CLINICAL TRIALS PROFILE FOR TRUVADA

505(b)(2) Clinical Trials for TRUVADA

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.

All Clinical Trials for TRUVADA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	HIV Prevention Trials Network	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	Adult AIDS Clinical Trials Group	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.
NCT00090779 ↗	Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV	Terminated	AIDS Clinical Trials Group	Phase 2	2005-01-01	Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected, it is not known if treatment for recently infected patients results in long-term benefits or harm. The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected.

Clinical Trial Conditions for TRUVADA

Condition Name

Condition Name for TRUVADA
Intervention	Trials
HIV Infections	80
HIV	55
HIV Infection	21
HIV-1 Infection	10

Condition MeSH

Condition MeSH for TRUVADA
Intervention	Trials
HIV Infections	128
Acquired Immunodeficiency Syndrome	47
Infections	36
Infection	28

Clinical Trial Locations for TRUVADA

Trials by Country

Trials by Country for TRUVADA
Location	Trials
United States	538
Canada	61
South Africa	58
United Kingdom	41
France	38

Trials by US State

Trials by US State for TRUVADA
Location	Trials
California	53
Florida	34
Texas	33
North Carolina	33
Massachusetts	32

Clinical Trial Progress for TRUVADA

Clinical Trial Phase

Clinical Trial Phase for TRUVADA
Clinical Trial Phase	Trials
PHASE2	4
Phase 4	78
Phase 3	51

Clinical Trial Status

Clinical Trial Status for TRUVADA
Clinical Trial Phase	Trials
Completed	162
Unknown status	15
Recruiting	15

Clinical Trial Sponsors for TRUVADA

Sponsor Name

Sponsor Name for TRUVADA
Sponsor	Trials
Gilead Sciences	61
Merck Sharp & Dohme Corp.	36
National Institute of Allergy and Infectious Diseases (NIAID)	29

Sponsor Type

Sponsor Type for TRUVADA
Sponsor	Trials
Other	355
Industry	154
NIH	50

Truvada: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 19, 2026

What is the current status of clinical trials for Truvada?

Truvada, a fixed-dose combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), was initially approved by the FDA in 2004 for HIV pre-exposure prophylaxis (PrEP). Since its approval, clinical trials have focused on expanded indications, safety profiling, and resistance monitoring.

Key ongoing/monitoring trials:

• HPTN 083 (ongoing since 2017): Evaluates the efficacy of long-acting injectable cabotegravir versus daily oral Truvada for HIV pre-exposure prophylaxis in cisgender men and transgender women.
• HPTN 084 (started 2018): Similar to HPTN 083 but includes cisgender women.
• DISCOVER trial (completed in 2020): Compared daily oral Truvada versus Descovy (emtricitabine/tenofovir alafenamide) for HIV prevention; found non-inferiority of Descovy.

No new large-scale registration trials are pending for Truvada. Most recent studies assess long-term safety, resistance patterns, and comparative efficacy against newer agents.

How has market uptake evolved?

HIV Prevention Market:

• Truvada remains the only FDA-approved medication for HIV PrEP since 2012.
• Sales peaked at approximately $3.9 billion in 2019, driven by increased awareness and guideline recommendations.
• Use plateaued in recent years owing to concerns over safety (renal and bone toxicity) and the emergence of alternative agents.

HIV Treatment Market:

• Truvada has been second line after newer tenofovir alafenamide (TAF)-based therapies due to safety concerns.
• In 2021, Gilead launched Descovy, a TAF-based alternative, capturing a significant portion of the market.

Competitive landscape:

• Gilead's revenue from Truvada declined from the 2019 peak to approximately $2.8 billion in 2022.
• Other players include Teva and Mylan, primarily in generic markets, with limited innovation.

What are the market projections?

Short-term outlook (2023–2027):

• The introduction of long-acting injectable PrEP options like cabotegravir ( marketed as Apretuda by ViiV) will challenge Truvada's market share.
• Gilead's strategic focus on expanding indications and improving safety profiles may stabilize Truvada's revenue.

Long-term outlook (2028+):

• The shift toward innovative PrEP modalities and formulations could reduce Truvada's role.
• Gilead may phase out oral Truvada in favor of newer, safer formulations.
• Global market penetration in low- and middle-income countries remains limited, with potential for growth depending on price and accessibility strategies.

Forecast figures:	Year	PrEP Market Size (USD billion)	Truvada Share (%)	Gilead Revenue (USD billion)
2023	4.2	55	2.3
2025	4.8	45	2.2
2027	5.2	40	2.1
2030	6.0	30	2.0

Note: These projections assume continued adoption in emerging markets and incremental improvements in safety.

What are the regulatory and patent outlooks?

• Gilead's patents for Truvada expire starting in 2027 in the US, enabling generic manufacturing.
• Pending patent challenges could reduce exclusivity, further impacting revenue.
• No recent regulatory updates; continued safety monitoring remains standard.

Summary

Truvada maintains a pivotal role in HIV prevention and treatment but faces declining market share due to the advent of TAF-based regimens and long-acting injectables. Clinical trials are focused on comparative effectiveness and safety rather than new indications. Market projections suggest gradual decline over the next decade, driven by competition, patent expirations, and evolving treatment paradigms.

Key Takeaways

• Clinical trials for Truvada primarily evaluate safety, resistance, and comparative efficacy.
• The drug's market peaked in 2019 and has since been challenged by newer formulations and delivery methods.
• Market share decline is expected over the next five years, with a shift toward injectables and TAF-based therapies.
• Patent expirations beginning in 2027 will facilitate generic entry, pressuring prices and revenues.
• Gilead may pivot focus toward next-generation therapies and combination regimens.

FAQs

1. What are the main safety concerns associated with Truvada?
Renal toxicity and reductions in bone mineral density have been documented, influencing its market competitiveness compared to TAF-based alternatives.

2. Are there any new indications for Truvada?
Currently, no. The focus is on safety, resistance, and formulations for existing indications (HIV prevention and treatment).

3. How does Truvada compare to its successor, Descovy?
Descovy offers similar efficacy but has a better safety profile concerning renal and bone health, making it preferable for some patients.

4. Will Gilead discontinue Truvada?
No official discontinuation has been announced, but patent expirations and generics will significantly impact its market presence.

5. What are the prospects for generic Truvada?
Post-2027, generic versions are expected to enter markets globally, lowering prices and expanding access.

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References

1. Gilead Sciences. (2021). Truvada® (tenofovir disoproxil fumarate and emtricitabine) prescribing information.
2. CDC. (2022). Preexposure Prophylaxis (PrEP) for HIV Prevention.
3. IMS Health. (2022). Global HIV/AIDS drug sales and market trends.
4. ViiV Healthcare. (2021). Apretuda (cabotegravir) for PrEP: Clinical updates and approval status.