Guanine Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Several clinical trials are evaluating research protocols associated with Guanine across conditions including heart failure with preserved ejection fraction, schizophrenia, and psychological stress. The portfolio encompasses Phase 4 studies and projects without applicable phase classifications, sponsored by academic medical centers and public institutions such as the Mayo Clinic, National Institute on Aging, Hospital Clinic of Barcelona, and University of Miami. Recruitment statuses across these investigations range from completed to active not recruiting or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03506412	Completed	Heart Failure With Preserved Ejection Fraction	Mayo Clinic\|National Institute on Aging (NIA)	2018-06-25	Phase 4
NCT04278027	Unknown status	Schizophrenia	Hospital Clinic of Barcelona\|National Alliance for Research on Schizophrenia and Depression\|Instituto de Salud Carlos III	2017-01-03	Not Applicable
NCT03955991	Active not recruiting	Stress	University of Miami\|Florida Department of Health	2016-07-21	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Guanine acts as an essential purine nucleobase that incorporates into nucleotide metabolic pathways, sustaining nucleic acid biosynthesis and regulating purinergic cell-signaling networks. By modulating purine pool dynamics and cell metabolic homeostasis, guanine-associated pathways modulate physiological stress and cellular function relevant to heart failure with preserved ejection fraction, schizophrenia, and stress.

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>).