2,3-Butanedione-2-monoxime Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate 2,3-Butanedione-2-monoxime across distinct therapeutic areas and physiological settings. A Phase 1 trial sponsored by HJB (Hangzhou) Co. Ltd., currently of unknown recruitment status, investigates the compound for osteoporosis. Additionally, a completed academic trial lacking a formal phase designation evaluated functional responses under fasting and fed conditions, highlighting both targeted research in bone disorders and broader physiological assessments.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05391776	Unknown status	Osteoporosis	HJB (Hangzhou) Co. Ltd.	2022-04-28	Phase 1
NCT01721187	Completed	Fasting\|Fed	Duke-NUS Graduate Medical School\|Singapore Institute for Clinical Sciences	2012-10	--

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

Check the 2,3-Butanedione-2-monoxime product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

2,3-Butanedione-2-monoxime acts as a low-affinity, non-competitive inhibitor of skeletal muscle myosin-II, binding the myosin motor domain to inhibit ATP hydrolysis and cross-bridge cycling. This biochemical blockade impairs actin-myosin interactions to suppress skeletal and cardiac muscle contraction, offering physiological relevance to musculoskeletal conditions such as osteoporosis studied in clinical investigations.

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>).