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.

Clinical Trial Conditions for emtricitabine; tenofovir disoproxil fumarate

Condition Name

Condition Name for emtricitabine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	67
Hiv	27
HIV-1 Infection	18
HIV Infection	13

Condition MeSH

Condition MeSH for emtricitabine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	104
Acquired Immunodeficiency Syndrome	44
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	4

Clinical Trial Status

Clinical Trial Status for emtricitabine; tenofovir disoproxil fumarate
Clinical Trial Phase	Trials
Completed	131
Recruiting	14
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)	46
AIDS Clinical Trials Group	12

Sponsor Type

Sponsor Type for emtricitabine; tenofovir disoproxil fumarate
Sponsor	Trials
Other	180
Industry	121
NIH	60

Emtricitabine; tenofovir disoproxil fumarate Market Analysis and Financial Projection

Last updated: April 28, 2026

Clinical Trials Update, Market Analysis and Projection for Emtricitabine; Tenofovir Disoproxil Fumarate (TDF)

What is the current clinical and regulatory status for emtricitabine (FTC) plus tenofovir disoproxil fumarate (TDF)?

FTC/TDF is a fixed-dose combination widely used as part of HIV treatment and HIV pre-exposure prophylaxis (PrEP). Public clinical evidence spans multiple indications, but the commercial pipeline is dominated by generic manufacturing and life-cycle changes rather than brand-new, combination-specific Phase 3 programs.

Core clinical positioning

• HIV treatment (ART): FTC/TDF backbone is used in combination regimens for viral suppression.
• HIV PrEP: FTC/TDF is used for daily oral PrEP to reduce HIV acquisition risk.

Regulatory anchor (US)

• The combination is approved in the US as part of antiretroviral therapy and for HIV PrEP using fixed-dose tablets:
  • Truvada (FTC/TDF) is the reference branded product for FTC/TDF.

What is being updated in clinical practice (not new pivotal trials)

• Practice is shifting toward:
  • TDF versus tenofovir alafenamide (TAF) selection based on renal and bone risk profiles.
  • Broader use of simplified regimens and guideline-driven adherence strategies.
• For FTC/TDF specifically, market-level updates typically arise from:
  • Real-world effectiveness and safety monitoring (renal and bone markers).
  • Expanded access programs and payer contracting rather than new dose-efficacy trials.

Impact on “clinical trials update”: For FTC/TDF, the executable new information in 2023-2026 is more often pharmacovigilance, comparative safety, adherence outcomes, and guideline updates than new regulatory-defining Phase 3 readouts of the same FTC/TDF fixed-dose combination.

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What clinical signals drive demand for FTC/TDF now?

FTC/TDF demand is shaped by three measurable factors: clinician comfort with long safety history, PrEP access scale, and renal/bone risk management.

Renal and bone safety management

TDF has known class effects affecting:

• Creatinine clearance and tubular function
• Bone mineral density reduction relative to TAF in comparative trials

These signals push clinicians to:

• Monitor renal function.
• Select TAF when appropriate.
• Use FTC/TDF where cost and access dominate.

Adherence and persistence for PrEP

PrEP demand depends on:

• Daily dosing adherence
• Program continuity under payer and public health budgets
• Testing cadence (HIV testing and STI screening schedules)

Generic supply and payer contracting

FTC/TDF is primarily an availability and pricing story:

• Generics and authorized suppliers widen access.
• Tender and formulary status drive volume more than new clinical efficacy.

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What does the market look like for FTC/TDF (size, competitive set, and pricing power)?

FTC/TDF sits in two product markets:

1. ART backbone tablets for HIV treatment
2. PrEP daily tablets for HIV prevention

Both markets are heavily genericized outside branded origin points, which limits pricing power and makes volume and contracting the main profit drivers.

Competitive landscape

FTC/TDF competes with:

• Other PrEP regimens (notably long-acting options in some markets, and TAF-based strategies where used)
• TAF-based backbones for treatment where clinicians prefer improved bone and renal profiles
• Generic FTC/TDF from multiple manufacturers

Commercial economics (how FTC/TDF prices move)

Key pricing dynamics:

• Tender-based pricing in public procurement markets
• Formulary tiering and restrictions tied to renal eligibility
• Generic entry timing that resets price baselines

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How should investors and R&D leaders project FTC/TDF demand through 2030?

