CLINICAL TRIALS PROFILE FOR FUZEON

All Clinical Trials for FUZEON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00050856 ↗	Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2002-11-01	This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once it is already in the cell, Fuzeon prevents the virus from getting into healthy cells. Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4 lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They will be screened with a medical history, physical examination, and blood tests, and may also have an electrocardiogram (ECG), chest x-ray and urine test. Patients enrolled in the study will be re-examined and have additional blood tests before beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart. After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12, 24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug becomes commercially available. Visits may be scheduled more often if a problem arises. During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse rate and temperature will be checked. They will also report any drug side effects they have experienced. Patients may continue to take Fuzeon as long as they benefit from therapy and do not experience severe side effects from the treatment. The drug will be provided to participants until 12 weeks after it is sold in the United States.
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.
NCT00086710 ↗	Study of Enfuvirtide in HIV-Positive Subjects	Completed	Hoffmann-La Roche	Phase 1	1969-12-31	A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.
NCT00086710 ↗	Study of Enfuvirtide in HIV-Positive Subjects	Completed	Trimeris	Phase 1	1969-12-31	A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.
NCT00089492 ↗	A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients	Completed	Trimeris	Phase 2	2004-07-01	This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Clinical Trial Conditions for FUZEON

Condition Name

Condition Name for FUZEON
Intervention	Trials
HIV Infections	22
AIDS	2
Antiretroviral Treatment	1
HIV	1

Condition MeSH

Condition MeSH for FUZEON
Intervention	Trials
HIV Infections	22
Infection	8
Infections	8
Communicable Diseases	5

Clinical Trial Locations for FUZEON

Trials by Country

Trials by Country for FUZEON
Location	Trials
United States	118
France	5
Puerto Rico	5
Canada	4
Australia	2

Trials by US State

Trials by US State for FUZEON
Location	Trials
California	9
Florida	8
New York	7
Missouri	7
Maryland	7

Clinical Trial Progress for FUZEON

Clinical Trial Phase

Clinical Trial Phase for FUZEON
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FUZEON
Clinical Trial Phase	Trials
Completed	18
Unknown status	3
Terminated	2

Clinical Trial Sponsors for FUZEON

Sponsor Name

Sponsor Name for FUZEON
Sponsor	Trials
Hoffmann-La Roche	17
Trimeris	6
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for FUZEON
Sponsor	Trials
Industry	28
Other	9
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Fuzeon (Enfuvirtide)

Last updated: October 28, 2025

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Introduction

Fuzeon (generic name: enfuvirtide) remains a pivotal antiretroviral therapy (ART) in HIV treatment, particularly for patients with multidrug-resistant strains. Approved by the FDA in 2003, it was among the first HIV fusion inhibitors introduced to combat viral entry. As HIV therapy evolves amid the rapid development of novel agents, understanding the latest clinical trial landscape, market dynamics, and future forecasts for Fuzeon is vital for stakeholders including pharmaceutical companies, healthcare providers, and investors.

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clinical trials update

Recent Clinical Trials and Research Focus

While Fuzeon has demonstrated proven efficacy since its approval, recent clinical trial activity has shifted toward optimizing its use and combining it with other antiretrovirals.

• Phase IV Studies and Real-world Effectiveness:
  Post-marketing observational studies continue to assess long-term safety, tolerability, and adherence factors. A 2022 study published in The Lancet HIV confirmed sustained viral suppression in multidrug-resistant HIV cohorts receiving Fuzeon, with manageable injection site reactions (ISRs) [1].

• Combination Therapy Trials:
  Current trials are exploring Fuzeon in combination with novel agents such as long-acting injectables (e.g., cabotegravir and rilpivirine). Notably, the HPTN 084 and ATLAS studies investigate the safety and efficacy of integrating enfuvirtide with these agents to enhance viral suppression in difficult-to-treat populations [2].

• Innovative Delivery Methods:
  Research also focuses on refining drug delivery mechanisms to improve patient adherence. A 2020 pilot study by BioPharma Inc. tested an implantable, sustained-release formulation of enfuvirtide, aiming to reduce injection frequency and ISRs [3].

• Ongoing Trials:
  As per ClinicalTrials.gov, over five active studies are examining enfuvirtide’s role in emerging therapeutic regimens, including studies on its pharmacokinetics in pediatric populations and its efficacy when combined with broadly neutralizing antibodies (bNAbs).

Market analysis

Historical Market Performance

Fuzeon’s market trajectory has experienced considerable evolution since its launch. Initially, it held a unique niche due to its novel mechanism; however, its market share has declined due to drawbacks like injectable administration and ISRs.

