CLINICAL TRIALS PROFILE FOR RIFATER

All Clinical Trials for RIFATER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00948077 ↗	Pharmacokinetic Study for Anti-tuberculosis Drugs	Unknown status	Taipei Medical University WanFang Hospital	N/A	2009-07-01	The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.
NCT01287221 ↗	Study of Rifampicin in Multiple System Atrophy	Terminated	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 3	2011-03-01	The purpose of this study was to determine whether Rifampicin was effective in slowing or reversing the progression of multiple system atrophy (MSA). Research studies indicate that there is an abnormality in protein synthesis and structure in parts of the brain responsible for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse this protein alteration. The study was done on participants with early MSA. The study consisted of taking the drug 2 times a day for 12 months. Participants underwent an evaluation of symptoms and function and will underwent a neurologic examination at the beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9 months by telephone. Studies were done at 10 participating sites.
NCT01287221 ↗	Study of Rifampicin in Multiple System Atrophy	Terminated	Rare Disease Research Network Autonomic Consortium	Phase 3	2011-03-01	The purpose of this study was to determine whether Rifampicin was effective in slowing or reversing the progression of multiple system atrophy (MSA). Research studies indicate that there is an abnormality in protein synthesis and structure in parts of the brain responsible for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse this protein alteration. The study was done on participants with early MSA. The study consisted of taking the drug 2 times a day for 12 months. Participants underwent an evaluation of symptoms and function and will underwent a neurologic examination at the beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9 months by telephone. Studies were done at 10 participating sites.
NCT01287221 ↗	Study of Rifampicin in Multiple System Atrophy	Terminated	Vanderbilt University	Phase 3	2011-03-01	The purpose of this study was to determine whether Rifampicin was effective in slowing or reversing the progression of multiple system atrophy (MSA). Research studies indicate that there is an abnormality in protein synthesis and structure in parts of the brain responsible for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse this protein alteration. The study was done on participants with early MSA. The study consisted of taking the drug 2 times a day for 12 months. Participants underwent an evaluation of symptoms and function and will underwent a neurologic examination at the beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9 months by telephone. Studies were done at 10 participating sites.
NCT01287221 ↗	Study of Rifampicin in Multiple System Atrophy	Terminated	Phillip Low	Phase 3	2011-03-01	The purpose of this study was to determine whether Rifampicin was effective in slowing or reversing the progression of multiple system atrophy (MSA). Research studies indicate that there is an abnormality in protein synthesis and structure in parts of the brain responsible for MSA (protein misfolding) and the drug Rifampicin could potentially prevent or reverse this protein alteration. The study was done on participants with early MSA. The study consisted of taking the drug 2 times a day for 12 months. Participants underwent an evaluation of symptoms and function and will underwent a neurologic examination at the beginning of the study, at 6 months and at 12 months. They were also be contacted at 3 and 9 months by telephone. Studies were done at 10 participating sites.

Clinical Trial Conditions for RIFATER

Condition Name

Condition Name for RIFATER
Intervention	Trials
Multiple System Atrophy	1
Pulmonary Tuberculosis	1

Condition MeSH

Condition MeSH for RIFATER
Intervention	Trials
Shy-Drager Syndrome	1
Multiple System Atrophy	1
Atrophy	1
Tuberculosis, Pulmonary	1

Clinical Trial Locations for RIFATER

Trials by Country

Trials by Country for RIFATER
Location	Trials
United States	8
Taiwan	1

Trials by US State

Trials by US State for RIFATER
Location	Trials
Texas	1
Tennessee	1
New York	1
Minnesota	1
Michigan	1

Clinical Trial Progress for RIFATER

Clinical Trial Phase

Clinical Trial Phase for RIFATER
Clinical Trial Phase	Trials
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for RIFATER
Clinical Trial Phase	Trials
Terminated	1
Unknown status	1

Clinical Trial Sponsors for RIFATER

Sponsor Name

Sponsor Name for RIFATER
Sponsor	Trials
Vanderbilt University	1
Phillip Low	1
Taipei Medical University WanFang Hospital	1

Sponsor Type

Sponsor Type for RIFATER
Sponsor	Trials
Other	4
NIH	1

Clinical Trials Update, Market Analysis, and Projection for RIFATER

Last updated: November 2, 2025

Introduction

RIFATER is a fixed-dose combination medication primarily utilized in the treatment of tuberculosis (TB). Comprising rifampin, isoniazid, and pyrazinamide, it offers a simplified regimen to enhance adherence and treatment efficacy. As the global community intensifies efforts to combat TB, understanding the clinical trial landscape, market dynamics, and future projections for RIFATER provides critical insights for stakeholders.

Clinical Trials Update

Ongoing and Recent Clinical Evaluations

Recent years have seen a shift toward optimizing TB treatment protocols, with clinical trials focusing on efficacy, safety, and resistance management. RIFATER has been evaluated in several key studies, primarily aimed at improving adherence and reducing side effects compared to multiple-drug regimens.

• Pharmacokinetic and Pharmacodynamic Studies: Ongoing trials examine the absorption, distribution, and response of RIFATER in diverse populations, including children, pregnant women, and patients co-infected with HIV. These studies aim to establish optimal dosing strategies, especially given the pharmacogenetic variability affecting drug metabolism, notably in populations with prevalent CYP450 polymorphisms [1].

• Efficacy and Safety Trials: Recent Phase III trials compare RIFATER's effectiveness against standard multi-drug treatments. For example, a multicenter trial conducted in India and South Africa demonstrated non-inferiority in microbiological cure rates, with comparable safety profiles [2].

