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
HIV Infections	4

Condition MeSH

Condition MeSH for Rifapentine
Intervention	Trials
Tuberculosis	54
Latent Tuberculosis	24
Infections	10
Tuberculosis, Pulmonary	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 and Market Analysis Projection

Last updated: April 23, 2026

What is rifapentine used for and where does it sit in the portfolio?

Rifapentine is a rifamycin-class antibacterial used in tuberculosis (TB) therapy. In practice it is most closely tied to regimens for drug-susceptible and drug-resistant TB, and to shorter-course approaches relative to older daily rifamycin regimens. Its commercial profile is driven by (1) uptake in standardized TB treatment protocols, (2) procurement cycles tied to national TB programs and donor-funded programs, and (3) ongoing lifecycle work in additional regimens and combinations.

What is the latest clinical-trial activity that matters commercially?

Clinical trials that are directly aligned to rifapentine revenue are concentrated in regimen optimization: shorter durations, earlier treatment phase switches, and combinations intended to improve adherence and reduce toxicity while maintaining noninferiority in cure and culture conversion outcomes.

However, a complete, current “clinical trials update” requires up-to-date trial-level indexing (registry IDs, status dates, readouts, and endpoints) that cannot be produced from the information available in this chat. Per operating constraints, the analysis below therefore focuses on what can be stated from established commercial and clinical positioning of rifapentine, without introducing trial-level claims that would need live registry verification.

What endpoints define rifapentine success in trials?

Commercially meaningful rifapentine trial endpoints typically include:

• Culture conversion at defined early timepoints (for example, 2 months) as a predictor of sustained response
• Sustained clinical and microbiologic cure measured through end-of-treatment and follow-up windows
• Treatment completion and adherence as regimen duration shortens
• Safety and tolerability (hepatotoxicity, hypersensitivity, and rifamycin class effects), with special attention to regimen switching dynamics

Where are the key trial design choices that affect adoption?

Market adoption correlates strongly with trial outcomes on:

• Noninferiority vs standard-of-care (often long-course regimens)
• Regimen duration reduction without loss of cure rates
• Applicability across subgroups such as baseline bacillary burden and prior TB exposure
• Operational simplicity: dosing convenience that supports directly observed therapy or community-based delivery models

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How big is the rifapentine market today, and what are the drivers?

Market structure

Rifapentine demand is dominated by:

• Public TB procurement (national TB programs, Global Fund-type purchasing mechanisms, and national tenders)
• Program-driven adoption of specific regimen standards
• Private-sector TB treatment in markets where MDR-TB and DST testing are increasing access

Primary demand drivers

• Short-course regimen preference: programs and payers favor regimens that compress duration and reduce loss-to-follow-up.
• Guideline inclusion: when rifapentine-containing regimens are prioritized in national treatment guidelines, tender volume concentrates.
• Rapid scale-up following procurement decisions: TB medicines follow multi-year procurement cycles, meaning market spikes can align with guideline-driven rollouts.

Primary constraints

• Formulary and tender cycles: sales often lag guideline publication by 6 to 24 months due to procurement lead times.
• Competition within rifamycins: price and availability vs rifampin and other rifamycin options can limit incremental adoption.
• Access to diagnostics: regimen selection depends on DST and program capacity.

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What market projections are realistic for rifapentine?

A defensible projection requires numeric assumptions (current annual sales, forecast horizon, expected penetration, tender timing, price erosion, and competitive displacement). Those inputs are not available in this chat, so a quantified projection cannot be produced without fabricating data.

Directionally, what outcomes move projections?

Rifapentine market growth will most likely track these variables:

• Inclusion in more national guideline pathways for drug-susceptible TB regimen shortening and for select MDR-TB pathways.
• Favorable trial readouts that expand eligibility (for example, broader patient types, fewer contraindications, better safety in combination).
• Manufacturing availability and procurement fill rates during high-volume tender windows.

Scenario logic (non-numeric, decision-grade)

• Bull case: rapid guideline adoption with minimal procurement friction, sustained regimen preference, and limited price compression.
• Base case: continued growth tied to partial pathway adoption with periodic competitive pressure and routine tender lag.
• Bear case: slower guideline translation into tender volume, higher price pressure versus alternatives, or safety signals that restrict use.

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What is the competitive and regulatory landscape risk profile?

Competitive dynamics

Rifapentine competes within TB rifamycin options where regimen selection depends on:

• dosing schedules and program logistics
• relative cost per treated patient
• evidence strength for the relevant patient population

Regulatory dynamics

The risk profile includes:

• label expansion or restrictions based on new clinical evidence
• jurisdiction-specific pricing and procurement policies
• local manufacturing and supply continuity requirements

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What business takeaways drive investment and R&D planning?

1. Clinical value maps to procurement behavior. Trial success that supports regimen shortening can change procurement standards, which drives sales more than incremental improvements in isolated endpoints.
2. Adoption depends on regimen eligibility scope. Expansion across patient subgroups and settings is usually what converts guideline language into tender volume.
3. Market timing is tender-driven. Even strong trial results may not translate into near-term revenue until guideline rollouts and procurement cycles complete.

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Key Takeaways

• Rifapentine’s commercial engine is TB regimen adoption and procurement cycles tied to national guideline translation.
• Trial success most directly affects growth via noninferiority/sustained cure evidence plus operational advantages that reduce duration and support adherence.
• A quantified market projection cannot be stated from the information available in this chat without introducing unsupported numeric claims.
• The highest-leverage R&D focus is expanding eligible populations and reinforcing regimen outcomes that procurement authorities prioritize.

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FAQs

1) What is rifapentine primarily used for commercially?
Rifapentine is used in tuberculosis treatment regimens, with demand concentrated in standardized TB program procurement pathways.

2) What trial outcomes most influence rifapentine uptake?
Noninferiority or superiority in sustained cure outcomes, culture conversion timelines that predict durability, and safety/tolerability that supports protocol adoption.

3) Why do rifapentine sales often track procurement rather than trial timing?
TB medicines follow multi-quarter tender and guideline implementation cycles, so revenue translation can lag clinical readouts.

4) What are the main competitive pressures for rifapentine?
Other rifamycin-based regimens and alternatives that compete on regimen duration, cost per treated patient, and program logistics.

5) What would change rifapentine market growth direction most?
Guideline expansion to broader patient categories and regimen pathways, plus evidence that sustains safety and efficacy while simplifying implementation.

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References

[1] U.S. FDA. Prescribing information for rifapentine (Rifadin/Rifapentine products as applicable).
[2] World Health Organization. Tuberculosis treatment guidance and regimen recommendations (rifamycin-based regimen updates).
[3] ClinicalTrials.gov. Rifapentine-related interventional studies and status records.
[4] CDC. Tuberculosis treatment guidelines and regimen summaries relevant to rifamycin use.