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.

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	11
PHASE3	7
PHASE2	35

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	1956
Industry	1094
NIH	322

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

Last updated: May 1, 2026

What is interferon alfa-2b and how is it positioned clinically?

Interferon alfa-2b is a recombinant interferon alpha product used for multiple viral and oncologic indications. In commercial practice, it is typically deployed as pegylated or non-pegylated interferon formulations depending on the therapeutic area and treatment protocol.

Clinical development of interferon alfa-2b is highly dependent on:

• The existence of active comparators (pegylated interferons, direct-acting antivirals, modern immune-oncology regimens).
• Treatment-line definitions (first-line versus refractory).
• Biomarker strategy and combination regimens.

The core market reality is that interferon alfa-2b’s addressable population has narrowed in some indications due to replacement by less toxic regimens. In other indications, interferon alfa-2b remains relevant where immune modulation has an established role or where newer regimens have specific access or population constraints.

What is the latest clinical-trial landscape?

A complete, current “trial-by-trial” update requires live registry data by NCT number and status. No such live data was provided in the prompt, and no registries were supplied to anchor a deterministic update. Without that, a precise update across trial phases, recruitment status, and outcomes cannot be produced.

Where does interferon alfa-2b still compete, and why does clinical cadence matter?

Interferon alfa-2b competes in settings where:

• Interferon-based immune modulation is part of guideline-consistent regimens.
• Alternative therapy is either contraindicated, not accessible, or less suitable for certain subgroups.
• Combination approaches are used to improve response durability.

Clinical cadence matters because interferon-alfa-2b commercial upside is tied to:

• Any new label expansions (new combinations, new treatment lines).
• Sustained payer coverage in existing indications.
• Ongoing prescriber adoption for long-duration courses, which affects adherence and total dose consumption.

What does the IP landscape imply for near-term competition?

Interferon products generally face a long-lived market with multiple branded and generic entrants over time. Commercial pressure typically comes from:

• Patent expiries around the specific product form and manufacturing process.
• Entry of biosimilar and/or non-original interferon products.
• Substitution by alternative standard-of-care therapies where treatment paradigms shift.

For an investment-grade projection, the key question is whether the remaining patent life and any formulation/process IP materially constrain competitors. Without document-level IP specifics for interferon alfa-2b in a defined geography and product (brand/form), the projection cannot be deterministically tied to enforceable exclusivity.

How big is the interferon alfa-2b market, and what are the demand drivers?

Interferon alfa-2b demand historically tracks three drivers:

1. Indication prevalence and regimen adoption (viral hepatitis, malignancies where interferon remains used).
2. Regimen length and adherence (fixed-dose schedules versus variable durations).
3. Competition intensity from pegylated interferons, biosimilars, and oral direct-acting antivirals or non-interferon oncology regimens.

In broad market dynamics:

• Viral hepatitis indications have faced major substitution in many settings due to direct-acting antivirals.
• Oncology use has shown more persistence but is also pressured by newer immune-oncology standards, with interferon-based regimens often relegated to specific contexts.

What is the market outlook and projection for interferon alfa-2b?

A numeric forecast requires anchoring to:

• Current sales baseline (global and/or regional), ideally by formulation.
• Indication-wise volumetrics and assumed guideline changes.
• Expected entry timing for competing products (biosimilars/generics) and uptake curves.
• Pricing trajectory (net price erosion versus volume offsets).

No baseline sales data, geography scope, formulation scope (pegylated vs non-pegylated), or competitor entry calendar was provided. Without these, any quantitative projection would be speculative.

Where are the highest-probability value pockets?

Even without registry-level trial detail, the most commercially plausible value pockets are:

• Indications where interferon-based therapy retains guideline support in specific subpopulations.
• Settings where newer regimens are unavailable or clinically unsuitable.
• Geographic markets with slower adoption of newer alternatives due to reimbursement or access.

This kind of selectivity changes the economics from “broad market growth” to “defensive share plus targeted volume retention.”

What would an actionable competitor/portfolio view look like?

A defensible portfolio view for interferon alfa-2b typically segments:

• Product form: non-pegylated vs pegylated (affects dosing economics and prescriber preference).
• Indication: each has separate payer and guideline dynamics.
• Region: access to DAAs and oncology standards differ by country and reimbursement system.
• Biosimilar pressure: intensity differs by market authorization and tendering.

Key Takeaways

• Interferon alfa-2b’s clinical and commercial trajectory is shaped more by guideline substitution and access than by new broad-based development.
• A rigorous “latest clinical trials update” and a numeric market projection require registry- and sales-baseline inputs; none were supplied in the prompt.
• The near-term commercial path is defensive: retaining share in pockets where interferon-based regimens remain appropriate, while facing category-level substitution pressures.

FAQs

1. Is interferon alfa-2b still used in hepatitis?
   Yes, but use is constrained in many regions by adoption of direct-acting antivirals and guideline shifts, with remaining use tied to specific clinical and access contexts.

2. Does interferon alfa-2b have active clinical development?
   Clinical activity exists for interferon-based regimens, but a “latest update” requires live registry status and trial identifiers to be accurate.

3. What most affects interferon alfa-2b sales: pricing or volume?
   Both, but volume is often the dominant driver where standards of care shift away from interferon.

4. How do biosimilars change the outlook?
   Biosimilars typically compress net pricing and can shift utilization through procurement and tender dynamics.

5. What is the best way to model market projection for interferon alfa-2b?
   Indication-level approach with baseline sales, net price erosion, guideline adoption rates for comparators, and competitor entry timing.

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References

No sources were provided in the prompt, and no external registry or sales datasets were included to support a complete, deterministic update and numeric projection.