PRIFTIN (rifapentine)
PRIFTIN is indicated for the treatment of Pulmonary Tuberculosis; Latent Tuberculosis Infection.
How PRIFTIN Works
Rifapentine inhibits DNA-dependent RNA polymerase in susceptible strains of *Mycobacterium tuberculosis*. By binding to the beta-subunit of the bacterial enzyme, it prevents the initiation of RNA transcription, thereby inhibiting protein synthesis and causing bacterial cell death. It is bactericidal against both intracellular and extracellular organisms.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-06-22
- Routes
- ORAL
- Dosage Forms
- TABLET
PRIFTIN Approval History
What PRIFTIN Treats
2 indicationsPRIFTIN is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Tuberculosis
- Latent Tuberculosis Infection
PRIFTIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03730181 | 6993 | Ph 1, Ph 2 | completed | Tuberculosis Clinical Trials Consortium Study 35 |
| NCT06253715 SMILE-TB | IRB00388853 | Ph 3 | recruiting | Shortened Regimen for Drug-susceptible TB in Children |
| NCT07124559 | IMPAACT 2024 38747 | Ph 1, Ph 2 | not yet recruiting | A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV |
| NCT05122026 DOLPHIN Moms | IRB00299011 3HP-MOMS-AUR1-6-351 | Ph 1, Ph 2 | active not recruiting | Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV |
| NCT02563327 S31PK/PD | CDC-NCHHSTP-6719 | Ph 3 | completed | Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis |
| NCT04311502 results posted | ACTG A5362 30148 | Ph 2 | terminated | Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study |
| NCT06191692 | TBIshort | Ph 3 | not yet recruiting | 1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam |
| NCT06281834 | 2024P000306 | Ph 1 | recruiting | Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention |
| NCT02410772 S31/A5349 results posted | 6655 | Ph 3 | completed | TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens |
| NCT03510468 results posted | 180087 18-CC-0087 | Ph 1 | completed | Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA) |
| NCT03266991 DOT-LTBI | A101A | Ph 4 | terminated | Treatment of Latent Tuberculosis in Socially Marginalised Citizens |
| NCT03474198 TRUNCATE-TB | TRUNCATE-TB | Ph 2, Ph 3 | completed | Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis |
| NCT05454345 | yzhang207 | Ph 3 | not yet recruiting | Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment |
| NCT02216331 | TMC207-CL002 | Ph 1 | completed | PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002) |
| NCT00694629 | CDC-NCHSTP-5399 | Ph 2 | completed | TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment |
| NCT07595042 | A5414 38987 | Ph 2 | not yet recruiting | A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRIFTIN FDA Label Details
Indications & Usage
FDA Label (PDF)PRIFTIN is indicated for the treatment of Pulmonary Tuberculosis; Latent Tuberculosis Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment