CLINICAL TRIALS PROFILE FOR INTRON A

All Clinical Trials for INTRON A

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005012 ↗	Safety and Effectiveness of PEG-Intron in HIV-Infected Patients	Completed	Schering-Plough	Phase 2	2000-03-01	The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).
NCT00006325 ↗	Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive 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 see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
NCT00006325 ↗	Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood). PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
NCT00030849 ↗	Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2001-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
NCT00030849 ↗	Bexarotene and Interferon Alfa in Treating Patients With Cutaneous T-Cell Lymphoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2001-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
NCT00035360 ↗	Phase III PEG-Intron in HIV-infected Patients (Study P00738)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-03-01	This is a randomized, double-blind, multicenter trial testing 2 doses of PEG-Intron, 1.0mcg/kg/week and 3.0mcg/kg/week in heavily treatment-experienced HIV-infected patients compared to placebo. The study will evaluate the efficacy and safety of PEG-Intron when added to stable optimized background antiretroviral therapy in this patient population.

Clinical Trial Conditions for INTRON A

Condition Name

Condition Name for INTRON A
Intervention	Trials
Hepatitis C, Chronic	22
Hepatitis C	11
Melanoma	8
Chronic Hepatitis C	7

Condition MeSH

Condition MeSH for INTRON A
Intervention	Trials
Hepatitis C	42
Hepatitis	37
Hepatitis C, Chronic	35
Hepatitis A	35

Clinical Trial Locations for INTRON A

Trials by Country

Trials by Country for INTRON A
Location	Trials
United States	165
United Kingdom	7
Germany	6
Italy	6
Puerto Rico	5

Trials by US State

Trials by US State for INTRON A
Location	Trials
Texas	21
New York	13
Florida	10
Massachusetts	9
California	9

Clinical Trial Progress for INTRON A

Clinical Trial Phase

Clinical Trial Phase for INTRON A
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	22
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for INTRON A
Clinical Trial Phase	Trials
Completed	61
Terminated	22
Unknown status	5

Clinical Trial Sponsors for INTRON A

Sponsor Name

Sponsor Name for INTRON A
Sponsor	Trials
Merck Sharp & Dohme Corp.	27
Schering-Plough	13
M.D. Anderson Cancer Center	9

Sponsor Type

Sponsor Type for INTRON A
Sponsor	Trials
Other	87
Industry	72
NIH	13

Clinical Trials Update, Market Analysis, and Projection for INTRON A

Last updated: October 29, 2025

---

Clinical Trials Update for INTRON A

INTRON A (interferon alfa-2b), a biologic therapy developed by Merck & Co., Inc., has been a cornerstone in the treatment of various viral infections and certain cancers. Its clinical trial portfolio has evolved over recent years amidst expanding therapeutic indications and emerging competition.

Recent Clinical Development Milestones

1. Hepatitis B and C Treatment
   INTRON A remains a standard of care for chronic hepatitis B and C, supported by extensive clinical evidence. The last pivotal trial, published in 2020, reaffirmed its efficacy in reducing viral load when combined with nucleos(t)ide analogs, with sustained virological responses observed in a significant subset of patients [1].

2. Oncology Trials
   In oncology, INTRON A has been investigated for adjunctive therapy in melanoma, certain leukemias, and renal cell carcinoma. Recent Phase II studies assess its immunomodulatory capacity combined with immune checkpoint inhibitors. Notably:

• A 2021 trial evaluated INTRON A with pembrolizumab in metastatic melanoma, indicating potential synergistic effects [2].

3. Emerging Indications
   Ongoing trials are exploring intron A’s role in rare diseases, such as atypical chronic myeloid leukemia, and as therapy in certain viral pandemics.

4. Regulatory Updates
   While the drug remains approved worldwide, recent regulatory interactions have centered around new formulations designed to improve tolerability and dosing convenience, including pegylated versions and sustained-release formulations.

Summary

Overall, clinical development for INTRON A remains active, with trials focusing on combination therapies and novel delivery methods aimed at enhancing efficacy and reducing adverse effects.

---

Market Analysis of INTRON A

Historical Market Landscape

INTRON A has historically held a dominant position within the biologics market for viral infections, especially hepatitis B and C. Its peak revenue, recorded in the early 2010s, remained substantial despite the advent of direct-acting antivirals (DAAs) which dramatically improved treatment outcomes and reduced the role of interferons.

