Ethambutol is evaluated across several Phase 1 and Phase 2 clinical trials and observational pharmacokinetic protocols focusing on active pulmonary, recurrent, and multidrug-resistant tuberculosis, alongside drug kinetics in breastfeeding mothers and children. Sponsored by academic, governmental, and non-profit organizations—such as the University of Liverpool, CAPRISA, INSERM, and Médecins Sans Frontières—these studies carry recruitment statuses ranging from actively recruiting to completed and unknown. Together, these investigations assess optimized dosing strategies and therapeutic combinations for diverse patient populations affected by tuberculosis.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| 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 | -- |
| NCT02114684 | Completed | Recurrent Tuberculosis |
Centre for the AIDS Programme of Research in South Africa |
2013-11 | Phase 1|Phase 2 |
| NCT02496572 | Unknown status | Multidrug Resistant Tuberculosis |
Medecins Sans Frontieres Netherlands|Ministry of Health Republic of Uzbekistan|Imperial College London |
2013-09 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).