DL-Buthionine-Sulfoximine Clinical Trials

Size	Price	Qty
10mg	USD 197
50mg	USD 509

Clinical Trials

A completed academic clinical trial sponsored by Kuopio University Hospital investigated patellofemoral instability in adolescent patients to evaluate joint pathophysiology. Designated as phase not applicable, this study utilized dynamic kinematic magnetic resonance imaging to assess both affected and unaffected knees. Consequently, the recorded evidence for this condition remains focused on academic research evaluating adolescent musculoskeletal knee disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01890551	Completed	Affected and Unaffected Knee in Adoloescent	Kuopio University Hospital	1998-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

DL-Buthionine-Sulfoximine acts as a potent inhibitor of gamma-glutamylcysteine synthetase, directly blocking the rate-limiting step of intracellular glutathione synthesis and depleting cellular antioxidant reserves. This depletion exacerbates oxidative stress and alters cellular redox balance, providing a mechanism to study redox-dependent cellular responses in musculoskeletal conditions such as adolescent knee joint instability.

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>).