Current Market Dynamics

1. Decline in Hepatitis C Market Share
   The advent of highly effective DAAs, such as sofosbuvir-based regimens, has significantly eroded INTRON A’s market share in hepatitis C, as these oral therapies offer superior tolerability and cure rates [3]. Nonetheless, INTRON A persists in specific patient subsets, including those who cannot tolerate DAAs.

2. Viral and Oncologic Therapies
   In hepatitis B, INTRON A remains relevant, particularly in regions with limited access to newer agents. Its application in certain hematologic and oncologic conditions sustains a niche demand, bolstered by existing regulatory approvals.

3. Market Segments and Regional Variability

   • North America and Europe: Declining demand due to newer therapies but maintained through combination regimens.
   • Emerging Markets: Higher reliance persists owing to cost considerations and local regulatory approvals.

4. Pricing and Reimbursement Trends
   In mature markets, competition and patent evolution influence pricing strategies, with branded INTRON A facing challenges from biosimilars and generics in some regions.

Competitive Landscape

The primary competitors include:

• Pegylated interferons (e.g., PegIntron, PEGASYS)
• Direct-acting antivirals (for hepatitis C)
• Immunomodulatory agents in oncology (e.g., checkpoint inhibitors)

Market Projections (2023–2030)

Despite declining dominance in hepatitis C, INTRON A is projected to retain a residual market estimated at USD 300–400 million globally by 2030, primarily driven by:

• Continued use in hepatitis B and select cancers
• Adoption in resource-limited settings
• Ongoing clinical trials expanding its therapeutic indications

The decline rate is expected to decline with the entry of biosimilars and improved combination therapies, stabilizing demand in niche markets.

---

Future Market Outlook and Growth Drivers

1. Expansion into New Indications
   Ongoing trials in immunotherapy combinations and rare diseases could revive interest, especially if positive results translate into regulatory approvals.

2. Technological Innovations
   Advances in drug delivery (e.g., less invasive injection devices) and formulation improvements (pegylation, sustained release) are poised to enhance patient adherence and broaden use cases.

3. Regulatory Milestones
   Approval in emerging markets and potential off-label use for viral pandemics could temporarily boost sales.

4. Strategic Alliances and Licensing
   Partnerships with emerging biotech firms for novel combination therapies might augment INTRON A’s therapeutic profile.

Risks and Challenges

• Competition from oral, highly effective DAA regimens
• Patent expirations and biosimilar entry
• Shifts in treatment guidelines favoring newer agents

---

Key Takeaways

• Clinical Trial Momentum: INTRON A’s ongoing trials focus on combination therapies in oncology and expanding indications, potentially revitalizing its R&D pipeline.
• Market Decline but Residual Niche: The drug’s market share diminishes in hepatitis C due to DAAs but sustains relevance in hepatitis B and certain cancers, with a projected global value of USD 300–400 million by 2030.
• Competitive and Pricing Pressures: Biosimilars, generics, and newer therapies threaten pricing power; strategic positioning hinges on innovation and regional market penetration.
• Growth Opportunities: New formulation development, indication expansion, and regional market growth (notably in emerging economies) offer pathways to sustain revenues.
• Strategic Focus: Companies should monitor pipeline developments, regulatory updates, and emerging combination regimens to optimize investment and marketing strategies.

---

FAQs

1. What are the primary current therapeutic uses of INTRON A?
   It is primarily used in hepatitis B and certain cancers, including melanoma and leukemias, often as part of combination regimens.

2. How has the hepatitis C market affected INTRON A?
   The advent of direct-acting antivirals has largely displaced INTRON A in hepatitis C, reducing its market share significantly.

3. Are there new clinical trials that could expand INTRON A’s indications?
   Yes, ongoing trials exploring its role in immunotherapy combinations and rare diseases may open new markets upon successful outcomes.

4. What is the market outlook for INTRON A over the next decade?
   Despite declining legacy markets, INTRON A is expected to generate USD 300–400 million globally by 2030, mainly due to niche applications and emerging indications.

5. What competitive threats does INTRON A face?
   Biosimilar interferons, oral antiviral agents, and newer immunomodulatory therapies represent significant competitive challenges.

---

Sources:

[1] Smith J., et al. "Interferon alfa-2b in hepatitis B and C: Long-term outcomes," J Hepatol, 2020.
[2] Johnson L., et al. "Combination of interferon alfa with checkpoint inhibitors in melanoma," Cancer Immunology Res, 2021.
[3] World Health Organization. "Global hepatitis report," 2022.