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
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

ASACOL HD Market Analysis and Financial Projection

Last updated: April 26, 2026

What do the latest clinical-trial signals and market outlook say for ASACOL HD (mesalamine)?

ASACOL HD is a delayed-release oral mesalamine (5-aminosalicylic acid) product positioned for ulcerative colitis (UC). Public clinical and regulatory visibility for the “ASACOL HD” brand is limited versus older generic mesalamine formulations, so the most decision-relevant lens for investors is (1) how mesalamine class demand tracks UC incidence and treatment patterns, (2) where branded pricing and payer coverage can persist, and (3) whether new entrants or reformulations erode share. On those dimensions, the forecast is driven more by class-level demand and payer behavior than by brand-specific late-stage trials.

What is ASACOL HD and how is it used clinically?

• Drug substance: mesalamine (5-aminosalicylic acid), delayed-release.
• Indication (standard labeling position for this product class/brand): ulcerative colitis (maintenance and treatment of mild-to-moderate UC depending on formulation and local label language).
• Therapeutic role: frontline oral 5-ASA option for UC; typically used for induction and/or maintenance in mild to moderate disease, with escalation to corticosteroids, immunomodulators, or biologics when control is inadequate.

Implication for trial updates: In UC, new mechanistic agents (JAK inhibitors, anti-TNFs, anti-integrins, IL-23 pathway drugs) have dominated recent late-stage innovation. For 5-ASAs, the competitive question is less “new efficacy signals” and more “persistence of use, switching costs, and adherence in real-world dosing.”

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What clinical-trial updates are available for ASACOL HD?

No complete, brand-specific, current-period (near-term) phase 2/3 trial dataset for ASACOL HD is available in the provided information stream. This leaves only a class-level expectation: 5-ASA products rarely generate high-visibility late-stage randomized trials today because UC development has shifted to biologics and small molecules.

Decision consequence: A market projection for ASACOL HD should not rely on brand-specific phase 3 readouts. It should treat the brand as a steady-state erosion/carry business where volume is influenced by guideline adherence, payer formulary placement, and generic penetration rather than new clinical proof.

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What is the market context for ASACOL HD (mesalamine) in ulcerative colitis?

Mesalamine is the largest historical oral UC segment within the broader 5-ASA category. Demand is shaped by:

1. UC prevalence and incidence growth (diagnosis rates and migration patterns).
2. Treatment migration between oral 5-ASA, steroid induction, and biologic escalation.
3. Generics and authorized equivalents that compress branded pricing across many markets.
4. Payer and pharmacy benefit management decisions (preferred tiers, step edits, and substitution rules).

Where mesalamine products still win

• Early-line UC care where severity is mild to moderate.
• Maintenance where long-term tolerability and adherence matter.
• Patients with stable disease who do not require biologic escalation.

Where mesalamine loses

• Patients needing biologic-level control.
• Settings with aggressive generic substitution.
• Formulary environments favoring lower-cost equivalents.

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How does branded ASACOL HD typically perform against generics?

For mesalamine, the usual branded dynamic is:

• Initial differentiation on dosing convenience, tablet size, delayed-release technology, and historical physician familiarity.
• Ongoing erosion as generics expand and payers tighten tiering.

For ASACOL HD, the principal economic variables are:

• Net price after rebates (not list price).
• Formulary position (preferred or non-preferred).
• Therapy persistence (how often patients switch out due to loss of symptom control, adherence issues, or payer-driven switching).

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What is the market forecast direction for ASACOL HD?

Given current UC drug development trends (biologics and small molecules leading new efficacy narratives) and the long-standing generic availability of mesalamine, the base-case forecast for a brand-level mesalamine product is typically low-to-mid single-digit revenue growth or mild decline depending on net price resilience and unit persistence, versus the UC market’s overall modest expansion.

A practical projection framework for ASACOL HD is to separate:

• Unit volume trend: tied to persistence in 5-ASA use.
• Value trend: tied to branded net price vs generics and rebate intensity.

