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CLINICAL TRIALS PROFILE FOR VIBERZI

All Clinical Trials for viberzi

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03489265 ↗	Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence	Withdrawn	Allergan	Phase 2	2019-04-01	Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is difficult to find a dose that does not cause constipation, and it does not reduce urge sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline. The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally twice a day will reduce the average number of days the patient has accidental bowel leakage, and to see if the rate of accidental bowel leakage increases when the patient stops taking eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge sensations. This is a small (pilot) study to show whether eluxadoline is an effective way of treating accidental bowel leakage. If the study shows this, a larger study will be needed. There are three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when you stop taking eluxadoline. To participate in the study, patients should be aged 18 or older. Patients with inflammatory bowel disease, anal fissures, or congenital malformations will be excluded. The primary outcome is the average number of days per week with any solid or liquid bowel accidents. Additional information includes: (1) Number of days per week the patient takes loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the study.
NCT03489265 ↗	Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence	Withdrawn	University of North Carolina, Chapel Hill	Phase 2	2019-04-01	Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is difficult to find a dose that does not cause constipation, and it does not reduce urge sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline. The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally twice a day will reduce the average number of days the patient has accidental bowel leakage, and to see if the rate of accidental bowel leakage increases when the patient stops taking eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge sensations. This is a small (pilot) study to show whether eluxadoline is an effective way of treating accidental bowel leakage. If the study shows this, a larger study will be needed. There are three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when you stop taking eluxadoline. To participate in the study, patients should be aged 18 or older. Patients with inflammatory bowel disease, anal fissures, or congenital malformations will be excluded. The primary outcome is the average number of days per week with any solid or liquid bowel accidents. Additional information includes: (1) Number of days per week the patient takes loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the study.
NCT04313088 ↗	Investigation of Eluxadoline for Diabetic Diarrhea	Recruiting	Temple University	Phase 2/Phase 3	2021-07-01	Diabetes is a chronic disease that affects a large part of the United States population. The majority of patients with diabetes will experience gastrointestinal symptoms. One of the most troublesome gastrointestinal symptoms that diabetes can cause is diarrhea, otherwise known as "Diabetic Diarrhea." This occurs because diabetes does damage to nerves that control the gut and prevent it from functioning normally. Currently, there are only several medications used to treat the symptoms of Diabetic Diarrhea, but many of these medications have serious side effects or do not work well. We are investigating the drug eluxadoline for the treatment of Diabetic Diarrhea. Eluxadoline is a gut-specific medication that is FDA approved to treat diarrhea related to irritable bowel syndrome (IBS-D). Our hypothesis is eluxadoline will safely and successfully reduce diarrhea symptoms (number of stools and less liquid stools) and improve the quality of life in patients with Diabetic Diarrhea when compared with placebo. Each patient with Diabetic Diarrhea who participates will take both eluxadoline and a placebo drug at separate times over a period of several months as part of a crossover study design. While on each medication, eluxadoline or placebo, the participants will keep a diary of symptoms and will be followed by the medical team through a combination of office visits and questionnaires. There will be five planned office visits and intermittent phone calls (questionnaires, surveys) over the 140-day study period. Participants will not be permitted to use any other anti-diarrhea medication during the study period and will continue on medication for management of their diabetes.

Clinical Trial Conditions for viberzi

Condition Name

Condition Name for viberzi
Intervention	Trials
Diarrhea	2
Fecal Incontinence	1
Urge Incontinence	1

Condition MeSH

Condition MeSH for viberzi
Intervention	Trials
Diarrhea	2
Urinary Incontinence, Urge	1
Fecal Incontinence	1

Clinical Trial Locations for viberzi

Trials by Country

Trials by Country for viberzi
Location	Trials
United States	2

Trials by US State

Trials by US State for viberzi
Location	Trials
Pennsylvania	1
North Carolina	1

Clinical Trial Progress for viberzi

Clinical Trial Phase

Clinical Trial Phase for viberzi
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for viberzi
Clinical Trial Phase	Trials
Recruiting	1
Withdrawn	1

Clinical Trial Sponsors for viberzi

Sponsor Name

Sponsor Name for viberzi
Sponsor	Trials
Allergan	1
University of North Carolina, Chapel Hill	1
Temple University	1

Sponsor Type

Sponsor Type for viberzi
Sponsor	Trials
Other	2
Industry	1

Viberzi Market Analysis and Financial Projection

Viberzi: Clinical Trials, Market Analysis, and Projections

Introduction to Viberzi

Viberzi, also known as eluxadoline, is a medication specifically designed to treat irritable bowel syndrome with diarrhea (IBS-D) in adults. It is developed by Allergan plc and has been a significant addition to the treatment options for IBS-D patients.

Clinical Trials Overview

Phase III Trials

The efficacy and safety of Viberzi were evaluated in two pivotal Phase III clinical trials, Study 1 and Study 2. These trials were randomized, multi-center, multi-national, double-blind, and placebo-controlled. Here are the key findings:

• Patient Demographics: The trials involved a total of 2425 patients with IBS-D, with a mean age of 45 years, 66% female, 86% white, 11% black, and 27% Hispanic[1][3][4].
• Treatment and Dosage: Patients were treated with either Viberzi 75 mg or 100 mg twice daily, or a placebo. The trials included a 12-week treatment period, with Study 1 extending to 52 weeks for long-term safety assessment and Study 2 including a 4-week single-blinded withdrawal period[1][3][4].
• Efficacy Endpoints: The primary endpoint was the proportion of composite responders, defined as patients who experienced a simultaneous reduction in the daily worst abdominal pain score by ≥30% and a reduction in the Bristol Stool Scale (BSS) to <5 on at least 50% of the days within a 12-week treatment interval[1][3][4].
• Results: The trials showed that significantly more patients treated with Viberzi experienced improvements in diarrhea and abdominal pain compared to those on placebo. The composite responder rates were statistically significantly higher for Viberzi, with differences ranging from 7% to 13% compared to placebo[1][3][4].

