Sulfadoxine is currently being evaluated across several clinical trials investigating its utility in malaria prevention, maternal malaria during pregnancy, and bioequivalence assessments. Encompassing Phase I, Phase III, Phase IV, and unclassified trial phases, these studies are sponsored by both research networks and pharmaceutical manufacturers. Spanning recruiting, active not recruiting, and unknown recruitment statuses, these efforts underscore the ongoing clinical interest in optimizing sulfadoxine-based combination regimens for parasitic disease control.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06162078 | Recruiting | Maternal Malaria During Pregnancy - Baby Not Yet Delivered |
Groupe de Recherche Action en Sante|European Vaccine Initiative |
2023-08-25 | -- |
| NCT05979896 | Recruiting | Malaria |
Malaria Consortium |
2023-07-28 | Phase 4 |
| NCT05478954 | Active not recruiting | Malaria |
Malaria Consortium |
2022-07-15 | Phase 4 |
| NCT05471544 | Active not recruiting | Malaria |
Malaria Consortium |
2022-07-18 | Phase 3 |
| NCT04577469 | Unknown status | Bioequivalence |
Emzor Pharmaceutical Industries Limited |
2020-12 | Phase 1 |
(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>).