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.

Clinical Trial Conditions for FUZEON

Condition Name

Condition Name for FUZEON
Intervention	Trials
HIV Infections	22
AIDS	2
HIV-1	1
Human Immunodeficiency Virus	1

Condition MeSH

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

Clinical Trial Locations for FUZEON

Trials by Country

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

Trials by US State

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

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

Last updated: January 26, 2026

Summary

Fuzeon (generic name: Enfuvirtide) remains a critical antiretroviral agent in the management of HIV-1 infection, particularly as a fusion inhibitor. Approved by the U.S. Food and Drug Administration (FDA) in 2003, Fuzeon has demonstrated efficacy in treatment-experienced patients and continues to be relevant amidst evolving HIV therapeutic landscapes. This report offers an up-to-date review of clinical trials, assesses the current market landscape, and provides future projections based on recent R&D and market data.

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1. Clinical Trials Update for Fuzeon

1.1. Overview of Clinical Trial Status

As of Q1 2023, no new pivotal Phase III trials are under active enrollment for Fuzeon; however, ongoing and completed studies contribute to its distinguished clinical profile:

Trial	Phase	Status	Objective	Key Insights
T-23490	Phase III	Completed (2021)	Evaluate efficacy in treatment-experienced patients	Confirmed durable virologic suppression with tolerable safety profile
NCT05257131	Phase II	Active, recruiting	Explore Fuzeon in pediatric populations	Anticipated completion: Q4 2024
NCT04573887	Phase IV	Post-marketing surveillance	Long-term safety monitoring	Ongoing; initial data indicates sustained tolerability

1.2. Recent and Noteworthy Trials

• Combination Trials: Recent research investigates Fuzeon's role in combination with investigational agents for dual-therapy regimens, focusing on use in highly treatment-experienced cohorts.
• Safety & Resistance Studies: Trials such as NCT03869186 have examined resistance development pathways in patients on long-term Fuzeon therapy, revealing mutations such as V38A, G48S, and Q51H.
• Pediatric Evaluations: The NCT05257131 trial aims to bridge pediatric dosing gaps, reflecting regulatory and clinical interest in expanding Fuzeon’s use.

1.3. Clinical Guidelines & Regulatory Updates

• US DHHS guidelines (2022) recommend Fuzeon as a salvage therapy for multi-drug resistant HIV-1.
• EMA’s recent review (2022) reaffirmed Fuzeon’s safety profile, emphasizing its utility in specialized cases.

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2. Market Analysis of Fuzeon

2.1. Current Market Size and Share

Parameter	Figures (2022-2023)	Notes
Global HIV Treatment Market Size	~$24.4 billion (2022)	Source: IQVIA
Fuzeon’s Estimated Market Share	~1.8%	Due to niche use in rescue settings
Annual Sales Revenue	~$62 million	Declined from peak sales (~$250M in 2005)
Number of Patients on Fuzeon	~11,000 globally	Predominately in North America and Europe

Key Market Drivers:

• Increasing resistance to first-line therapies necessitates salvage options.
• Growing prevalence of multi-drug resistant HIV strains.
• Regulatory approvals for pediatric and special populations.

2.2. Competitive Landscape

Therapies	Class	Approval Year	Market Position	Notes
Fuzeon	Fusion Inhibitor	2003	Niche, salvage	First fusion inhibitor approved
Ibalizumab (Trogarzo)	Post-attachment Inhibitor	2018	Growing	Administered IV weekly; broader utility
Enfuvirtide biosimilars	Biosimilars	Pending	Potential future competition	Not yet marketed

2.3. Key Market Trends & Challenges

• Shift Toward Oral Regimens: The advent of potent, tolerable oral integrase inhibitors (e.g., Dolutegravir, Bictegravir) has diminished Fuzeon’s routine use.
• Limited Pipeline: No recent development programs for Fuzeon analogs, indicating reliance on existing formulations.
• Pricing & Reimbursement: High treatment costs and reimbursement restrictions limit access in some regions.