Base-case projection (structural, not brand-specific trial-driven)

• Units: modest growth or stable use in the mild-to-moderate maintenance segment, offset by generic switching and therapy escalation.
• Revenue: typically lags unit growth due to branded price compression.

Net effect: ASACOL HD value is more sensitive to payer coverage than to new clinical evidence.

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What payer and guideline forces influence ASACOL HD uptake?

Even without brand-specific trial readouts, these forces determine class demand:

• Formulary tiering: preferred tier placement preserves volume; non-preferred status accelerates switching.
• Step therapy: payers often require documented prior 5-ASA use or prove intolerance before advanced therapies.
• Guideline alignment: oral 5-ASA remains a cornerstone for mild-to-moderate UC and maintenance in many pathways.

Investor takeaway: Any projection should model a coverage-driven volume curve (stability while preferred) versus a generic-driven decline curve (after losing preferred positioning).

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What are the competitive risks to ASACOL HD’s market share?

Key risk vectors for mesalamine brands include:

• Generic substitution (pharmacy-level and payer-driven).
• Therapeutic switching to advanced UC drugs as disease severity increases.
• Adherence dynamics (dosing frequency, tablet burden, and intolerance management).
• Manufacturing and supply continuity risks that affect pharmacy fulfillment (brand reputation effects).

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What could change the outlook for ASACOL HD?

Without a visible brand-specific late-stage pipeline, meaningful upside would come from:

• Improved net pricing via renegotiated payer contracts.
• Re-formulation or lifecycle management that preserves patient adherence and reduces discontinuation.
• Evidence generation that strengthens guideline use (real-world outcomes, adherence studies), which tends to be lower visibility than drug-development trials.

Downside would come from:

• Further formulary disfavor.
• Accelerating switching to lower-cost generics.
• Clinical escalation driven by patient populations shifting to biologic-first patterns.

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Key Takeaways

• ASACOL HD is a mesalamine delayed-release UC product; current decision-making hinges on payer coverage, net price, and generic substitution rather than brand-specific late-stage clinical trial breakthroughs.
• Publicly visible, near-term, brand-specific phase 2/3 trial update signals are not available in the provided information stream, so the market view must be anchored in class-level dynamics for 5-ASA in UC.
• The base-case market outlook is steady-state with erosion risk: modest unit stability or growth in mild-to-moderate maintenance segments, with revenue pressured by branded net price compression against generics.
• Forecast sensitivity is highest for formulary position (preferred vs non-preferred) and persistence in 5-ASA treatment before escalation to advanced therapies.

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FAQs

1. Is ASACOL HD still relevant for ulcerative colitis treatment?
   Yes. Mesalamine remains a frontline option for mild-to-moderate UC and maintenance in many care pathways, but branded share typically erodes under generic competition.

2. Do new clinical-trial results for ASACOL HD drive the market?
   Not in a way comparable to biologics and advanced small molecules. For mesalamine brands, market changes usually follow payer and formulary dynamics more than new late-stage efficacy readouts.

3. What determines ASACOL HD revenue more: units or net price?
   Net price and rebate dynamics usually matter most, because generics compress branded pricing even when units remain relatively stable.

4. What is the biggest threat to long-term ASACOL HD share?
   Generic substitution combined with payer tier shifts that reduce branded coverage and increase switching.

5. What would be the most credible upside scenario for the brand?
   Sustained preferred formulary placement and improved net pricing that offsets generic-driven share erosion, plus evidence that supports adherence and persistence in maintenance.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug Trials Snapshots (archive and related pages). FDA. https://www.fda.gov/
[2] DailyMed. (n.d.). ASACOL HD (mesalamine) delayed-release tablets prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
[3] Crohn’s & Colitis Foundation. (n.d.). Ulcerative colitis treatment information and care resources. https://www.crohnscolitisfoundation.org/
[4] National Institute for Health and Care Excellence (NICE). (n.d.). Ulcerative colitis guidance and treatment recommendations. https://www.nice.org.uk/
[5] ClinicalTrials.gov. (n.d.). Search results for mesalamine and ulcerative colitis trials. https://clinicaltrials.gov/