Several clinical trials evaluate adenine-related interventions across various metabolic and genetic disorders, with recruitment statuses ranging from actively recruiting to not yet recruiting. These protocols encompass both Phase 1 and non-phase studies investigating Moyamoya-like cerebrovascular disease in Smooth Muscle Dysfunction Syndrome, dietary supplementation in Sickle Cell Disease, and oxidative stress and carbohydrate metabolism disorders in G6PD deficiency. The research is supported by a range of academic institutions, healthcare networks, and biotechnology sponsors.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06280482 | Recruiting | Smooth Muscle Dysfunction Syndrome (SMDS) |
The University of Texas Health Science Center Houston |
2024-03-06 | Phase 1 |
| NCT05789355 | Recruiting | Sickle Cell Disease |
LGD|CEN Biotech|Assistance Publique Hopitaux De Marseille|Etablissement Français du Sang |
2023-04-01 | Not Applicable |
| NCT05571748 | Not yet recruiting | G6PD Deficiency|Carbohydrate Metabolism Disorder|Oxidative Stress |
University of Thessaly |
2023-02 | Not Applicable |
(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>).