CLINICAL TRIALS PROFILE FOR ENFUVIRTIDE

All Clinical Trials for enfuvirtide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002239 ↗	A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults	Completed	Trimeris	Phase 2	1999-05-01	The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
NCT00001118 ↗	Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1	1969-12-31	The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children. T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).
NCT00001118 ↗	Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children. T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).
NCT00002228 ↗	A Study of T-20 in HIV-Positive Adults	Completed	Trimeris	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give T-20 to HIV-positive adults. T-20 is an anti-HIV drug.

Clinical Trial Conditions for enfuvirtide

Condition Name

Condition Name for enfuvirtide
Intervention	Trials
HIV Infections	39
HIV	4
HIV Infection	3
AIDS	2

Condition MeSH

Condition MeSH for enfuvirtide
Intervention	Trials
HIV Infections	43
Infections	9
Infection	7
Acquired Immunodeficiency Syndrome	6

Clinical Trial Locations for enfuvirtide

Trials by Country

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Trials by Country for enfuvirtide
Location	Trials
United States	263
Canada	11
Puerto Rico	10
France	10
Spain	8

Trials by US State

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−

Trials by US State for enfuvirtide
Location	Trials
California	22
Florida	19
New York	18
Texas	16
North Carolina	14

Clinical Trial Progress for enfuvirtide

Clinical Trial Phase

Clinical Trial Phase for enfuvirtide
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for enfuvirtide
Clinical Trial Phase	Trials
Completed	43
Unknown status	3
Terminated	3

Clinical Trial Sponsors for enfuvirtide

Sponsor Name

Sponsor Name for enfuvirtide
Sponsor	Trials
Hoffmann-La Roche	22
Trimeris	10
National Institute of Allergy and Infectious Diseases (NIAID)	9

Sponsor Type

Sponsor Type for enfuvirtide
Sponsor	Trials
Industry	55
Other	23
NIH	10

Enfuvirtide (Fuzeon): Clinical Trials, Market Analysis, and Projections

Introduction

Enfuvirtide, marketed under the brand name Fuzeon, is a peptide-based antiretroviral medication that has been a crucial option for managing HIV-1 infection, particularly in patients who exhibit resistance to conventional antiretroviral therapies. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Mechanism of Action and Clinical Trials

Enfuvirtide functions by inhibiting the fusion of the HIV virus with the plasma membrane of CD4+ T-cells, thereby preventing viral replication. It is a peptide mimetic of an essential region within the viral envelope glycoprotein gp41 and blocks gp41 structural rearrangements at a transitional pre-fusion conformation[3].

In clinical trials, enfuvirtide has shown high efficacy and low toxicity. It has been demonstrated to be effective in patients with advanced HIV disease who have failed other antiretroviral therapies. However, primary resistance to enfuvirtide has not been observed, and enfuvirtide-naive isolates remain clinically sensitive[3].

Use in Pregnancy

Studies on the use of enfuvirtide during pregnancy are limited but indicate that it does not readily cross the human placenta. Minimal placental passage of enfuvirtide has been reported, and there is no evidence of teratogenicity or adverse pregnancy outcomes in both animal and limited human studies[1].

Market Analysis

Market Drivers

The market for enfuvirtide is driven by several key factors:

• Increasing Prevalence of HIV: The growing number of HIV cases, especially those resistant to standard therapies, increases the demand for alternative treatments like enfuvirtide[2].
• Advancements in Biotechnology: Continuous advancements in biotechnological research and development offer opportunities for improved formulations and delivery systems, enhancing patient compliance and efficacy[2].
• Need for Personalized Medicine: The trend towards personalized medicine allows for tailored treatments that address specific resistance patterns, making enfuvirtide a valuable option for certain patients[2].

Market Restraints

Despite its benefits, the market for enfuvirtide faces several challenges:

• High Cost of Treatment: The expensive nature of enfuvirtide treatment is a significant barrier to its widespread adoption[2].
• Administration Challenges: The injectable nature of enfuvirtide poses logistical challenges compared to oral antiretrovirals[2].
• Emergence of Newer Therapies: The development of newer, more effective oral antiretrovirals has reduced the medical need for enfuvirtide, leading to a decline in its market share[4].

