CLINICAL TRIALS PROFILE FOR EMTRICITABINE

505(b)(2) Clinical Trials for Emtricitabine

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002335 ↗	The Safety and Effectiveness of 524W91	Completed	Glaxo Wellcome	Phase 1	1969-12-31	To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in HIV-infected patients. To determine the effects of food on bioavailability of 524W91.
NCT00002362 ↗	A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs	Suspended	Triangle Pharmaceuticals	Phase 3	1999-08-01	This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.
NCT00002416 ↗	Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination	Completed	Triangle Pharmaceuticals	Phase 3	1969-12-31	The purpose of this study is to compare two anti-HIV drugs, FTC and lamivudine (3TC), when given with either stavudine (d4T) or zidovudine (ZDV) and one other anti-HIV drug.
NCT00006144 ↗	A Study of HIV-Disease Development in Aging	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2000-10-01	The purpose of this study is to better understand the relationship between age and HIV disease progression. This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.

Clinical Trial Conditions for Emtricitabine

Condition Name

Condition Name for Emtricitabine
Intervention	Trials
HIV Infections	168
HIV	96
HIV-1 Infection	46
HIV Infection	34

Condition MeSH

Condition MeSH for Emtricitabine
Intervention	Trials
HIV Infections	262
Acquired Immunodeficiency Syndrome	102
Infections	81
Infection	60

Clinical Trial Locations for Emtricitabine

Trials by Country

Trials by Country for Emtricitabine
Location	Trials
Canada	168
Spain	121
France	118
South Africa	110
Germany	104

Trials by US State

Trials by US State for Emtricitabine
Location	Trials
California	140
Florida	115
Texas	108
New York	100
North Carolina	92

Clinical Trial Progress for Emtricitabine

Clinical Trial Phase

Clinical Trial Phase for Emtricitabine
Clinical Trial Phase	Trials
Phase 4	161
Phase 3	130
Phase 2/Phase 3	22

Clinical Trial Status

Clinical Trial Status for Emtricitabine
Clinical Trial Phase	Trials
Completed	319
Recruiting	50
Not yet recruiting	33

Clinical Trial Sponsors for Emtricitabine

Sponsor Name

Sponsor Name for Emtricitabine
Sponsor	Trials
Gilead Sciences	144
National Institute of Allergy and Infectious Diseases (NIAID)	62
Merck Sharp & Dohme Corp.	38

Sponsor Type

Sponsor Type for Emtricitabine
Sponsor	Trials
Other	605
Industry	366
NIH	93

Emtricitabine: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Emtricitabine

Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI), has been a cornerstone in the treatment and prevention of HIV/AIDS for over two decades. It is commonly used in combination with other antiretroviral drugs, most notably as part of the fixed-dose combination Truvada (emtricitabine and tenofovir disoproxil fumarate).

Clinical Trials and Efficacy

Historical Context

Emtricitabine has been extensively studied and proven effective in various clinical trials. Initially approved for the treatment of HIV-1 infection, it has also been used for pre-exposure prophylaxis (PrEP) to prevent HIV infection in high-risk individuals[3].

Comparison with Newer Agents

Recent clinical trials have compared emtricitabine-based regimens with newer agents. For instance, Gilead's twice-yearly lenacapavir has demonstrated superior efficacy to daily Truvada in two pivotal Phase 3 trials. These trials showed that lenacapavir reduced HIV infections by 96%, outperforming the daily Truvada regimen[1][4].

Market Analysis

Current Market Position

Emtricitabine, particularly in the form of Truvada, has been a dominant player in the prophylactic HIV drugs market. However, the market is evolving with the introduction of new long-acting agents.

Market Drivers

• High Prevalence of HIV/AIDS: The ongoing global HIV/AIDS epidemic continues to drive demand for effective prophylactic treatments.
• Increasing Government Initiatives: Government programs and public health initiatives aimed at reducing HIV transmission rates support the market growth.
• R&D Activities: Continuous research and development in HIV prevention, including the emergence of long-acting agents, are expected to boost market expansion[2].

