Alsterpaullone Clinical Trials

Size	Price	Qty
5mg	USD 1,077

Clinical Trials

Several clinical trials are currently evaluating therapeutic interventions for conditions including chronic kidney disease, end-stage kidney failure, heart failure with reduced ejection fraction, secondary hyperparathyroidism, primary biliary cholangitis, and primary sclerosing cholangitis. Spanning Phase 1 through Phase 3 as well as trials designated as Not Applicable, these studies are sponsored by pharmaceutical companies and academic centers, including Resverlogix Corp, Ipsen, Galmed Pharmaceuticals, and Ottawa Heart Institute Research Corporation. All of these studies currently share a recruitment status of not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03160430	Not yet recruiting	Kidney Failure Chronic	Resverlogix Corp	2024-11-22	Phase 1\|Phase 2
NCT06377293	Not yet recruiting	End-Stage Kidney Disease	Far Eastern Memorial Hospital	2024-11	Not Applicable
NCT06405555	Not yet recruiting	Heart Failure With Reduced Ejection Fraction\|Hypotension\|LV Dysfunction	Ottawa Heart Institute Research Corporation	2024-08-01	Phase 2\|Phase 3
NCT06398002	Not yet recruiting	Secondary Hyperparathyroidism\|End-stage Kidney Disease	Iain Bressendorff\|Herlev Hospital	2024-08-01	Phase 2
NCT06383403	Not yet recruiting	Primary Biliary Cholangitis	Ipsen	2024-07-01	Phase 3
NCT06095986	Not yet recruiting	Primary Sclerosing Cholangitis	Galmed Research and Development Ltd.\|Virginia Commonwealth University\|Galmed Pharmaceuticals Ltd	2024-06	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alsterpaullone acts as a potent inhibitor of cyclin-dependent kinases (CDK1, CDK2, CDK5) and glycogen synthase kinase-3 (GSK-3α/β), effectively blocking downstream phosphorylation events essential for cellular proliferation and signaling. By suppressing kinase activity and activating caspase-9 pathways, Alsterpaullone triggers targeted apoptosis and suppresses cell proliferation, highlighting its therapeutic potential in proliferative and neurodegenerative disorders.

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>).