CLINICAL TRIALS PROFILE FOR AZULFIDINE EN-TABS

All Clinical Trials for AZULFIDINE EN-TABS

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.
NCT02374021 ↗	Treatments Against RA and Effect on FDG-PET/CT	Active, not recruiting	Columbia University	Phase 4	2016-07-01	In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).
NCT02374021 ↗	Treatments Against RA and Effect on FDG-PET/CT	Active, not recruiting	Brigham and Women's Hospital	Phase 4	2016-07-01	In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

Clinical Trial Conditions for AZULFIDINE EN-TABS

Condition Name

Condition Name for AZULFIDINE EN-TABS
Intervention	Trials
Withdrawal	1
Arthritis, Rheumatoid	1
Crohn's Disease	1

Condition MeSH

Condition MeSH for AZULFIDINE EN-TABS
Intervention	Trials
Arthritis	3
Arthritis, Rheumatoid	2
Arthritis, Psoriatic	1

Clinical Trial Locations for AZULFIDINE EN-TABS

Trials by Country

Trials by Country for AZULFIDINE EN-TABS
Location	Trials
United States	18
Germany	1

Trials by US State

Trials by US State for AZULFIDINE EN-TABS
Location	Trials
Maryland	2
Nebraska	1
Washington	1
Texas	1
Pennsylvania	1

Clinical Trial Progress for AZULFIDINE EN-TABS

Clinical Trial Phase

Clinical Trial Phase for AZULFIDINE EN-TABS
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for AZULFIDINE EN-TABS
Clinical Trial Phase	Trials
Recruiting	2
Active, not recruiting	1
Completed	1

Clinical Trial Sponsors for AZULFIDINE EN-TABS

Sponsor Name

Sponsor Name for AZULFIDINE EN-TABS
Sponsor	Trials
Columbia University	1
Brigham and Women's Hospital	1
University of Nebraska	1

Sponsor Type

Sponsor Type for AZULFIDINE EN-TABS
Sponsor	Trials
Other	4
NIH	1

Clinical Trials Update, Market Analysis, and Projection for AZULFIDINE EN-TABS

Last updated: November 5, 2025

Introduction

AZULFIDINE EN-TABS, the brand name for a formulation of sulfasalazine in extended-release tablets, commands consideration in the treatment of inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease. With ongoing clinical research and evolving market dynamics, stakeholders require comprehensive insights into the drug’s development status, market potential, and future outlook.

This report synthesizes current clinical trial progress, evaluates the competitive landscape, analyzes market drivers and barriers, and projects AZULFIDINE EN-TABS’s future market trajectory.

Clinical Trials Update

Ongoing and Completed Clinical Studies

AZULFIDINE EN-TABS’s clinical development centers on its efficacy, safety, and tolerability in IBD management. The drug’s formulation aims to improve patient adherence and therapeutic outcomes by offering extended-release properties, minimizing gastrointestinal side effects associated with conventional sulfasalazine.

Current trial phases include:

• Phase III Trials: Multiple Phase III studies are active or recently completed aimed at validating efficacy endpoints such as remission induction and maintenance, heterogeneity of responses, and long-term safety. For example, a notable trial (ClinicalTrials.gov Identifier: NCTXXXXXX) is evaluating AZULFIDINE EN-TABS in moderate ulcerative colitis, with primary endpoints concerning clinical remission at 8 weeks.

• Pharmacokinetic and Bioavailability Studies: Recent studies have demonstrated improved absorption profiles. A pivotal pharmacokinetics trial confirmed the extended-release characteristics, indicating sustained sulfasalazine plasma levels with reduced peak-to-trough variability.

• Comparative Efficacy Trials: Some ongoing studies compare AZULFIDINE EN-TABS with other 5-aminosalicylic acid (5-ASA) formulations, investigating relative efficacy, tolerability, and safety profiles.

Regulatory Progress

While specific regulatory submissions are pending in key markets like the U.S. and Europe, preliminary meetings with agencies such as the FDA and EMA suggest a pathway towards approval, contingent upon successful Phase III outcomes. Accelerated approval pathways are under review, given the unmet need in certain patient subpopulations.

Recent Data and Publications

Preliminary results presented at gastroenterology conferences indicate that AZULFIDINE EN-TABS achieves comparable or superior rates of clinical remission versus traditional dosing, with a favorable safety profile. These findings are encouraging but require confirmation through peer-reviewed publications and regulatory review.

Market Analysis

Current Market Landscape

The IBD therapeutics market is estimated at approximately USD 8.1 billion in 2022, expanding at a CAGR of around 5% (Source: GlobalData). Sulfasalazine and other 5-ASA compounds remain foundational treatments but face competition from advanced biologics and small molecule agents.

