Several clinical trials evaluate a diverse array of conditions, including HER2-mutated non-small cell lung cancer, drug-drug interactions, chronic spontaneous urticaria, periodontitis, metabolic syndrome, and surgical transfusion complications. Spanning Phase 1/2 through Phase 4 protocols as well as non-interventional designs, these studies assess targeted antitumor efficacy and interaction dynamics across active recruiting, completed, suspended, and pending statuses. The research is sponsored by academic hospitals, research institutes, and biopharmaceutical entities, including West China Hospital, Anbogen Therapeutics Inc., and the Royal College of Surgeons in Ireland.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06399536 | Not yet recruiting | Transfusion Related Complication|Hemodilution |
West China Hospital |
2024-06-01 | Not Applicable |
| NCT05532696 | Recruiting | Advanced Solid Tumor|Non Small Cell Lung Cancer|HER2 Mutations |
Anbogen Therapeutics Inc. |
2022-09-27 | Phase 1|Phase 2 |
| NCT05449249 | Completed | Healthy|Periodontitis |
Buchinger Wilhelmi Development & Holding GmbH|Buchinger Wilhelmi Clinic|University of Geneva Switzerland|King''s College London|ETH Zurich (Switzerland) |
2022-09-01 | Not Applicable |
| NCT06108869 | Suspended | Chronic Spontaneous Urticaria |
Royal College of Surgeons Ireland |
2022-06-01 | Not Applicable |
| NCT04053569 | Unknown status | Metabolic Syndrome Protection Against |
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis |
2019-10-01 | Not Applicable |
| NCT04006353 | Completed | Drug Interaction |
Shanghai Public Health Clinical Center |
2019-07-11 | Phase 4 |
(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>).
- 1-Aminobenzotriazole Solubility in DMSO
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- 1-Aminobenzotriazole Molecular Weight
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- 1-Aminobenzotriazole CAS Number
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