Succimer Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate succimer (DMSA) and its radiopharmaceutical formulations across diverse pediatric and adult conditions, including vesico-ureteral reflux, brain glioma, acute pyelonephritis, renal sclerosis, and split renal function. Conducted by academic medical centers such as Boston Children's Hospital, Assiut University, and the University of Wisconsin-Madison, these studies range from Phase 1 to unassigned or non-applicable trial phases. Current recruitment statuses across the portfolio include recruiting, not yet recruiting, and unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03653702	Not yet recruiting	Vesico-Ureteral Reflux	Boston Children''s Hospital	2023-10-01	Phase 1
NCT05595863	Not yet recruiting	Brain Glioma	Assiut University	2022-11	--
NCT05593809	Not yet recruiting	Brain Glioma	Assiut University	2022-10	--
NCT04091685	Unknown status	Dimercaptosuccinic Acid SPECT and Planar	Assiut University	2019-09	--
NCT03959163	Recruiting	Pyelonephritis\|Pyelonephritis Acute\|Renal Sclerosis	University of Wisconsin Madison	2019-05-07	Not Applicable
NCT03879005	Unknown status	The Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney Patients	Assiut University	2019-04	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Succimer functions as a dithiol chelating agent that coordinates heavy metal ions or radiometals through its vicinal sulfhydryl groups, disrupting toxic biochemical interactions and promoting stable, excretable complex formation. This specific uptake in proximal tubular renal cells and pathological tissues reduces cellular toxicity and enables diagnostic SPECT nuclear imaging in clinical conditions such as pyelonephritis, renal sclerosis, and brain glioma.

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>).