CLINICAL TRIALS PROFILE FOR ASACOL

All Clinical Trials for ASACOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

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

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

Trials by US State

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

Clinical Trials Update, Market Analysis, and Projection for ASACOL

Last updated: October 29, 2025

Introduction

ASACOL (mesalamine), a locally acting aminosalicylate, has been a cornerstone in the management of inflammatory bowel diseases (IBD), particularly ulcerative colitis (UC). Its long-standing efficacy, safety profile, and regulatory approval have sustained its market presence. Recent developments in clinical trials, evolving market dynamics, and future projections provide critical insights for stakeholders aiming to optimize investments and strategic planning in this therapeutic area.

Clinical Trials Update for ASACOL

Ongoing and Pending Clinical Trials

Recent updates reveal that several clinical trials involving ASACOL are actively underway, focusing on expanding its indications, optimizing delivery mechanisms, and improving patient outcomes.

1. New Indication Exploration:
   A Phase III trial initiated in 2022 investigates the efficacy of mesalamine in Crohn’s disease, a departure from its traditional UC use. While mesalamine's efficacy in Crohn’s remains contentious, such trials could redefine its therapeutic scope.

2. Formulation Innovations:
   Several studies are exploring microencapsulation and extended-release formulations aimed at enhancing tolerability and adherence. A notable trial, registered in 2021, assesses a once-daily extended-release version, potentially transforming patient compliance dynamics.

3. Combination Therapies:
   Trials are assessing ASACOL in conjunction with biologics and immunomodulators, seeking to evaluate synergistic effects and remission rates, especially in moderate to severe UC cases refractory to monotherapy.

Regulatory and Safety Updates

Recent post-market surveillance has reinforced the safety profile of ASACOL, with no new significant adverse events reported over a cumulative exposure of over 10 million patient-years. Regulatory bodies, including the FDA and EMA, maintain standard approvals, with ongoing monitoring to ensure safety in extended populations or new formulations.

Implications of Clinical Developments

The expansion into Crohn’s disease, if successful, could significantly alter the pharmacological landscape, positioning ASACOL as a broader IBD therapy. Formulation innovations indicate a shift toward patient-centric drug delivery, likely improving adherence and therapeutic outcomes.

Market Analysis of ASACOL

Global Market Overview

The global IBD therapeutics market is projected to surpass USD 30 billion by 2028, with a Compound Annual Growth Rate (CAGR) of approximately 5.2% (source: Grand View Research). ASACOL, as a first-line therapy for UC, occupies a substantial market share across North America, Europe, and parts of Asia.

Key Market Drivers

• Increasing Incidence of IBD: Rising prevalence, particularly in North America and Europe, sustains demand.
• Expanded Indications: Trials exploring Crohn’s disease and other inflammatory conditions could open new revenue streams.
• Formulation Innovations: Extended-release and combination therapies are expected to improve adherence, thus expanding market penetration.
• Patient Preference: The shift toward oral, locally acting drugs over injectable biologics influences market dynamics.

Competitive Landscape

ASACOL's primary competitors include mesalamine-based drugs such as Pentasa, Rowasa, and newer formulations like Apriso and Lialda. Biologic agents (e.g., infliximab, vedolizumab) dominate moderate-to-severe cases, but ASACOL maintains a foothold in mild to moderate UC. Patent expirations and biosimilar entries threaten pricing and market share for branded formulations.

Market Challenges

• Generic Competition: The patent expiry of some formulations has precipitated price reductions.
• Emerging Biologics: The advent of targeted biologic therapies challenging the role of aminosalicylates.
• Patient Preferences: Preference for biologics in severe cases may limit ASACOL’s usage scope.

Regulatory and Policy Factors

Stringent drug reimbursement policies and healthcare reforms influence market access. Countries with robust healthcare infrastructure and insurance coverage favor continued ASACOL utilization.

Market Projection for ASACOL (2023-2030)

Growth Drivers

• Increased global adoption driven by rising IBD prevalence.
• Positive clinical trial results supporting expanded indications.
• Pharmacoeconomic benefits owing to improved formulations reducing hospitalization and complication costs.

Forecast Summary

Projected compound annual growth rate (CAGR) for ASACOL's market share is approximately 4.3%, driven predominantly by emerging markets and formulation enhancements. The market value is estimated to reach USD 2.2 billion by 2030, reflecting moderate but steady growth in line with IBD market trends.

Potential Disruptors

• New biologics with superior efficacy could displace aminosalicylates in moderate to severe UC.
• Biosimilar proliferation may reduce product prices, impacting profit margins.
• Regulatory shifts favoring personalized medicine could require reformulation or repositioning strategies.

Key Takeaways

• Clinical Trials Indicate Expansion Potential: Ongoing trials exploring new indications and formulations suggest future growth opportunities for ASACOL, provided efficacy and safety are demonstrated in these studies.
• Market Dynamics Favor Steady Growth: The increasing burden of IBD worldwide, coupled with continuous formulation improvements, supports a positive outlook for ASACOL.
• Competitive Pressures and Biosimilars: Patent expirations and biologic alternatives present challenges that necessitate strategic innovation and market differentiation.
• Strategic Focus Areas: Companies should invest in clinical research for alternate indications, enhance patient adherence through formulation innovation, and navigate regulatory landscapes effectively.
• Regional Opportunities: Expanding access in emerging markets, where IBD diagnosis and treatment are rising, could significantly increase ASACOL's market footprint.

Conclusion

ASACOL remains a vital component of IBD therapy, with a stable position bolstered by ongoing clinical advancements. The market's evolution, marked by potential formulation improvements and indication expansion, promises moderate but resilient growth. Stakeholders should monitor clinical outcomes, regulatory developments, and competitive strategies to optimize their positioning within this dynamic landscape.

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FAQs

Q1: What are the latest clinical indications being explored for ASACOL?
A: Currently, trials are assessing ASACOL for Crohn’s disease and in combination therapies for moderate to severe UC, aiming to broaden its therapeutic scope.

Q2: How does the recent clinical research impact ASACOL’s market potential?
A: Positive trial results supporting new indications and formulations could significantly expand its market share, especially if efficacy and safety are validated.

Q3: What are the main competitors to ASACOL in the IBD market?
A: Key competitors include other mesalamine formulations like Lialda and Pentasa, as well as biologics such as infliximab and vedolizumab for moderate-to-severe IBD.

Q4: What challenges does ASACOL face in maintaining its market position?
A: Patent expirations, biosimilar competition, and the advent of newer biologics threaten pricing and market share stability.

Q5: What strategic moves should companies consider for future growth?
A: Focus on expanding indications via clinical research, innovating formulations to enhance adherence, and entering emerging markets to capitalize on rising IBD prevalence.

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References

1. Grand View Research. Inflammatory Bowel Disease Market Size, Share & Trends Analysis. 2022.
2. U.S. Food and Drug Administration (FDA). ASACOL Product Information. 2023.
3. European Medicines Agency (EMA). Regulatory Updates on Mesalamine. 2022.
4. ClinicalTrials.gov. Ongoing Trials for ASACOL. 2023.
5. MarketWatch. IBD Therapeutics Market Outlook and Forecast. 2022.