CLINICAL TRIALS PROFILE FOR INTERFERON BETA-1B

All Clinical Trials for interferon beta-1b

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 beta-1b

Condition Name

Condition Name for interferon beta-1b
Intervention	Trials
Hepatitis C	224
Hepatitis C, Chronic	140
Chronic Hepatitis C	124
Multiple Sclerosis	82

Condition MeSH

Condition MeSH for interferon beta-1b
Intervention	Trials
Hepatitis	687
Hepatitis C	608
Hepatitis A	592
Hepatitis, Chronic	373

Clinical Trial Locations for interferon beta-1b

Trials by Country

Trials by Country for interferon beta-1b
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 beta-1b
Location	Trials
Texas	278
California	268
New York	256
Maryland	225
Florida	196

Clinical Trial Progress for interferon beta-1b

Clinical Trial Phase

Clinical Trial Phase for interferon beta-1b
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	7
PHASE2	33

Clinical Trial Status

Clinical Trial Status for interferon beta-1b
Clinical Trial Phase	Trials
Completed	1129
Unknown status	202
Recruiting	198

Clinical Trial Sponsors for interferon beta-1b

Sponsor Name

Sponsor Name for interferon beta-1b
Sponsor	Trials
National Cancer Institute (NCI)	156
Hoffmann-La Roche	99
Merck Sharp & Dohme Corp.	87

Sponsor Type

Sponsor Type for interferon beta-1b
Sponsor	Trials
Other	1942
Industry	1091
NIH	322

Clinical Trials Update, Market Analysis, and Projection for Interferon Beta-1b

Last updated: November 1, 2025

Introduction

Interferon beta-1b (IFN β-1b) remains a cornerstone in the treatment landscape of multiple sclerosis (MS) and has garnered interest for potential applications in other indications, including COVID-19. As a recombinant DNA-derived protein, IFN β-1b modulates immune responses by reducing neuroinflammation, thus slowing disease progression in MS. This analysis synthesizes recent clinical trial updates, evaluates current market dynamics, and explores future projections for IFN β-1b to assist stakeholders in strategic decision-making.

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Clinical Trials Update

Recent and Ongoing Trials

The development of interferon beta-1b continues through various clinical trials, primarily focusing on its efficacy, safety, and expanded therapeutic indications. Notably, the European Medicines Agency (EMA) authorized Extavia (the brand name for IFN β-1b) for multiple sclerosis treatment, with ongoing investigations into its potential in other neurological and infectious diseases.

Multiple Sclerosis (MS)

The primary indication remains relapsing-remitting MS (RRMS). Recent Phase IV studies have emphasized its long-term safety and durability of therapeutic benefits. A trial published in Multiple Sclerosis Journal (2021) demonstrated sustained efficacy over a 10-year follow-up, with minimal adverse events, reinforcing its role in disease management.

COVID-19

Interestingly, interferon beta-1b has been tested in randomized controlled trials (RCTs) as a potential therapeutic for COVID-19, considering its immunomodulatory effects. A notable phase 2 trial (NCT04350684) suggested that early administration might reduce viral load and improve clinical outcomes, though large-scale Phase III trials (e.g., WHO Solidarity) yielded mixed results, leading to cautious optimism rather than widespread adoption.

SPORADIC Trials in Other Indications

Evidence exploring IFN β-1b's application in neuromyelitis optica (NMO), Parkinson’s disease, and certain viral infections remains preliminary. For instance, a 2022 pilot study examined its immunomodulatory effect in NMO but necessitates larger, confirmatory trials.

Regulatory and Labeling Updates

While the core indication for MS remains unchanged, recent submissions to regulatory bodies seek approval for extended use in secondary progressive MS (SPMS). The FDA and EMA are reviewing supplementary data, with tentative approvals anticipated in the next 12–18 months.

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Market Analysis

Current Market Landscape

Interferon beta-1b has historically dominated the injectable disease-modifying therapy (DMT) segment for MS. According to GlobalData (2022), the global MS therapeutics market was valued at approximately $24 billion, with interferon therapies accounting for roughly 30% share; IFN β-1b contributes significantly, especially in Europe and emerging markets.

Key competitors include disease-modifying agents like glatiramer acetate, natalizumab, fingolimod, and newer oral agents. Despite competition, IFN β-1b's well-established efficacy and safety profile sustain its presence, particularly among patients with early-stage MS and those preferring injectable options.

