Thioflavin T Clinical Trials

Size	Price	Qty
500mg	USD 147
5g	USD 290

Clinical Trials

Multiple clinical trials have evaluated conditions such as anxiety and alcohol-related disorders, specifically examining physical exercise impacts on hippocampal behavior and hepatic function. These completed studies encompass a Phase 4 trial and an unassigned phase trial, sponsored by academic medical centers and industry collaborators including the New York State Psychiatric Institute, Columbia University, Denver Health and Hospital Authority, and McNeil Consumer & Specialty Pharmaceuticals.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03036371	Completed	Anxiety	New York State Psychiatric Institute\|Columbia University	2017-03-28	Not Applicable
NCT00402571	Completed	Alcohol Related Disorders	Denver Health and Hospital Authority\|McNeil Consumer & Specialty Pharmaceuticals a Division of McNeil-PPC Inc.	2002-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thioflavin T selectively binds to cross-beta sheet structures of amyloid fibrils, inducing a conformational restriction that dramatically enhances its fluorescent emission yield to enable quantitative detection of protein aggregates. This fluorimetric detection of pathological protein misfolding provides vital diagnostic and biochemical tracking capability relevant to clinical investigations in anxiety and alcohol-related disorders.

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>).