Senkyunolide I Clinical Trials

Size	Price	Qty
1mg	USD 167
5mg	USD 397

Clinical Trials

Several clinical trials are currently on record for this compound landscape, investigating conditions including HER2-positive, HER2-low, and general breast cancer, advanced cancer, anaphylactic reactions, and behavioral health conditions. Featuring unassigned or non-applicable phase classifications, these studies are sponsored by pharmaceutical leaders such as Daiichi Sankyo and AstraZeneca alongside academic centers including Clinica Universidad de Navarra and University Hospital Tours. Recruitment statuses across these trials vary, with studies listed as either actively recruiting or completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06210776	Recruiting	HER2-positive Breast Cancer\|HER2-low Breast Cancer\|Breast Cancer\|Advanced Cancer	Daiichi Sankyo	2024-01-15	--
NCT05592483	Recruiting	Breast Cancer	AstraZeneca	2023-07-07	--
NCT06405399	Completed	Anaphylactic Reaction	Clinica Universidad de Navarra Universidad de Navarra	2023-05-10	Not Applicable
NCT05013996	Recruiting	Offense Sex	University Hospital Tours	2022-01-20	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Senkyunolide I upregulates Erk1/2 phosphorylation and induces Nrf2 nuclear translocation to drive HO-1 and NQO1 antioxidant expression while increasing the Bcl-2/Bax ratio to inhibit caspase-3 and caspase-9 activation. This dual enhancement of cytoprotective antioxidant defenses and blockade of apoptotic pathways suppresses cell death, demonstrating clinical relevance to disease models such as advanced breast cancer evaluated in clinical research.

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>).