Clinical Trials

Multiple clinical trials evaluate rifapentine for infectious disease indications, including latent tuberculosis, active tuberculosis, and pediatric HIV co-infection. Sponsored by government agencies such as the Centers for Disease Control and Prevention, academic institutions, and pharmaceutical organizations like Sanofi, these protocols encompass Phase I pharmacokinetic studies, pediatric safety trials, Phase III comparative evaluations, and pragmatic implementation studies. Across these trials, recruitment statuses range from completed studies to actively recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06281834 Not yet recruiting
Pediatric HIV Infection|Latent Tuberculosis
Brigham and Women''s Hospital|APIN Public Health Initiatives|University of Cape Town
 2024-05 Phase 1
NCT05655702 Recruiting
Tuberculosis
ANRS Emerging Infectious Diseases|Haiphong University of Medicine and Pharmacy|Expertise France|Université Montpellier|New York University|CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES
 2023-10-02 Not Applicable
NCT03730181 Recruiting
Latent Tuberculosis
Centers for Disease Control and Prevention|University of Stellenbosch|Johns Hopkins University|Sanofi|University of Cape Town|Chris Hani Baragwanath Academic Hospital|Washington D.C. Veterans Affairs Medical Center
 2019-10-12 Phase 1|Phase 2
NCT04094012 Completed
Latent Tuberculosis Infection
National Taiwan University Hospital
 2019-09-24 Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Rifapentine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rifapentine selectively binds to bacterial DNA-dependent RNA polymerase, blocking transcription and preventing downstream bacterial protein synthesis. This selective inhibition leads to bactericidal action against Mycobacterium tuberculosis, supporting its utility in clinical trials for active, latent, and pediatric HIV-associated tuberculosis infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.