Multiple clinical trials are currently evaluating diagnostic and therapeutic applications for conditions such as non-alcoholic steatohepatitis, dry age-related macular degeneration, and various solid cancers. Spanning early phase 1, phase 1, phase 2, and unassigned protocols, these studies maintain recruitment statuses ranging from not yet recruiting to actively recruiting. Sponsored by academic medical centers, healthcare institutes, and pharmaceutical organizations, these initiatives aim to advance management across oncology and metabolic diseases.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04596670 | Recruiting | Cancer |
Peking University Cancer Hospital & Institute|Peking University Health Science Center |
2024-09-20 | Early Phase 1 |
| NCT06160271 | Not yet recruiting | Non-alcoholic Steatohepatitis |
Central Hospital Nancy France |
2024-09-01 | Phase 2 |
| NCT06376253 | Not yet recruiting | Ovarian Cancer|Lung Cancer |
Novartis Pharmaceuticals|Novartis |
2024-09-06 | Phase 1 |
| NCT05170048 | Not yet recruiting | Non-Exudative (Dry) Age-related Macular Degeneration (dAMD) |
Evergreen Therapeutics Inc. |
2024-09 | Phase 2 |
| NCT06369831 | Not yet recruiting | Metastatic Breast Cancer |
ABSCINT NV/SA |
2024-08 | Phase 2 |
| NCT04495959 | Not yet recruiting | Prostatic Cancer |
British Columbia Cancer Agency |
2024-08 | -- |
(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>).