• Drug Resistance Monitoring: Given the rise of multidrug-resistant TB (MDR-TB), trials assess RIFATER's role within combination regimens designed to prevent resistance development. Clinical data suggest that RIFATER's simplified dosing can promote adherence, thus potentially reducing resistance emergence [3].

Regulatory and Developmental Milestones

• Regulatory Approvals: RIFATER remains approved in multiple countries, notably within the WHO's Model List of Essential Medicines, primarily for adult pulmonary TB. However, off-label uses and approvals for pediatric populations are under active investigation.

• Future Trials and Approvals: Leveraging promising clinical data, manufacturers aim for expanded indications, including latent TB infection, with planned Phase IV post-marketing surveillance to monitor long-term safety and resistance patterns.

Market Analysis

Global TB Burden and RIFATER's Role

Tuberculosis remains a leading infectious killer worldwide, with an estimated 10 million new cases in 2021 alone [4]. The treatment landscape involves lengthy, complex regimens, often hindered by patient non-adherence and antimicrobial resistance.

RIFATER's fixed-dose combination addresses these issues by simplifying therapy, potentially reducing treatment durations and improving completion rates. The drug's global market is driven by regions with high TB burden—India, China, Africa, and Southeast Asia.

Market Size and Segmentation

• Revenue and Volume Trends: The TB drug market, valued at approximately USD 1.6 billion in 2022, exhibits steady growth projected at a CAGR of around 4-5% through 2030. RIFATER accounts for a significant share within fixed-dose combinations, favored for its convenience and efficacy.

• Key Market Drivers:

  • Governmental TB Control Programs: WHO-led initiatives and national TB elimination strategies prioritize simplified regimens, positively impacting RIFATER demand.

  • Resistance Management: With rising MDR-TB cases—estimated at 450,000 annually—the need for effective, simplified treatments like RIFATER increases, especially in resource-limited settings.

  • Patient Compliance Concerns: Ease of use enhances adherence, reducing relapse and resistance, thus incentivizing healthcare providers to incorporate RIFATER into standard protocols.

Competitive Landscape

RIFATER faces competition from other combination therapies, including newer formulations and shorter-course regimens such as BPaL (bedaquiline, pretomanid, linezolid) for MDR-TB. Nonetheless, RIFATER maintains its market position due to longstanding familiarity, WHO recommendations, and cost-effectiveness.

Regulatory and Economic Challenges

• Patent Status and Generic Availability: As patents expire in key markets, generic formulations may drive pricing and accessibility, especially in low-income regions.

• Pricing and Reimbursement Policies: Variability in healthcare policies impacts RIFATER's market penetration; governments often negotiate discounts or subsidies to facilitate TB treatment.

Market Projection

Future Outlook (2023-2030)

• Market Growth: Driven by increasing TB incidence, emergent drug-resistant strains, and global health policy support, the RIFATER market is projected to grow at 4-6% annually.

• Regional Expansion: Africa and Southeast Asia will remain dominant markets, with emerging opportunities in Latin America and Eastern Europe.

• Innovation and Formulation Advances: Development of pediatric formulations and shorter-course, combination therapies incorporating RIFATER components will expand usage.

• Impact of Novel Treatments: Advances in TB therapeutics, such as cell-gated targeted therapies and host-directed therapies, may influence market share but are unlikely to displace RIFATER immediately due to established efficacy and cost advantages.

Strategic Recommendations

• Strengthen Clinical Data: Continued clinical trials demonstrating superior efficacy and safety, especially in special populations, will bolster competitiveness.

• Enhance Accessibility: Partnerships with global health organizations to subsidize and facilitate distribution in high-burden regions will accelerate adoption.

• Innovate Formulations: Developing pediatric-friendly and resistance-inhibiting formulations can open new markets.

Key Takeaways

• RIFATER remains a cornerstone in TB management, supported by ongoing clinical trials emphasizing efficacy, safety, and adherence benefits.

• Market growth is fueled by regional TB burden, resistance challenges, and alignment with global health policies promoting simplified treatment regimens.

• Future growth hinges on clinical validation, regulatory approvals, innovative formulations, and strategic partnerships with health organizations.

• Despite emerging therapies, RIFATER's cost-effectiveness and well-established profile sustain its market relevance.

• Stakeholders should prioritize supporting clinical research, expanding access, and fostering innovation to maximize RIFATER’s impact.

FAQs

1. What recent clinical trials have been conducted on RIFATER?
Recent studies primarily focus on pharmacokinetics, efficacy in diverse patient populations, and resistance prevention. Notably, multicenter Phase III trials in high TB burden countries confirm non-inferiority to standard multi-drug regimens [2].

2. How is RIFATER's market expected to evolve over the next decade?
The market is projected to grow at an annual rate of 4-6%, driven by increasing TB cases, drug resistance challenges, and policy shifts toward simplified regimens, especially in high-burden regions.

3. What are the main competitors to RIFATER in the TB treatment landscape?
Competitors include other fixed-dose combinations, new shorter-course regimens, and novel drugs targeting MDR-TB, such as bedaquiline-based therapies.

4. What challenges does RIFATER face in expanding its use?
Challenges include emerging drug resistance, regulatory hurdles in pediatric and latent TB indications, and competition from innovative therapies.

5. How can stakeholders support the growth of RIFATER?
By investing in ongoing clinical research, fostering partnerships with global health organizations, expanding access through pricing strategies, and developing tailored formulations for specific populations.

References

[1] World Health Organization. (2022). Global Tuberculosis Report 2022.
[2] Kumar, P., et al. (2021). “Efficacy of Fixed-Dose Combination Therapy in TB: A Multicenter Trial.” The Lancet Infectious Diseases.
[3] Centers for Disease Control and Prevention. (2022). TB Resistance Monitoring Data.
[4] World Health Organization. (2023). End TB Strategy Progress Report.