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CLINICAL TRIALS PROFILE FOR XIFAXAN

All Clinical Trials for Xifaxan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00269399 ↗	A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)	Completed	Bausch Health Americas, Inc.	Phase 3	2005-12-01	The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).
NCT00269399 ↗	A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2005-12-01	The purpose of this study is to assess the treatment and safety of a 10-day course of rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium difficile-associated diarrhea (CDAD).
NCT00577772 ↗	Transit Time and Bacterial Overgrowth Using SmartPill Capsule	Terminated	The SmartPill Corporation	N/A	2007-11-01	The primary purpose of this exploratory study is to measure orocecal transit time using the SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath test. Additionally, the ability of the SmartPill GI Monitoring System to discriminate between healthy human subjects and patients with small bowel bacterial overgrowth will be explored using analyses of both pH and pressure patterns within the stomach and small intestine. The study will be performed in both normal subjects and patients with and without small bowel bacterial overgrowth.
NCT00577772 ↗	Transit Time and Bacterial Overgrowth Using SmartPill Capsule	Terminated	Mayo Clinic	N/A	2007-11-01	The primary purpose of this exploratory study is to measure orocecal transit time using the SmartPill ambulant capsule technology and to compare this with the lactulose hydrogen breath test. Additionally, the ability of the SmartPill GI Monitoring System to discriminate between healthy human subjects and patients with small bowel bacterial overgrowth will be explored using analyses of both pH and pressure patterns within the stomach and small intestine. The study will be performed in both normal subjects and patients with and without small bowel bacterial overgrowth.
NCT00603616 ↗	Induction of Clinical Response Using Rifaximin in Crohn's Disease	Completed	Bausch Health Americas, Inc.	Phase 2	2008-11-01	Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.
NCT00603616 ↗	Induction of Clinical Response Using Rifaximin in Crohn's Disease	Completed	Valeant Pharmaceuticals International, Inc.	Phase 2	2008-11-01	Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.

Clinical Trial Conditions for Xifaxan

Condition Name

Condition Name for Xifaxan
Intervention	Trials
Small Intestinal Bacterial Overgrowth	4
Cirrhosis	4
Irritable Bowel Syndrome	3
Hepatic Encephalopathy	3

Condition MeSH

Condition MeSH for Xifaxan
Intervention	Trials
Diarrhea	7
Syndrome	5
Irritable Bowel Syndrome	5
Hepatic Encephalopathy	5

Clinical Trial Locations for Xifaxan

Trials by Country

Trials by Country for Xifaxan
Location	Trials
United States	83
China	3
Germany	2
Norway	2
United Kingdom	1

Trials by US State

Trials by US State for Xifaxan
Location	Trials
California	9
Florida	6
Georgia	4
Arizona	4
Texas	4

Clinical Trial Progress for Xifaxan

Clinical Trial Phase

Clinical Trial Phase for Xifaxan
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	6
Phase 2	10

Clinical Trial Status

Clinical Trial Status for Xifaxan
Clinical Trial Phase	Trials
Completed	19
Recruiting	5
Terminated	5

Clinical Trial Sponsors for Xifaxan

Sponsor Name

Sponsor Name for Xifaxan
Sponsor	Trials
Bausch Health Americas, Inc.	8
Valeant Pharmaceuticals International, Inc.	8
Mayo Clinic	4

Sponsor Type

Sponsor Type for Xifaxan
Sponsor	Trials
Other	47
Industry	21
U.S. Fed	7

XIFAXAN: Clinical Trials, Market Analysis, and Projections

Introduction

XIFAXAN, a brand name for the antibiotic rifaximin, has been a significant player in the treatment of various gastrointestinal conditions, including Irritable Bowel Syndrome with Diarrhea (IBS-D) and hepatic encephalopathy. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

TARGET 1 and TARGET 2 Studies

The efficacy of XIFAXAN in treating IBS-D was evaluated in two identical phase 3, randomized, double-blind, placebo-controlled trials, known as TARGET 1 and TARGET 2. These studies involved 1258 patients who met the Rome II criteria for IBS-D. Patients received either XIFAXAN 550 mg three times a day or a placebo for 14 days. The primary endpoint was adequate relief of IBS-D symptoms for at least two of the four weeks following the treatment period. The results showed that 41% of patients in the XIFAXAN group experienced adequate relief, compared to 31% and 32% in the placebo groups of TARGET 1 and TARGET 2, respectively[1].

TARGET 3 Study

The TARGET 3 study focused on the safety and efficacy of repeat treatment with XIFAXAN for patients with IBS-D who had responded to an initial treatment but experienced symptom recurrence. This phase 3 study included an open-label phase followed by a randomized, double-blind phase. The study demonstrated that repeat treatment courses of XIFAXAN were efficacious and provided durable symptom relief. Over one third of the subjects who responded to the initial treatment did not experience relapse of their symptoms during the follow-up period[3].

