CLINICAL TRIALS PROFILE FOR IMURAN

All Clinical Trials for IMURAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00113503 ↗	Imuran Dosing in Crohn's Disease Study	Terminated	Prometheus Laboratories	Phase 2	2005-07-01	This study will compare two different dosing methods of azathioprine (IMURAN) in participants with Crohn's disease who are currently taking steroids (e.g. prednisone or budesonide)or who have just started steroids. The study can be up to 54 weeks long. All participants enrolled will receive active drug. Participants will take doses either based upon weight or based on the patient's ability to breakdown the drug (monitored by 6-thioguanine nucleotides (6-TGN) metabolite levels in the blood). All patients enrolled in the study will receive active study drug.
NCT00098111 ↗	Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease	Terminated	Massachusetts General Hospital	Phase 3	2005-04-01	The purpose of this study is to identify an optimal weight based dose of azathioprine that is safe and effective in the treatment of subjects with active Crohn's disease requiring treatment with corticosteroids, and for maintaining remission in those subjects.
NCT00104299 ↗	Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis	Completed	Genentech, Inc.	Phase 2/Phase 3	2005-01-01	Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
NCT00104299 ↗	Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis	Completed	Immune Tolerance Network (ITN)	Phase 2/Phase 3	2005-01-01	Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
NCT00104299 ↗	Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3	2005-01-01	Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
NCT00001789 ↗	BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	1999-06-01	The purpose of this study is to investigate whether the experimental drug BG9588 can be used to treat lupus nephritis more effectively and with less toxicity than standard treatments, including cyclophosphamide (Cytoxan), azothioprine (Imuran) and prednisone. The body's immune system naturally produces antibodies to fight foreign substances like bacteria and viruses. In autoimmune diseases like lupus, however, the body makes antibodies that attack its own tissues, causing inflammation and organ damage. Lupus antibodies attack and damage kidney cells. BG9588 can interfere with the production of these antibodies, and therefore, may lessen kidney damage in people with lupus nephritis. This study will look at: how BG9588 enters and leaves the blood and body tissue over time; adverse effects of the drug; and whether treatment with BG9588 can result in less kidney damage than other therapies. Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for three doses and then once every 28 days for four doses. Patients' steroid dosage may be tapered; individual adjustments will be made as required. Patients screened for the study will undergo a physical examination, medical history, various blood and urine tests, as well as complete a quality of life questionnaire. Results of a previous kidney biopsy and chest X ray are also required. Many of these tests will be repeated throughout the study. In a previous animal study, BG9588 treatment of mice with lupus nephritis improved their disease and survival.

Clinical Trial Conditions for IMURAN

Condition Name

Condition Name for IMURAN
Intervention	Trials
Crohn's Disease	8
Lupus Nephritis	6
Ulcerative Colitis	3
Microscopic Polyangiitis	2

Condition MeSH

Condition MeSH for IMURAN
Intervention	Trials
Crohn Disease	10
Nephritis	6
Lupus Nephritis	6
Vasculitis	3

Clinical Trial Locations for IMURAN

Trials by Country

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Trials by Country for IMURAN
Location	Trials
United States	77
Canada	7
Netherlands	7
Italy	4
Australia	3

Trials by US State

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−

Trials by US State for IMURAN
Location	Trials
New York	9
Ohio	8
Minnesota	6
Pennsylvania	6
California	5

Clinical Trial Progress for IMURAN

Clinical Trial Phase

Clinical Trial Phase for IMURAN
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	9
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for IMURAN
Clinical Trial Phase	Trials
Completed	18
Terminated	8
Unknown status	3

Clinical Trial Sponsors for IMURAN

Sponsor Name

Sponsor Name for IMURAN
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
GlaxoSmithKline	2

Sponsor Type

Sponsor Type for IMURAN
Sponsor	Trials
Other	37
Industry	18
NIH	9

Clinical Trials, Market Analysis, and Projections for IMURAN (Azathioprine)

Introduction

IMURAN, also known as azathioprine, is a widely used immunosuppressive drug with applications in preventing organ rejection in transplant patients and managing autoimmune diseases such as rheumatoid arthritis. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Use in Rheumatoid Arthritis

Azathioprine is indicated for the treatment of active rheumatoid arthritis to reduce signs and symptoms. However, its use in combination with other disease-modifying anti-rheumatic drugs (DMARDs) has not been extensively studied for added benefits or potential adverse effects[1].

