CLINICAL TRIALS PROFILE FOR PRIFTIN

All Clinical Trials for PRIFTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00023452 ↗	Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection	Completed	VA Office of Research and Development	Phase 3	2001-06-01	Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).
NCT00023452 ↗	Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection	Completed	Centers for Disease Control and Prevention	Phase 3	2001-06-01	Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).
NCT00694629 ↗	TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment	Completed	Sanofi	Phase 2	2008-12-01	Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimen in which rifapentine is substituted for rifampin. Primary Objective - To compare the antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE). Secondary Objectives - To determine and compare for each regimen the time to culture-conversion, using data from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses). - To determine and compare for each regimen the proportion of patients with any Grade 3 or 4 adverse reactions - To determine the correlation of the MGIT/BACTEC liquid culture growth index and other mycobacterial and clinical biomarkers with time to culture conversion and treatment failure - To store serum for future assessment of biomarkers of TB treatment response and hypersensitivity to study drugs. - To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients - To determine the tolerability and safety, and estimate the antimicrobial activity, of experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily. Assessment of these doses of rifapentine will be performed as an extension to the main study after enrollment in the main study has been completed. Design This will be a prospective, multicenter, open-label clinical study. Adults suspected of having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive either the experimental intensive phase tuberculosis treatment regimen or the standard intensive phase tuberculosis treatment regimen. Randomization will be stratified by presence/absence of cavitation on baseline chest radiograph, and by geographic continent. All doses of study drugs will be given under direct observation and administered 5 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. The study extension will be a prospective, multicenter clinical trial. Eligibility criteria will be the same as for the main study. Participants will be randomized to one of four regimens: the standard intensive phase treatment regimen, an investigational regimen in which rifapentine 10 mg/kg/dose is substituted for rifampin, an investigational regimen in which rifapentine 15 mg/kg/dose is substituted for rifampin, or an investigational regimen in which rifapentine 20 mg/kg is substituted for rifampin. Randomization will be stratified by the presence/absence of cavitation on baseline chest radiograph, and by study site. Study drugs will be administered 7 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. Subjects will have blood drawn for one pharmacokinetic determination of rifapentine concentration at or after the week 2 visit during intensive phase therapy. This study is being conducted in 2 phases. 1. The main study compares a 10 mg/kg dose of rifapentine, open label, against 10 mg/kg rifampin in an otherwise standard intensive phase regimen of treatment for pulmonary tuberculosis. The projected sample size was 480 enrollments; 530 patients were actually enrolled. 2. The study extension evaluates higher doses of rifapentine, with the specific rifapentine doses (10 mg/kg, 15 mg/kg, and 20 mg/kg) blinded to patients and clinicians, with data collection and endpoints otherwise similar to the main study. The projected sample size for the study extension is 320 enrollments.
NCT00694629 ↗	TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment	Completed	Centers for Disease Control and Prevention	Phase 2	2008-12-01	Protocol Synopsis The goal of this Phase 2 clinical trial is to evaluate the antimicrobial activity and safety of an experimental intensive phase (first 8 weeks of treatment) tuberculosis treatment regimen in which rifapentine is substituted for rifampin. Primary Objective - To compare the antimicrobial activity and safety of standard daily regimen comprised of rifampin (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (RHZE) to that of an experimental regimen comprised of rifapentine (approximately 10 mg/kg/dose) + isoniazid + pyrazinamide + ethambutol (PHZE). Secondary Objectives - To determine and compare for each regimen the time to culture-conversion, using data from 2-, 4-, 6-, and 8-week cultures (10, 20, 30, 40 doses). - To determine and compare for each regimen the proportion of patients with any Grade 3 or 4 adverse reactions - To determine the correlation of the MGIT/BACTEC liquid culture growth index and other mycobacterial and clinical biomarkers with time to culture conversion and treatment failure - To store serum for future assessment of biomarkers of TB treatment response and hypersensitivity to study drugs. - To compare adverse events and 2-month culture conversion rates among HIV-infected patients vs. HIV-uninfected patients - To determine the tolerability and safety, and estimate the antimicrobial activity, of experimental regimens that include isoniazid + pyrazinamide + ethambutol plus either rifapentine 15 mg/kg/dose or rifapentine 20 mg/kg/dose, all administered daily. Assessment of these doses of rifapentine will be performed as an extension to the main study after enrollment in the main study has been completed. Design This will be a prospective, multicenter, open-label clinical study. Adults suspected of having pulmonary tuberculosis who meet eligibility criteria will be randomized to receive either the experimental intensive phase tuberculosis treatment regimen or the standard intensive phase tuberculosis treatment regimen. Randomization will be stratified by presence/absence of cavitation on baseline chest radiograph, and by geographic continent. All doses of study drugs will be given under direct observation and administered 5 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. The study extension will be a prospective, multicenter clinical trial. Eligibility criteria will be the same as for the main study. Participants will be randomized to one of four regimens: the standard intensive phase treatment regimen, an investigational regimen in which rifapentine 10 mg/kg/dose is substituted for rifampin, an investigational regimen in which rifapentine 15 mg/kg/dose is substituted for rifampin, or an investigational regimen in which rifapentine 20 mg/kg is substituted for rifampin. Randomization will be stratified by the presence/absence of cavitation on baseline chest radiograph, and by study site. Study drugs will be administered 7 days per week. After a subject completes intensive phase therapy, he/she then will be treated with a non-experimental continuation phase tuberculosis treatment regimen. Subjects will have blood drawn for one pharmacokinetic determination of rifapentine concentration at or after the week 2 visit during intensive phase therapy. This study is being conducted in 2 phases. 1. The main study compares a 10 mg/kg dose of rifapentine, open label, against 10 mg/kg rifampin in an otherwise standard intensive phase regimen of treatment for pulmonary tuberculosis. The projected sample size was 480 enrollments; 530 patients were actually enrolled. 2. The study extension evaluates higher doses of rifapentine, with the specific rifapentine doses (10 mg/kg, 15 mg/kg, and 20 mg/kg) blinded to patients and clinicians, with data collection and endpoints otherwise similar to the main study. The projected sample size for the study extension is 320 enrollments.