Market Opportunities

There are several opportunities for growth and innovation in the enfuvirtide market:

• Novel Delivery Systems: Developing new delivery systems could improve patient compliance and reduce the complexity associated with the current injectable form[2].
• Cost Reduction: Improving manufacturing processes to reduce costs could make enfuvirtide more accessible to a broader patient population[2].
• Strategic Partnerships: Establishing partnerships with local healthcare providers and pharmaceutical companies can enhance the distribution and adoption of enfuvirtide[2].

Market Projections

Discontinuation of Commercial Distribution

As of February 28, 2025, Genentech will discontinue all marketing and commercial distribution of Fuzeon (enfuvirtide) in the United States. This decision is based on evolving clinical practices and the availability of novel alternative treatment options that have significantly reduced the medical need for enfuvirtide[4].

Global Market Trends

Despite the discontinuation in the U.S., the global market for enfuvirtide is expected to see moderate growth driven by the increasing prevalence of HIV and the need for alternative treatments in regions where newer therapies may not be readily available.

• Market Penetration: The current market landscape includes healthcare facilities such as hospitals and specialized clinics. There is potential for market penetration in emerging markets and expansion opportunities in mature segments[2].
• Competitive Landscape: The market is characterized by moderate competition, with major pharmaceutical companies continually working to expand their product portfolios in HIV treatment. Balancing affordability with innovation will be crucial for capitalizing on market opportunities[2].

Key Takeaways

• Enfuvirtide is a peptide-based antiretroviral medication effective in treating HIV-1 infection, particularly in patients resistant to conventional therapies.
• Clinical trials have shown high efficacy and low toxicity, with no primary resistance observed.
• The drug has minimal placental transfer and no evidence of teratogenicity.
• Market drivers include the increasing prevalence of HIV and advancements in biotechnology, while restraints include high costs and administration challenges.
• Opportunities for growth lie in novel delivery systems, cost reduction, and strategic partnerships.
• Commercial distribution of enfuvirtide will be discontinued in the U.S. as of February 28, 2025, due to the availability of newer treatment options.

FAQs

What is the mechanism of action of enfuvirtide?

Enfuvirtide blocks the fusion of the HIV virus with the plasma membrane of CD4+ T-cells by mimicking an essential region within the viral envelope glycoprotein gp41, thereby preventing viral replication[3].

Is enfuvirtide safe for use during pregnancy?

Studies indicate that enfuvirtide does not readily cross the human placenta and has shown no evidence of teratogenicity or adverse pregnancy outcomes in both animal and limited human studies[1].

Why is Genentech discontinuing the commercial distribution of Fuzeon (enfuvirtide) in the U.S.?

Genentech is discontinuing the commercial distribution of Fuzeon due to evolving clinical practices and the significantly reduced medical need resulting from the availability of novel alternative treatment options[4].

What are the main challenges facing the enfuvirtide market?

The main challenges include the high cost of treatment, administration challenges due to its injectable form, and the emergence of newer, more effective oral antiretrovirals[2].

What opportunities exist for the growth of the enfuvirtide market?

Opportunities include the development of novel delivery systems, cost reduction through improved manufacturing processes, and establishing strategic partnerships with healthcare providers and pharmaceutical companies[2].

How does the global market for enfuvirtide look despite the U.S. discontinuation?

The global market is expected to see moderate growth driven by the increasing prevalence of HIV and the need for alternative treatments in regions where newer therapies may not be readily available[2].

Sources

1. NIH - Clinical Info HIV.gov: Archived Drugs: Enfuvirtide (Fuzeon).
2. 360iResearch: Enfuvirtide for Injection Market Size & Share 2025-2030.
3. Journal of Antimicrobial Chemotherapy: Resistance to enfuvirtide, the first HIV fusion inhibitor.
4. Genentech: Genentech Provides Update on Fuzeon® (enfuvirtide) in the United States.
5. Market Research Reports: Global Enfuvirtide for Injection Market Growth 2024-2030.