Pyrazinamide is currently evaluated across several clinical trials of unspecified phases assessing its pharmacokinetics, diagnostic applications, and efficacy in active pulmonary tuberculosis, multidrug-resistant tuberculosis, HIV or diabetes comorbidities, and breastfeeding mother-infant pairs. Sponsored by academic institutions, national research agencies, and healthcare trusts, these studies currently encompass recruiting, active not recruiting, completed, and unknown recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05329415 | Active not recruiting | Tuberculosis|Diabetes Mellitus |
London North West Healthcare NHS Trust |
2022-02-01 | -- |
| NCT05840809 | Recruiting | Tuberculosis Active|Breastfeeding|Tuberculosis |
University of Liverpool|Infectious Diseases Institute Makerere University College of Health Sciences |
2022-01-20 | -- |
| NCT04972903 | Unknown status | Tuberculosis|Pulmonary |
Institut National de la Santé Et de la Recherche Médicale France|National Agency for Research on AIDS and Viral Hepatitis (ANRS) |
2021-08 | -- |
| NCT04239326 | Completed | Tuberculosis Multidrug-Resistant |
Foundation for Innovative New Diagnostics Switzerland |
2021-04-16 | -- |
| NCT03800381 | Recruiting | Tuberculosis|Human Immunodeficiency Virus|Coinfection |
University of Florida|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
2019-01-28 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Check the
Pyrazinamide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.