Clinical Trial Conditions for PRIFTIN

Condition Name

Condition Name for PRIFTIN
Intervention	Trials
Tuberculosis	4
Latent Tuberculosis	2
Latent Tuberculosis Infection	2
Human Immunodeficiency Virus	1

Condition MeSH

Condition MeSH for PRIFTIN
Intervention	Trials
Tuberculosis	11
Latent Tuberculosis	5
Tuberculosis, Pulmonary	4
Infection	2

Clinical Trial Locations for PRIFTIN

Trials by Country

Trials by Country for PRIFTIN
Location	Trials
United States	47
South Africa	11
Canada	5
Brazil	4
Spain	4

Trials by US State

Trials by US State for PRIFTIN
Location	Trials
Texas	6
California	5
New York	5
Colorado	5
Tennessee	4

Clinical Trial Progress for PRIFTIN

Clinical Trial Phase

Clinical Trial Phase for PRIFTIN
Clinical Trial Phase	Trials
Phase 3	6
Phase 2/Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for PRIFTIN
Clinical Trial Phase	Trials
Completed	7
Unknown status	2
Not yet recruiting	1

Clinical Trial Sponsors for PRIFTIN

Sponsor Name

Sponsor Name for PRIFTIN
Sponsor	Trials
Centers for Disease Control and Prevention	7
AIDS Clinical Trials Group	2
VA Office of Research and Development	1

Sponsor Type

Sponsor Type for PRIFTIN
Sponsor	Trials
Other	13
U.S. Fed	8
Industry	2

Last updated: May 23, 2026

Priftin (rifapentine) clinical trials update, market analysis, and exclusivity-driven projections

What is Priftin (rifapentine) and what is the current clinical-trials landscape?

Priftin is the brand name for rifapentine, a rifamycin-class antibiotic used in tuberculosis (TB) regimens, most prominently in shorter-course treatment strategies that include rifapentine-based combinations.

Which key Priftin clinical programs drive the pipeline?

Rifapentine’s development and lifecycle have concentrated on:

• Active pulmonary TB regimens (short-course combinations).
• Latent TB infection (LTBI) therapy and treatment shortening (often via once-weekly schedules).
• Operationally simplified dosing aligned with TB public-health programs.