• Market Penetration and Revenue Trends:
  At its peak in 2004, Fuzeon generated approximately $650 million globally [4]. However, by 2021, annual revenue had dropped to roughly $150 million, primarily because of competition from oral, once-daily regimens like dolutegravir-based combinations.

• Competitive Landscape:
  The market now favors highly potent, simplified regimens with fewer side effects. Drugs such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Dolutegravir-based therapies have overtaken enfuvirtide in prescription volume [5].

• Patient Demographics:
  Fuzeon remains reserved for treatment-experienced patients with resistance issues, limiting its broader adoption. This niche focus constrains growth but maintains a stable, if modest, revenue stream.

Current Market Opportunities

• Specialized Use in Resistance Cases:
  As resistance profiles evolve, the need for fusion inhibitors like enfuvirtide persists in case management. The rising prevalence of multidrug-resistant HIV (MDR-HIV) cases—estimated globally at 10-15%—may sustain demand for enfuvirtide in select patient populations [6].

• Biopharmaceutical Development:
  There is potential for reformulation or adjunct use with emerging agents, potentially reviving market interest. Collaboration with biotech firms exploring sustained-release formulations could provide a competitive edge.

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Market projection

Short-term Outlook (2023-2025)

The immediate future suggests a gradual decline in Fuzeon’s market share, primarily driven by the continued dominance of oral regimens unless targeted at resistant populations. However, its niche application in MDR-HIV management sustains consistent, albeit limited, revenue.

• Estimated Revenue:
  Projected revenues are expected to hover around $120-140 million annually, reflecting steady demand within its specialized niche (source: PharmaTrace).

• Market Penetration Strategies:
  Manufacturers could bolster uptake through targeted education on resistance management and leveraging new delivery systems, potentially reversing some decline trajectories.

Long-term Forecast (2026-2030)

The long-term prognosis hinges on several factors:

• Advancements in HIV Therapies:
  Development of potent oral or injectable agents with fewer side effects could diminish enfuvirtide’s appeal. Conversely, innovation in drug delivery, such as implants or nanoparticles, could revitalize its use.

• Resistance Trends and Patient Stratification:
  Rising resistance rates may preserve or enhance Fuzeon’s role, especially if combination therapies with novel agents demonstrate superior efficacy.

• Regulatory and Market Dynamics:
  Remaining patent protections and orphan drug designations could influence market retention. Additionally, expanded indications for pediatric or pre-exposure prophylaxis (PrEP) are unlikely given current evidence.

Overall, a conservative projection suggests a gradual decline in market size, stabilizing at approximately $100-120 million annually by 2030, primarily driven by resistant HIV cases.

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Key considerations for stakeholders

• The primary commercial opportunity for Fuzeon lies within resistant HIV cases rather than broader novel indications.
• Innovation in delivery systems and combination regimens can potentially extend product lifecycle.
• Ongoing clinical trials emphasizing safety, tolerability, and resistance management are essential to maintaining relevance.

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Key takeaways

• Fuzeon remains a vital option for multidrug-resistant HIV, though market penetration is limited.
• Recent clinical trials focus on combination therapies with long-acting injectables and delivery innovations.
• The global HIV resistance landscape sustains demand in niche markets, preventing total obsolescence.
• Market projections depict a gradual decline but suggest stability owing to resistant populations’ needs.
• Strategic initiatives including formulation advances and targeted clinical studies could extend its commercial viability.

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FAQs

1. Is Fuzeon still recommended as a first-line HIV treatment?
No. Due to its mode of administration (injectable with injection site reactions), Fuzeon is reserved mainly for treatment-experienced patients with resistant HIV strains, not as initial therapy.

2. What are the main challenges facing Fuzeon in the current market?
Key challenges include patient preference for oral regimens, injection-associated adverse effects, and competition from newer ART classes offering simpler dosing schedules.

3. Are there ongoing efforts to improve Fuzeon’s delivery or efficacy?
Yes. Research includes long-acting formulations, implantable devices, and combination with novel agents to enhance tolerability and adherence.

4. How significant is Fuzeon’s role in managing resistant HIV cases today?
While its role has diminished nationally and globally, Fuzeon remains crucial for patients with multidrug-resistant strains unresponsive to other therapies.

5. What is the potential for Fuzeon in pediatric HIV treatment?
Clinical investigations are limited, but past studies suggest possible pediatric application, pending further trials and regulatory approval.

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Sources:

[1] Lancet HIV, 2022
[2] ClinicalTrials.gov
[3] BioPharma Inc., 2020 Pilot Study
[4] IMS Health Data, 2004
[5] IQVIA, 2021 Market Reports
[6] WHO HIV Resistance Reports, 2022