Data updated: Jun 28, 2026
RIFAPENTINE
Approved 1998-06-22
1
Indication
--
Phase 3 Trials
28
Years on Market
Details
- Status
- Prescription
- First Approved
- 1998-06-22
- Routes
- ORAL
- Dosage Forms
- TABLET
RIFAPENTINE Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Jun 2026 ORIGINAL
Update
What RIFAPENTINE Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2026) New
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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) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
RIFAPENTINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.