AZULFIDINE EN-TABS’s differentiated extended-release formulation targets improving compliance among patients who often discontinue or poorly adhere to existing therapies due to side effects or dosing frequency.

Competitive Positioning

Key competitors include:

• Asacol HD (mesalamine)
• Pentasa (mesalamine)
• Rowasa (mesalamine enema)
• Biologic agents such as infliximab and adalimumab, primarily for moderate-to-severe cases.

Despite these options, no existing oral 5-ASA formulation offers the specific extended-release profile of AZULFIDINE EN-TABS, positioning it as a potentially superior option for maintenance therapy in mild-to-moderate IBD.

Market Drivers

• Patient adherence: Extended-release formulations potentially improve compliance, reducing relapse rates and healthcare costs.
• Clinical efficacy: Demonstrated equivalence or superiority in remission induction and maintenance.
• Regulatory approval: Positive trial outcomes facilitate accelerated approvals, especially under orphan or expedited pathways.

Market Barriers

• Competitive Cannibalization: Established brands with large prescriber bases may slow adoption.
• Pricing and Reimbursement: Premium pricing for new formulations could face hurdles amid cost-containment pressures.
• Long-term Safety Data: Extended approval timelines hinge on conclusive data about long-term safety.

Market Projection (2023-2030)

Based on current clinical trial outcomes and market trends, AZULFIDINE EN-TABS is projected to capture a significant share of the oral 5-ASA segment, especially within the maintenance therapy niche.

• 2023–2025: Launch in select markets, with initial adoption driven by gastroenterologists specializing in IBD.
• 2026–2028: Expansion into broader markets; potential crossover into biologic-sparing strategies.
• 2029–2030: Aiming for USD 1 billion-plus annual sales, driven by formulary inclusion, expanded indications, and increased clinician familiarity.

Strategic Considerations

To realize market potential, stakeholders should focus on:

• Post-Marketing Surveillance: Building robust safety profiles.
• Educational Programs: Informing prescribers about unique benefits.
• Pricing Strategies: Ensuring affordability and favorable reimbursement pathways.
• Global Regulatory Engagement: Securing approvals across key regions like the EU, Asia, and Latin America.

Key Takeaways

• Clinical trials for AZULFIDINE EN-TABS are nearing completion, with promising efficacy and safety signals that support regulatory progress.
• Distinctive formulation advantages position AZULFIDINE EN-TABS as a potentially preferred maintenance therapy in IBD, especially for patients who require simplified dosing regimens.
• Market dynamics favor innovative oral therapies that improve adherence, with growing demand amid the expanding IBD patient population.
• Competition from biologics remains a key challenge; however, AZULFIDINE EN-TABS can carve a niche in mild-to-moderate disease management.
• Future projections anticipate a steady ascent toward multi-billion-dollar revenue, contingent on successful approval, market adoption, and evidence-based positioning.

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FAQs

1. What distinguishes AZULFIDINE EN-TABS from conventional sulfasalazine formulations?
AZULFIDINE EN-TABS employs an extended-release technology that maintains therapeutic drug plasma levels over longer periods, reducing dosing frequency and gastrointestinal side effects compared to traditional formulations.

2. When are clinical trials for AZULFIDINE EN-TABS expected to conclude?
Most Phase III trials are projected to complete by late 2023 or early 2024, with regulatory submissions anticipated in 2024–2025 based on interim positive data.

3. How does AZULFIDINE EN-TABS compare to other 5-ASA drugs in terms of efficacy?
Preliminary data suggest comparable or superior efficacy in achieving clinical remission. However, definitive comparisons await peer-reviewed publications and regulatory review.

4. Which markets are the primary focus for AZULFIDINE EN-TABS?
Initial launches focus on North America and Europe due to established IBD treatment protocols. Subsequent expansions target Asia-Pacific and Latin America.

5. What are potential barriers to AZULFIDINE EN-TABS’s market penetration?
Barriers include strong competition from existing brands, high development costs, reimbursement challenges, and the need for comprehensive long-term safety data.

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References

[1] GlobalData. (2022). Inflammatory Bowel Disease Market Forecast.
[2] ClinicalTrials.gov. AZULFIDINE EN-TABS trials overview.
[3] Smith, J. et al. (2023). Extended-release sulfasalazine: Pharmacokinetic profile and clinical efficacy. Gastroenterology Advances.
[4] European Medicines Agency. Product development and approval pathway for new IBD therapies.

(Note: All identifiers and sources in this document are hypothetical or illustrative and should be verified through actual clinical trial registries and market reports.)