CLINICAL TRIALS PROFILE FOR ASACOL

All Clinical Trials for ASACOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00094458 ↗	Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC	Completed	Schering-Plough	Phase 3	2005-03-01	The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
NCT00092508 ↗	CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 3	2004-05-01	This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.
NCT00007163 ↗	Monoclonal Antibody Treatment of Crohn's Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2000-12-01	This study will examine the safety and effectiveness of an experimental drug called J695 for treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine. This disease is currently treated with steroids, sulfasalazine (Azulfidine), 5-ASA drugs (Pentasa, Asacol), immune suppressants, antibiotics, and an antibody against TNF-alpha. Despite the number and variety of available therapies for Crohn's disease, many patients do not respond adequately to treatment or they develop severe side effects from the medicines. Therefore, new treatments must be developed. J695 is an antibody that is identical to a human antibody but chemically changed so that it can attach to and eliminate an inflammatory chemical made by the body called interleukin-12 (IL-12). Animal studies have shown that eliminating IL-12 with an antibody can prevent inflammation in the gut and can also heal inflammation that has already developed. Patients 18 years of age and older who have had Crohn's disease for at least 4 months may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, chest X-ray, blood and urine tests, stool analysis and possibly a review of medical records. They will complete a Crohn's Disease Activity Index Questionnaire for 7 days. Participants will be randomly assigned to one of two treatment groups, as follows: Group 1 Patients in this group will receive an injection of either J695 or placebo (a solution that does not contain any active medicine) under the skin on day 1 of the study, on day 29, and then weekly for a total of seven injections. After the last injection, patients will be followed for an additional 18 weeks. They will be monitored periodically throughout the study with physical examinations, disease activity index scores, and blood and urine tests. Group 2 Patients in group 2 will receive an injection of J695 or placebo on day 1 of the study and then weekly for a total of six injections. They will be followed for an additional 18 weeks. Patients will be monitored as described above for group 1. Participants may be asked to undergo additional tests as part of a sub-study in this protocol. These include colonoscopies to examine changes in inflammation in the gut and blood tests to analyze changes in the cells and body chemicals that affect the inflammation.
NCT00073021 ↗	Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis	Completed	Warner Chilcott	Phase 3	2000-09-01	This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.

Clinical Trial Conditions for ASACOL

Condition Name

Condition Name for ASACOL
Intervention	Trials
Ulcerative Colitis	19
Colitis, Ulcerative	5
Crohn Disease	2
Quality of Life	1

Condition MeSH

Condition MeSH for ASACOL
Intervention	Trials
Colitis, Ulcerative	27
Ulcer	26
Colitis	26
Crohn Disease	3

Clinical Trial Locations for ASACOL

Trials by Country

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Trials by Country for ASACOL
Location	Trials
United States	333
Canada	37
Germany	9
India	9
Romania	5

Trials by US State

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Trials by US State for ASACOL
Location	Trials
Florida	15
Texas	14
New York	14
New Jersey	13
California	13

Clinical Trial Progress for ASACOL

Clinical Trial Phase

Clinical Trial Phase for ASACOL
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	20
Phase 2	5

Clinical Trial Status

Clinical Trial Status for ASACOL
Clinical Trial Phase	Trials
Completed	27
Terminated	4
Recruiting	2

Clinical Trial Sponsors for ASACOL

Sponsor Name

Sponsor Name for ASACOL
Sponsor	Trials
Warner Chilcott	9
Tillotts Pharma AG	6
Procter and Gamble	4

Sponsor Type

Sponsor Type for ASACOL
Sponsor	Trials
Industry	35
Other	23
NIH	1

ASACOL: Clinical Trials, Market Analysis, and Projections

Introduction

ASACOL, a brand name for the drug mesalamine, is a widely used medication for the treatment of ulcerative colitis (UC) and other inflammatory bowel diseases (IBD). This article will delve into the clinical trials, market analysis, and future projections for ASACOL.

Clinical Trials and Efficacy

Overview of Clinical Trials

ASACOL has been extensively studied in various clinical trials to establish its efficacy and safety profile. These trials have included both adult and pediatric populations.

• Adult Studies: ASACOL HD, a formulation of mesalamine, has been evaluated in several six-week, active-controlled studies. These studies compared ASACOL HD 4.8 grams per day with mesalamine delayed-release tablets 2.4 grams per day in patients with mildly to moderately active ulcerative colitis. The results showed that ASACOL HD was effective in treating UC, with common adverse reactions including headache, nausea, nasopharyngitis, abdominal pain, diarrhea, and dyspepsia[4].

