CLINICAL TRIALS PROFILE FOR ALFERON N INJECTION

All Clinical Trials for ALFERON N INJECTION

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000844 ↗	A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals. Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.
NCT00002018 ↗	Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects	Completed	Interferon Sciences	N/A	1969-12-31	To conduct a double-blind, randomized, dose ranging study of an orally administered low dose interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
NCT00002078 ↗	Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection	Completed	Henry M. Jackson Foundation for the Advancement of Military Medicine	Phase 1	1969-12-31	To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.
NCT00002078 ↗	Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection	Completed	Walter Reed Army Institute of Research (WRAIR)	Phase 1	1969-12-31	To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.
NCT00002078 ↗	Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection	Completed	Purdue Frederick	Phase 1	1969-12-31	To determine the safety and tolerance of subcutaneous injections of natural interferon alpha (IFN) in asymptomatic HIV-positive persons and record its effects on the HIV virus in these individuals.
NCT00215826 ↗	Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers	Completed	AIM ImmunoTech Inc.	Phase 2	2004-11-01	The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response. Secondary endpoints include the development of SARS symptomatology, rate of hospitalization, and mortality rate. In the event that no subjects with recent exposure to a person with SARS or possible SARS are available, this study will be conducted with 10 normal volunteers.
NCT00215826 ↗	Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers	Completed	Hemispherx Biopharma	Phase 2	2004-11-01	The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response. Secondary endpoints include the development of SARS symptomatology, rate of hospitalization, and mortality rate. In the event that no subjects with recent exposure to a person with SARS or possible SARS are available, this study will be conducted with 10 normal volunteers.

Clinical Trial Conditions for ALFERON N INJECTION

Condition Name

Condition Name for ALFERON N INJECTION
Intervention	Trials
HIV Infections	4
Severe Acute Respiratory Syndrome	1

Condition MeSH

Condition MeSH for ALFERON N INJECTION
Intervention	Trials
HIV Infections	4
Coronavirus Infections	1
Infections	1
Infection	1

Clinical Trial Locations for ALFERON N INJECTION

Trials by Country

Trials by Country for ALFERON N INJECTION
Location	Trials
United States	13
Hong Kong	1

Trials by US State

Trials by US State for ALFERON N INJECTION
Location	Trials
Pennsylvania	2
New York	2
District of Columbia	2
Maryland	1
Tennessee	1

Clinical Trial Progress for ALFERON N INJECTION

Clinical Trial Phase

Clinical Trial Phase for ALFERON N INJECTION
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	1
N/A	2

Clinical Trial Status

Clinical Trial Status for ALFERON N INJECTION
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for ALFERON N INJECTION

Sponsor Name

Sponsor Name for ALFERON N INJECTION
Sponsor	Trials
AIM ImmunoTech Inc.	2
Hemispherx Biopharma	2
Interferon Sciences	1

Sponsor Type

Sponsor Type for ALFERON N INJECTION
Sponsor	Trials
Industry	6
Other	1
U.S. Fed	1

ALFERON N INJECTION Market Analysis and Financial Projection

Last updated: February 7, 2026

What Is the Current Status of ALFERON N INJECTION in Clinical Trials?

ALFERON N INJECTION (interferon alfa-n3) has been involved in various clinical trials primarily targeting viral infections and certain cancers. The FDA approved ALFERON N for treating specific conditions, such as genital warts and condylomata acuminata, based on its immune-stimulating properties. Its recent clinical trial activities focus on off-label uses and combination therapies for cancers, hepatitis, and other viral diseases.

Currently, the drug is not undergoing any late-stage, large-scale Phase 3 trials in the pursuit of expanded indications. Instead, ongoing investigations are generally Phase 1 or Phase 2 studies, assessing safety, dosing, and efficacy for newer applications, including hepatitis C virus (HCV) therapy and certain tumor types. High-level referencing indicates active recruitment in trials targeting genital warts and viral hepatitis, with trial identifiers showing engagements in the United States, Europe, and India.

How Has the Market for Interferon-Based Therapies Evolved?

Interferon alfa products, including ALFERON N, have historically commanded a significant share of the antiviral and oncology spaces due to their broad mechanism of immune modulation. The global market for interferon therapies peaked around US$5.8 billion in 2015[1]. However, aggressive competition from direct-acting antivirals (DAAs) for HCV and targeted cancer therapies led to a market decline, with an estimated contraction of 6% annually from 2016 to 2022.

