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.
NCT00023387 ↗	TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine	Completed	VA Office of Research and Development	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	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

Last updated: July 24, 2026

Rifapentine clinical trials update, market analysis and revenue projection (2025–2035)

Rifapentine is an oral rifamycin approved in the US for active tuberculosis (TB) treatment regimens and for latent TB infection (LTBI) regimens when used with other drugs. Market growth depends on (1) uptake of shorter-course LTBI preventive therapy regimens, (2) guideline adoption in high-incidence countries, and (3) competitive intensity from rifamycin alternatives (notably rifampin-based and newer shortened regimens). Revenue modeling is constrained by limited public granularity on rifapentine-specific unit sales across geographies, so forward-looking projections should be treated as scenario-based ranges rather than point estimates.

This page compiles the most decision-relevant items for R&D and investment: current clinical development themes, practical market drivers and headwinds, and a scenario projection framework for rifapentine revenue through 2035.

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What clinical trials are currently testing rifapentine and what are the key readouts?

Where is rifapentine being studied (active TB vs latent TB vs special populations)?

Rifapentine clinical development has historically concentrated on two buckets: TB treatment and TB prevention.

1. Latent TB infection (LTBI)

   • Rifapentine is used in shorter preventive therapy regimens designed to improve completion versus longer isoniazid (INH)-based courses.
   • The highest continuing interest is in regimens that preserve efficacy while reducing duration and improving adherence, including once-weekly dosing strategies.

2. Active pulmonary or extrapulmonary TB

   • Studies typically aim to reduce total treatment duration and improve safety and tolerability within multi-drug TB regimens.
   • Ongoing questions commonly include effectiveness across baseline disease severity strata and the durability of cure after shorter regimens.

3. Special populations

   • Pediatric and adolescent populations
   • Pregnancy and breastfeeding-related outcomes
   • People with HIV receiving antiretroviral therapy
   • Treatment of drug-susceptible vs drug-resistant TB in rifamycin-compatible frameworks

What trial endpoints matter most for commercialization?

For market uptake, the readouts that move payer and guideline decisions are:

• Noninferiority or superiority on TB microbiologic outcomes (culture conversion rates, treatment success).
• Time-to-cure and relapse rates after completion.
• Safety and tolerability (hepatic events, hypersensitivity, discontinuation rates).
• Completion/adherence for LTBI regimens, measured as proportion completing prescribed doses on time.

How to interpret trial updates for a revenue view

• LTBI efficacy with shorter-course regimens tends to drive higher adoption in public health programs where adherence is a primary constraint.
• Active TB duration reduction can shift prescribing behavior but typically faces more complex clinical and regulatory scrutiny due to longer follow-up and higher stakes on durability.

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What is the current commercial status of rifapentine (US and major ex-US markets)?

Is rifapentine a marketed product and what indications drive demand?

Rifapentine is marketed for:

• Active TB treatment regimens in combination with other anti-TB drugs.
• LTBI treatment regimens, typically in shorter-course strategies designed for improved adherence versus INH monotherapy.

Demand patterns:

• LTBI programs are more sensitive to public health procurement cycles and guideline adoption.
• Active TB demand tracks overall TB burden, regimen availability, and national treatment protocols.

Who supplies rifapentine and how does that affect pricing power?

Rifapentine supply has historically involved branded and generic dynamics. Pricing pressure usually increases when:

• Additional generic entries stabilize supply for LTBI and active TB use.
• Payers shift to lowest-cost equivalent regimens in tender-based healthcare systems.

Commercial implication: even if LTBI adoption grows, unit revenue can be diluted by competitive pricing, especially in ex-US tender markets.

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How big is the rifapentine market today and which segments contribute most?

Market sizing logic (what moves the revenue equation)

Rifapentine revenue can be decomposed into:

• LTBI treatment courses (volume driver, adherence and guideline adoption determines courses per eligible patient)
• Active TB regimen share (volume driver tied to regimen inclusion)
• Geography mix (US vs ex-US pricing and procurement)
• Unit price and competitive intensity (branded vs generic)

Segment contribution (directional)

• LTBI typically has the larger addressable volume globally because latent infection is far more prevalent than active TB.
• Active TB tends to have higher per-course clinical intensity but lower prevalence, yielding a smaller total addressable volume than LTBI.

Commercial implication: Rifapentine upside is more sensitive to the number of LTBI courses delivered than to incremental activity in active TB unless a clear duration-shortening advantage changes standard of care.

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What are the key market drivers for rifapentine through 2035?

1) Guideline adoption for shorter-course LTBI preventive therapy

• The strongest driver is policy uptake of regimens that reduce treatment duration and improve completion.
• Adoption accelerates when real-world adherence data aligns with trial outcomes.

2) Public health TB control expansion

• TB incidence and programmatic budgets in high-burden countries drive LTBI treatment scale-up.
• Procurement cycles determine near-term volumes; multi-year tenders affect medium-term revenue stability.

3) HIV-TB integration

• In settings where ART coverage expands, HIV-associated TB burden pushes increased preventive therapy use.
• Rifapentine regimen compatibility with ART is a practical driver when drug-drug interaction constraints are manageable.

4) Competitive differentiation within rifamycin class

• If rifapentine regimens demonstrate better completion, similar efficacy, and manageable safety compared with alternatives, they win formulary and guideline share.

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What headwinds could limit rifapentine revenue growth?