• Pediatric Studies: The efficacy of ASACOL in pediatric patients was extrapolated from adequate and well-controlled trials in adults. Additional pediatric uncontrolled clinical trials were conducted to assess safety. These studies found that the safety profile of ASACOL in pediatric patients aged 5 to 17 years was comparable to that in adults[1].

Bioequivalence and Reformulation

Due to safety concerns regarding the use of dibutyl phthalate (DBP) in the original formulation of ASACOL, the drug was reformulated to Delzicol, which uses dibutyl sebacate instead. Bioequivalence and dissolution studies confirmed that Delzicol is bioequivalent to ASACOL 400 mg delayed-release tablets[1].

Market Analysis

Market Size and Growth

The global market for 5-aminosalicylates, which includes ASACOL, is projected to grow at a CAGR of 3.5% from 2023 to 2031. This growth is driven by the increasing prevalence of ulcerative colitis and Crohn's disease, as well as advancements in healthcare and diagnostic technologies[2].

• Regional Dominance: North America dominates the global 5-aminosalicylates market, largely due to better healthcare practices, high treatment rates, and the presence of strong market participants[2].

• Segmentation: The market is segmented by type (sulfasalazine, mesalazine, olsalazine, etc.) and indication (ulcerative colitis, inflammatory bowel disease, etc.). The ulcerative colitis segment holds the largest revenue share due to a large patient pool and the introduction of new medications[2].

Competitive Landscape

The market for 5-aminosalicylates is competitive, with key players including Tillotts Pharma AG, WALLACE PHARMA, Takeda Pharmaceutical Company Limited, Abbvie, Inc., and Cosmo Pharmaceuticals NV. ASACOL, specifically, has been a significant player in the UC market due to mesalamine's well-known safety profile[2][3].

Market Projections

Future Trends

The UC market is expected to see significant growth driven by several factors:

• Increasing Prevalence: The increasing number of patients with ulcerative colitis and Crohn's disease will continue to drive market revenue. In the United States alone, over 1.6 million individuals are affected by IBD, with around 70,000 new cases diagnosed annually[2].

• Biosimilars and New Therapies: The anticipated launch of biosimilars, following the patent expiry of blockbusters like Remicade and Humira, will impact the market. Additionally, the entry of new biologic therapies such as Simponi and Entyvio will further expand treatment options[3].

• Government and Technological Advancements: Government initiatives to improve healthcare and advancements in diagnostic and therapeutic technologies will also contribute to market growth[2].

Regional Growth

North America is expected to maintain its dominance in the 5-aminosalicylates market due to its robust healthcare system and high adoption rates of new medications. Other regions, such as Europe and Asia Pacific, will also see significant growth driven by increasing healthcare spending and awareness of IBD[2].

Key Takeaways

• Clinical Efficacy: ASACOL has been proven effective in treating mildly to moderately active ulcerative colitis in both adult and pediatric populations.
• Market Growth: The global 5-aminosalicylates market, including ASACOL, is projected to grow at a CAGR of 3.5% from 2023 to 2031.
• Regional Dominance: North America leads the market due to better healthcare practices and high treatment rates.
• Competitive Landscape: The market is competitive, with ASACOL being a significant player due to its safety profile.
• Future Trends: The market will be driven by increasing disease prevalence, the launch of biosimilars, and advancements in healthcare technologies.

FAQs

What is ASACOL used for?

ASACOL is used for the treatment of mildly to moderately active ulcerative colitis in adults and pediatric patients aged 5 to 17 years.

What are the common side effects of ASACOL?

Common side effects include headache, nausea, nasopharyngitis, abdominal pain, diarrhea, and dyspepsia[4].

Why was ASACOL reformulated to Delzicol?

ASACOL was reformulated to Delzicol due to safety concerns regarding the use of dibutyl phthalate (DBP), which was replaced with dibutyl sebacate[1].

What is the projected growth rate of the 5-aminosalicylates market?

The global 5-aminosalicylates market is projected to grow at a CAGR of 3.5% from 2023 to 2031[2].

Which region dominates the 5-aminosalicylates market?

North America dominates the global 5-aminosalicylates market due to better healthcare practices and high treatment rates[2].

Sources

1. FDA: Mesalamine N204 412S003 Clinical PREA.
2. GlobeNewswire: 5-Aminosalicylates Drugs Market Is Projected to increase at a CAGR of around 3.5% during 2023 to 2031.
3. Business Wire: Research and Markets: Asacol HD (Ulcerative Colitis) - Forecast and Market Analysis to 2022.
4. FDA: ASACOL HD (mesalamine) delayed-release tablets, for oral use.
5. Business Wire: China Mesalazine Market Research Report 2021: Sales 2016-2020, Major Manufacturers, Prices 2020-2021, Prospects 2021-2025.