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Last Updated: July 8, 2025

CLINICAL TRIALS PROFILE FOR PENTASA


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All Clinical Trials for Pentasa

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.
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.
NCT00167882 ↗ The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels Completed VU University Medical Center Phase 4 2005-07-01 The purpose of this study is to determine the influence of different 5-aminosalicylate concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with inflammatory bowel disease.
NCT00209300 ↗ Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission Completed Ferring Pharmaceuticals Phase 3 2005-05-01 This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months. Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months). Number of Subjects (Planned and Analysed): - 360 patients for demonstration of non-inferiority between once daily and twice daily; - 326 to be analysed in per-protocol (PP) analyses; and - 360 in intention-to-treat (ITT) analyses.
NCT00225810 ↗ A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease Completed Ferring Pharmaceuticals Phase 4 2005-10-01 The primary objective of the clinical trial is the assessment of the acceptability of the new Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500 mg in children with Crohn's disease. After the screening period (which includes medical history, physical examination, basic haematology, serum chemistry , urine analysis and stool microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose 2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will record the acceptability of the both forms of the medication. In 6 patients from each group (selected by the randomization), stool and urine will be taken to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3. Adverse events will be recorded during the whole course of the treatment period.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pentasa

Condition Name

Condition Name for Pentasa
Intervention Trials
Ulcerative Colitis 9
Crohn's Disease 5
Colitis, Ulcerative 2
Crohn Disease 2
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Condition MeSH

Condition MeSH for Pentasa
Intervention Trials
Colitis, Ulcerative 15
Ulcer 15
Colitis 14
Crohn Disease 8
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Clinical Trial Locations for Pentasa

Trials by Country

Trials by Country for Pentasa
Location Trials
United States 105
Canada 20
Poland 10
Belgium 7
Netherlands 6
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Trials by US State

Trials by US State for Pentasa
Location Trials
California 7
Florida 6
North Carolina 6
Michigan 5
Maryland 5
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Clinical Trial Progress for Pentasa

Clinical Trial Phase

Clinical Trial Phase for Pentasa
Clinical Trial Phase Trials
Phase 4 5
Phase 3 12
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Pentasa
Clinical Trial Phase Trials
Completed 19
Terminated 3
Unknown status 2
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Clinical Trial Sponsors for Pentasa

Sponsor Name

Sponsor Name for Pentasa
Sponsor Trials
Ferring Pharmaceuticals 11
Merck Sharp & Dohme Corp. 1
HIV Immunotherapeutics Institute 1
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Sponsor Type

Sponsor Type for Pentasa
Sponsor Trials
Industry 15
Other 13
NIH 2
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PENTASA: Clinical Trials, Market Analysis, and Projections

Last updated: January 3, 2025

Introduction to PENTASA

PENTASA, also known as mesalamine, is a medication used primarily for the treatment of ulcerative colitis and Crohn's disease. It belongs to the class of aminosalicylates, which work by reducing inflammation in the gastrointestinal tract.

Clinical Trials Overview

Efficacy Parameters

Clinical trials for PENTASA have been extensive and well-documented. In two randomized, double-blind, placebo-controlled trials (UC-1 and UC-2) involving 625 patients with active mild to moderate ulcerative colitis, PENTASA demonstrated significant efficacy. The trials evaluated primary efficacy parameters such as Physician Global Assessment (PGA), Treatment Failure (Tx F), and Symptomatic Index (SI)[1][3][4].

  • PGA: The 4-g/day dose of PENTASA showed a marked improvement in 59% and 57% of patients in trials UC-1 and UC-2, respectively, compared to 36% in the placebo group.
  • Tx F: The treatment failure rate was significantly lower in the PENTASA group, at 9% and 18% in trials UC-1 and UC-2, respectively, compared to 22% and 31% in the placebo group.
  • SI: The Symptomatic Index improved by -5.0 and -4.3 in trials UC-1 and UC-2, respectively, for the 4-g/day dose of PENTASA.
  • Remission: The 4-g/day dose of PENTASA induced remission in 26% and 24% of patients in trials UC-1 and UC-2, respectively, as assessed by endoscopic and symptomatic endpoints.

Secondary Efficacy Parameters

In addition to the primary parameters, the 4-g/day dose of PENTASA also improved secondary efficacy parameters, including the frequency of trips to the toilet, stool consistency, rectal bleeding, abdominal/rectal pain, and urgency[1][3][4].

Adverse Events and Safety

PENTASA therapy was generally well-tolerated in clinical trials. The most common adverse events included diarrhea, headache, nausea, abdominal pain, dyspepsia, vomiting, and rash. These events were not dose-related, and withdrawal from therapy due to adverse events was more common in the placebo group than in the PENTASA group[1][3][4].

