Lumefantrine Clinical Trials

Size	Price	Qty
25mg	USD 157

Clinical Trials

Several clinical trials evaluate the therapeutic efficacy, safety, and pharmacokinetic profiles of lumefantrine-containing antimalarial regimens targeting uncomplicated Plasmodium falciparum and broader malaria indications. Incorporating late-phase clinical evaluations and observational pharmacokinetic studies, these research efforts are sponsored by academic institutions and government public health agencies, including Makerere University, the Centers for Disease Control and Prevention, the Ministry of Public Health of the Democratic Republic of the Congo, and the United States Agency for International Development. Active protocols encompass both actively recruiting and active non-recruiting statuses across participating patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06076213	Active not recruiting	Uncomplicated Plasmodium Falciparum Malaria	Ministry of Public Health Democratic Republic of the Congo\|Centers for Disease Control and Prevention\|Global Fund	2023-05-01	Phase 4
NCT05676645	Recruiting	MalariaFalciparum	University of Liverpool\|Infectious Diseases Institute Makerere University College of Health Sciences\|Malawi-Liverpool-Wellcome Clinical Research Programme	2023-03-20	--
NCT05605925	Recruiting	Malaria	Makerere University	2022-08-04	Phase 4
NCT05343312	Active not recruiting	Malaria	Centro de Investigacao em Saude de Manhica\|United States Agency for International Development (USAID)	2022-03-16	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lumefantrine inhibits the detoxification of toxic free heme into inert hemozoin crystals within the parasite food vacuole, leading to the accumulation of cytotoxic heme complexes that induce lipid peroxidation and membrane disruption. This targeted destruction of blood-stage Plasmodium schizonts provides essential therapeutic efficacy in clearing erythrocytic infection and resolving acute uncomplicated 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>).