard-of-care protocols.

4. Cost Reductions: Patent expirations have spurred generic manufacturing, dramatically lowering treatment costs and expanding access.

Market Challenges

• Toxicity Concerns: Long-term TDF use has been associated with nephrotoxicity and decreased bone mineral density, prompting shifts toward TAF where available.

• Regulatory Changes: Evolving guidelines and safety warnings influence prescribing patterns and market shares.

• Emergence of Alternatives: New drugs with improved safety profiles, such as tenofovir alafenamide (TAF), threaten to encroach upon TDF’s market dominance.

Future Market Projections

The next five years are poised for considerable growth with an expected CAGR of approximately 4% for the global TDF market, reaching an estimated USD 9.5 billion by 2028[1]. Growth drivers include:

• Broadened access in LMICs fueled by generic production.
• Advances in combination therapies improving adherence.
• Expanded indications, potentially including prophylactic applications for emerging viral threats.

However, the market’s trajectory will be tempered by safety concerns and the adoption of newer formulations like TAF, which offer improved safety profiles.

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Economic and Regulatory Outlook

Gilead’s patent expiration on Viread declined in major markets, leading to a surge in generic TDF formulations. Regulatory agencies are increasingly scrutinizing long-term safety, but the compelling efficacy and affordability sustain demand.

Investment in R&D for TDF derivatives and combination therapies continues abroad, especially in emerging markets, to address unmet needs. Patent expirations may open the market further to generics, with a projected price decline of 20-30% over the next three years.

Countries’ healthcare policies emphasizing cost-effective regimes will influence TDF’s utilization. International programs like PEPFAR and Global Fund play pivotal roles in sustaining TDF's presence in global health strategies.

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Conclusion

Tenofovir Disoproxil Fumarate remains a vital antiviral agent, supported by extensive clinical evidence and favorable market dynamics. While safety considerations propel the development of improved formulations like TAF, TDF's affordability and proven efficacy ensure its continued relevance. Industry stakeholders, healthcare providers, and policymakers should monitor ongoing clinical trials and regulatory shifts to adapt strategies effectively. The future of TDF hinges on balancing its therapeutic benefits against safety concerns, with innovation and accessibility driving policy and market decisions.

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Key Takeaways

• Clinical developments focus on safety profiles, combination therapy efficacy, and new formulations like TAF, which could impact TDF’s market share.
• Market share remains significant driven by HIV and HBV treatment, with a growing segment in LMICs facilitated by generic manufacturing.
• Projected growth indicates a CAGR of roughly 4% through 2028, reaching around USD 9.5 billion globally.
• Safety concerns related to nephrotoxicity and bone density remain critical, influencing shifts toward safer alternatives.
• Policy and regulation will shape market dynamics, particularly with patent expiries and generic proliferation.

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FAQs

1. How does TDF compare to TAF in terms of safety and efficacy?
TDF has a well-established efficacy profile but is associated with renal and bone toxicity with long-term use. TAF offers similar antiviral efficacy with improved safety, reducing renal and bone adverse effects, making it a preferred choice where available.

2. What factors are driving the increased adoption of generic TDF formulations?
Patent expiration, procurement price reductions, and global health initiatives emphasizing affordability have significantly expanded access to generic TDF, especially in resource-limited settings.

3. Are there ongoing efforts to develop new indications for TDF?
Yes. Research explores TDF's potential for pre-exposure prophylaxis (PrEP), as well as prophylactic use against emerging viral infections, although these are still in experimental phases.

4. What are the main challenges facing the TDF market?
Safety concerns over renal and bone toxicity, competition from newer formulations like TAF, and regulatory shifts are primary market challenges.

5. How will patent expirations influence future TDF sales?
Patent expirations will likely cause price reductions and increased market penetration of generics, fostering broader access but potentially reducing profit margins for brand-name manufacturers.

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References

[1] MarketWatch. “Global Antiviral Drugs Market Forecast 2023-2028,” 2023.