Puromycin aminonucleoside Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 387

Clinical Trials

A Phase 2 clinical trial is investigating this therapeutic compound as a novel treatment strategy for recurrent acute pancreatitis. Sponsored by academic and federal entities, specifically the University of Alabama at Birmingham in conjunction with the Congressionally Directed Medical Research Programs, the study is currently categorized as not yet recruiting participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06253117	Not yet recruiting	Recurrent Acute Pancreatitis	University of Alabama at Birmingham\|Congressionally Directed Medical Research Programs	2024-06-01	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Puromycin aminonucleoside reversibly binds to and inhibits dipeptidyl-peptidase II and cytosol alanyl aminopeptidase, thereby suppressing downstream enzymatic cleavage, decreasing cell viability, and inducing apoptosis alongside an elevated inflammatory response. This regulation of peptidase activity and local inflammatory dynamics underscores its clinical relevance in ongoing trials investigating therapeutic approaches for managing recurrent acute pancreatitis.

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>).