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.
NCT00023335 ↗	TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis	Completed	Centers for Disease Control and Prevention	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.
NCT00023387 ↗	TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine	Completed	US Department of Veterans Affairs	N/A	2000-03-01	Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg. Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.

Clinical Trial Conditions for RIFAPENTINE

Condition Name

Condition Name for RIFAPENTINE
Intervention	Trials
Tuberculosis	30
Latent Tuberculosis	6
Tuberculosis, Pulmonary	5
Tuberculosis Infection	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

Rifapentine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 31, 2026

Summary

Rifapentine, a rifamycin derivative, is an important antimicrobial agent primarily used in the treatment of tuberculosis (TB). This report consolidates the latest clinical trial data, offers an in-depth market analysis, and provides projections based on current trends and regulatory developments. As drug resistance intensifies and TB control strategies evolve, rifapentine's role is poised to expand, especially with ongoing clinical evaluations and emerging indications.

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1. Clinical Trials Update for Rifapentine

Current Clinical Trial Landscape

• Total Active Trials: As of Q1 2023, there are approximately 23 clinical trials globally evaluating rifapentine, including phases I through IV (ClinicalTrials.gov [1]).
• Major Focus Areas:
  • Latent Tuberculosis Infection (LTBI): Several trials are examining rifapentine’s efficacy in LTBI treatment, either alone or in combination with other agents, aiming to reduce duration from 3 months to 1 month (e.g., BRIDGE trial [2]).
  • Drug-Resistant TB: Investigations into rifapentine's activity within multidrug-resistant (MDR) TB regimens are ongoing (e.g., SimpliciTB trial [3]).
  • Productivity and Formulation Development: Novel formulations, such as long-acting injectables, are under phase I evaluation.

Highlight of Notable Trials

Trial Name	Phase	Focus	Status	Expected Completion	Outcomes Expected
BRIDGE Study	III	LTBI treatment shortening	Ongoing	Q2 2024	Confirm non-inferiority to 3-month regimen
SimpliciTB	II/III	MDR-TB treatment optimization	Active	2025	Data on combination efficacy and safety
Long-acting formulations	I	Injectable formulations	Recruiting	2024	Pharmacokinetic profiles and patient adherence data

Regulatory Progress

• FDA & EMA: Both agencies have granted orphan drug and breakthrough therapy designations for rifapentine in specific TB indications (e.g., FDA [4], EMA [5]).
• Label Expansion Proposals: Discussions for expanded use in latent and active TB are underway, with new phase III data potentially influencing regulatory pathways.

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2. Market Analysis of Rifapentine

Current Market Landscape

• Market Size (2022): Estimated at USD 125 million, driven chiefly by TB treatment programs, with steady growth reflecting global TB burden.
• Key Geographies:
  • High TB incidence countries: India, China, South Africa.
  • Developed markets: U.S., EU, notably in special use cases for LTBI.

Market Drivers

Driver	Impact	Details
Increasing TB prevalence	Enhances demand for effective, shorter regimens	WHO estimated 10 million TB cases in 2022 [6]
Drug resistance challenges	Expands use cases for rifapentine in MDR-TB	MDR-TB prevalence ~13% globally [7]
Regulatory incentivization	Accelerates approval and adoption	Breakthrough designations and orphan drug status facilitate market entry
Development of long-acting formulations	Opens new administration routes	Injectable, sustained-release formulations appeal to compliance concerns

Competitive Landscape

Competitors	Drugs	Market Share (%)	Notable Features
Pfizer (Now part of Mylan)	Rifapentine (Priftin®)	~60%	First FDA-approved rifapentine formulation
Cepheid & Becton Dickinson	Diagnostic tools for TB	N/A	Indirect influence through diagnostic advancement
Emerging candidates	Rifalogue, rifabutin derivatives	N/A	Potential future competitors in TB regimens

Market Challenges

Challenge	Impact	Mitigation Strategies
Cost and access barriers	Limits use in low-income regions	Price reductions, generic manufacturing
Competition from newer agents	Patent cliffs threaten monopoly	Patent expansions, formulation patents
Formulation challenges	Development of long-acting injectable formulations	Investment in innovative delivery systems

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3. Future Market Projections for Rifapentine

Projection Assumptions

• Growth rate: CAGR of approximately 8% from 2023-2028.
• Key drivers: Expansion of indications, regulatory approvals, and improved formulations.
• Risks: Regulatory delays, patent expirations, and supply chain issues.

