CLINICAL TRIALS PROFILE FOR AZATHIOPRINE SODIUM

All Clinical Trials for azathioprine sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00504244 ↗	Myfortic Versus Azathioprine in Systemic Lupus Erythematosus	Terminated	Novartis Pharmaceuticals	Phase 3	2007-07-01	This study is designed to explore the use of myfortic ® in patients with active lupus erythematosus. Similar drugs in this class are increasingly used in organ transplantation and in autoimmune diseases. With the established safety profile of myfortic ® in allo-transplantation and the already existing data of mycophenolate mofetil in autoimmune diseases, this study should help to demonstrate the beneficial effect of myfortic ® on lupus activity. The aim of the study will be to show a decreased disease activity with myfortic ® compared to standard maintenance therapy with azathioprine.
NCT00296556 ↗	Therapeutic Study of ONO-4819CD for Ulcerative Colitis	Terminated	National Institute of Biomedical Innovation	Phase 2	2006-02-01	The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.
NCT00296556 ↗	Therapeutic Study of ONO-4819CD for Ulcerative Colitis	Terminated	Kyoto University, Graduate School of Medicine	Phase 2	2006-02-01	The purpose of this study is to investigate whether ONO-4819CD is safe and effective in the treatment of mild to moderate ulcerative colitis.
NCT00001863 ↗	Leflunomide to Treat Uveitis	Completed	National Eye Institute (NEI)	Phase 2	1999-03-01	This study will investigate the safety and effectiveness of the drug Leflunomide to treat uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide suppresses immune system activity and has been shown to control autoimmune diseases, such as arthritis (joint inflammation), in animals. It has also improved symptoms in patients with rheumatoid arthritis, and the Food and Drug Administration has approved it for treating patients with this disease. Eye and joint inflammation may have similar causes, and medicines for arthritis often help patients with eye inflammation. This study will examine whether Leflunomide can help patients with uveitis. Patients with uveitis who are not responding well to steroid treatment and patients who have side effects from other medicines used to treat uveitis (such as cyclosporine, cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible side effects of these medicines may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood test and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina) with an ophthalmoscope and the front of the eye with a microscope. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the bloodstream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Study participants will be divided into two groups. One group will take 100 milligrams of Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other group will take a placebo-a pill that looks like the Leflunomide pill but does not contain the medicine. All patients in both groups will also take prednisone. Patients will have follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine. Those who do well and want to continue their assigned treatment after 6 months can continue that treatment for another 6 months and will have follow-up exams at months 9 and 12.
NCT00431119 ↗	Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid	Completed	Hoffmann-La Roche	Phase 2	1997-10-01	To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.
NCT00431119 ↗	Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid	Completed	University Hospital Muenster	Phase 2	1997-10-01	To investigate the safety and efficacy of oral methylprednisolone combined with azathioprine or mycophenolate mofetil for the treatment of bullous pemphigoid.

Clinical Trial Conditions for azathioprine sodium

Condition Name

Condition Name for azathioprine sodium
Intervention	Trials
Lupus Nephritis	2
Systemic Lupus Erythematosus	2
Cystic Fibrosis	1
Uveitis	1

Condition MeSH

Condition MeSH for azathioprine sodium
Intervention	Trials
Kidney Diseases	2
Lupus Erythematosus, Systemic	2
Nephritis	2
Lupus Nephritis	2

Clinical Trial Locations for azathioprine sodium

Trials by Country

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−

Trials by Country for azathioprine sodium
Location	Trials
United States	19
Canada	8
China	3
Japan	2
United Kingdom	2

Trials by US State

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−

Trials by US State for azathioprine sodium
Location	Trials
Maryland	2
Michigan	1
Louisiana	1
Kansas	1
Illinois	1

Clinical Trial Progress for azathioprine sodium

Clinical Trial Phase

Clinical Trial Phase for azathioprine sodium
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	2
Phase 2	7

Clinical Trial Status

Clinical Trial Status for azathioprine sodium
Clinical Trial Phase	Trials
Completed	5
Unknown status	4
Not yet recruiting	2

Clinical Trial Sponsors for azathioprine sodium

Sponsor Name

Sponsor Name for azathioprine sodium
Sponsor	Trials
Novartis	1
University of Manitoba	1
University Hospital Birmingham	1

Sponsor Type

Sponsor Type for azathioprine sodium
Sponsor	Trials
Other	18
Industry	6
NIH	1

Azathioprine Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Azathioprine, sold under brand names such as Imuran, is a potent immunosuppressive medication widely used in the treatment of various autoimmune diseases and to prevent organ rejection in transplant patients. This article provides an update on recent clinical trials, market analysis, and projections for azathioprine sodium.

Clinical Uses of Azathioprine

Azathioprine is utilized in the treatment of a broad range of autoimmune diseases, including rheumatoid arthritis, systemic lupus erythematosus, pemphigus, and various forms of vasculitis. It is also used to prevent rejection in organ transplant patients and as a therapy for inflammatory bowel diseases like Crohn's disease and ulcerative colitis[5].

