CLINICAL TRIALS PROFILE FOR INTERFERON ALFA-2B

All Clinical Trials for interferon alfa-2b

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000401 ↗	Oral Collagen for Rheumatoid Arthritis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	1999-07-01	Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.
NCT00000401 ↗	Oral Collagen for Rheumatoid Arthritis	Completed	University of Tennessee	Phase 2	1999-07-01	Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.
NCT00000647 ↗	An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To restore immunologic function and virus-free state in HIV-infected patients. Based on previous studies showing temporary improvement in immune function in HIV-infected patients using peripheral lymphocyte transfers and bone marrow transplantation, and based on studies documenting the antiretroviral effects of zidovudine (AZT) and interferon-alfa (IFN-A) as well as the preliminary test tube and patient studies suggesting anti-HIV effects of recombinant CD4-IgG, we propose to treat HIV-infected patients using combination antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from previously immunized donors in an attempt to restore immunologic function and a virus-free state.
NCT00000687 ↗	Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.
NCT00000694 ↗	A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To define the best doses of sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ), interferon alfa-2b ( IFN-A2b ), and zidovudine ( AZT ) to give together in patients with AIDS-associated Kaposi's sarcoma ( KS ), to learn about the side effects of these drugs when they are given together for 8 weeks, and to find out whether the combination of GM-CSF, IFN-A2b, and AZT has any effect on KS, HIV, or the immune system. Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of patients. IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and perhaps in patients. AZT has also been shown to reduce the growth of HIV and show improvements in the immune system with fewer infections. Test tube experiments show that when IFN-A2b and AZT are used together, they reduce the growth of the HIV virus much more effectively than when either drug is used alone. In recent studies of the combination of interferon alpha and AZT in patients with KS, more than 40 percent of the patients showed shrinkage of their tumors, and some showed evidence for suppression of HIV growth in the body. However, the combination of IFN-A2b with AZT often caused a marked lowering of the white blood cell (WBC) count, especially a type of WBC called the granulocyte (or neutrophil) which is important in the body's defense against infection. Recombinant human GM-CSF is a human protein which is produced in bacteria. It has been shown to cause an increase in the WBC count.
NCT00000695 ↗	Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
NCT00000696 ↗	A Phase I/II Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and hepatic transaminase levels. To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity. AZT is known to be an effective treatment for HIV infection. However, patients may develop reactions to AZT when it is administered for long periods of time. Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone. This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone.

Clinical Trial Conditions for interferon alfa-2b

Condition Name

Condition Name for interferon alfa-2b
Intervention	Trials
Hepatitis C	224
Hepatitis C, Chronic	140
Chronic Hepatitis C	124
Multiple Sclerosis	82

Condition MeSH

Condition MeSH for interferon alfa-2b
Intervention	Trials
Hepatitis	687
Hepatitis C	608
Hepatitis A	592
Hepatitis, Chronic	373

Clinical Trial Locations for interferon alfa-2b

Trials by Country

Trials by Country for interferon alfa-2b
Location	Trials
Canada	423
Korea, Republic of	91
Taiwan	88
Netherlands	87
Puerto Rico	82

Trials by US State

Trials by US State for interferon alfa-2b
Location	Trials
Texas	278
California	268
New York	256
Maryland	225
Florida	196

Clinical Trial Progress for interferon alfa-2b

Clinical Trial Phase

Clinical Trial Phase for interferon alfa-2b
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	7
PHASE2	33

Clinical Trial Status

Clinical Trial Status for interferon alfa-2b
Clinical Trial Phase	Trials
Completed	1129
Unknown status	202
Recruiting	198

Clinical Trial Sponsors for interferon alfa-2b

Sponsor Name

Sponsor Name for interferon alfa-2b
Sponsor	Trials
National Cancer Institute (NCI)	156
Hoffmann-La Roche	99
Merck Sharp & Dohme Corp.	87

Sponsor Type

Sponsor Type for interferon alfa-2b
Sponsor	Trials
Other	1942
Industry	1091
NIH	322

Clinical Trials Update, Market Analysis, and Projection for Interferon Alfa-2b

Last updated: October 30, 2025

Introduction

Interferon alfa-2b, a recombinant cytokine, has long been a mainstay in the treatment of various viral infections and malignancies, notably hepatitis B and C, malignant melanoma, and certain leukemias. Recent developments—including novel clinical trial outcomes, evolving regulatory landscapes, and shifting market dynamics—warrant an in-depth review. This article synthesizes current clinical trial data, analyzes market trends, and provides projections, positioning stakeholders for informed strategic decision-making.

Clinical Trials Update

Current Status and Recent Findings

Interferon alfa-2b continues to be under investigation, particularly in the realm of emerging infectious diseases and oncological indications. Recent clinical trial activities focus primarily on its role in:

• Hepatitis C Virus (HCV): Although direct-acting antivirals (DAAs) have eclipsed interferon-based therapies, some ongoing trials explore combinations or alternatives for resistant cases or specific populations.

• COVID-19: Several trials have assessed interferon alfa-2b as part of combination regimens to enhance antiviral immunity. For instance, a Phase II trial in China demonstrated that recombinant interferon alfa-2b, administered via inhalation, could reduce viral clearance time in COVID-19 patients (e.g., ChiCTR2000030054).

• Cancer Indications: Investigative studies are examining interferon alfa-2b’s immunomodulatory effects in cancers, especially melanoma and certain leukemias. A Phase III trial published in 2022 indicated efficacy in reducing recurrence rates in high-risk melanoma when used as adjuvant therapy.

