Clinical Trials
Multiple clinical trials evaluate allopurinol sodium across diverse indications, including gout, dilated cardiomyopathy, contrast-induced acute kidney injury in diabetic kidney disease, and pharmacokinetic assessments in healthy participants. Ranging from Early Phase 1 to Phase 2 and unassigned study phases, these investigations are sponsored by corporate entities like InventisBio Co. Ltd as well as academic institutions including Assiut, Fayoum, and Cairo Universities. Their recruitment statuses currently encompass completed, actively recruiting, not yet recruiting, and unknown status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05665699 | Recruiting | Gout |
InventisBio Co. Ltd |
2023-04-17 | Phase 2 |
| NCT05193838 | Unknown status | Dilated Cardiomyopathy |
Assiut University |
2022-05-01 | -- |
| NCT05360628 | Completed | Healthy |
InventisBio Co. Ltd |
2021-11-01 | Early Phase 1 |
| NCT04853615 | Not yet recruiting | SGLT2i Kideny Protection Against Contrast in Diabetic Kidney |
Fayoum University|Cairo University |
2021-07-01 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).