Sodium stibogluconate Clinical Trials

Size	Price	Qty
200mg	USD 147

Clinical Trials

Multiple clinical trials evaluate therapeutic interventions for primary visceral leishmaniasis and deep burn injuries. Ranging in status from actively recruiting to completed, these efforts encompass a Phase 2 trial assessing treatment efficacy and safety alongside a feasibility study focused on skin tissue matrix application. Sponsoring entities include collaborative non-profits such as Drugs for Neglected Diseases, pharmaceutical corporations such as Novartis, and governmental bodies including the Department of Health and Human Services and the Biomedical Advanced Research and Development Authority.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05957978	Recruiting	Primary Visceral Leishmaniasis	Drugs for Neglected Diseases\|Novartis Pharmaceuticals	2024-04-03	Phase 2
NCT02905435	Completed	Burns	PolyNovo Biomaterials Pty Ltd.\|PPD\|Department of Health and Human Services\|Biomedical Advanced Research and Development Authority	2016-11-05	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium stibogluconate acts as a potent inhibitor of protein tyrosine phosphatases, including SHP-1, SHP-2, and PTP1B, preventing the dephosphorylation of key intracellular signaling substrates. This disruption of phosphatase activity alters cellular signal transduction, ultimately conferring antiparasitic activity suitable for treating primary visceral leishmaniasis.

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>).