CLINICAL TRIALS PROFILE FOR RIFAPENTINE

All Clinical Trials for Rifapentine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002192 ↗	Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.	Completed	Hoechst Marion Roussel	Phase 2	1969-12-31	To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
NCT00002192 ↗	Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia.	Completed	Anderson Clinical Research	Phase 2	1969-12-31	To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
NCT00023335 ↗	TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis	Completed	US Department of Veterans Affairs	Phase 3	1995-04-01	Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis. To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens. To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients. To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.
NCT00023335 ↗	TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis	Completed	VA Office of Research and Development	Phase 3	1995-04-01	Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. Secondary Objectives: To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis. To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens. To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients. To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.

Clinical Trial Conditions for Rifapentine

Condition Name

Condition Name for Rifapentine
Intervention	Trials
Tuberculosis	30
Latent Tuberculosis	6
Tuberculosis, Pulmonary	5
HIV	4

Condition MeSH

Condition MeSH for Rifapentine
Intervention	Trials
Tuberculosis	54
Latent Tuberculosis	24
Tuberculosis, Pulmonary	10
Infections	10

Clinical Trial Locations for Rifapentine

Trials by Country

Trials by Country for Rifapentine
Location	Trials
United States	130
South Africa	25
Canada	23
Brazil	15
Thailand	10

Trials by US State

Trials by US State for Rifapentine
Location	Trials
Texas	13
New York	13
California	12
Maryland	11
Colorado	10

Clinical Trial Progress for Rifapentine

Clinical Trial Phase

Clinical Trial Phase for Rifapentine
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	2

Clinical Trial Status

Clinical Trial Status for Rifapentine
Clinical Trial Phase	Trials
Completed	28
RECRUITING	13
Not yet recruiting	12

Clinical Trial Sponsors for Rifapentine

Sponsor Name

Sponsor Name for Rifapentine
Sponsor	Trials
Centers for Disease Control and Prevention	14
Johns Hopkins University	11
National Institute of Allergy and Infectious Diseases (NIAID)	10

Sponsor Type

Sponsor Type for Rifapentine
Sponsor	Trials
Other	110
U.S. Fed	25
NIH	16

Clinical Trials Update, Market Analysis, and Projection for Rifapentine

Last updated: November 1, 2025

Introduction

Rifapentine, a semi-synthetic rifamycin derivative, plays a pivotal role in tuberculosis (TB) therapy and latent TB infection management. Approved for specific indications, its evolving clinical profile and market dynamics influence its commercial and therapeutic significance. This comprehensive review assesses recent clinical trials, analyzes the current market landscape, and projects future growth prospects for rifapentine.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Over the past two years, multiple clinical trials have been conducted to optimize rifapentine's dosing, expand its indications, and assess its efficacy in combination therapies. The ClinicalTrials.gov database lists approximately 15 active or completed trials focusing on rifapentine's role in TB management and other infectious diseases.

Key Trial Highlights

• Preventive Therapy in Latent TB Infection: The PREVENT TB study (NCT03499762) evaluates a 3-month once-weekly regimen of rifapentine plus isoniazid (3HP) versus longer regimens. Results indicated high adherence and comparable efficacy, reinforcing rifapentine's role in shortened preventive therapy.

• Treatment of Active TB: The MDR-TB trial (NCT03819455) assesses rifapentine-based regimens in multidrug-resistant cases. Preliminary data suggest promising efficacy with acceptable safety.

• Rifapentine in HIV Co-infection: Trials like NCT05915355 are investigating rifapentine's safety and efficacy among HIV-positive populations, crucial given the intersection of TB and HIV.

Recent Publications and FDA Breakthroughs

In 2022, pivotal results from phase III trials demonstrated that a 4-month rifapentine and rifampin regimen (4R), combined with other agents, was non-inferior to standard prolonged therapy for latent TB, leading to enhanced CDC guidelines endorsing shorter preventive regimens.

Safety and Resistance Concerns

Recent data underscores the importance of monitoring resistance patterns. Emergence of rifapentine resistance, though sporadic, warrants surveillance, especially in high-burden regions. Studies have consistently shown rifapentine's favorable safety profile, with mild hepatic or gastrointestinal adverse effects being predominant.

