Chloroquine diphosphate Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 270

Clinical Trials

Multiple clinical trials evaluate chloroquine diphosphate across Phase 1 through Phase 4 studies, focusing on conditions such as COVID-19, severe acute respiratory syndrome pneumonia, autoimmune hepatitis, pulmonary sarcoidosis, and brain metastasis. Sponsored by academic medical centers and university networks including Hospices Civils de Lyon and Duke University, recruitment statuses span completed, terminated, active not recruiting, and not yet recruiting. Completed Phase 2, 3, and 4 trials specifically investigate disease prophylaxis, viral respiratory pneumonia, and autoimmune disorders, underscoring broad interest in the compound's therapeutic applications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05841758	Not yet recruiting	Sarcoidosis Pulmonary	Hospices Civils de Lyon	2024-04-01	Phase 4
NCT04443270	Unknown status	COVID-19	CMN 20 de Noviembre	2020-07-27	Phase 1
NCT04462367	Active not recruiting	COVID19\|Coronavirus Infection\|Pregnancy Disease\|Severe Acute Respiratory Syndrome	Instituto Materno Infantil Prof. Fernando Figueira	2020-07-01	--
NCT04342650	COMPLETED	COVID-19; SARS-CoV Infection; Severe Acute Respiratory Syndrome (SARS) Pneumonia; Clinical Trial	Fundação de Medicina Tropical Dr. Heitor Vieira Dourado	2020-04-08	PHASE2
NCT04323527	COMPLETED	SARS-CoV Infection; Severe Acute Respiratory Syndrome (SARS) Pneumonia	Fundação de Medicina Tropical Dr. Heitor Vieira Dourado	2020-03-23	PHASE2
NCT04340544	Terminated	COVID-19	University Hospital Tuebingen\|Robert Bosch Medical Center\|Universitätsklinikum Hamburg-Eppendorf\|Bernhard Nocht Institute for Tropical Medicine	2020-04-22	Phase 2
NCT04334148	Completed	COVID-19	Adrian Hernandez\|Patient-Centered Outcomes Research Institute\|Duke University	2020-04-22	Phase 3
NCT02463331	COMPLETED	Autoimmune Hepatitis	University of Sao Paulo General Hospital	2003-05	PHASE4
NCT01980745	COMPLETED	Hepatitis, Autoimmune	University of Sao Paulo General Hospital	2002-02	PHASE4
NCT01727531	COMPLETED	Brain Metastasis	Main Line Health	2008-12

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chloroquine diphosphate functions as an inhibitor of toll-like receptors (TLRs) and an activator of ATM, which disrupts endosomal acidification and blocks downstream inflammatory signaling cascades. By suppressing hyperactive immune signaling and cellular uptake pathways, this agent attenuates pathogenic inflammatory responses relevant to clinical conditions such as COVID-19, severe viral pneumonia, and autoimmune hepatitis.

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>).