Market Restraints

• Lower Penetration in Underdeveloped Markets: Limited access to healthcare and lower economic resources in underdeveloped regions hinder the market's full potential.
• Side Effects: Common side effects such as vomiting, nausea, tiredness, and diarrhea associated with emtricitabine and other antiretroviral drugs can restrain market growth[2].

Market Projections

Growth Trends

The prophylactic HIV drugs market, which includes emtricitabine, is expected to register a Compound Annual Growth Rate (CAGR) of 4.10% during the forecast period. This growth is driven by product developments, launches, and regulatory approvals of new and advanced preventive therapies[2].

Competitive Landscape

The market is becoming increasingly competitive with the approval and launch of new drugs. For example, Apretude (cabotegravir long-acting injectable and tablets) by GSK PLC and ViiV Healthcare has been approved for HIV prevention, offering an alternative to daily oral regimens like Truvada[2].

Future of Emtricitabine

While emtricitabine remains a crucial component of current HIV prevention strategies, its market share is expected to be impacted by the emergence of long-acting agents. Lenacapavir, for instance, is projected to gain significant market share by 2025, potentially reducing the dominance of emtricitabine-based regimens[5].

Regulatory and Approval Status

Emtricitabine, as part of Truvada, has been widely approved and is a standard treatment option. However, the regulatory landscape is shifting with the introduction of new agents. Gilead is set to begin global regulatory filings for lenacapavir by the end of 2024, which could lead to the launch of this new agent in 2025[1][4].

Impact on Public Health

The availability of effective prophylactic treatments like emtricitabine has significantly improved public health outcomes by reducing HIV transmission rates. However, the introduction of long-acting agents like lenacapavir and cabotegravir is expected to further enhance these efforts by offering more convenient and potentially more effective prevention options.

"With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic," said Daniel O’Day, Chairman and Chief Executive Officer of Gilead[4].

Conclusion

Emtricitabine has been a vital component in the fight against HIV/AIDS, but the landscape is evolving with the emergence of new, long-acting agents. While emtricitabine will continue to play a role, its market share is likely to be impacted by these newer treatments.

Key Takeaways

• Clinical Efficacy: Emtricitabine has been proven effective in clinical trials, but newer agents like lenacapavir have shown superior efficacy.
• Market Trends: The prophylactic HIV drugs market is growing, driven by new product developments and regulatory approvals.
• Competitive Landscape: The market is becoming more competitive with the introduction of long-acting agents.
• Regulatory Status: New agents are nearing regulatory approval, which could change the market dynamics.
• Public Health Impact: Effective prophylactic treatments continue to improve public health outcomes, with newer agents offering potential for further improvement.

FAQs

What is emtricitabine used for?

Emtricitabine is used for the treatment and prevention of HIV-1 infection, often in combination with other antiretroviral drugs.

How does emtricitabine compare to newer agents like lenacapavir?

Recent clinical trials have shown that lenacapavir, a twice-yearly treatment, is more effective than daily Truvada (which includes emtricitabine) in preventing HIV infections.

What are the market projections for emtricitabine?

The market for prophylactic HIV drugs, including emtricitabine, is expected to grow at a CAGR of 4.10%, but emtricitabine's market share may decline with the introduction of new long-acting agents.

What are the common side effects of emtricitabine?

Common side effects include vomiting, nausea, tiredness, and diarrhea.

How will the introduction of new agents impact public health?

The introduction of long-acting agents like lenacapavir and cabotegravir is expected to enhance HIV prevention efforts by offering more convenient and potentially more effective options.

Sources

1. MMIT Network: "Twice-Yearly PrEP Shows Promise in Clinical Trials" - September 19, 2024.
2. Mordor Intelligence: "Prophylactic HIV Drugs Market Size & Share Analysis - Growth Trends".
3. Gilead Sciences: "Gilead Provides Update on Development of Fixed Dose Regimen of Truvada and Sustiva" - April 26, 2005.
4. Gilead Sciences: "Gilead's Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada in Second Pivotal Phase 3 Trial".
5. DelveInsight: "Top Drugs To Watch in HIV (2025)" - November 19, 2021.