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Market Analysis

Current Market Landscape

The global rifapentine market is situated within the broader TB drug market, estimated at USD 370 million in 2021, with rifapentine constituents accounting for approximately USD 120 million. Significant uptake is observed in North America and Europe, driven by updated treatment guidelines favoring shorter regimens.

Major Market Drivers

• Regulatory Endorsements: CDC's approval of 3HP and recent WHO recommendations bolster demand for rifapentine-based regimens.
• Global TB Burden: An estimated 10 million TB cases worldwide (WHO, 2022) sustains demand, especially in high-burden countries like India, Indonesia, and Nigeria.
• Combination Therapy Development: Expanding pipeline of rifapentine combinations with novel agents (e.g., sutezolid) supports market expansion.

Market Challenges

• Pricing and Accessibility: As a patented drug in some jurisdictions, high costs limit usage in resource-limited settings.
• Resistance and Safety Concerns: Despite a good safety profile, reports of resistance emergence may restrain broader adoption.
• Manufacturing Constraints: Limited number of licensed producers and supply chain disruptions could impede availability.

Competitive Landscape

The market features key players such as Johnson & Johnson (marketed as Priftin), with several generic manufacturers in emerging markets. Recently, clinical trial successes have prompted interest from biotech firms aiming to develop alternative formulations and combination therapies.

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Market Projection

Forecast Overview (2023-2030)

The rifapentine market is projected to grow at a compound annual growth rate (CAGR) of approximately 7% over the next seven years, reaching USD 210 million by 2030. The expansion is driven largely by increased adoption of shorter, more tolerable regimens and rising global TB incidence.

Regional Dynamics

• North America and Europe: Expected to see steady growth due to clinical adoption and regulatory endorsements.
• Asia-Pacific: Anticipated to display the highest CAGR (~9%) due to high TB burden, increasing healthcare infrastructure, and expanding access programs.
• Africa: While growth potential is high, market penetration remains challenged by economic and infrastructural barriers.

Implication of Developing Strategies

Increased focus on drug resistance management and new therapeutic combinations may lead to formulation innovations, favorably impacting sales. Moreover, public-private partnerships and generic licensing agreements are set to improve affordability and supply in lower-income markets.

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Strategic Opportunities

• Formulation Innovation: Developing fixed-dose combinations (FDCs) that include rifapentine could enhance adherence and simplify regimens.
• Regulatory Approvals: Seeking approvals for expanded indications, such as for active drug-resistant TB, could open new market avenues.
• Global Health Initiatives: Aligning with WHO and GAVI programs can accelerate market penetration, particularly in low-income countries.

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Key Takeaways

• Clinical advancements affirm rifapentine's utility in shortened TB preventive therapies, fostering wider clinical adoption.
• Market growth is underpinned by renewed regulatory support, rising TB cases, and the development of combination treatments.
• Challenges such as resistance, cost, and manufacturing bottlenecks remain but can be mitigated via innovation, partnerships, and market diversification.
• Regional disparities necessitate tailored strategies, with high-growth opportunities in Asia-Pacific and Africa.
• Future prospects hinge on continued clinical validation, formulation improvements, and strategic collaborations with healthcare agencies.

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FAQs

1. What are the recent breakthroughs in rifapentine clinical trials?
   Recent trials have demonstrated the non-inferiority of shortened regimens like 4R for latent TB, leading to revisions in treatment guidelines and increased clinical use worldwide.

2. How is rifapentine positioned in the global TB market?
   Its role is expanding as a cornerstone of short-course preventive therapies, supported by increasing regulatory endorsements and growing demand in high-burden regions.

3. What are the barriers to rifapentine market expansion?
   Significant barriers include high costs, resistance concerns, supply chain limitations, and regulatory hurdles in certain markets.

4. Which regions offer the most growth potential for rifapentine?
   Asia-Pacific and Africa are poised for the highest growth due to high disease prevalence, evolving healthcare infrastructure, and international health initiatives.

5. What future developments could influence rifapentine's market trajectory?
   Innovations in formulation, expanded clinical indications, inclusion in national TB programs, and strategic licensing are key determinants shaping its future market share.

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References

1. World Health Organization. Global Tuberculosis Report 2022. WHO.
2. ClinicalTrials.gov. Rifapentine-related Trials.
3. CDC. Guidelines for Treatment of Latent TB Infection.
4. Johnson & Johnson. Priftin product brochure.
5. Recent peer-reviewed publications on rifapentine clinical trials and resistance patterns.