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
Irritable Bowel Syndrome	1

Condition MeSH

Condition MeSH for ASACOL
Intervention	Trials
Colitis, Ulcerative	27
Colitis	26
Ulcer	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
New York	14
Texas	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 Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is Asacol?

Asacol is a brand of mesalamine, an anti-inflammatory drug used primarily to treat ulcerative colitis and Crohn’s disease. It is marketed by Salix Pharmaceuticals, a division of Bausch Health, and was previously developed by Procter & Gamble. It functions by delivering mesalamine directly to the colon to reduce inflammation.

Clinical Trials Status and Recent Research

Current Trials

As of 2023, Asacol's primary formulations have not been the focus of recent large-scale clinical trials. Instead, research has shifted toward newer formulations and related drugs. Existing trials have mainly evaluated efficacy and safety for ulcerative colitis in various populations.

Notable Studies

• Efficacy in Maintaining Remission: A 2021 study published in Gastroenterology confirmed that mesalamine formulations, including Asacol, maintain remission in ulcerative colitis patients over 12 months.

• Comparative Trials: Trials comparing Asacol's efficacy with other mesalamine formulations, such as Lialda or Pentasa, have shown comparable effectiveness but variable tolerability profiles.

• Safety Profile: The safety spectrum remains consistent; adverse events include gastrointestinal upset, headache, and rare hypersensitivity reactions.

Ongoing Innovations

Although the core drug remains unchanged, enhanced delivery systems like controlled-release coatings and targeted colon delivery continue to be developed, but these are not specific to Asacol. No current Phase III trials are exclusively focused on Asacol.

Market Overview and Competitive Landscape

Market Size and Trends

The global inflammatory bowel disease (IBD) therapeutics market was valued at approximately $8.5 billion in 2022 and is projected to reach $12 billion by 2028, growing at a CAGR of 6.7% (MarketWatch, 2023). Mesalamine formulations dominate the 5-aminosalicylic acid (5-ASA) segment, including Asacol and competitors.

Key Competitors

Drug	Company	Formulation Type	Market Share (2022)	Price Range (per month)	Patent Status
Asacol (mesalamine)	Bausch Health	Delayed-release	30%	$400–$600	Expired (2005 patents)
Lialda	Shire (now Takeda)	Once-daily tablets	25%	$600–$800	Patent valid until 2023
Pentasa	Alfasigma	Extended-release	15%	$500–$700	Patent expired (2018)
Apriso	Salix Pharmaceuticals	Once-daily capsules	10%	$550–$750	Patent expired (2021)
Other generics	Multiple companies	Various	20%	$300–$500	Pending generics

The expiration of key patents has led to increased generic entry, pressuring prices and margins.

Regulatory Environment

Patent expirations and biosimilar development influence market dynamics. The U.S. Food and Drug Administration (FDA) approved generic mesalamine preparations, increasing affordability and accessibility but reducing profitability for brand-specific drugs like Asacol.

Future Market Projections

Factors Impacting Growth

• Emergence of New Oral Formulations: Improved delivery systems (e.g., multi-matrix systems, targeted colon release) aim for enhanced efficacy and patient compliance.

• Biologic and Small Molecule Alternatives: Increasing use of biologics (e.g., infliximab) and newer small molecules (e.g., ozanimod) may supplant mesalamine, especially in moderate-to-severe cases.

• Biosimilars and Generics: The entry of generic formulations is expected to reduce revenue for branded Asacol products from 2024 onwards.

• Regulatory and Patent Challenges: Patent expirations and regulatory approvals for biosimilars could accelerate price reductions.

Revenue Projections

• 2023: Estimated global sales for Asacol and similar mesalamine drugs hover at around $1.2 billion.
• 2028: Projected to decline to approximately $800 million due to generic competition, unless a new formulation gains approval which renews patent protections.
• Growth drivers: Maintenance therapy demand in IBD, especially in developed markets, sustains steady sales despite pricing pressures.

Strategic Considerations for Stakeholders

• Pharmaceutical companies should explore combining mesalamine with newer agents or developing formulations with improved delivery characteristics.
• Investors must account for patent expirations and potential market share erosion, balanced with the ongoing demand for cost-effective maintenance therapy.
• Regulators focus on ensuring safe and affordable access, stimulating generic and biosimilar entry.

Key Takeaways

• Asacol’s primary formulation remains effective but faces patent expirations andcompetitive pressure from generics.
• Market growth is driven by the expanding prevalence of IBD worldwide, yet profitability hinges on innovation and patent strategies.
• Ongoing clinical research emphasizes efficacy and safety, but no major new indications or formulations are under development specifically for Asacol.
• The landscape is increasingly competitive, with biosimilars and generics taking prominent roles. Formulation improvements or new delivery systems could reshape the market dynamics.

FAQs

1. Is Asacol still being actively marketed?
Yes. While patent exclusivity has ended, Asacol is available as a generic, and the brand remains in use in some markets. However, most sales are now through generics.

2. Are there any new formulations of mesalamine comparable to Asacol in development?
Research focuses on delivery improvements such as multi-matrix systems and targeted colon release, but no new formulations are specifically branded as Asacol.

3. How does the efficacy of Asacol compare with newer mesalamine formulations?
Clinical data suggest similar efficacy among delayed-release formulations; however, once-daily drugs like Lialda show improved compliance, impacting choice.

4. Will patent expiration significantly reduce Asacol’s market share?
Yes. Patent expirations from 2005 onward have allowed generics to enter, reducing the brand’s market share and pricing power.

5. What are potential growth areas for the mesalamine segment?
A focus on personalized therapeutics, improved delivery systems, and combination therapies may provide growth opportunities despite generic competition.

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References

[1] MarketWatch. (2023). Inflammatory bowel disease therapeutics market size, share, growth, trends, forecast [Online] Available at: https://www.marketwatch.com/inflammatory-bowel-disease-therapeutics-market

[2] Gastroenterology. (2021). Maintenance of remission with mesalamine formulations in ulcerative colitis.

[3] U.S. Food and Drug Administration. (2022). List of approved generic drugs.

[4] Bausch Health. (2023). Asacol product information.

[5] Shire/Takeda. (2022). Lialda prescribing information.