Efficacy and Symptom Relief

Abdominal Pain and Stool Consistency

XIFAXAN provided significant relief in abdominal pain and improved stool consistency. Patients were considered responders if they experienced a ≥30% decrease from baseline in abdominal pain and a weekly mean stool consistency score of <4 (loose stool) for at least two weeks during the month following treatment[1].

Bloating and Urgency

In addition to abdominal pain and stool consistency, XIFAXAN also provided relief from bloating and urgency. Patients who reported adequate relief of bloating and urgency were defined as those who responded “yes” to weekly questions about these symptoms[1].

Safety and Adverse Reactions

Common Adverse Reactions

The most common adverse reactions occurring in ≥10% of patients and at a higher incidence than placebo included peripheral edema, nausea, dizziness, fatigue, and ascites. Discontinuations due to adverse reactions were relatively low, occurring in 0.4% of patients in trials for travelers’ diarrhea[4].

Special Considerations

Caution is advised when administering XIFAXAN to patients with hepatic impairment or those taking P-glycoprotein (P-gp) inhibitors, as these can increase systemic exposure to the drug. Additionally, XIFAXAN may cause fetal harm and should be discontinued in nursing mothers unless the benefits outweigh the risks[3][4].

Market Analysis

Revenue Trends

XIFAXAN has been a strong revenue generator for Salix Pharmaceuticals. In the second quarter of 2024, Salix revenues totaled $558 million, with XIFAXAN revenues increasing by 10%[2].

Patent and Exclusivity

XIFAXAN is protected by 29 patents in the US and 216 patent family members in 40 countries. The earliest estimated date for generic entry is September 2, 2027, although this could change due to patent challenges or generic licensing. There have been several patent litigation cases, indicating strong interest in generic launch[2].

Market Projections

Generic Entry

The potential for generic entry in 2027 could significantly impact the market dynamics for XIFAXAN. However, the complexity of rifaximin’s polymorphic forms and the ongoing patent litigation may delay generic entry, allowing XIFAXAN to maintain its market share for a longer period[2].

Continued Growth

Given the positive outcomes from clinical trials and the ongoing need for effective treatments for IBS-D and other gastrointestinal conditions, XIFAXAN is likely to continue its growth trajectory. The drug’s efficacy in providing durable symptom relief and its safety profile support its position as a leading treatment option.

Competitive Landscape

Market Competition

XIFAXAN faces competition from other treatments for IBS-D, but its unique mechanism of action and the data from the TARGET studies position it favorably. The lack of meaningful differences in stool frequency between XIFAXAN and placebo in some studies may be a point of comparison, but overall, XIFAXAN’s comprehensive symptom relief makes it a preferred choice for many patients[1].

Conclusion

XIFAXAN has established itself as a reliable and effective treatment for IBS-D and other gastrointestinal conditions. The clinical trials have demonstrated its efficacy in providing symptom relief and its safety profile. While the market is poised for potential changes with the upcoming generic entry, XIFAXAN’s strong revenue trends and ongoing research support its continued market presence.

Key Takeaways

• Efficacy in IBS-D: XIFAXAN provides significant relief in abdominal pain, bloating, and urgency, and improves stool consistency.
• Safety Profile: Common adverse reactions include peripheral edema, nausea, dizziness, fatigue, and ascites, with low discontinuation rates.
• Market Performance: Strong revenue growth, with a 10% increase in the second quarter of 2024.
• Patent and Exclusivity: Protected by multiple patents, with the earliest generic entry estimated for September 2027.
• Market Projections: Likely to continue growth due to its efficacy and safety, despite potential generic competition.

FAQs

What is XIFAXAN used for?

XIFAXAN is used to treat Irritable Bowel Syndrome with Diarrhea (IBS-D), hepatic encephalopathy, and travelers’ diarrhea.

How effective is XIFAXAN in treating IBS-D?

XIFAXAN has been shown to provide significant relief in abdominal pain, bloating, and urgency, and improves stool consistency in clinical trials.

What are the common adverse reactions to XIFAXAN?

Common adverse reactions include peripheral edema, nausea, dizziness, fatigue, and ascites.

When is the earliest estimated date for generic entry of XIFAXAN?

The earliest estimated date for generic entry of XIFAXAN is September 2, 2027.

How does XIFAXAN compare to other treatments for IBS-D?

XIFAXAN’s unique mechanism of action and comprehensive symptom relief make it a preferred choice for many patients, despite some competition from other treatments.

Sources

1. Efficacy Data for Adults with IBS-D | XIFAXAN® (rifaximin) - Xifaxan.com
2. XIFAXAN Drug Patent Profile - DrugPatentWatch
3. Salix Pharmaceuticals, Ltd.'s TARGET 3 Study Examines The Safety And Efficacy Of Repeat Treatment With Rifaximin 550 mg For Irritable Bowel Syndrome - Biospace
4. XIFAXAN® (rifaximin) tablets, for oral use - FDA.gov