Muscone Clinical Trials

Size	Price	Qty
25mg	USD 90
1g	USD 490

Clinical Trials

A Phase 4 clinical trial is currently evaluating therapeutic formulations containing Muscone for acute ischemic stroke in patients presenting with mild-to-severe neurovascular events. Sponsored by medical institutions including Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital and Dongzhimen Hospital Beijing, along with principal investigator Ying Gao, the study is actively recruiting participants to assess pharmacodynamic active substances and clinical outcomes. This research underscores the ongoing clinical translation of Muscone interventions in emergency neurovascular management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05559307	Recruiting	Ischemic Stroke Acute	Ying Gao\|Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital\|Dongzhimen Hospital Beijing	2022-08-16	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Muscone exerts anti-inflammatory activity by inhibiting NF-κB signaling and NLRP3 inflammasome activation, thereby suppressing downstream inflammatory cascades and downregulating cellular production of pro-inflammatory cytokines such as IL-1β, TNF-α, and IL-6. By attenuating this hyperinflammatory cytokine release, Muscone reduces neurovascular tissue injury and cellular damage associated with acute ischemic stroke.

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>).