Comparison with Other Treatments

The RITAZAREM trial compared the efficacy of azathioprine with rituximab in preventing relapse in patients with relapsing ANCA-associated vasculitis (AAV). The trial showed that rituximab was more effective than azathioprine in maintaining remission over a 36-month period[4].

Safety and Monitoring

Clinical trials and real-world data highlight the importance of monitoring patients on azathioprine due to the risk of severe bone marrow suppression, cytopenias, and serious infections. Regular complete blood counts (CBC) and TPMT testing are recommended to manage these risks[1].

Market Analysis

Current Market

The immunosuppressive drug market, which includes azathioprine, is part of a broader landscape that includes treatments for inflammatory bowel disease (IBD), rheumatoid arthritis, and organ transplantation. The global IBD treatment market, for instance, was estimated at USD 20.74 billion in 2023 and is projected to grow at a CAGR of 3.8% from 2024 to 2030[3].

Competitive Landscape

Azathioprine faces competition from newer and more targeted therapies such as JAK inhibitors (e.g., upadacitinib) and biologics (e.g., mirikizumab), which have shown promising results in treating IBD and other autoimmune diseases. These newer drugs are expected to drive market growth and potentially shift prescription patterns away from traditional immunosuppressants like azathioprine[3].

Market Trends

The pharmaceutical industry is witnessing significant changes, including a focus on innovative sales, marketing, and education efforts to boost the sales of existing drugs. This trend is expected to continue in 2025, with pharma companies investing heavily in personalized patient engagement and creative advertising strategies[5].

Projections for IMURAN

Revenue Impact

Given the competitive landscape and the emergence of newer therapies, the revenue generated by azathioprine is likely to face challenges. The market share of azathioprine may decline as healthcare providers increasingly prefer newer, more effective treatments.

Usage in Specific Indications

Azathioprine remains a viable option for certain patient populations, particularly in cases where newer treatments are not accessible or affordable. Its use in renal homotransplantation and in managing rheumatoid arthritis in patients who cannot tolerate other DMARDs will continue, albeit with a potentially reduced market share.

Regulatory and Safety Considerations

Regulatory bodies continue to emphasize the importance of safety monitoring for patients on azathioprine. The need for regular CBCs and TPMT testing will remain a critical aspect of its use, ensuring that the drug is used safely and effectively[1].

Key Takeaways

• Efficacy and Safety: Azathioprine remains effective in certain clinical contexts but faces challenges from newer, more targeted therapies.
• Market Competition: The market is shifting towards biologics and JAK inhibitors, which may reduce the market share of azathioprine.
• Regulatory Focus: Safety monitoring and TPMT testing are crucial for the safe use of azathioprine.
• Market Trends: Pharmaceutical companies are focusing on innovative marketing and patient engagement strategies, which may impact the sales of existing drugs like azathioprine.

FAQs

What are the primary indications for IMURAN (azathioprine)?

IMURAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation and for the management of active rheumatoid arthritis to reduce signs and symptoms[1].

What are the potential side effects of azathioprine?

Azathioprine can cause severe bone marrow suppression, cytopenias, and serious infections. It also carries a risk of malignancy and can affect sperm viability and fertility in animals[1].

How does azathioprine compare to newer treatments like JAK inhibitors?

Newer treatments such as JAK inhibitors have shown faster onset of action and higher efficacy in certain autoimmune diseases, potentially making them preferred options over azathioprine[3].

What is the importance of TPMT testing in patients on azathioprine?

TPMT testing is crucial to identify patients with low or absent TPMT activity, as these patients are at higher risk of severe bone marrow suppression and other adverse effects[1].

How is the market for immunosuppressive drugs expected to evolve in 2025?

The market is expected to see a shift towards newer therapies, increased investment in innovative sales and marketing strategies, and a focus on personalized patient engagement[5].

Sources

1. IMURAN (azathioprine) 50-mg Scored Tablets Rx only WARNING. FDA.
2. Pfizer Provides Full-Year 2025 Guidance and Reaffirms Full-Year 2024 Guidance. Pfizer.
3. Inflammatory Bowel Disease Treatment Market Report, 2030. Grand View Research.
4. RITAZAREM trial. BMJ.
5. 8 Predictions for Healthcare 2025: What the Market is Signaling for the Future. Hospitalogy.