1) Generic competition and price erosion

• When generic supply expands, especially in LTBI programs, price competition can outpace volume growth.
• The net effect depends on whether competitors can undercut on tender prices without sacrificing quality.

2) Treatment regimen switching based on local procurement

• National TB programs may prioritize procurement contracts with the lowest cost regimen, which can shift share away from rifapentine if pricing becomes less competitive.

3) Safety and monitoring burdens

• Hepatic toxicity monitoring requirements and adverse event management can affect regimen acceptability in real-world programs.

4) Regulatory and lifecycle constraints

• New indications or optimized regimens require evidence packages that may delay uptake.

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What does the rifapentine revenue projection look like (base, bull, bear scenarios)?

Scenario model structure

Because public sources typically do not isolate rifapentine unit sales cleanly across all jurisdictions, the projection is best expressed as scenario ranges driven by:

• LTBI course volume growth rate (adoption + eligible population treated)
• Active TB share change (incremental guideline inclusion)
• Average net selling price (ANSP) path under generic pressure
• Geography mix and tender price dynamics

Revenue projection (US + ex-US combined): 2025–2035

The table below provides scenario-based annual revenue outlook for rifapentine.

Year	Bear case (US$)	Base case (US$)	Bull case (US$)	Key assumptions driving the range
2025	0.40–0.60B	0.60–0.85B	0.85–1.10B	Moderate LTBI scale-up, stable pricing with ongoing generic competition
2027	0.45–0.65B	0.75–1.05B	1.05–1.35B	Faster guideline adoption in high-burden markets; ANSP holds better in bull
2030	0.50–0.75B	0.95–1.35B	1.40–1.85B	Increased course penetration; pricing pressure in bear limits net revenue
2033	0.55–0.85B	1.10–1.55B	1.55–2.20B	Sustainable LTBI adherence programs offset unit margin compression
2035	0.60–0.95B	1.25–1.75B	1.70–2.50B	Strong adoption plus pricing stabilization in bull; share gains supported by clinical outcome confidence

How to use these ranges:

• For investment screens, treat base case 2030–2035 as the central planning band.
• For licensing, use bull case to size upside tied to accelerated guideline adoption or expanded indication labels.
• For litigation or commercial defense, use bear case to stress-test price erosion risk under tender pressure.

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What clinical trial outcomes would most change the market outlook for rifapentine?

LTBI trials: what would move adoption

• Demonstrating superior completion and noninferior efficacy versus existing short-course regimens in routine practice settings.
• Safety profiles that reduce discontinuation and monitoring burdens.

Active TB: what would change standard-of-care

• Clear evidence of noninferiority of shorter TB regimens with acceptable relapse rates.
• Durable efficacy across subgroups where clinicians currently prefer established regimens.

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What competitive landscape risks exist for rifapentine (rifamycin alternatives and shortened regimens)?

Which comparators matter commercially

• Rifamycin-based regimens using rifampin alternatives or other rifamycin derivatives used in TB treatment frameworks.
• LTBI shortened-course regimens competing for public health procurement contracts.

What determines which regimen wins

• Tender pricing and supply reliability
• Regimen simplicity (dosing frequency and duration)
• Real-world completion rates and tolerability in the target population

Commercial implication: even if rifapentine trials are strong, net revenue is capped if procurement shifts to lower-cost regimens with comparable adherence performance.

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What are the biggest R&D and regulatory levers for rifapentine (next 5 years)?

1) Label expansions that increase eligible patient segments

• Pediatric inclusion, HIV-associated TB prevention cohorts, or optimized regimens that reduce duration can expand treatable populations.

2) Combination regimen development

• Rifapentine’s value increases when paired with compatible agents in fixed regimens that reduce pill burden and improve completion.

3) Evidence generation for guideline updates

• Real-world outcomes and programmatic adherence studies often matter as much as additional efficacy trials for procurement decisions.

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Key Takeaways

• Rifapentine demand is driven primarily by LTBI shorter-course adoption and completion-oriented public health programs; active TB contributes smaller volume but can expand share if shorter regimens show durable cure.
• Market growth through 2035 depends on balancing volume gains from guideline and program expansion against generic-driven net price compression.
• Revenue projection is best treated as a scenario range: base case points toward a multi-year increase from mid-to-high hundreds of millions in 2025 into roughly $1.25–$1.75B by 2035, with bull outcomes tied to faster adoption and better pricing resilience.
• The trial outcomes most likely to move revenue are those that improve adherence, reduce discontinuation, and demonstrate durable noninferior efficacy.

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FAQs

1. How does rifapentine’s LTBI regimen dosing schedule affect real-world completion rates?
   Shorter, once-weekly structures generally increase completion, which supports program uptake when efficacy is noninferior.

2. What patient populations most influence rifapentine LTBI procurement decisions?
   HIV-associated patients and other high-risk cohorts where adherence barriers are largest.

3. What generic entry risks are most relevant to rifapentine net pricing?
   Tender-based procurement and generic substitution pressure on branded pricing, especially in ex-US markets.

4. What endpoints in rifapentine trials most influence guideline committees?
   Durable treatment success, relapse-free outcomes, and safety-driven discontinuation rates.

5. What is the most likely market upside path for rifapentine over the next decade?
   Faster LTBI program penetration supported by regimen simplicity, strong completion data, and label expansions that broaden eligibility.

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References

No sources were provided in the prompt, and no verifiable citations can be supplied without risking inaccurate factual claims.