Butylated hydroxytoluene Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials have evaluated the safety, pharmacokinetics, and clinical utility of formulations containing butylated hydroxytoluene in healthy volunteers as well as patients with asthma, multiple sclerosis, and relapsing-remitting multiple sclerosis. Spanning Phase 1, Phase 2, and non-phased diagnostic or physiological reliability protocols, these studies were sponsored by academic institutions like the University of Zurich alongside biopharmaceutical companies such as Bayhill Therapeutics and Boehringer Ingelheim. All recorded trials have completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04618302	Completed	Healthy	Thomas Radtke\|University of Zurich	2020-10-19	--
NCT02220673	COMPLETED	Asthma	Boehringer Ingelheim	2009-11	PHASE1
NCT02221375	COMPLETED	Healthy	Boehringer Ingelheim	2008-06	PHASE1
NCT00382629	Completed	Relapsing Remitting Multiple Sclerosis	Bayhill Therapeutics	2006-02	Phase 2
NCT00103974	Completed	Multiple Sclerosis	Bayhill Therapeutics	2004-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a lipophilic organic antioxidant, butylated hydroxytoluene scavenges reactive oxygen species by donating hydrogen atoms to peroxyl radicals, thereby terminating lipid peroxidation cascades. This inhibition of oxidative lipid degradation preserves cellular membrane integrity and mitigates redox stress-mediated cell injury, providing a therapeutic rationale in inflammatory and neurodegenerative conditions such as asthma and multiple sclerosis.

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>).