CLINICAL TRIALS PROFILE FOR IMODIUM

All Clinical Trials for Imodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075868 ↗	Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-01	RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
NCT00075868 ↗	Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer	Completed	Radiation Therapy Oncology Group	Phase 3	2003-12-01	RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
NCT00292344 ↗	Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea	Completed	Bausch Health Americas, Inc.	Phase 4	2004-06-01	Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
NCT00292344 ↗	Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2004-06-01	Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
NCT00292344 ↗	Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea	Completed	The University of Texas Health Science Center, Houston	Phase 4	2004-06-01	Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
NCT00360828 ↗	Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas	Terminated	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2006-02-01	Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.

Clinical Trial Conditions for Imodium

Condition Name

Condition Name for Imodium
Intervention	Trials
Diarrhea	5
Fecal Incontinence	3
Travelers' Diarrhea	2
Healthy	2

Condition MeSH

Condition MeSH for Imodium
Intervention	Trials
Diarrhea	10
Fecal Incontinence	3
Dysentery	2
Short Bowel Syndrome	2

Clinical Trial Locations for Imodium

Trials by Country

Trials by Country for Imodium
Location	Trials
United States	59
Mexico	6
Spain	3
United Kingdom	1
Russian Federation	1

Trials by US State

Trials by US State for Imodium
Location	Trials
California	5
Texas	5
North Carolina	4
Alabama	2
Washington	2

Clinical Trial Progress for Imodium

Clinical Trial Phase

Clinical Trial Phase for Imodium
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Imodium
Clinical Trial Phase	Trials
Completed	12
Terminated	5
Recruiting	2

Clinical Trial Sponsors for Imodium

Sponsor Name

Sponsor Name for Imodium
Sponsor	Trials
McNeil AB	2
M.D. Anderson Cancer Center	2
Johnson & Johnson Consumer and Personal Products Worldwide	2

Sponsor Type

Sponsor Type for Imodium
Sponsor	Trials
Other	29
Industry	18
NIH	4

Clinical Trials, Market Analysis, and Projections for IMODIUM (Loperamide)

Introduction to IMODIUM (Loperamide)

IMODIUM, also known as loperamide, is a synthetic antidiarrheal medication used for the control and symptomatic relief of acute nonspecific diarrhea and chronic diarrhea associated with inflammatory bowel disease. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Recent Studies on Loperamide for Chemotherapy-Induced Diarrhea

A recent sub-study of the phase II PHAEDRA trial investigated the efficacy of loperamide in preventing grade ≥3 diarrhea in patients undergoing chemotherapy. The study compared the outcomes of patients receiving loperamide for 21 days versus 42 days. The results indicated no significant differences between the two durations in preventing severe diarrhea, suggesting that the shorter duration may be sufficient for many patients[1].

Clinical Development and Safety

Clinical trials have consistently shown that loperamide acts by slowing intestinal motility and affecting water and electrolyte movement through the bowel. It binds to opiate receptors in the gut wall, reducing peristalsis and increasing intestinal transit time. Studies have also indicated that loperamide has a low abuse potential and does not lead to tolerance over time[4].

Ongoing and Future Trials

The market assessment report on loperamide for chemotherapy-induced diarrhea (CID) highlights ongoing and future clinical trials. These trials focus on trial interventions, conditions, and status, providing comprehensive information on the clinical development of loperamide in CID. The report also covers late-stage emerging therapies for CID, which could impact the future market landscape[3].

Market Analysis

Current Market Size and Growth

The global market for digestive and intestinal remedies, which includes loperamide, was valued at USD 21.7 billion in 2024. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.65% from 2025 to 2035, reaching USD 35.78 billion by 2035. The growth is driven by the increasing prevalence of gastrointestinal disorders such as GERD, IBS, and IBD, as well as the aging global population[2].

Regional Market Analysis

North America is currently the largest market for digestive and intestinal remedies, including loperamide. However, the Asia-Pacific region is expected to be the fastest-growing market due to expanding healthcare access and the increasing adoption of telemedicine and online sales[2].

Competitive Landscape

The market for loperamide is part of a broader competitive landscape that includes both marketed therapies and late-stage emerging therapies for CID. The report on loperamide for CID provides a SWOT analysis and insights from analysts, highlighting the strengths, weaknesses, opportunities, and threats in the market[3].

Product Segment Analysis

Loperamide is a key player in the antidiarrheal segment of the digestive and intestinal remedies market. The probiotics segment, however, is the largest and is expected to remain dominant due to growing consumer awareness of gut health benefits. Loperamide's market share is significant, particularly in the context of chemotherapy-induced diarrhea and other specific indications[2].

Market Projections

Sales Forecast

The sales of loperamide for CID are forecasted to continue growing through 2032. The report provides detailed sales data for the seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. This growth is supported by the increasing incidence of cancer and the subsequent need for effective management of chemotherapy-induced side effects[3].

Regulatory Milestones and Patents

The report on loperamide for CID also covers regulatory milestones and patent information. Understanding the patent expiry timeline and regulatory developments is crucial for predicting market dynamics and potential competition from generic or new therapies[3].

Key Takeaways

• Clinical Trials: Recent trials indicate no significant difference in preventing severe diarrhea between 21-day and 42-day loperamide durations.
• Market Size: The global digestive and intestinal remedies market, including loperamide, is projected to reach USD 35.78 billion by 2035.
• Regional Growth: North America is the largest market, but the Asia-Pacific region is expected to grow the fastest.
• Competitive Landscape: Loperamide faces competition from both existing and emerging therapies for CID.
• Sales Forecast: Sales of loperamide for CID are expected to grow through 2032.

FAQs

What is the current market size of the digestive and intestinal remedies market, and how is it expected to grow?

The market was valued at USD 21.7 billion in 2024 and is expected to reach USD 35.78 billion by 2035, growing at a CAGR of 4.65% between 2025 and 2035[2].

Which region is the largest market for digestive and intestinal remedies, and which is the fastest-growing?

North America is the largest market, while the Asia-Pacific region is the fastest-growing[2].

What are the key drivers for the growth of the loperamide market?

Key drivers include the increasing prevalence of gastrointestinal disorders, the aging global population, and the expansion of healthcare access in emerging markets[2].

What is the mechanism of action of loperamide?

Loperamide acts by slowing intestinal motility and affecting water and electrolyte movement through the bowel by binding to opiate receptors in the gut wall[4].

Are there any significant differences in the efficacy of loperamide when administered for 21 days versus 42 days?

Recent studies indicate no significant differences in preventing grade ≥3 diarrhea between the two durations[1].

What is the forecasted sales outlook for loperamide in the context of chemotherapy-induced diarrhea?

Sales of loperamide for CID are forecasted to continue growing through 2032, driven by the increasing incidence of cancer and the need for effective management of chemotherapy-induced side effects[3].

Sources

1. A randomized, parallel-group sub-study of the phase II PHAEDRA trial - Elife Sciences.
2. Digestive and Intestinal Remedies Market Size 2025-2035 - MetaTech Insights.
3. Loperamide for Chemotherapy-Induced Diarrhea Research 2024 - Business Wire.
4. IMODIUM® (loperamide hydrochloride) - FDA.
5. Global Loperamide Market to 2025 - GlobeNewswire.