2-Methylenebutyrolactone Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial is investigating treatment modalities for Carbapenem-Resistant Enterobacteriaceae infections involving MBL-producing bacterial dynamics. Sponsored by Qianfoshan Hospital, the study evaluates combination antibacterial regimens alongside novel therapeutic approaches, maintaining an active recruitment status with a phase classification of Not Applicable. This research highlights ongoing efforts to address severe hospital-acquired bacterial infections and combat antimicrobial resistance.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05850871	Recruiting	Carbapenem-Resistant Enterobacteriaceae Infection	Qianfoshan Hospital	2023-01-06	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

2-Methylenebutyrolactone features an electrophilic exocyclic methylene group that acts as a Michael acceptor, covalently binding to sulfhydryl groups on functional cysteine residues of vital cellular proteins to inhibit essential downstream enzymatic pathways and induce cellular toxicity. This alkylation-mediated disruption of critical biochemical processes suppresses cell growth and viability, offering mechanistic relevance for therapeutic investigations targeting Carbapenem-Resistant Enterobacteriaceae Infection.

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>).