CLINICAL TRIALS PROFILE FOR LIALDA

All Clinical Trials for LIALDA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00652145 ↗	Dose Escalation and Remission (DEAR)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 4	2008-09-01	The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels <50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.
NCT00652145 ↗	Dose Escalation and Remission (DEAR)	Completed	Shire	Phase 4	2008-09-01	The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels <50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.
NCT00652145 ↗	Dose Escalation and Remission (DEAR)	Completed	James Lewis	Phase 4	2008-09-01	The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels <50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.
NCT00545103 ↗	Prevention of Recurrence of Diverticulitis	Completed	Shire	Phase 3	2007-12-06	The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
NCT00446849 ↗	Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)	Completed	Shire	Phase 4	2007-05-01	To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
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 LIALDA

Condition Name

Condition Name for LIALDA
Intervention	Trials
Ulcerative Colitis	6
Healthy	4
Colitis, Ulcerative	1
Diverticulitis	1

Condition MeSH

Condition MeSH for LIALDA
Intervention	Trials
Colitis, Ulcerative	6
Ulcer	5
Colitis	5
Diverticulitis	1

Clinical Trial Locations for LIALDA

Trials by Country

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Trials by Country for LIALDA
Location	Trials
United States	105
Canada	13
India	11
South Africa	9
Brazil	8

Trials by US State

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−

Trials by US State for LIALDA
Location	Trials
Florida	7
Pennsylvania	5
Maryland	5
Kansas	5
Texas	5

Clinical Trial Progress for LIALDA

Clinical Trial Phase

Clinical Trial Phase for LIALDA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for LIALDA
Clinical Trial Phase	Trials
Completed	12
Terminated	1

Clinical Trial Sponsors for LIALDA

Sponsor Name

Sponsor Name for LIALDA
Sponsor	Trials
Shire	9
University of Utah	1
Food and Drug Administration (FDA)	1

Sponsor Type

Sponsor Type for LIALDA
Sponsor	Trials
Industry	11
Other	4
U.S. Fed	1

LIALDA (Mesalamine): Clinical Trials, Market Analysis, and Projections

Introduction to LIALDA

LIALDA, a delayed-release tablet containing mesalamine, is a medication used for the treatment of ulcerative colitis, a type of inflammatory bowel disease. Here, we will delve into the clinical trials, market analysis, and future projections for LIALDA.

Clinical Trials and Efficacy

Induction of Remission

LIALDA was initially approved by the FDA in 2007 for the induction of remission in patients with active, mild to moderate ulcerative colitis. This approval was based on two eight-week, placebo-controlled clinical trials that demonstrated the safety and effectiveness of LIALDA. In these trials, patients received either 2.4 g or 4.8 g of LIALDA once daily, and the most common adverse reactions included headache, flatulence, and abnormal liver function tests[1][3][4].

Maintenance of Remission

In 2011, LIALDA gained an additional FDA approval for the maintenance of remission in patients with ulcerative colitis. This approval was supported by a six-month, double-blind, non-inferiority study and two 12- to 14-month open-label studies. The study showed that 83.7% of patients receiving 2.4 g of LIALDA once daily maintained remission at Month 6, which was comparable to the results from the comparator group[3].

Pediatric Studies

Clinical trials have also been conducted in pediatric patients aged 5 to 17 years. A multicenter, randomized, double-blind trial and additional pharmacokinetic analyses showed a safety profile in pediatric patients similar to that observed in adults. However, the safety and effectiveness of LIALDA have not been established in patients weighing less than 24 kg[1][4].

Adverse Reactions and Safety Profile

The safety profile of LIALDA has been extensively evaluated in clinical trials. Common adverse reactions include:

• Headache: Reported in 5.6% and 3.4% of patients receiving 2.4 g and 4.8 g of LIALDA, respectively[1][4].
• Flatulence: Observed in 4% and 2.8% of patients receiving 2.4 g and 4.8 g of LIALDA, respectively[1][4].
• Liver Function Test Abnormal: Reported in less than 1% to 2.2% of patients[1][4].
• Pancreatitis: Occurred in less than 1% of patients and led to discontinuation of therapy[1][4].

