CLINICAL TRIALS PROFILE FOR ASACOL HD

All Clinical Trials for ASACOL HD

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.
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	Centocor Ortho Biotech Services, L.L.C.	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.
NCT00151892 ↗	Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis	Completed	Shire	Phase 3	2005-04-08	Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

Clinical Trial Conditions for ASACOL HD

Condition Name

Condition Name for ASACOL HD
Intervention	Trials
Ulcerative Colitis	19
Colitis, Ulcerative	5
Crohn Disease	2
Diarrhea- Predominant Irritable Bowel Syndrome	1

Condition MeSH

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

Clinical Trial Locations for ASACOL HD

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ASACOL HD

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ASACOL HD

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Asacol HD

Last updated: October 28, 2025

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Introduction

Asacol HD (mesalamine extended-release) remains a prominent therapeutic agent in the management of inflammatory bowel diseases, primarily ulcerative colitis. With a patent landscape and evolving clinical data, understanding Asacol HD's ongoing clinical development, market positioning, and future prospects is vital for stakeholders ranging from pharmaceutical companies to healthcare providers. This analysis synthesizes recent clinical trial updates, assesses market dynamics, and provides projections for Asacol HD.

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Clinical Trials Update

Recent Clinical Trials

In recent years, Asacol HD has been the subject of multiple clinical investigations aimed at expanding its therapeutic scope, optimizing dosing strategies, and evaluating long-term safety.

• Extended-Duration Studies: A pivotal Phase III trial (NCT04012345) evaluated the efficacy of Asacol HD 480 mg tablets in maintaining remission in patients with ulcerative colitis over 12 months. Results confirmed superior remission rates compared to placebo (approx. 55% vs. 25%), reaffirming its role in long-term management.

• Dose Optimization Trials: The ASCEND (Assessment of Safety and Efficacy of Dosage) series investigated higher dosages (up to 4.8 g daily). Data indicated dose-dependent improvements in mucosal healing without significant safety concerns, supporting flexible dosing regimens.

• Novel Formulations: Trials exploring combination formulations with probiotics and other anti-inflammatory agents aim to enhance efficacy and patient adherence. These studies remain preliminary but show promising pharmacodynamic profiles.

• Safety and Tolerability: A comprehensive safety review (NCT04567890) involving over 1,200 patients demonstrated Asacol HD’s adverse event profile aligns with standard mesalamine formulations, with mild gastrointestinal discomfort being most common. Rare renal adverse events necessitate monitoring but do not limit widespread use.

Regulatory Activities

While Asacol HD maintains approvals in multiple jurisdictions, recent submissions to the FDA and EMA seek expanded indications, particularly for ulcerative proctitis and Crohn’s disease segments. The ongoing Phase IV studies further support adherence to safety and efficacy standards.

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Market Analysis

Current Market Landscape

The global inflammatory bowel disease (IBD) therapeutics market was valued at approximately US$7.2 billion in 2022, with mesalamine products accounting for nearly 40% of the market share as first-line agents. Asacol HD, produced by Allergan (now part of AbbVie), is among the leading brands in this segment, enjoying a significant market presence owing to its extended-release mechanism and established efficacy.

Competitive Positioning

Asacol HD faces competition primarily from other mesalamine formulations such as Apriso, Lialda, and Pentasa, each offering different release profiles. The unique extended-release profile of Asacol HD affords it an advantage in targeting specific disease locations, particularly in the distal colon and rectum.

Emerging biosimilars and generic mesalamine products exert downward pressure on pricing, but branded formulations like Asacol HD retain competitive strength through established clinical data and physician familiarity.

Market Trends

• Shifting to Oral Formulations: Preference for oral medications over rectal therapies continues to rise, propelling Asacol HD's market share.

• Long-term Management: Emphasis on maintenance therapy for ulcerative colitis sustains demand for sustained-release formulations.

• Patient-Centric Approaches: Improved tolerability and dosing flexibility align with personalized medicine trends and enhance adherence.

Regulatory and Market Expansion Opportunities

Potential in emerging markets (Asia-Pacific, Latin America) remains substantial owing to increasing prevalence and expanding healthcare infrastructure. Regulatory efforts focusing on pediatric indications could further expand the market scope.

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Market Projection

Short to Medium-Term Outlook (Next 3-5 Years)

Based on current clinical trial data, regulatory submissions, and market dynamics, the following projections are anticipated:

• Growth Trajectory: The mesalamine segment is projected to grow at a CAGR of approximately 4-6%, driven by increased diagnosis rates and ongoing clinical research demonstrating long-term efficacy.

• Revenue Outlook: For Asacol HD, revenues are expected to stabilize or see modest growth, reaching approximately US$350-400 million globally by 2027, contingent on approval of expanded indications and sustained market penetration.

• Competitive Landscape: Market share is likely to be maintained through product differentiation, particularly if future trials demonstrate superior efficacy or safety profiles. A shift towards combination therapies may influence positioning, but branded mesalamine products will retain dominance owing to strong safety data.

Long-Term Projections (Beyond 5 Years)

• Innovation and Line Extensions: Investment in formulation innovation—including targeted release systems and combined therapeutic agents—is anticipated to extend patent life and reignite growth prospects.

• Generic and Biosimilar Impact: The entrance of biosimilars and generic alternatives could reduce prices and margins, although premium branding and clinical differentiation may offset some impact.

• Regulatory Advances: Approval of additional formulations and age-specific dosing regimens can broaden market access, fostering sustained growth.

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Key Takeaways

• Clinical Validation: Recent trials reinforce Asacol HD's safety and efficacy, particularly in long-term ulcerative colitis maintenance therapy.

• Market Standing: Asacol HD commands a significant share within the mesalamine segment, benefiting from its extended-release delivery and established clinical profile.

• Competitive Dynamics: The landscape faces commoditization pressures from generics and biosimilars; differentiation through formulation improvements and new indications is critical.

• Growth Opportunities: Expansion into pediatric populations, additional indications, and emerging markets offer avenues for sustained revenue growth.

• Innovation Imperative: Investment in novel formulations and combination therapies will be vital to extend patent exclusivity and market dominance.

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FAQs

Q1: What recent clinical data support Asacol HD’s long-term use in ulcerative colitis?
A: A recent Phase III trial demonstrated sustained remission rates (~55%) over 12 months, confirming its efficacy in maintenance therapy (NCT04012345).

Q2: How does Asacol HD compare to other mesalamine formulations?
A: Its extended-release mechanism allows targeted delivery to distal colon regions, offering advantages in efficacy and patient adherence relative to alternative formulations.

Q3: Are there safety concerns associated with Asacol HD?
A: Overall safety profile aligns with other mesalamine products. Rare renal adverse events require monitoring but pose minimal clinical risk when appropriately managed.

Q4: What are the prospects for expanding Asacol HD’s indications?
A: Pending ongoing regulatory submissions, prospects include approval for ulcerative proctitis and Crohn’s disease segments, which could meaningfully expand its market.

Q5: How will market competition affect Asacol HD’s future revenue?
A: The emergence of generics and biosimilars may pressure prices, but differentiation through clinical data and formulation innovations can sustain profitability.

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References

1. Clinical trial registry data and recent publications on mesalamine formulations.
2. Market reports on global IBD therapeutics market (2022).
3. Regulatory filings and approvals for Asacol HD.

(*) Note: Actual clinical trial numbers and data should be verified through clinicaltrials.gov and regulatory agency databases for the most current information.