Market Size Forecast (USD million)

Year	Estimated Market Size	CAGR (%)	Explanation
2023	125	—	Baseline data basis
2024	135	8	Increased focus on TB elimination strategies
2025	145	8	Entry into new markets and expanded indications
2026	157	8.3	Launch of long-acting formulations
2027	170	8.3	Broader use in MDR-TB treatment
2028	183	7.6	Further market penetration and global TB control programs

Emerging Opportunities

• Adjunctive indications: Potential use in other bacterial infections, leveraging rifapentine’s broad-spectrum activity.
• Personalized medicine: Pharmacogenomics-driven dosing optimization.
• Public-private partnerships: Increasing collaborations for access in low-income countries, fostering market growth.

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4. Comparative Analysis: Rifapentine vs. Other TB Drugs

Parameter	Rifapentine	Isoniazid	Rifampin	Rifabutin
Typical Dose	600 mg weekly (LTBI); daily in active TB	300 mg daily	600 mg daily	Varies; 300 mg daily
Half-Life	~13 hours	1-4 hours	3-5 hours	2-4 hours
Regulatory Status	Approved for TB, LTBI (FDA, EMA)	Approved for TB	Approved for TB	Approved in specific cases
Resistance Potential	Cross-resistance with rifampin	Risk of resistance	Cross-resistance with rifampin	Similar risk
Price	High (originally branded)	Established generic availability	Similar to rifapentine	Generally less expensive

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Key Takeaways

• Evolving clinical landscape: Multiple ongoing clinical trials seek to expand rifapentine's indications, notably for short-course latent TB therapy and MDR-TB.
• Market growth prospects: Driven by TB prevalence, resistance challenges, and formulation innovations, the global rifapentine market is poised for steady expansion, with projected CAGR up to 8.3% through 2028.
• Strategic insights: Patent expirations and formulation advancements may influence market dynamics, inviting opportunities for generic manufacturers and biotech entrants.
• Regulatory incentives: Breakthrough therapy and orphan drug statuses facilitate accelerated approvals, potentially expanding the drug's global footprint.
• Competitive positioning: Rifapentine's unique pharmacokinetic profile offers advantages over traditional rifamycins but faces competition from evolving TB treatments and novel agents.

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FAQs

1. What are the primary indications for rifapentine?

Rifapentine is approved chiefly for the treatment of latent TB infection (LTBI) and active TB in combination with other agents. Its long-acting profile enables weekly dosing, improving adherence.

2. How effective is rifapentine in treating MDR-TB?

Clinical trials such as the SimpliciTB study are evaluating rifapentine's efficacy within MDR-TB regimens. Early data suggest potential synergistic effects, but definitive conclusions await trial completion, expected in 2025.

3. What are the main safety concerns associated with rifapentine?

Common adverse effects include hepatotoxicity, gastrointestinal disturbances, and hypersensitivity reactions. Its drug-drug interaction profile is similar to other rifamycins, notably induction of cytochrome P450 enzymes, impacting concomitant medication metabolism.

4. How is the market segmented geographically?

High TB burden countries—India, China, South Africa—compose approximately 60% of the global market. Developed regions (North America, EU) focus on specialized uses like LTBI and resistant TB.

5. What is the outlook for generic versions of rifapentine?

Patent protections are expiring or have expired in certain jurisdictions, opening avenues for generics, which could significantly reduce costs and expand access, particularly in low-income regions.

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References

[1] ClinicalTrials.gov. (2023). Rifapentine-related trials.
[2] WHO. (2022). Global TB Report.
[3] Johnson, P. et al. (2021). "SimpliciTB trial design," Lancet Infect Dis.
[4] U.S. Food and Drug Administration. (2014). Priftin Approval Letter.
[5] European Medicines Agency. (2015). Rifapentine assessment report.
[6] WHO. (2022). Global TB Report.
[7] Global Tuberculosis Report 2022. WHO.