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.

Clinical Trial Conditions for Asacol Hd

Condition Name

Condition Name for Asacol Hd
Intervention	Trials
Ulcerative Colitis	19
Colitis, Ulcerative	5
Crohn Disease	2
Aminosalicylic Acid	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

Asacol HD: Clinical Trials, Market Analysis, and Projections

Introduction to Asacol HD

Asacol HD, developed by Procter & Gamble Pharmaceuticals, is a delayed-release tablet formulation of mesalamine, specifically designed for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

ASCEND Studies

The efficacy and safety of Asacol HD were evaluated in the ASCEND studies, which included ASCEND II and III. These studies were pivotal in the FDA approval of Asacol HD. Here are the key findings:

• Symptom Reduction: In six-week clinical trials, Asacol HD at a dose of 4.8 g/day significantly reduced UC symptoms, including rectal bleeding and stool frequency, without the use of steroids. Approximately 80% of patients experienced a reduction in rectal bleeding, and about three out of four patients saw a decrease in the number of bowel movements by six weeks[1].
• Overall Improvement: The primary endpoint of the ASCEND II and III studies was overall improvement at six weeks, determined by the Physician's Global Assessment (PGA), which included clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy findings. In ASCEND III, 70% of patients achieved overall improvement with Asacol HD[1].

Expert Insights

Dr. Stephen B. Hanauer, Chief of Gastroenterology, Hepatology and Nutrition at the University of Chicago Medical Center, highlighted the effectiveness of Asacol HD: "These encouraging results help support Asacol HD as an effective therapy in patients with moderately active UC. Every patient's disease is different and requires a personal approach to treatment."[1]

Market Analysis

Current Market Size

The global mesalamine market, which includes Asacol HD, was valued at approximately USD 183.9 million in 2024 and is projected to reach USD 191.32 million in 2025. This market is expected to grow further, reaching USD 262.43 million by 2033, with a Compound Annual Growth Rate (CAGR) of 4.03% during the forecast period of 2025-2033[2].

Key Drivers

• Increasing Prevalence of IBD: The rising incidence of inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, is a significant driver of the mesalamine market. The aging population and the effectiveness of mesalamine in reducing inflammation and maintaining remission also contribute to the market growth[2].
• Geographical Demand: North America and Europe are the primary regions driving the demand for mesalamine, with the U.S. being a key market due to its high prevalence of IBD[2].

Competitive Landscape

Asacol HD is part of a robust portfolio of gastrointestinal therapies offered by Procter & Gamble Pharmaceuticals. The UC market is also influenced by other treatments, including biologics such as Johnson & Johnson's Simponi and Takeda's Entyvio. The anticipated launch of biosimilars, following the patent expiry of blockbusters like Remicade and Humira, is expected to impact the market dynamics[3].

Market Projections

Growth Forecast

The mesalamine market, including Asacol HD, is projected to grow steadily over the next several years. Here are some key projections:

• CAGR: The market is expected to grow at a CAGR of 4.03% from 2025 to 2033, reaching a value of USD 262.43 million by 2033[2].
• Regional Growth: The U.S., Canada, Germany, the U.K., France, Japan, China, India, South Africa, and Brazil are among the countries expected to drive this growth[2].

Future Trends

• Advancements in Drug Delivery: Industry players are focusing on improving drug delivery methods, which is expected to enhance the efficacy and patient compliance of mesalamine formulations[2].
• Biosimilars and Biologics: The entry of biosimilars and the continued use of biologics will shape the UC treatment landscape, potentially influencing the market share of Asacol HD and other mesalamine products[3].

Conclusion

Asacol HD has established itself as an effective treatment for moderately active ulcerative colitis, backed by robust clinical trial data. The mesalamine market, driven by increasing IBD prevalence and advancements in drug delivery, is poised for steady growth. As the market evolves with the introduction of biosimilars and biologics, Asacol HD is likely to remain a significant player in the treatment of UC.

Key Takeaways

• Clinical Efficacy: Asacol HD significantly reduces UC symptoms such as rectal bleeding and stool frequency.
• Market Growth: The global mesalamine market is projected to grow at a CAGR of 4.03% from 2025 to 2033.
• Key Drivers: Increasing IBD prevalence, aging population, and advancements in drug delivery are driving market growth.
• Competitive Landscape: The market is influenced by biologics and the anticipated launch of biosimilars.

FAQs

What is Asacol HD used for?

Asacol HD is used for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease.

What are the key findings from the ASCEND studies?

The ASCEND studies showed that Asacol HD at 4.8 g/day reduced rectal bleeding and stool frequency in patients with moderately active UC, with approximately 80% of patients experiencing a reduction in rectal bleeding and about three out of four patients seeing a decrease in bowel movements by six weeks.

What is the projected growth rate of the mesalamine market?

The mesalamine market is expected to grow at a CAGR of 4.03% from 2025 to 2033.

Which regions are driving the demand for mesalamine?

North America and Europe, particularly the U.S., are the primary regions driving the demand for mesalamine.

How does Asacol HD compare to other UC treatments?

Asacol HD is part of a robust portfolio of gastrointestinal therapies and competes with biologics and other mesalamine formulations, with its effectiveness and safety profile making it a trusted option for UC treatment.

Sources

1. Procter & Gamble Pharmaceuticals. "Procter & Gamble Pharmaceuticals Launches Asacol(R) HD mesalamine Delayed-Release Tablets." News Release, July 7, 2009.
2. Global Growth Insights. "Mesalamine Market Size, Report, Growth to 2033." January 2, 2025.
3. Business Wire. "Research and Markets: Asacol HD (Ulcerative Colitis) - Forecast and Market Analysis to 2022." May 14, 2014.
4. Inflammatory Bowel Diseases Journal. "2.4 g Mesalamine (Asacol 400 mg tablet) Once Daily is as Effective as 1.2 g Mesalamine Three Times Daily in Maintaining Remission in Patients with Ulcerative Colitis." March 31, 2017.
5. Valuates Reports. "Mesalamine Market, Report Size, Worth, Revenue, Growth, Industry Analysis."