Numerous clinical trials evaluate the therapeutic and pharmacokinetic profiles of proguanil, primarily focusing on Plasmodium falciparum malaria, chemoprophylaxis, drug metabolism, membrane transport, and CYP2C19 genotypes. Spanning Phase 1 through Phase 4, these studies encompass completed, withdrawn, and terminated protocols evaluating drug safety, tolerability, and combination regimens. Major industry and institutional sponsors supporting this research include GlaxoSmithKline, Medicines for Malaria Venture, Radboud University Medical Center, and Seoul National University Hospital.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06294912 | COMPLETED | Malaria |
Merck Sharp & Dohme LLC |
2024-04-18 | PHASE1 |
| NCT05974267 | COMPLETED | Malaria Infection |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2023-11-28 | PHASE2 |
| NCT03726593 | UNKNOWN | Plasmodium Falciparum Malaria (Drug Resistant) |
Armed Forces Research Institute of Medical Sciences, Thailand |
2018-10-04 | PHASE4 |
| NCT04568772 | COMPLETED | Gastroesophageal Reflux Disease |
Seoul National University Hospital |
2020-11-25 | PHASE1 |
| NCT04203186 | WITHDRAWN | Plasmodium Falciparum |
U.S. Army Medical Research and Development Command |
2020-03 | |
| NCT03813108 | TERMINATED | Malaria,Falciparum; Controlled Human Malaria Infection; Immunization; Infection |
Radboud University Medical Center |
2019-04-01 | |
| NCT03178643 | COMPLETED | Malaria,Falciparum |
Duke University |
2018-01-23 | PHASE4 |
| NCT03278808 | WITHDRAWN | Malaria |
U.S. Army Medical Research and Development Command |
2018-09-17 | PHASE2 |
| NCT04002687 | COMPLETED | Malaria |
Medicines for Malaria Venture |
2019-04-04 | PHASE1 |
| NCT04002687 | Completed | Malaria |
Medicines for Malaria Venture|Richmond Pharmacology Limited |
2019-04-04 | Phase 1 |
| NCT03454048 | COMPLETED | Malaria,Falciparum; Gametocytes; Controlled Human Malaria Infection; Transmission |
Radboud University Medical Center |
2018-05-07 | |
| NCT02564471 | COMPLETED | Rabies |
State University of New York - Upstate Medical University |
2016-11-11 | PHASE4 |
| NCT02858817 | COMPLETED | Malaria |
University Hospital Tuebingen |
2016-11-28 | PHASE1 |
| NCT02836002 | COMPLETED | Malaria |
Radboud University Medical Center |
2016-06 | PHASE1; PHASE2 |
| NCT02054299 | COMPLETED | Drug Metabolism; Membrane Transport |
University Medical Center Goettingen |
2013-04 | PHASE1 |
| NCT02297477 | UNKNOWN | Malaria |
Armed Forces Research Institute of Medical Sciences, Thailand |
2014-12 | PHASE4 |
| NCT02098590 | COMPLETED | Malaria |
Radboud University Medical Center |
2014-10 | |
| NCT02080026 | COMPLETED | Malaria |
Radboud University Medical Center |
2014-06 | |
| NCT01150344 | COMPLETED | Malaria |
Assistance Publique - Hôpitaux de Paris |
2010-07 | PHASE4 |
| NCT01456546 | COMPLETED | CYP2C19 Genotypes |
University of Southern Denmark |
2011-10 | PHASE1 |
| NCT01319448 | COMPLETED | Malaria; Sickle Cell Crisis |
London School of Hygiene and Tropical Medicine |
2011-09 | PHASE1; PHASE2 |
| NCT01858831 | COMPLETED | Malaria |
GlaxoSmithKline |
2012-04 | PHASE1 |
| NCT01858831 | Completed | Malaria |
GlaxoSmithKline |
2012-04 | Phase 1 |
| NCT01456546 | Completed | CYP2C19 Genotypes |
University of Southern Denmark |
2011-10 | Phase 1 |
| NCT00984256 | COMPLETED | Malaria |
U.S. Army Medical Research and Development Command |
2009-09 | PHASE2 |
| NCT00379821 | COMPLETED | Plasmodium Falciparum Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2007-02 | PHASE3 |
| NCT00421473 | COMPLETED | HIV Infections; Malaria |
Radboud University Medical Center |
2007-03 | PHASE4 |
| NCT00444106 | COMPLETED | Malaria; Falciparum |
Novartis |
2007-05 | PHASE4 |
| NCT00386750 | TERMINATED | Malaria; Falciparum |
Novartis Pharmaceuticals |
2005-06 | PHASE4 |
| NCT00451139 | COMPLETED | Malaria |
Jimma University |
PHASE4 | |
| NCT00084227 | COMPLETED | Malaria, Falciparum |
Pfizer |
2004-07 | PHASE2; PHASE3 |
(data from https://clinicaltrials.gov, updated on 2025-01-13)
Check the
Proguanil
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.