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.

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
HIV-1 Infection	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

Tenofovir disoproxil fumarate Market Analysis and Financial Projection

Tenofovir Disoproxil Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction

Tenofovir disoproxil fumarate (TDF) is a crucial medication in the treatment and prevention of HIV/AIDS and chronic hepatitis B. This article delves into the latest clinical trials, market analysis, and future projections for TDF, highlighting its efficacy, safety, market trends, and growth potential.

Clinical Trials Update

Efficacy and Safety of TDF

Recent clinical trials have reaffirmed the efficacy and safety of TDF. A systematic review of 14 clinical trials compared TDF with its newer formulation, tenofovir alafenamide (TAF), in terms of viral suppression and safety endpoints. The study found that while both TDF and TAF are highly effective, TAF may have a slight edge in terms of safety, particularly regarding bone mineral density and nephrotoxicity risks. However, TDF remains a cornerstone in antiretroviral therapy (ART) due to its proven track record[3].

Weight Loss Associated with TDF

A meta-analysis of seven clinical trials involving 19,359 HIV-negative individuals revealed that TDF is associated with weight loss compared to placebo. This study found that individuals taking TDF were more likely to experience weight loss, with an odds ratio of 1.44 (95% CI 1.12 – 1.85, p = 0.005). Additionally, TDF exposure was linked to higher odds of vomiting but not other gastrointestinal adverse events like nausea, diarrhea, or loss of appetite[4].

Market Analysis

Market Size and Growth

The Tenofovir Disoproxil Fumarate market is experiencing significant growth. As of 2022, the market size was valued at USD 1.5 billion and is projected to reach USD 2.5 billion by 2030, growing at a CAGR of 7.5% from 2024 to 2030. This growth is driven by the increasing global demand for HIV and hepatitis B treatments, particularly in regions like Sub-Saharan Africa and Asia[5].

Regional Market Dynamics

The TDF market spans several key regions, each with its own economic conditions, regulatory frameworks, and consumer preferences. North America, particularly the United States, is a significant market due to the presence of major pharmaceutical companies like Gilead Sciences Inc. The region is projected to grow with a CAGR of 5.2% during the forecast period, driven by the increasing number of HIV and hepatitis B patients[2].

End User Segments

The market is segmented by end users, with pregnant women being a significant segment. TDF is recommended for pregnant women to prevent the transmission of HIV to their babies and to protect their own health. According to the Joint United Nations Programme on HIV/AIDS, in 2020, 85% of pregnant women with HIV received antiretroviral therapy, which includes TDF, highlighting its critical role in this demographic[2].

Market Drivers

Growing Number of Hepatitis B Patients

The increasing cases of hepatitis B globally are driving the demand for TDF. According to the World Health Organization, in 2019, 296 million people were living with chronic hepatitis B infection, resulting in an estimated 820,000 deaths. This high number of active cases and deaths due to hepatitis B will continue to boost the usage of TDF[2].

Increase in Number of Female HIV Patients

Women are more vulnerable to HIV infection, and the growing awareness and efforts to prevent HIV transmission among females are driving the market. The World Health Organization reported that in 2020, 1.5 million people acquired HIV, with a significant portion being women. This trend is expected to increase the usage of TDF in antiretroviral therapy[2].

Challenges and Side Effects

Side Effects of TDF

While TDF is effective, it is associated with several side effects, including nausea, rash, diarrhea, headache, pain, and depression. These side effects can restrict its usage in some medical contexts. Additionally, there are concerns about the impact of TDF on bone mineral density and the risk of nephrotoxicity, especially when used with boosted co-formulations like ritonavir or cobicistat[2][3].

Future Projections

Regulatory Filings and New Treatments

Gilead Sciences is set to begin global regulatory filings for its new HIV pre-exposure prophylaxis (PrEP) treatment, lenacapavir, by the end of 2024, with potential launches in 2025. Lenacapavir, administered twice-yearly, has shown a 96% reduction in HIV infections in clinical trials. This development could potentially impact the TDF market as new treatments emerge[1].

Generic Competition and Affordable Access

The expiration of Gilead's patent on TDF has led to the entry of generic versions into the market, driving cost reductions and increasing availability. This trend is expected to continue, making TDF more accessible to low and middle-income countries through government-sponsored programs and generic drug production[5].

Key Takeaways

• Clinical Efficacy: TDF remains highly effective in treating and preventing HIV/AIDS and hepatitis B, despite some safety concerns.
• Market Growth: The TDF market is projected to grow significantly, driven by increasing global demand and generic competition.
• Regional Dynamics: North America, particularly the U.S., is a key market, while other regions like Sub-Saharan Africa and Asia also show high growth potential.
• End User Focus: Pregnant women and female HIV patients are significant segments driving the market.
• Challenges: Side effects and safety concerns, such as bone mineral density and nephrotoxicity risks, need to be managed.
• Future Outlook: New treatments like lenacapavir and continued generic competition will shape the market landscape.

FAQs

What is Tenofovir Disoproxil Fumarate (TDF) used for?

TDF is used to treat chronic hepatitis B and to prevent HIV/AIDS. It acts as a nucleotide reverse transcriptase inhibitor to prevent the HIV and hepatitis B viruses from multiplying in the body[2].

What are the common side effects of TDF?

Common side effects include nausea, rash, diarrhea, headache, pain, and depression. There are also concerns about its impact on bone mineral density and the risk of nephrotoxicity[2][3].

How is the TDF market expected to grow?

The TDF market is projected to grow at a CAGR of 7.5% from 2024 to 2030, reaching USD 2.5 billion by 2030. This growth is driven by increasing global demand and generic competition[5].

Which regions are driving the growth of the TDF market?

North America, particularly the U.S., is a significant market, but regions like Sub-Saharan Africa and Asia also show high growth potential due to the prevalence of HIV and hepatitis B[2].

What impact do generic versions have on the TDF market?

The entry of generic versions into the market has driven cost reductions and increased availability, making TDF more accessible to low and middle-income countries[5].

Are there new treatments emerging that could impact the TDF market?

Yes, new treatments like lenacapavir, which has shown a 96% reduction in HIV infections in clinical trials, are set to enter the market, potentially impacting the TDF market landscape[1].