Trimethylamine N-oxide dihydrate Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate trimethylamine N-oxide (TMAO) modulation, dietary interventions, and gut microbial metabolites across conditions including end-stage kidney disease, cardiovascular diseases, hypertensive disorders of pregnancy, and liver transplantation. Spanning Phase 3 investigations alongside non-applicable phase protocols, these studies maintain recruitment statuses ranging from recruiting to not yet recruiting. This body of research is sponsored by academic and medical institutions, including The Cleveland Clinic, Virginia Commonwealth University, Far Eastern Memorial Hospital, and Penn State University in collaboration with the American Egg Board.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06377293	Not yet recruiting	End-Stage Kidney Disease	Far Eastern Memorial Hospital	2024-11	Not Applicable
NCT06120400	Not yet recruiting	Cardiovascular Diseases	Penn State University\|American Egg Board	2024-05	Phase 3
NCT06362356	Recruiting	Hypertensive Disorder of Pregnancy	The Cleveland Clinic	2024-03-05	--
NCT06043531	Recruiting	Liver Transplant	Virginia Commonwealth University	2024-01-18	Not Applicable

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

Check the Trimethylamine N-oxide dihydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trimethylamine N-oxide dihydrate functions as a zwitterionic osmolyte and protein conformational stabilizer that directly interacts with the peptide backbone to favor folded protein states and protect macromolecules against urea-induced denaturing stress. By stabilizing cellular proteins and altering metabolic signaling cascades, this compound modulates downstream physiological pathways, which is clinically relevant to understanding vascular dysfunction and metabolic dysregulation in cardiovascular diseases, end-stage kidney disease, and liver transplantation.

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>).