Clinical Trials

Several clinical trials sponsored by academic medical centers, psychiatric research institutes, and government facilities are evaluating purine-related biological responses and clinical protocols across diverse medical conditions. The research scope encompasses acute myocardial infarction, depressive and bipolar disorders, traumatic brain injury with posttraumatic stress disorder, and various malignant neoplasms, with specific investigations into post-infarction autonomic responses and psychiatric biomarkers. Ranging from combined Phase 1/Phase 2 to unspecified phases, these studies currently hold recruiting, withdrawn, or unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06298513 Recruiting
Acute Myocardial Infarction: Rehabilitation Phase
Istituto Auxologico Italiano
2023-05-02 --
NCT05463562 Recruiting
Depressive Disorder|Bipolar Disorder
Max-Planck-Institute of Psychiatry
2022-02-24 --
NCT04262895 Withdrawn
Mild to Moderate TBI|Posttraumatic Stress Disorder
VA Office of Research and Development
2021-10-01 Phase 1|Phase 2
NCT04198051 Unknown status
Gastric Cancer|Colon Cancer
The First Affiliated Hospital of Dalian Medical University
2019-12-20 Not Applicable
NCT04202848 Unknown status
Lung Cancer|Breast Cancer|Gastrointestinal Cancer|Malignant Neoplasms
The First Affiliated Hospital of Dalian Medical University
2019-12-20 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential heterocyclic aromatic scaffold, purine integrates into nucleic acids and critical cofactors such as ATP and cyclic AMP to regulate fundamental enzymatic cascades and cellular bioenergetics. Interruption or regulation of purine metabolic pathways suppresses nucleotide biosynthesis and cell viability, which directly informs clinical investigations targeting neoplastic growth in gastric, breast, and lung cancers as well as neuro-psychiatric and cardiovascular conditions.

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.