Market Analysis

Global Market Overview

The global PENTASA market for ulcerative colitis is analyzed based on various factors including production, revenue, price, market share, and growth rate. Here are some key points:

  • Market Segmentation: The market is segmented by regions such as China, the USA, Europe, Japan, Korea, and Southeast Asia. Each region's market performance is evaluated in terms of volume and value[2][5].
  • Product Types: The market is also segmented by product types, including PENTASA tablets and granules. These segments are analyzed for their production, revenue, price, and market share[2][5].

Regional Market Performance

  • USA Market: The USA is a significant market for PENTASA, with a substantial share of the global market. The market performance in the USA is driven by the high prevalence of ulcerative colitis and the availability of advanced healthcare facilities[2][5].
  • Europe Market: Europe is another major market for PENTASA, with several key players operating in the region. The market here is influenced by regulatory policies and the presence of a well-developed healthcare system[2][5].
  • Asia-Pacific Market: Countries like China, Japan, and Korea are emerging markets for PENTASA. These regions are expected to grow significantly due to increasing awareness and improving healthcare infrastructure[2][5].

Key Players

The global PENTASA market is dominated by several key players, including:

  • Ferring GmbH
  • Laboratórios Ferring Ltda
  • Shire US Inc.
  • Takeda
  • Prescription Hope, Inc
  • GiCare
  • Treato
  • Prasco[5].

These companies are analyzed based on their production capacity, revenue, market share, and SWOT analysis.

Market Projections

Forecast by Regions

The global PENTASA market is forecasted to grow significantly from 2020 to 2025 across various regions. Here are some projections:

  • Global Capacity Forecast: The global capacity for PENTASA is expected to increase, driven by growing demand and expanding production facilities[2].
  • Sales and Revenue Forecast: Sales and revenue are projected to rise, reflecting the increasing prevalence of ulcerative colitis and the effectiveness of PENTASA in treating the condition[2][5].

Forecast by Product Types

  • PENTASA Tablets and Granules: The market for PENTASA tablets and granules is expected to grow, with each segment contributing to the overall market performance[2][5].

Growth Rate and Market Share

The global PENTASA market is expected to exhibit a positive growth rate, driven by the increasing adoption of the drug and the expansion of key players into new markets. The market share of each player is expected to fluctuate based on their strategic initiatives and market dynamics[2][5].

Economic and Political Environment

The market for PENTASA is influenced by economic and political factors, including healthcare policies, regulatory environments, and economic stability. These factors can impact the availability, pricing, and accessibility of the drug in different regions[5].

Conclusion

PENTASA has demonstrated significant efficacy in clinical trials for the treatment of ulcerative colitis and Crohn's disease. The global market for PENTASA is expected to grow, driven by increasing demand, expanding production, and the presence of key players. However, the market is also influenced by various economic and political factors that can impact its growth and accessibility.

Key Takeaways

  • Clinical Efficacy: PENTASA has shown consistent improvement in primary and secondary efficacy parameters in clinical trials.
  • Market Growth: The global PENTASA market is projected to grow significantly from 2020 to 2025.
  • Regional Performance: The USA, Europe, and Asia-Pacific regions are key markets for PENTASA.
  • Key Players: Ferring GmbH, Shire US Inc., and Takeda are among the major players in the market.
  • Economic and Political Factors: Healthcare policies and regulatory environments play a crucial role in shaping the market.

Frequently Asked Questions (FAQs)

What is PENTASA used for?

PENTASA is used for the treatment of ulcerative colitis and Crohn's disease, reducing inflammation in the gastrointestinal tract.

What are the common adverse events associated with PENTASA?

Common adverse events include diarrhea, headache, nausea, abdominal pain, dyspepsia, vomiting, and rash.

How effective is PENTASA in clinical trials?

PENTASA has shown significant improvement in primary and secondary efficacy parameters, including PGA, Tx F, SI, and remission rates, in clinical trials.

Who are the key players in the global PENTASA market?

Key players include Ferring GmbH, Laboratórios Ferring Ltda, Shire US Inc., Takeda, and others.

What is the projected growth rate of the global PENTASA market?

The global PENTASA market is expected to exhibit a positive growth rate from 2020 to 2025, driven by increasing demand and expanding production.

Cited Sources

  1. FDA Label: PENTASA (mesalamine) Extended-Release Capsules - https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020049s036lbl.pdf
  2. Global Pentasa (Ulcerative Colitis) Market Professional Survey Report - https://www.visionresearchreports.com/global-pentasa-ulcerative-colitis-market-professional-survey-report/27613
  3. FDA NDA: Pentasa (mesalamine) Controlled-Release Capsules - https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020049Orig1s027.pdf
  4. FDA Label: PENTASA (mesalamine) Controlled-Release Capsules - https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf
  5. Pentasa (Ulcerative Colitis) Market Analysis, Trends and CAGR Projections - https://www.mynewsdesk.com/us/healthcare-market-desk/pressreleases/pentasa-ulcerative-colitis-market-analysis-trends-and-cagr-projections-2020-2027-3058806

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