Regulatory and Approval Landscape

While globally some regulatory agencies like the FDA and EMA have limited recent approvals specifically for interferon alfa-2b, many countries have maintained its availability through off-label use and existing formulations. Notably:

• China and India continue to utilize interferon alfa-2b extensively for hepatitis B and C, backed by local clinical data.

• New formulations: Efforts are ongoing to develop pegylated forms to improve pharmacokinetics and reduce dosing frequency; some are in late-stage clinical trials.

Clinical Challenges and Opportunities

Key challenges involve:

• Adverse effects: Flu-like symptoms, hematologic abnormalities, and neuropsychiatric effects limit tolerability.

• Efficacy relative to DAAs: In hepatitis, interferon’s efficacy has diminished, prompting a decline in its use.

However, opportunities emerge in niches where DAAs are inaccessible or contraindicated, such as in certain resource-limited settings or specific patient subpopulations.

Market Analysis

Market Size and Dynamics

The global interferon alfa-2b market was valued at approximately USD 300 million in 2022, with steady growth driven by demand in hepatitis therapy in emerging markets. Key market segments include:

• Hepatitis B & C: Dominant revenue generators, especially in Asia-Pacific where hepatitis prevalence remains high.

• Oncology: Smaller segment, primarily off-label use and in clinical trials.

• COVID-19: Temporary surge during the early pandemic, now waning as newer therapies emerge.

Competitive Landscape

Major players comprise:

• Merck & Co. (REbetol): Historically dominant supplier for hepatitis.

• Biotech firms: Such as Bio-Pharma and generic manufacturers producing off-patent formulations.

• Emerging biotech offerings: Focused on pegylated interferons, with some in late-stage trials emphasizing extended dosing intervals.

Regulatory and Market Challenges

• Patent expirations have led to increased generic competition, exerting downward pricing pressure.

• The shift towards targeted therapies has reduced the footprint of interferon-based treatments in some indications.

• Vaccination programs and DAAs have diminished the global demand for interferon therapies in hepatitis.

Growth Opportunities

Opportunities for market expansion hinge on:

• Developing new formulations with improved side-effect profiles.

• Expanding indications into oncology and antiviral niches (e.g., COVID-19, emerging viral outbreaks).

• Leveraging biosimilar development to capture cost-sensitive markets.

Market Projection

Short-Term Outlook (2023–2025)

The market is expected to experience a compound annual growth rate (CAGR) of 2-3%, primarily from increasing use in emerging markets and niche indications. Demand is likely to plateau or decline in Western markets owing to DAA dominance and newer therapeutics.

Medium to Long-Term Outlook (2026–2030)

Projected growth hinges on:

• Innovative formulations: Pegylated interferon alfa-2b could see renewed interest owing to dosing convenience and improved tolerability.

• New therapeutic areas: Especially if interferon demonstrates efficacy in COVID-19 or other viral infections in ongoing or future trials.

• Regulatory approvals for novel indications can catalyze market resurgence, particularly in countries with less access to newer drugs.

Overall, global market size may stabilize around USD 350-400 million by 2030, contingent on successful development and regulatory positioning.

Strategic Considerations

Stakeholders should explore:

• Collaborations with biotech firms pioneering pegylation and delivery innovations.

• Investment in clinical research targeting unmet needs, notably in oncology and emerging infectious diseases.

• Market expansion in underserved regions where generics dominate but regulatory barriers are lower.

• Portfolio diversification to include interferon-based combination therapies, aligning with personalized medicine trends.

Key Takeaways

• Clinical landscape remains active, with ongoing trials exploring interferon alfa-2b's role in COVID-19 and cancer therapies, despite reduced prominence in hepatitis management.

• Market size is declining in mature markets but maintains growth in emerging regions and niche indications, especially via biosimilars.

• Innovation in formulations and new indications are vital to prolong the product lifecycle and sustain revenues.

• Regulatory pathways for novel uses could rejuvenate market interest, provided adequate clinical evidence supports efficacy and safety.

• Pricing pressures and changing treatment patterns necessitate strategic agility for manufacturers and investors.

FAQs

1. What are the primary clinical indications for interferon alfa-2b today?
   Its main current uses include treatment of hepatitis B and C in select regions, certain cancers like melanoma, and investigational roles in COVID-19. However, its use is decreasing in hepatitis due to more effective DAAs.

2. Are there any recent advances in interferon alfa-2b formulations?
   Yes, pegylated forms with extended half-life are in development, aiming to reduce dosing frequency and improve tolerability, potentially revitalizing its clinical utility.

3. How has the COVID-19 pandemic affected the interferon alfa-2b market?
   Initial trials suggested potential benefits, leading to temporary increased demand. However, subsequent studies and availability of alternative treatments have limited its market impact in this indication.

4. What are the main regulatory challenges facing interferon alfa-2b?
   Regulatory hurdles include demonstrating efficacy for new indications, managing side effects, and competing with emerging oral therapies, which often require extensive clinical data for approval.

5. What is the outlook for interferon alfa-2b in developing markets?
   Growth prospects remain favorable due to high hepatitis prevalence and limited access to newer therapies. Cost-effective biosimilars and generic formulations will play a significant role in expansion.

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References

1. [1] World Health Organization. Global hepatitis report 2017.
2. [2] Chinese Clinical Trial Registry. Study on interferon alfa-2b for COVID-19 (ChiCTR2000030054).
3. [3] European Medicines Agency. Summary of product characteristics for Pegasys (peginterferon alfa-2a).
4. [4] MarketWatch. Interferon market analysis and forecasts 2023–2030.
5. [5] ClinicalTrials.gov. Ongoing trials involving interferon alfa-2b in oncology and infectious diseases.