Clinical Trials

Several clinical trials evaluate conditions associated with this research domain, including sepsis syndrome, myocardial ischemia, and type 2 diabetes. Ranging from unassigned phases and non-applicable designs to Phase 4 trials, these investigations are sponsored by academic and clinical institutions, including West China Hospital, Triemli Hospital in collaboration with the University of Alberta, and Seoul National University Bundang Hospital. Reflecting terminated or unknown recruitment statuses, these studies collectively assess metabolic, cardiovascular, and inflammatory pathways across diverse patient cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03842371 Unknown status
Sepsis Syndrome
West China Hospital
2019-02-11 --
NCT02407626 Terminated
Myocardial Ischemia
Triemli Hospital|University of Alberta
2015-09 Not Applicable
NCT02315287 Unknown status
Type 2 Diabetes
Seoul National University Bundang Hospital
2014-09 Phase 4

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

Check the PP2 (AGL 1879) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PP2 functions as a selective Src family kinase inhibitor that potently binds to Lck and Fyn, thereby suppressing downstream tyrosine phosphorylation and immune receptor-mediated signal transduction pathways. By attenuating these intracellular signaling cascades, the compound reduces inflammatory cell activation and cellular stress, which provides therapeutic relevance in the context of sepsis syndrome, myocardial ischemia, and metabolic disorders like type 2 diabetes.

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>).

Note: Technical data last updated: Sep 1, 2026.