CLINICAL TRIALS PROFILE FOR RIFAXIMIN

505(b)(2) Clinical Trials for Rifaximin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03124199 ↗	Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection	Completed	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 3	2014-02-01	Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.

All Clinical Trials for Rifaximin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00098384 ↗	Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea	Completed	Bausch Health Americas, Inc.	Phase 2	2003-06-01	The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
NCT00098384 ↗	Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea	Completed	The University of Texas Health Science Center, Houston	Phase 2	2003-06-01	The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
NCT00098384 ↗	Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea	Completed	Valeant Pharmaceuticals International, Inc.	Phase 2	2003-06-01	The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
NCT00098384 ↗	Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea	Completed	DuPont, Hurbert L., MD	Phase 2	2003-06-01	The purpose of this study is to evaluate the effectiveness of poorly absorbed rifaximin in the prevention of travelers' diarrhea among U.S. college students in Mexico for five weeks.
NCT00259155 ↗	Rifaximin for the Treatment of Irritable Bowel Syndrome	Completed	Bausch Health Americas, Inc.	Phase 2	2003-07-01	We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.
NCT00259155 ↗	Rifaximin for the Treatment of Irritable Bowel Syndrome	Completed	University of Chicago	Phase 2	2003-07-01	We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.
NCT00259155 ↗	Rifaximin for the Treatment of Irritable Bowel Syndrome	Completed	Valeant Pharmaceuticals International, Inc.	Phase 2	2003-07-01	We have recently shown that the majority of patients with irritable bowel syndrome (IBS) have an abnormal lactulose breath test to suggest the presence of bacterial overgrowth of the small intestine. In open label and double blind treatment of IBS subjects with antibiotics, a dramatic improvement in clinical symptoms are observed. In these studies, the antibiotic chosen was neomycin, which is noted to have an efficacy of 20-25% in normalizing the lactulose breath test. A more efficacious antibiotic is needed. Therefore the aim of this study is to determine the efficacy of rifaximin in normalizing the lactulose breath test in IBS subjects with concomitant improvement in clinical symptoms.

Clinical Trial Conditions for Rifaximin

Condition Name

Condition Name for Rifaximin
Intervention	Trials
Hepatic Encephalopathy	30
Liver Cirrhosis	15
Irritable Bowel Syndrome	11
Cirrhosis	9

Condition MeSH

Condition MeSH for Rifaximin
Intervention	Trials
Brain Diseases	38
Hepatic Encephalopathy	38
Liver Cirrhosis	27
Fibrosis	25

Clinical Trial Locations for Rifaximin

Trials by Country

Trials by Country for Rifaximin
Location	Trials
United States	405
China	14
Italy	13
India	11
Mexico	9

Trials by US State

Trials by US State for Rifaximin
Location	Trials
California	25
New York	21
Florida	19
Virginia	17
Texas	16

Clinical Trial Progress for Rifaximin

Clinical Trial Phase

Clinical Trial Phase for Rifaximin
Clinical Trial Phase	Trials
Phase 4	32
Phase 3	31
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for Rifaximin
Clinical Trial Phase	Trials
Completed	71
Recruiting	30
Unknown status	27

Clinical Trial Sponsors for Rifaximin

Sponsor Name

Sponsor Name for Rifaximin
Sponsor	Trials
Bausch Health Americas, Inc.	36
Valeant Pharmaceuticals International, Inc.	33
Alfasigma S.p.A.	7

Sponsor Type

Sponsor Type for Rifaximin
Sponsor	Trials
Other	210
Industry	93
U.S. Fed	19

Rifaximin: Clinical Trials, Market Analysis, and Projections

Introduction to Rifaximin

Rifaximin is a broad-spectrum antibiotic that has been widely used for the treatment of various gastrointestinal conditions, including irritable bowel syndrome with diarrhea (IBS-D), traveler's diarrhea, and hepatic encephalopathy. Here, we will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are currently underway or have recently been completed to evaluate the efficacy and safety of rifaximin in different indications.

• Hepatic Encephalopathy and Cirrhosis: A study at the University of California Health, scheduled to end in September 2025, is investigating the use of Rifaximin Soluble Solid Dispersion (SSD) for the delay of hepatic encephalopathy in patients with cirrhosis[4].
• IBS-D and Repeat Treatment: Phase 3 trials, such as the TARGET 1 and TARGET 2 studies, have shown that rifaximin is effective in treating IBS-D, with 40.7% of patients experiencing adequate relief of global IBS symptoms compared to 31.7% on placebo. A subsequent trial evaluated the safety and efficacy of repeat treatment with rifaximin, showing significant improvements in symptoms and low adverse event rates[3].
• Other Indications: Rifaximin is also being studied in various other conditions, including ascites, fibrosis, spontaneous bacterial peritonitis, and Crohn's disease. For example, a Phase 3 trial analyzed the effect of perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant patients[1].

