PP1 Clinical Trials

Size	Price	Qty
10mg	USD 210

Clinical Trials

Several completed clinical trials sponsored by academic institutions, including the University of Pennsylvania and Yale University, evaluated interventions associated with this entry. These include a Phase 2 trial investigating myocardial structure and function in patients with congestive heart failure, as well as a study focused on early childhood development and education.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07506603	COMPLETED	Early Education; Early Childhood Development	Yale University	2023-12-04
NCT00791843	Completed	Congestive Heart Failure	University of Pennsylvania	2004-03	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-04-01)

Check the PP1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PP1 functions as a selective inhibitor of Src family tyrosine kinases, specifically binding and inhibiting Lck and Fyn to block downstream intracellular transphosphorylation cascades. By suppressing downstream signaling pathways, PP1 attenuates cellular activation and proliferation, demonstrating potential therapeutic relevance in cardiovascular conditions such as congestive heart failure.

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>).