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Last Updated: April 16, 2025

CLINICAL TRIALS PROFILE FOR CANASA


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All Clinical Trials for CANASA

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01172444 ↗ Clinical Trial With Mesalamine 1g Suppositories Terminated Sandoz Phase 3 2010-06-01 An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative Proctitis will be conducted in 533 patient with a estimated duration of 18months.
NCT01016262 ↗ Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis Terminated Axcan Pharma Phase 3 2009-11-30 This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).
NCT01016262 ↗ Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis Terminated Forest Laboratories Phase 3 2009-11-30 This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for CANASA

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1ProctitisProctitis, UlcerativeUlcerative Proctitis[disabled in preview]
Condition Name for CANASA
Intervention Trials
Proctitis 1
Proctitis, Ulcerative 1
Ulcerative Proctitis 1
[disabled in preview] 0
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Condition MeSH

2110-0.200.20.40.60.811.21.41.61.822.2ProctitisUlcerColitis, Ulcerative[disabled in preview]
Condition MeSH for CANASA
Intervention Trials
Proctitis 2
Ulcer 1
Colitis, Ulcerative 1
[disabled in preview] 0
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Clinical Trial Locations for CANASA

Trials by Country

+
Trials by Country for CANASA
Location Trials
India 16
United States 15
Canada 4
Poland 1
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Trials by US State

+
Trials by US State for CANASA
Location Trials
Arizona 1
Alabama 1
Wisconsin 1
Texas 1
Tennessee 1
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Clinical Trial Progress for CANASA

Clinical Trial Phase

100.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 3[disabled in preview]
Clinical Trial Phase for CANASA
Clinical Trial Phase Trials
Phase 3 2
[disabled in preview] 0
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Clinical Trial Status

100.0%0-0.200.20.40.60.811.21.41.61.822.2Terminated[disabled in preview]
Clinical Trial Status for CANASA
Clinical Trial Phase Trials
Terminated 2
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Clinical Trial Sponsors for CANASA

Sponsor Name

trials000001111111Axcan PharmaForest LaboratoriesSandoz[disabled in preview]
Sponsor Name for CANASA
Sponsor Trials
Axcan Pharma 1
Forest Laboratories 1
Sandoz 1
[disabled in preview] 0
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Sponsor Type

100.0%000.511.522.53Industry[disabled in preview]
Sponsor Type for CANASA
Sponsor Trials
Industry 3
[disabled in preview] 0
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CANASA (Mesalamine) Suppositories: Clinical Trials, Market Analysis, and Projections

Introduction

CANASA, a mesalamine suppository, is a crucial treatment option for adults suffering from mildly to moderately active ulcerative proctitis, a form of ulcerative colitis. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Clinical trials have been instrumental in establishing the efficacy and safety of CANASA. Two double-blind, placebo-controlled, multicenter trials conducted in North America demonstrated that mesalamine suppositories were statistically superior to placebo in improving stool frequency and other symptoms associated with ulcerative proctitis[1][4].

In an additional multicenter, open-label, randomized, parallel group study, 99 patients were treated with either 1000 mg of CANASA once daily at bedtime or 500 mg of mesalamine suppository twice daily. Both treatment groups showed significant decreases in the clinical disease activity index (DAI) after 6 weeks, with a decrease of greater than 75% in both groups. The study concluded that both dosing regimens were effective, with 78% and 86% of patients achieving a DAI score of less than 3, respectively[1][4].

Adverse Reactions and Safety

While CANASA has proven to be effective, it is not without potential adverse reactions. Common adverse reactions include headache, flatulence, abdominal pain, diarrhea, and nausea. More serious reactions, such as blood dyscrasias (e.g., agranulocytosis, neutropenia, and pancytopenia), have been reported, particularly in patients aged 65 and older. It is recommended to monitor complete blood cell counts and platelet counts during treatment[4].

Market Analysis

The pharmaceutical suppositories market, which includes CANASA, has been experiencing robust growth. In 2023, the global market size for pharmaceutical suppositories was $1.6 billion, and it is projected to grow to $1.7 billion in 2024 at a compound annual growth rate (CAGR) of 6.3%. By 2028, the market is expected to reach $2.19 billion, driven by factors such as increased healthcare expenditure, new regulatory approvals, and the rising prevalence of diseases like kidney damage and hemorrhoids[2].

Key Trends and Drivers

  • Product Innovation: Major players in the pharmaceutical suppositories market are focusing on developing innovative products. For example, Teva Pharmaceuticals Inc. launched a generic version of CANASA in the U.S. in April 2021, which has contributed to market growth[2].
  • Strategic Partnerships: Companies are engaging in strategic partnerships to enhance their market positions. Rising Pharmaceuticals, for instance, launched a generic version of CANASA after receiving FDA approval, expanding their portfolio of generic medicines[5].
  • Patient Convenience and Adherence: There is a growing emphasis on developing products that enhance patient convenience and adherence, which is expected to drive market growth in the forecast period[2].

Market Projections

The pharmaceutical suppositories market, including CANASA, is anticipated to see significant growth in the coming years. Here are some key projections:

  • Global Market Size: The market is expected to grow from $1.7 billion in 2024 to $2.19 billion by 2028 at a CAGR of 6.5%[2].
  • Regional Growth: The Asia Pacific region is expected to expand at the fastest CAGR, driven by the increasing prevalence of infectious and chronic diseases. North America and Europe will also contribute significantly to the market growth due to increased R&D expenditure by pharmaceutical and biotechnology companies[3].
  • Product Launches: The launch of generic versions of CANASA and other suppository medications will continue to drive market growth. Rising Pharmaceuticals, for example, has over 125 approved and commercial products in the U.S. market, with an additional 82 products pending launch or in development[5].

Key Takeaways

  • Efficacy and Safety: CANASA has demonstrated significant efficacy in treating mildly to moderately active ulcerative proctitis, with a favorable safety profile when used as directed.
  • Market Growth: The pharmaceutical suppositories market is expected to grow substantially, driven by product innovation, strategic partnerships, and increasing healthcare expenditure.
  • Regional Expansion: The Asia Pacific region will see the fastest growth due to the rising prevalence of chronic diseases.
  • Generic Competition: The launch of generic versions of CANASA will continue to influence market dynamics.

FAQs

What is CANASA used for?

CANASA (mesalamine) suppositories are used for the treatment of mildly to moderately active ulcerative proctitis in adults.

What are the common adverse reactions associated with CANASA?

Common adverse reactions include headache, flatulence, abdominal pain, diarrhea, and nausea. More serious reactions such as blood dyscrasias can occur, especially in older patients.

How is CANASA administered?

The recommended dosage of CANASA is 1000 mg administered rectally once daily at bedtime.

What is the projected market size for pharmaceutical suppositories by 2028?

The global market size for pharmaceutical suppositories is expected to reach $2.19 billion by 2028.

Which region is expected to see the fastest growth in the pharmaceutical suppositories market?

The Asia Pacific region is expected to expand at the fastest CAGR due to the increasing prevalence of infectious and chronic diseases.

Sources

  1. CenterWatch: Canasa (mesalamine) suppositories.
  2. ResearchAndMarkets: Pharmaceutical Suppositories Global Market Report 2024.
  3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032].
  4. FDA: CANASA® (mesalamine) suppositories, for rectal use.
  5. Biospace: Rising Pharmaceuticals Announces the Launch of Mesalamine Suppository.

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