Safety and Efficacy

Clinical trials have consistently shown that rifaximin has a favorable safety profile. In blinded comparisons, rifaximin has been found to have no side effects that differ significantly from placebo. The drug has been approved by the US FDA for the treatment of IBS-D since May 2015[3].

Market Analysis

Current Market Trends

The market for rifaximin is influenced by several factors, including supply-demand imbalances, economic conditions, and strategic pricing decisions.

• Price Forecast: In Germany, the prices of rifaximin are expected to decline modestly due to a buildup of inventory by pharmaceutical distributors and wholesalers, reduced consumer spending, and lower energy costs. This cautious market sentiment and strategic pricing are likely to maintain competitive pricing without significant fluctuations[2].
• Global Market: The global market for rifaximin API is expected to see stable demand over the next few years. A market research report forecasts overall sales and demand from 2024 to 2030, highlighting the global market share and ranking of key players in the healthcare and pharma industry[5].

Economic Factors

Economic conditions play a crucial role in shaping the market for rifaximin.

• Consumer Spending: A decline in consumer spending in Germany, reflected in weak retail performance, has contributed to reduced demand for pharmaceuticals, including rifaximin. This reduced demand has led to lower prices as retailers and suppliers aim to remain competitive[2].
• Energy Costs: The reduction in energy prices in November 2024 has helped lower operational costs for pharmaceutical manufacturers and distributors, allowing these savings to be passed on to consumers in the form of reduced prices[2].

Supply Chain Considerations

The supply chain for rifaximin, particularly the import of Active Pharmaceutical Ingredients (APIs) from Asian markets like China, is another critical factor.

• Preemptive Ordering: As the Chinese Lunar New Year approaches, market participants may place orders in advance to ensure sufficient supply during the holiday season, potentially leading to a slight uptick in prices at the start of the year[2].

Market Projections

Short-Term Projections

In the short term, the market for rifaximin is expected to remain stable with only slight price changes.

• Stable Pricing: The forecast for early 2025 suggests a stable market with competitive pricing maintained by cautious market sentiment and strategic pricing decisions by industry players[2].

Long-Term Projections

Over the long term, the demand for rifaximin is expected to be driven by its efficacy in treating various gastrointestinal conditions.

• Global Demand: The global market for rifaximin API is projected to see steady demand from 2024 to 2030, driven by its use in treating IBS-D, hepatic encephalopathy, and other conditions. The market research report provides detailed forecasts and rankings of key players in the industry[5].

Key Takeaways

• Clinical Trials: Rifaximin continues to be evaluated in various clinical trials for its efficacy and safety in treating different gastrointestinal conditions.
• Market Stability: The market for rifaximin is expected to remain stable with slight price changes due to supply-demand imbalances and economic factors.
• Economic Influence: Economic conditions, such as consumer spending and energy costs, significantly impact the pricing and demand for rifaximin.
• Supply Chain: The import of APIs from Asian markets and preemptive ordering strategies influence the supply chain and pricing of rifaximin.

FAQs

What is Rifaximin used for?

Rifaximin is used for the treatment of various gastrointestinal conditions, including irritable bowel syndrome with diarrhea (IBS-D), traveler's diarrhea, and hepatic encephalopathy.

Are there any ongoing clinical trials for Rifaximin?

Yes, several clinical trials are ongoing, including a study on the use of Rifaximin Soluble Solid Dispersion (SSD) for the delay of hepatic encephalopathy in patients with cirrhosis.

Why are Rifaximin prices expected to decline in Germany?

Rifaximin prices are expected to decline in Germany due to a buildup of inventory by pharmaceutical distributors, reduced consumer spending, and lower energy costs.

What is the global market outlook for Rifaximin API?

The global market for rifaximin API is expected to see steady demand from 2024 to 2030, driven by its use in treating various gastrointestinal conditions.

How does the supply chain affect Rifaximin prices?

The supply chain, particularly the import of APIs from Asian markets and preemptive ordering strategies, can lead to slight price fluctuations, especially around the Chinese Lunar New Year.

Sources

1. Patsnap Synapse: Rifaximin - Drug Targets, Indications, Patents.
2. ChemAnalyst: Rifaximin Prices to Decline Modestly in Germany Amid Supply-Demand Imbalances.
3. ClinicalTrials.gov: Evaluation of the Efficacy and Safety of Rifaximin in Combination.
4. ClinicalTrials.ucbraid.org: Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Hepatic Encephalopathy and Cirrhosis.
5. MarketResearchReports.com: Rifaximin API - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.