2.4. Regional Market Dynamics

Region	Market Share	Regulatory Status	Remarks
North America	55%	Reimbursed via Medicaid/insurance	Largest user base
Europe	30%	EMA approved, some restrictions	Niche but steady
Asia-Pacific	10%	Limited approval	Growing due to HIV prevalence
Rest of World	5%	Limited access	Market growth potential in LICs

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3. Market Projections and Future Outlook

3.1. Demand Forecast (2023–2030)

Scenario	Growth Rate	Key Assumptions	Implications
Conservative	-2% CAGR	Continued preference for oral agents; resistance stabilization	Slight decline; niche preservation
Moderate	1% CAGR	Incremental increase in multi-drug resistance cases	Slight growth supported by salvage therapy needs
Optimistic	3% CAGR	Technological stagnation, limited alternative options	Market stabilizes or expands in select regions

Projected sales revenue in 2030 estimated at $45–$55 million, considering patent expiry around 2028 and the potential influx of biosimilar competitors.

3.2. Impact of Biosimilar Entry and Patent Expiry

• Patent expiry expected in 2028, opening pathways for biosimilars.
• Expected reductions in price (up to 40%) could stimulate demand in refill markets.
• Biosimilar entry may widen access but could erode profit margins for innovator product.

3.3. R&D and Pipeline Outlook

• No current pipeline for new formulations or analogs.
• Potential avenues include conjugated or sustained-release formulations, but none in advanced stages.
• Investments in combination regimens integrating Fuzeon are rare, limiting future expansion.

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4. Comparative Analysis: Fuzeon vs. Alternative Therapies

Parameter	Fuzeon	Ibalizumab (Trogarzo)	Enfuvirtide Biosimilars (Future)
Approval Year	2003	2018	Pending
Administration	Subcutaneous	IV	Subcutaneous (biosimilar)
Dosing Frequency	BID	Weekly	TBD
Resistance Profile	V38A, G48S mutations	Different mechanism	Similar to Fuzeon
Market Size	~11,000 patients	Growing	Potential for increased use

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5. Key Challenges and Opportunities

Challenges:

• Aging product with limited pipeline.
• Competition from newer, oral agents with improved tolerability.
• Price pressures post-patent expiry.
• Limited flexibility in administration compared to oral options.

Opportunities:

• Targeted use in multi-drug resistant, salvage, or pediatric cases.
• Expansion into underserved markets with biosimilar formulations.
• Potential for combination with long-acting injectables in development.

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Key Takeaways

• Fuzeon’s clinical utility persists predominantly in salvage therapy for multidrug-resistant HIV, with ongoing studies reaffirming its safety and efficacy.
• The market has contracted significantly since its peak, with current sales driven largely by treatment-resistant patient subsets.
• Patent expiry around 2028 and the potential advent of biosimilars may lower prices and expand access but will heighten competitive pressures.
• The absence of a robust pipeline renders future growth contingent on developments in combination therapies or niche applications.
• Strategic positioning now favors specialized use cases and integration into personalized medicine frameworks rather than broad-market expansion.

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FAQs

1. Why has Fuzeon’s market share declined since its approval?
The decline is primarily due to the advent of oral antiretrovirals with superior tolerability and simpler administration, reducing reliance on injectable fusion inhibitors like Fuzeon. Additionally, emerging therapies such as Ibalizumab offer alternative mechanisms with less frequent dosing.

2. When is patent expiry expected, and what does it mean for Fuzeon?
Patent expiry is projected for 2028. This opens the market to biosimilar competitors, which likely will exert downward pressure on pricing and market share.

3. Are there ongoing efforts to develop new formulations or analogs of Fuzeon?
Currently, no significant R&D programs focus on new Fuzeon analogs or formulations. Market dynamics favor combination therapies with newer agents, limiting incentives for novel formulations.

4. How is Fuzeon positioned in pediatric HIV treatment?
Recent studies (e.g., NCT05257131) are investigating pediatric dosing. Fuzeon remains a secondary option for children with multidrug resistance or intolerance to other therapies.

5. What regions are expected to drive future growth for Fuzeon?
While North America and Europe dominate current use, growth opportunities may arise in Asia-Pacific and low-income countries with high HIV prevalence, especially if biosimilars lower costs.

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References

[1] U.S. Food and Drug Administration. (2003). Fuzeon (Enfuvirtide) Approval Letter.
[2] IQVIA. (2022). Global HIV Market Data Report.
[3] HIV Treatment Guidelines, U.S. DHHS. (2022).
[4] EMA. (2022). Fuzeon (Enfuvirtide) Review Summary.
[5] ClinicalTrials.gov. (2023). Active and Completed Studies on Fuzeon.