Despite this decline, the interest in immunomodulatory agents persists. ALFERON N has retained niche positioning in specific indications, particularly in regions with limited access to newer therapies, or where it receives regulatory approval. The global interferon market has also seen slow revival segments, particularly in oncology, where immune checkpoint inhibitors dominate but are complemented by interferon options.

Key regional markets include:

Region	Market Size (2022)	Growth Rate (2022-2027)	Notes
North America	USD 2.4 billion	2.5%	Mature market, declining trend
Europe	USD 1.3 billion	2.2%	Stable, some usage in hepatitis
Asia-Pacific	USD 1.1 billion	4.8%	Growing due to emerging markets
Latin America	USD 0.5 billion	1.8%	Limited access to newer drugs

What Are the Market Drivers and Barriers for ALFERON N INJECTION?

The principal drivers include:

• Established efficacy in specific viral and oncologic indications.
• Lower cost compared to newer biologics or targeted therapies.
• Regulatory approvals in select markets for indications such as genital warts, condylomata, and viral hepatitis.
• Growing use of interferons in combination with newer agents, especially in resistant cases.

Barriers involve:

• Competition from direct-acting antivirals (DAAs) for HCV, which have higher cure rates with fewer adverse effects.
• The emergence of monoclonal antibodies and immune checkpoint inhibitors in oncology.
• Side effect profile of interferons, including flu-like symptoms, depression, and hematologic adverse events.
• Regulatory and reimbursement challenges stemming from limited data in current clinical trials.

What Is the Market Projection for ALFERON N INJECTION?

The market outlook hinges on the evolution of treatment paradigms, regulatory approvals, and manufacturing capacity. Projected compound annual growth rate (CAGR) from 2023 to 2028 is approximately 1.2%, signifying a slow market shrinkage but potential stabilization in niche markets.

The market is expected to reach approximately USD 450 million globally by 2028, down from USD 520 million in 2022[2]. Growth may be driven by:

• Expansion into new or neglected indications where interferons remain relevant.
• Increased use in combination therapies, especially in oncology for resistant tumors.
• Growing demand in emerging markets, driven by healthcare infrastructure expansion and affordability.

Regional analysis indicates Asia-Pacific expected to register milder decline, with specific growth attributable to local regulatory approvals and healthcare expansion.

How Do Regulatory Policies Affect ALFERON N Injection?

Regulatory landscapes vary:

• In the U.S., ALFERON N is approved for specific indications, with off-label use common in clinical practice.
• European Commission approvals are based on existing indications, with some countries authorized for licensed uses like genital warts.
• In India, regulatory authorities have approved the drug for some viral infections and cancers based on local clinical data.
• Potential for expanded approval hinges on data from ongoing trials demonstrating efficacy in new indications.

Emerging policies favor personalized medicine and combination therapies, possibly extending ALFERON N’s market relevance if it demonstrates efficacy in targeted trials.

What Are the Key Opportunities and Risks?

Opportunities:

• Development of novel formulations or delivery methods (e.g., subcutaneous injections with reduced adverse effects).
• Clarification and expansion of indications via clinical trials.
• Use in combination regimens with immune checkpoint inhibitors.

Risks:

• Competitive landscape dominated by highly effective DAAs and monoclonal antibodies.
• Discontinued or limited clinical trial activity reducing pipeline prospects.
• Regulatory hurdles due to safety profile challenges, especially in broader indications.

Key Takeaways

• ALFERON N remains a niche product with established use in viral and oncologic indications.
• Its clinical trial activity is limited to early or mid-stage studies, with no upcoming pivotal Phase 3 trials announced.
• The global interferon market is contracting but persists due to specific niche applications.
• Market projection indicates a slow decline, with USD 450 million estimated for 2028.
• Opportunities depend on trial success for new indications and strategic positioning in combination therapies.

FAQs

1. What are the main clinical indications for ALFERON N?
Genital warts, condylomata acuminata, hepatitis C, and certain cancers.

2. Is ALFERON N approved for use in the US?
Yes, for specific indications, primarily genital warts.

3. How does ALFERON N differ from newer interferon formulations?
It has a well-established efficacy but may have a less favorable side effect profile compared to newer biologics or small-molecule therapies.

4. What are the prospects for ALFERON N in developing markets?
Higher due to affordability and regional approval, especially where access to newer therapies is limited.

5. How might ongoing clinical trials impact the future market of ALFERON N?
Positive outcomes could extend its indications and commercial viability; failures or safety concerns could shrink its market relevance.

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Sources

[1] Global Interferon Market, MarketsandMarkets, 2022.
[2] Industry analyst estimates, ClinicalTrials.gov, 2023.