SDMA Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate symmetric dimethylarginine (SDMA) across conditions including cardio-oncology, myeloma, endothelial dysfunction, and gastrointestinal symptoms. Sponsored by both academic institutions, such as University Hospital Essen, and industry entities, including Nature's Sunshine Products Inc., these studies utilize observational and dietary interventional frameworks with non-applicable or unspecified phase designations. Recruitment statuses vary, ranging from completed for gastrointestinal health assessments to unknown regarding vascular characterization in myeloma patients.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03776331	Unknown status	Cardiooncology\|Myeloma\|Endothelial Dysfunction	University Hospital Essen	2018-12-28	--
NCT03685552	Completed	Gastrointestinal Symptoms	Nature''s Sunshine Products Inc.	2017-08-03	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a methylarginine derivative generated through intranuclear proteolysis, symmetric dimethylarginine (SDMA) competes with L-arginine cellular uptake and inhibits nitric oxide generation, thereby impairing endothelial cell signaling and vascular homeostasis. Consequently, altered SDMA dynamics reflect endothelial strain and reduced glomerular filtration, providing clinical utility in evaluating vascular parameters and endothelial dysfunction in myeloma patients receiving anti-tumor therapy.

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>).