Multiple clinical trials evaluate therapeutic applications across diverse conditions, including uterine corpus carcinoma and Lynch syndrome, type 2 diabetes, vestibular disorders, and pediatric acute asthma exacerbations. Spanning early Phase 1/2 safety evaluations, Phase 2 efficacy studies, and non-applicable phase designations, these trials are supported by academic medical centers, government entities such as the National Cancer Institute and Gynecologic Oncology Group Foundation, and industry sponsors like Shanghai HEP Pharmaceutical Co. Ltd. Across these records, reported recruitment statuses consist of not yet recruiting and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01199250 | Not yet recruiting | Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer |
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation |
2100-01 | -- |
| NCT04662164 | Withdrawn | Type 2 Diabetes Patients |
Shanghai HEP Pharmaceutical Co. Ltd. |
2025-12 | Phase 1|Phase 2 |
| NCT06177132 | Not yet recruiting | Vestibular Disorder |
University Hospital Ghent|University Ghent |
2025-11 | Not Applicable |
| NCT03277170 | Not yet recruiting | Asthma; Status|Asthma in Children|Asthma Acute|Asthma Attack|Acute Asthma Exacerbation |
Vanderbilt University Medical Center |
2025-09-01 | Phase 2 |
(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>).