Safety Profile

The clinical trials demonstrated that Viberzi has an acceptable safety profile. The identified safety issues can be managed through labeling and adequate monitoring. The most common adverse events included constipation, nausea, and abdominal pain. However, the benefits of Viberzi therapy were considered to outweigh the potential risks[3].

Market Analysis

Current Market Size and Segmentation

The global irritable bowel syndrome treatment market was valued at USD 3.64 billion in 2024. The IBS-D segment, which includes Viberzi, dominated the market with a 49.8% revenue share due to an increase in diagnosed cases and a better understanding of the condition's impact on quality of life[2][5].

Drug Class and Revenue Share

Viberzi is one of the key drugs in the IBS-D segment. While Linzess/Constella dominated the overall IBS treatment market with a 37.3% revenue share, Viberzi's unique mechanism of action and effectiveness in regulating bowel function and reducing abdominal discomfort make it a preferred choice for many patients with IBS-D[2][5].

Distribution Channels

Hospital pharmacies led the market in terms of distribution channels, accounting for the largest revenue share. This is attributed to their comprehensive infrastructure and integrated patient care systems[5].

Regional Market

North America, particularly the U.S., dominates the global IBS treatment market, accounting for 37.5% of the revenue share. This is due to the high prevalence of IBS and increasing awareness of its management options[5].

Market Projections

Growth Rate

The global IBS treatment market is anticipated to grow at a CAGR of 8.8% from 2025 to 2030. The IBS-D segment, driven by drugs like Viberzi, is expected to continue its dominance[2].

Viberzi's Growth

Viberzi is projected to grow at a CAGR of 7.5% over the forecast period. This growth is driven by its effectiveness, ongoing clinical trials, and increasing awareness among healthcare providers about available treatment options for IBS-D[2].

Competitive Landscape

The market is competitive, with other key players including Ironwood Pharmaceuticals, Astellas Pharma, Takeda Pharmaceutical Company, and AstraZeneca. However, Viberzi's unique mechanism and the expanding market for IBS-D treatments position it for continued growth[2][5].

Key Factors Driving Growth

Increasing Prevalence and Awareness

The rising prevalence of IBS-D and increasing awareness among patients and healthcare providers are significant drivers of the market. Educational campaigns and patient education initiatives encourage more individuals to seek appropriate care, thereby expanding the market[2][5].

Ongoing Clinical Trials and Research

Continuous research and clinical trials aimed at enhancing IBS treatments are expected to solidify Viberzi's position in the market. New therapies and advancements in drug development will further drive growth in the IBS-D segment[2].

Regulatory Approvals

Viberzi has received regulatory approvals in several countries, including the U.S. and Canada, which has helped in its widespread adoption. Health Canada granted the Notice of Compliance for Viberzi based on its positive clinical trial results[3].

Conclusion

Viberzi has established itself as a significant treatment option for IBS-D, backed by robust clinical trial data and a favorable safety profile. The drug's market is expected to grow substantially, driven by increasing prevalence, awareness, and ongoing research in the field.

Key Takeaways

• Clinical Efficacy: Viberzi has shown significant improvements in diarrhea and abdominal pain in patients with IBS-D through Phase III clinical trials.
• Market Dominance: The IBS-D segment, led by Viberzi, dominates the global IBS treatment market.
• Growth Projections: Viberzi is expected to grow at a CAGR of 7.5% from 2025 to 2030.
• Competitive Landscape: The market is competitive, but Viberzi's unique mechanism and expanding market for IBS-D treatments position it for continued growth.
• Driving Factors: Increasing prevalence, awareness, and ongoing clinical trials are key drivers of the market.

FAQs

What is Viberzi used for?

Viberzi (eluxadoline) is used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults, reducing abdominal pain and making stool less watery[4].

What were the key findings of the Phase III trials for Viberzi?

The Phase III trials showed that Viberzi significantly improved diarrhea and abdominal pain in patients with IBS-D, with composite responder rates higher than those on placebo[1][3][4].

How does Viberzi compare to other IBS treatments in the market?

Viberzi is a preferred choice for IBS-D due to its unique mechanism of action and effectiveness, although Linzess/Constella dominates the overall IBS treatment market in terms of revenue share[2][5].

What is the projected growth rate for Viberzi in the coming years?

Viberzi is expected to grow at a CAGR of 7.5% from 2025 to 2030, driven by its effectiveness and increasing awareness among healthcare providers[2].

What are the main factors driving the growth of the IBS-D treatment market?

The main factors include increasing prevalence, awareness, ongoing clinical trials, and advancements in drug development[2][5].

Sources

1. PR Newswire: VIBERZI™ (eluxadoline) Phase III Trial Results Published in The New England Journal of Medicine.
2. Grand View Research: Irritable Bowel Syndrome Treatment Market Size Report 2030.
3. Health Canada: Summary Basis of Decision for Viberzi.
4. FDA: Drug Trials Snapshots: VIBERZI.
5. Research and Markets: Irritable Bowel Syndrome Treatment Market Size & Competitors.