A practical projection framework is anchored on:

• PrEP incidence and program coverage
• Competitive pressure from TAF and long-acting options
• Generic pricing erosion and tender cycles
• Real-world safety management that determines continuation rates

Base-case volume logic (directional)

• PrEP remains a major use case through 2030, particularly in lower-cost delivery settings.
• TDF versus TAF substitution continues in more affluent markets where monitoring and product affordability permit TAF uptake.
• Long-acting PrEP (where adopted) pressures daily oral demand in specific geographies, but does not eliminate daily oral demand due to access, provider workflow, and uptake constraints.

Base-case outcome

• FTC/TDF volumes likely remain positive but compress at the unit-price level in most mature markets.
• Revenue growth is constrained by generic competition and price competition.
• Earnings resilience is strongest for:
  • Low-cost producers
  • Contract winners with scale
  • Manufacturers with reliable supply chain performance

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What market scenarios best fit FTC/TDF to 2030?

Below are decision-useful scenarios that map to expected revenue direction rather than speculative epidemiology.

Scenario	Drivers	Expected revenue trend (FTC/TDF)	Expected volume trend
Conservative	Faster oral PrEP share shift to non-TDF options; more TAF switching in treatment	Flat to declining	Slight decline or stable
Base case	Continued PrEP coverage, partial TDF-to-TAF substitution	Low growth to flat	Stable to modest growth
Upside	Stronger program funding and generic penetration in key geographies; adherence improvement initiatives	Moderate growth	Moderate growth

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Where do regulatory or clinical policy shifts most affect uptake?

FTC/TDF uptake shifts when guidelines change patient selection or monitoring burden.

Key policy levers:

• Renal eligibility thresholds
• Monitoring frequency requirements
• Switch triggers from TDF to TAF due to renal function decline or bone health concerns
• Program eligibility for PrEP (risk-based criteria, lab access capacity)

These levers determine continuation and switching rates, which directly affect both ART and PrEP demand.

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What actionable insights does this mean for R&D strategy and investment?

For FTC/TDF specifically, “investment in innovation” is rarely about new efficacy. It is more about commercial execution and lifecycle tactics that protect margins.

Commercial and execution priorities

• Supply continuity and cost leadership (generic market is margin-driven)
• Tender contracting capability in public health and payer channels
• Renal monitoring support programs (to reduce discontinuations and support eligible persistence)
• Co-formulation or next-generation delivery (where permitted) to reduce pill burden and improve adherence

R&D focus that can move the needle

• If pursuing new development, the practical targets are:
  • Adherence and persistence enhancements (formulation, dosing adherence support, patient monitoring)
  • Comparative effectiveness evidence supporting clinical decision pathways
  • Safety management strategies that reduce discontinuation rates

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Key Takeaways

• FTC/TDF is anchored in HIV treatment and daily oral PrEP; clinical leadership now comes more from real-world safety, adherence, and policy execution than new pivotal trials of the same fixed-dose combination.
• Demand is sustained by PrEP program coverage and HIV treatment backbone utility, but pricing power is structurally weak due to generic competition.
• Through 2030, FTC/TDF is most likely to show stable to modest volume growth with unit-price compression; revenue is highly sensitive to tender outcomes and PrEP regimen mix.
• Competitive displacement risk is real from TAF backbones and long-acting prevention options, but not uniform across geographies due to access and implementation constraints.

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FAQs

1. Is FTC/TDF still used for PrEP?
   Yes. Daily oral FTC/TDF remains a core PrEP regimen in multiple guidelines and access programs.

2. What safety issues most affect FTC/TDF use?
   The dominant clinical considerations are renal function monitoring and bone mineral density effects associated with TDF.

3. How does TAF affect FTC/TDF demand?
   TAF tends to attract patients and clinicians when renal and bone concerns outweigh cost, increasing substitution risk for TDF backbones in some markets.

4. Why does generic competition matter for FTC/TDF market projections?
   Because pricing is driven by tender and formulary contracting, which can rapidly erode unit margins when new suppliers enter.

5. What most strongly determines long-term revenue for FTC/TDF producers?
   Contract wins, cost position, supply reliability, and persistence driven by monitoring and eligibility management.

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References

[1] U.S. Food and Drug Administration. Truvada (emtricitabine and tenofovir disoproxil fumarate) prescribing information. FDA label.
[2] Centers for Disease Control and Prevention. Clinical Guidance for PrEP (guidelines and regimen recommendations for emtricitabine/tenofovir disoproxil fumarate). CDC.
[3] World Health Organization. Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. WHO.
[4] International Antiviral Society-USA (IAS-USA). Recommendations for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. IAS-USA Panel.
[5] U.S. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. HIV.gov.