What are the most relevant trial milestones to track?

For business decisions, the critical “go/no-go” signals are:

• Phase 3 efficacy readouts for non-inferiority against standard-of-care regimens in TB populations.
• Relapse rates at clinically meaningful follow-up windows (not only early sputum conversion).
• Safety/tolerability that supports fixed-dose regimen scale-up in high-volume settings (liver enzymes, drug interaction profile).
• Regimen simplification outcomes, such as fewer visits or reduced treatment duration while preserving cure rates.

What is the practical implication for the next 12 to 24 months?

Rifapentine’s near-term commercial trajectory is driven less by brand-new molecular trials and more by:

• Protocol adoption in national TB programs (guideline inclusion changes demand).
• Tender and procurement cycles (timing and batch release).
• In-market competition (generic rifapentine and regulator approvals).

How large is the Priftin market and what are the commercial demand drivers?

Market demand drivers

• TB incidence and treatment targets: LTBI and active TB programs are the demand pools.
• Guideline positioning: inclusion in WHO and national protocols affects prescribing volume.
• Treatment duration and adherence economics: rifapentine-based intermittent regimens can reduce patient time burden, which changes health-system willingness-to-adopt.

Where does demand concentrate?

• High-burden TB geographies: procurement-driven markets where programmatic dosing matters.
• Private vs public mix: rifapentine utilization rises faster when payer coverage and procurement support intermittent regimens.

What are the main risks to Priftin volume growth?

• Generic erosion in rifamycin-containing TB therapy.
• Shift in first-line regimen preferences if competing combinations show better outcomes or lower program costs.
• Supply continuity and manufacturing capacity, because TB procurement is sensitive to shortages.

What is the exclusivity and patent expiration outlook for Priftin?

How long does Priftin maintain market protection?

Priftin’s exclusivity profile follows a mature drug pattern:

• Regulatory exclusivity (if any) and patent estate govern branded retention.
• Rifapentine is an established API with extensive generic presence risk once meaningful patent protection ends.

What matters for exclusivity in practice

Even when active patents expire, practical exclusivity depends on:

• Orange Book-listed patents linked to specific dosage forms and strengths.
• Method-of-use and formulation patents that can extend litigation leverage.
• Settlement agreements that can delay generic launches even after core patents expire.

What patents protect Priftin and what formulations or methods are covered?

Patent estate categories to map

For rifapentine products like Priftin, the enforceable IP typically clusters into:

• Method-of-use for specific TB regimen schedules (including intermittent dosing).
• Formulation (drug product composition and/or release characteristics).
• Combination regimen claims covering rifapentine in specified schedules with companion drugs.

How many patents typically cover each Priftin product strength?

Patent coverage for established TB brands is often segmented by:

• Individual strengths
• Different dosage forms (if multiple exist)
• Separate method claims for active TB vs LTBI

What jurisdiction coverage is most relevant for generic launch risk?

• United States via FDA Orange Book listings and Hatch-Waxman litigation.
• Other jurisdictions (EU, UK, Canada, key APAC markets) via national filings and enforcement norms.

What is the Orange Book status of Priftin and which Paragraph IV challenges are most likely?

Orange Book-driven launch risk framework

Generic entry timing for Priftin depends on:

• Whether an ANDA filer files a Paragraph IV certification to challenge Orange Book patents.
• Whether litigation triggers a stay and how it resolves (dismissal, settlement, or judgment).

What is the practical meaning for market forecasting?

• Early Paragraph IV filings often signal near-term branded price pressure.
• Settlements can create a delayed generic entry window even after patent expiry.

How does Priftin compare with competing rifapentine and TB regimen products?

Therapy-level competition

Priftin faces competition from:

• Generic rifapentine products.
• Alternative short-course TB regimens that use different rifamycin strategies or combinations.
• Competing provider preferences shaped by local guidelines and formulary decisions.

Brand vs generic economics

Once generic rifapentine enters, the branded product’s revenue typically falls via:

• Formulary substitution
• Procurement re-bids with lower-cost alternatives
• Margin compression from price matching

What clinical endpoints and trial signals matter most for Priftin adoption?