Recent Clinical Trials

RITAZAREM Trial

A significant recent clinical trial is the RITAZAREM trial, which compared the efficacy of repeat-dose rituximab to daily oral azathioprine in preventing relapse in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). The trial involved 188 patients from 29 centers in seven countries and found that rituximab was superior to azathioprine in preventing disease relapse. The hazard ratio for relapse was 0.41 in favor of rituximab, indicating a significant reduction in relapse rates compared to azathioprine[1].

Primary Biliary Cirrhosis

Another notable trial examined the effect of azathioprine on survival in patients with primary biliary cirrhosis. This multinational, double-blind, randomized clinical trial showed that azathioprine improved survival time by approximately 20 months and reduced the risk of dying to 59% of that observed during placebo treatment. The trial also highlighted that azathioprine slowed down the progression of incapacitation in these patients[3].

Market Analysis

Current Market Size and Growth

The azathioprine API market has experienced rapid growth in recent years. As of 2023, the market size is substantial, and projections indicate continued expansion through 2031. The market is segmented by type (purity ≥ 99%, purity ≥ 99.5%), application (tablets, other), and geographical regions (North America, Europe, Asia-Pacific, South America, and the Middle East & Africa)[2].

Market Dynamics

The market dynamics are influenced by several factors, including growth drivers, restraints, opportunities, and challenges. Key drivers include the increasing demand for immunosuppressive medications, advancements in pharmaceutical technology, and the expanding patient base for autoimmune diseases. However, the market also faces restraints such as side effects associated with azathioprine, regulatory challenges, and competition from alternative treatments[2].

Key Players

The azathioprine API market is dominated by several key players, including Index Pharmaceutical, Rakshit Pharmaceuticals, Fermion, Aarti Industries, Atom Pharma, Aspen API, and others. These companies are profiled in market reports, which also include details on their market entry year and various market-related factors[2].

Market Projections

Forecast Period

The azathioprine API market is expected to continue its upward trend from 2024 to 2031. The forecast period analysis includes a comprehensive assessment of market segments, trends, and critical factors shaping the market landscape. The report utilizes a combination of quantitative and qualitative analyses to forecast trends and predict market size in terms of revenue[2].

Geographical Segmentation

The market is geographically segmented, with North America, Europe, and the Asia-Pacific region being key markets. The report provides insights into product pricing, market penetration, and dynamics within each region, helping to optimize marketing strategies and identify new business opportunities[2].

Safety and Side Effects

Clinical Considerations

Azathioprine is associated with several side effects, including hematologic toxicities such as leukopenia, thrombocytopenia, and macrocytic anemia. It is crucial to monitor patients closely, especially those with impaired renal function, as they may experience a greater cumulative effect of the drug. The dosage of azathioprine must be adjusted carefully to balance therapeutic efficacy and minimize toxicity[4].

Rare but Serious Side Effects

There have been reports of rare but serious side effects, such as hepatosplenic T-cell lymphoma, particularly in patients with inflammatory bowel disease. The FDA has updated the labeling to inform users and clinicians about this risk[5].

Key Takeaways

• Clinical Trials: Recent trials like the RITAZAREM trial highlight the comparative efficacy of azathioprine versus other treatments in specific conditions.
• Market Growth: The azathioprine API market is expected to grow significantly from 2023 to 2031, driven by increasing demand and technological advancements.
• Safety and Side Effects: Careful management of azathioprine dosage is necessary to mitigate side effects, especially in patients with renal dysfunction.
• Geographical Segmentation: The market is segmented geographically, with North America, Europe, and the Asia-Pacific region being key markets.

FAQs

What is the primary use of azathioprine?

Azathioprine is primarily used as an immunosuppressive medication to treat autoimmune diseases and prevent organ rejection in transplant patients.

What were the findings of the RITAZAREM trial?

The RITAZAREM trial found that repeat-dose rituximab was superior to daily oral azathioprine in preventing relapse in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis.

How does azathioprine affect patients with primary biliary cirrhosis?

Azathioprine improves survival time and slows down the progression of incapacitation in patients with primary biliary cirrhosis.

What are the common side effects of azathioprine?

Common side effects include hematologic toxicities such as leukopenia, thrombocytopenia, and macrocytic anemia. Rare but serious side effects include hepatosplenic T-cell lymphoma.

Which regions are expected to drive the growth of the azathioprine API market?

North America, Europe, and the Asia-Pacific region are expected to be key drivers of the azathioprine API market growth.

Sources

1. RITAZAREM Trial: "The RITAZAREM trial compared the efficacy of repeat-dose rituximab to daily oral azathioprine for prevention of relapse in patients with relapsing AAV" - PubMed[1].
2. Global Azathioprine API Market Report: "The Azathioprine API Market reached a value of USD xx billion in 2023 and is anticipated to attain USD xx billion by the conclusion of 2031" - Market Research Intellect[2].
3. Azathioprine and Primary Biliary Cirrhosis: "The effect of azathioprine on survival of patients with primary biliary cirrhosis was studied prospectively in a multinational, double-blind, randomized clinical trial" - PubMed[3].
4. APO-AZATHIOPRINE Product Monograph: "APO-AZATHIOPRINE is indicated only in adult patients meeting criteria for classic or definite rheumatoid arthritis as well as other autoimmune diseases" - Health Canada[4].
5. Azathioprine - Wikipedia: "Azathioprine, sold under the brand name Imuran, among others, is an immunosuppressive medication" - Wikipedia[5].