Severe adverse reactions, particularly gastrointestinal disorders, were also noted, but these were generally consistent with symptoms associated with ulcerative colitis[3].

Market Analysis

Current Market Size

As of 2023, the global Mesalamine (LIALDA) market size was valued at US$ 153.1 million. This market is driven by the growing demand for effective treatments for ulcerative colitis and other inflammatory bowel diseases[2].

Market Projections

The global Mesalamine (LIALDA) market is forecast to grow to US$ 227.3 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.8% during the review period. This growth is anticipated due to increasing awareness and diagnosis of ulcerative colitis, as well as advancements in healthcare infrastructure[2].

Regional Market Forecast

The market is expected to show significant growth across various regions, including:

• Americas: The United States, Canada, Mexico, and Brazil are expected to be key markets.
• APAC: Countries such as China, Japan, Korea, and Southeast Asia will contribute to the growth.
• Europe: Germany, France, the UK, and Italy will be significant contributors.
• Middle East & Africa: Countries like Egypt, South Africa, Israel, and Turkey will also see growth[2].

Industry Trends and Outlook

Increasing Demand for Ulcerative Colitis Treatments

The rising prevalence of ulcerative colitis and the need for effective maintenance therapies are driving the demand for LIALDA. As healthcare systems improve and more patients are diagnosed and treated, the market for LIALDA is expected to expand[2].

Competitive Landscape

The market for mesalamine-based treatments is competitive, with several other formulations available. However, LIALDA's once-daily dosing regimen and established safety and efficacy profile make it a preferred option for many patients and healthcare providers[3].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceuticals. The FDA approvals for both induction and maintenance of remission have been pivotal in establishing LIALDA's position in the market. Continued regulatory support and compliance will be essential for future growth[1][3][4].

Key Takeaways

• Clinical Efficacy: LIALDA has demonstrated efficacy in both inducing and maintaining remission in patients with ulcerative colitis.
• Safety Profile: Common adverse reactions include headache, flatulence, and abnormal liver function tests, with pancreatitis being a rare but serious side effect.
• Market Size and Growth: The global Mesalamine (LIALDA) market is valued at US$ 153.1 million in 2023 and is projected to grow to US$ 227.3 million by 2030.
• Regional Growth: Significant growth is expected across the Americas, APAC, Europe, and the Middle East & Africa.
• Industry Trends: Increasing demand for ulcerative colitis treatments and a competitive market landscape are key factors influencing the market.

FAQs

What is LIALDA used for?

LIALDA is used for the induction and maintenance of remission in patients with active, mild to moderate ulcerative colitis.

What are the common adverse reactions associated with LIALDA?

Common adverse reactions include headache, flatulence, and abnormal liver function tests.

What is the recommended dosage for LIALDA?

For the induction of remission, the recommended dosage is two or four 1.2 g tablets taken once daily with a meal. For the maintenance of remission, the recommended dosage is two 1.2 g tablets taken once daily with a meal.

What is the projected market size for LIALDA by 2030?

The global Mesalamine (LIALDA) market is forecast to grow to US$ 227.3 million by 2030.

Which regions are expected to contribute significantly to the growth of the LIALDA market?

The Americas, APAC, Europe, and the Middle East & Africa are expected to be key contributors to the market growth.

Sources

1. FDA: LIALDA (Mesalamine) - accessdata.fda.gov
2. Orbis Research: Global Mesalamine (Lialda) Market Growth (Status and Outlook 2024-2030) - orbisresearch.com
3. FiercePharma: Shire plc: Lialda® (Mesalamine) Now Approved in U.S. for Maintenance of Remission of Ulcerative Colitis - fiercepharma.com
4. FDA: LIALDA (Mesalamine) Label - accessdata.fda.gov