For TB therapies, the adoption threshold is driven by:

• Cure and relapse outcomes
• Microbiologic conversion at standardized timepoints
• Safety under programmatic use, including:
  • Hepatotoxicity management
  • Drug interaction considerations (rifamycin metabolism induction)
  • Adherence tolerance for intermittent regimens

What is the regulatory status of Priftin and what FDA pathway changes could affect competition?

FDA framework

Rifapentine drug product availability is primarily impacted by:

• ANDA approvals for generics
• Potential 505(b)(2) pathways for modified claims, if reformulations or new regimens are pursued

What regulatory actions can shift commercial outlook quickly?

• New generic approvals that remove supply dependence on branded product.
• Label expansions tied to new regimen claims that can expand patient pools.
• Safety communications that can temporarily reduce utilization.

What patent litigation affects Priftin and how do settlements impact launch timing?

Litigation outcome sensitivity

Market projections depend on whether enforcement resolves via:

• Judgment sustaining key patents (slows entry)
• Settlement agreements (often creates launch calendars)
• Early dismissals or narrower claim interpretations (accelerates generic entry)

Forecast linkage

• Litigation-driven stays affect near-term brand revenue.
• Settlement terms often define the exact quarter when price pressure starts.

What generic entry risks exist for Priftin?

Entry risk channels

• ANDA filings against Orange Book patents
• Final approvals tied to litigation resolution
• Potential “authorized generic” structures depending on settlement terms

What is the likely commercial effect once generics launch?

• Immediate volume shift to lower-priced product
• Slower branded recovery unless brand regains differentiation via:
  • supply assurance,
  • contracts,
  • or label-advantaged indications

Clinical trials update and market projection: 3-scenario outlook

Base case (continued adoption, gradual pricing pressure)

• TB program adoption continues but branded pricing faces sustained compression.
• Generic share expands as procurement cycles reset.

Upside case (label expansion or stronger protocol inclusion)

• If rifapentine regimens gain additional guideline support, demand offsets part of price erosion.
• Revenue decline is slower; market share is more durable.

Downside case (faster generic penetration and procurement substitution)

• If multiple generics launch within a tight window due to rapid patent resolution or settlement-defined entries, branded revenue declines accelerate.

Revenue exposure model: what to forecast

A practical forecast should separate:

1. Unit demand (patient regimens purchased)
2. Net price (after rebates, tender contract discounts)
3. Mix (strength and regimen type)
4. Supply constraints (if any)
5. Time-to-generic entry (litigation and settlement calendar)

Key Takeaways

• Priftin’s near-term market outlook is dominated by TB program adoption and procurement cycles, not new molecular differentiation.
• The main swing factor for revenue projections is generic entry timing, governed by Orange Book patent landscape, Paragraph IV challenges, and settlement calendars.
• Clinical updates that matter most are those that influence guideline inclusion, relapse protection, and safety tolerability at program scale.

FAQs

When do generics typically enter rifapentine products after patent expiry?

Generic entry timing usually follows Orange Book patent expiry plus any litigation stay or settlement-defined launch date, which can shift entry by quarters.

Does rifapentine have biosimilar risk like biologics?

No. Rifapentine is a small molecule; the competitive threat is generics/authorized generics, not biosimilars.

Which TB indications drive rifapentine demand most?

Demand is typically strongest in latent TB infection treatment programs and short-course active TB regimens where intermittent dosing is operationally preferred.

What trial endpoints most influence guideline uptake for rifapentine regimens?

Non-inferiority vs standard regimens with low relapse rates, acceptable safety, and operationally favorable schedules (adherence and monitoring burden).

How do tender contracts change Priftin revenue projections?

Tender awards reset net pricing and volume. Once generics are eligible, procurement tends to shift rapidly toward lowest cost unless supply or label differences create exceptions.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. United States Food and Drug Administration.
2. FDA. Paragraph IV Certification Guidance and Hatch-Waxman regulatory framework materials. United States Food and Drug Administration.
3. World Health Organization. Tuberculosis treatment guidelines and recommendations (rifamycin-based regimens, LTBI recommendations). World Health Organization.