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 Ranging from combined Phase 1/Phase 2 to unspecified phases, these studies currently hold recruiting, withdrawn, or unknown recruitment statuses.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| NCT04262895 | Withdrawn | Mild to Moderate TBI|Posttraumatic Stress Disorder |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)
Mechanism and Biochemical Profile
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>).