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Mesalazine

Phase 3

Ulcerative Colitis | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Jun 11, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment343

FDA Designations

No designations recorded

Clinical trial landscape

Mesalazine · 1 trial · 1 indication

Phase 3 1
NCT00548574Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative ColitisUlcerative Colitis
COMPLETED343 Analytics
PHASE3COMPLETED
Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of subjects in remission (UC-DAI score <=1, with scores of 0 for rectal bleeding and stool frequency and a sigmoidoscopy score reduction of 1 point or more from baseline)
8 weeks

Secondary Endpoints

Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score
8 weeks
Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA
8 weeks
Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazineDRUG -
MesalazineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of =\> 1 and a PGA \<=2) with compatible histology * females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy t...

Countries:Belgium
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Frequently asked questions about Mesalazine

What is Mesalazine used for?

Mesalazine is used for the treatment of acute, mild to moderate ulcerative colitis, a form of inflammatory bowel disease affecting the colon and rectum. It is being developed as a small molecule therapy for this gastrointestinal condition.

Who makes Mesalazine?

Mesalazine is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK.

What phase is Mesalazine in?

Mesalazine is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its efficacy and safety in patients with ulcerative colitis.

What clinical trials is Mesalazine in?

Mesalazine has one completed Phase 3 clinical trial, identified as NCT00548574. This trial evaluated the efficacy and safety of two doses of Mesalazine, 2.4g and 4.8g once daily, compared with a reference treatment, in 343 subjects with acute, mild to moderate ulcerative colitis.

How does Mesalazine work?

Mesalazine is a small molecule that works by delivering mesalazine, an anti-inflammatory agent, directly to the colon. It is designed to reduce inflammation in the gastrointestinal tract, which helps to alleviate the symptoms of ulcerative colitis.