Clinical Trials

Several clinical trials investigate primaquine diphosphate across Phase 1 to Phase 4 research stages and unassigned feasibility evaluations. These studies target Plasmodium vivax and Plasmodium falciparum malaria, alongside safety assessments involving glucose-6-phosphate dehydrogenase deficiency and healthy lactating volunteers. Supported by academic, non-profit, and governmental health organizations, the trials encompass completed transmission-blockade studies, actively recruiting short-course radical cure evaluations, and studies with withdrawn or unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05879224 Recruiting
Vivax Malaria|G6PD Deficiency
Menzies School of Health Research|Gadjah Mada University|Universitas Sumatera Utara|Indonesia University|Yayasan Pengembangan Kesehatan dan Masyarakat|Indonesian National Malaria Control Program Ministry of Health|National Research and Innovation Agency of Indonesia|Burnet Institute|University of Melbourne|Medicines for Malaria Venture|PATH|UNITAID|Institute of Tropical Medicine Belgium
 2023-08-07 Not Applicable
NCT04984759 Withdrawn
Healthy Lactating Women
University of Oxford|Mahidol Oxford Tropical Medicine Research Unit
 2023-07-01 Phase 4
NCT05874271 Recruiting
Vivax Malaria|G6PD Deficiency
Macfarlane Burnet Institute for Medical Research and Public Health Ltd|Papua New Guinea Institute of Medical Research|Papua New Guinea National Department of Health|Menzies School of Health Research|University of Melbourne|Medicines for Malaria Venture|PATH|UNITAID
 2023-07-10 Not Applicable
NCT05044637 Recruiting
Malaria Vivax
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado|Bill and Melinda Gates Foundation|Conselho Nacional de Desenvolvimento Científico e Tecnológico
 2021-08-26 Phase 2
NCT04073953 Unknown status
G6PD Deficiency
University of Mississippi Oxford|University of Colorado Denver|Southern Research Institute
 2020-09-01 Phase 1
NCT04049916 COMPLETED
Malaria,Falciparum
London School of Hygiene and Tropical Medicine
 2019-09-12 PHASE2; PHASE3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Primaquine diphosphate exerts its antimalarial activity by undergoing metabolic activation to generate reactive oxygen species and disrupt plasmodial mitochondrial electron transport, thereby inhibiting essential biochemical pathways and cellular respiration. This organellar damage selectively destroys mature Plasmodium gametocytes and latent hepatic hypnozoites, directly facilitating radical cure and transmission prevention in clinical studies targeting Plasmodium vivax and Plasmodium falciparum malaria.

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.