Amygdalin Clinical Trials

Size	Price	Qty
25mg	USD 120

Clinical Trials

A clinical trial is currently evaluating therapeutic formulations incorporating amygdalin as a key pharmacodynamic constituent in a combined Phase 2 and Phase 3 study targeting acute ischemic stroke. Sponsored by academic and medical institutions, including Dongzhimen Hospital of Beijing University of Chinese Medicine alongside principal investigator Ying Gao, the study investigates the therapeutic impacts of traditional herbal decoctions containing this glycoside. Currently, the recruitment status for this acute cerebrovascular trial remains categorized as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05560152	Not yet recruiting	Ischemic Stroke Acute	Ying Gao\|Dongzhimen Hospital of Beijing University of Chinese Medicine Beijing\|Dongzhimen Hospital Beijing	2022-09-25	Phase 2\|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amygdalin undergoes enzymatic cleavage by beta-glucosidase to liberate active metabolites that modulate mitochondrial respiratory complexes and intracellular oxidative signaling pathways, thereby regulating cellular metabolism and survival under stress conditions. This modulation of cellular bioenergetics and inflammatory signaling cascades contributes to neuroprotective cellular responses, providing a mechanistic basis for investigating its therapeutic potential in 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>).