Clinical Trials

Multiple clinical trials are currently evaluating various therapeutic and diagnostic protocols across diverse conditions, including anxiety and mood disorders, post-concussion syndrome, kidney stones, prediabetes, type 2 diabetes, and primary sclerosing cholangitis. Predominantly classified as Early Phase 1 or Not Applicable, these studies are sponsored by academic and medical research institutions, such as Stanford University, the National Institute of Mental Health, and Charité University Berlin. Current recruitment statuses range from not yet recruiting to actively recruiting, with protocols investigating topics such as glucose metabolism and microbiota-based interventions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06364137 Not yet recruiting
Anxiety Disorders|Mood Disorders
Stanford University|National Institute of Mental Health (NIMH)|MainSquare Co. (dba ''Teleo'')
 2024-07-01 Not Applicable
NCT06376500 Not yet recruiting
Transcranial Direct Current Stimulation|Post-Concussion Syndrome|Functional Magnetic Resonance Imaging|Magnetic Resonance Spectroscopy
The Hong Kong Polytechnic University
 2024-06 Not Applicable
NCT05516472 Not yet recruiting
Kidney Stones
Joshua Stern|University of Minnesota|Albert Einstein College of Medicine|Litholink Corporation|Intermountain Health Care Inc.
 2024-04 Early Phase 1
NCT06382480 Recruiting
Overweight|Obesity|Prediabetes|Type 2 Diabetes
German Institute of Human Nutrition|Charite University Berlin Germany|Helmholtz Center Munich|Hasso Plattner Institute Potsdam Germany
 2024-04-12 Not Applicable
NCT06197308 Recruiting
Primary Sclerosing Cholangitis
University of Minnesota
 2024-03-01 Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thiazolyl Blue penetrates cell membranes and undergoes intracellular reduction by mitochondrial dehydrogenase enzymes, converting the yellow tetrazolium substrate into insoluble purple formazan crystals. This biochemical reduction serves as an indicator of active cellular metabolism, allowing quantitative evaluation of cell proliferation, cytotoxicity, and apoptosis in research relevant to metabolic and inflammatory conditions such as type 2 diabetes and primary sclerosing cholangitis.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.