Demeclocycline HCl Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

A Phase 1 clinical trial sponsored by Massachusetts General Hospital is evaluating Demeclocycline HCl in neuro-oncology. This early-stage study explores the agent's intrinsic fluorescence properties to facilitate intraoperative delineation and surgical visualization of brain tumors, though its recruitment status is currently designated as unknown. Overall, these data reflect preliminary translational efforts to repurpose the compound's optical characteristics for surgical guidance.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02740933	Unknown status	Brain Tumor	Massachusetts General Hospital	2016-04	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Demeclocycline HCl reversibly binds to the 30S ribosomal subunit of susceptible microorganisms, blocking the access of aminoacyl-tRNA to the ribosomal acceptor site and thereby halting bacterial protein synthesis. Beyond its core antimicrobial mode of action, the compound exhibits intrinsic optical fluorescence that accumulates in neoplastic tissue, providing diagnostic utility for the intraoperative delineation of brain tumors in clinical settings.

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>).