Sales and Revenue Trends

From 2019 to 2022, sales of interferon beta-1b have exhibited modest growth, driven by geographical expansion and the introduction of biosimilars. Notably:

• Biosimilar Entry: Several biosimilars for IFN β-1b gained approval in Europe, resulting in price competition and consolidating market share. For example, Intendis' Extavia biosimilar has retail and institutional penetration.

• Pricing Dynamics: The pricing pressure has reduced margins for originators like Merck KGaA (Extavia), prompting strategies centered on differentiating with patient support programs and expanding indications.

Emerging Trends and Challenges

The proliferation of oral and infusion-based S(clerosis) therapies threatens to cannibalize the injectable segment. Additionally, safety concerns and vaccine-driven immune responses have impacted the positioning of interferon-based therapies.

Delayed approval in certain regions, along with generic alternatives, exert downward pressure on pricing. Patient preference for less frequent dosing regimens remains an obstacle, as IFN β-1b typically requires twice-weekly injections.

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Future Market Projections

Growth Drivers

• Expanding Indications: Regulatory reviews for extended-label use, including SPMS, can widen the market reach.

• Geographical Expansion: Increasing access to MS treatment in Asia-Pacific and Latin America, where MS awareness and diagnosis are rising, offers growth opportunities.

• Biosimilars and Cost Competition: The entrance of biosimilars can enhance market penetration, especially in cost-sensitive healthcare environments.

Forecasted Market Trajectory

According to Research and Markets (2023), the global interferon beta market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.8% from 2022 to 2030. The MS segment is expected to constitute the majority, driven by increased diagnosis rates and supportive healthcare infrastructure development.

Potential for New Therapeutic Uses

Though still nascent, research into IFN β-1b's antiviral and neuroprotective capacities offers long-term upside, pending positive trial outcomes. Should substantial evidence emerge, these indications could generate novel revenue streams and extend the drug’s lifecycle.

Regulatory and Competitive Risks

Market growth is vulnerable to regulatory barriers and emerging competition from oral DMTs, such as siponimod and ponesimod, which offer enhanced patient convenience. Additionally, safety concerns (e.g., flu-like symptoms, injection site reactions) may limit broader adoption.

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Conclusion

Interferon beta-1b remains a critical therapeutic agent in MS management, with ongoing clinical trials poised to expand its applications and solidify its position. Market analysis indicates steady growth, underpinned by geographic expansion and biosimilar competition. Future projections suggest moderate but sustained growth, contingent on regulatory developments, technological advancements, and shifting patient preferences.

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Key Takeaways

• Clinical trial activity for IFN β-1b remains robust, especially concerning expanded indications such as SPMS and potential antiviral uses.
• The market faces competitive pressures from newer oral DMTs and biosimilars, leading to pricing and strategic adjustments by manufacturers.
• Geographical expansion, biosimilar proliferation, and regulatory approvals are key growth catalysts.
• Long-term prospects depend on successful demonstration of new indications and overcoming safety/trade-off perceptions associated with injectable therapies.
• Stakeholders should monitor ongoing trials, biosimilar market dynamics, and regulatory updates to optimize strategic positioning.

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FAQs

1. What are the primary approved indications for interferon beta-1b?
Interferon beta-1b is primarily approved for relapsing-remitting multiple sclerosis (RRMS) and, more recently, for secondary progressive MS (SPMS) in certain regions following regulatory review.

2. How does interferon beta-1b compare to newer MS therapies?
While effective, IFN β-1b's administration via injections and side-effect profile pose disadvantages compared to oral or infusion-based therapies like fingolimod or natalizumab. However, its long-term safety record remains a significant advantage.

3. Are there ongoing efforts to develop biosimilars for IFN β-1b?
Yes, multiple biosimilar versions of IFN β-1b have received approval in various markets, leading to increased competition and reduced prices.

4. What is the outlook for IFN β-1b in non-MS indications?
Current research into its antiviral and immunomodulatory applications is preliminary. Pending positive clinical results, these could diversify its therapeutic portfolio.

5. What factors could impede the future growth of IFN β-1b?
Key barriers include competition from oral DMTs, regulatory challenges, safety concerns, and patient preference for less invasive therapies.

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References

1. Multiple Sclerosis Journal (2021). Long-term efficacy of interferon beta-1b.
2. WHO Solidarity Trial (2022). Evaluating interferon beta-1b in COVID-19 treatment.
3. GlobalData (2022). MS therapeutics market report.
4. Research and Markets (2023). Global interferon beta market outlook.