Several clinical trials are currently recorded in this evaluation domain, targeting diverse conditions including Chronic Obstructive Pulmonary Disease, COVID-19, Tricuspid Regurgitation, and hemoglobinopathies such as Sickle Cell Disease and Transfusion-dependent Beta-Thalassemia. Spanning Phase 4 evaluations as well as non-applicable or unassigned phase designations, these studies assess topics ranging from pulmonary treatment responses to pharmacokinetic bioequivalence in viral disease. Sponsored by a combination of academic foundations and corporate entities, these trials are currently documented as not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06334575 | Not yet recruiting | Chronic Obstructive Pulmonary Disease |
Maria Joyera Rodríguez|Fundacion Clinic per a la Recerca Biomédica |
2024-07 | Phase 4 |
| NCT06096571 | Not yet recruiting | Viral Infection COVID-19 |
Valenta Pharm JSC |
2024-06-15 | Not Applicable |
| NCT06368401 | Not yet recruiting | Tricuspid Regurgitation |
Versa Vascular Inc |
2024-06-01 | Not Applicable |
| NCT06363760 | Not yet recruiting | Sickle Cell Disease|Transfusion-dependent Beta-Thalassemia|Hemoglobinopathies |
Editas Medicine Inc. |
2024-06-04 | -- |
(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>).
- Taxifolin 7-rhamnoside Solubility in DMSO
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- Taxifolin 7-rhamnoside Storage
- Taxifolin 7-rhamnoside Stability
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- Taxifolin 7-rhamnoside SMILES
- Taxifolin 7-rhamnoside CAS Number
- Taxifolin 7-rhamnoside Chemical Structure (2D and 3D)
- Taxifolin 7-rhamnoside SDS|MSDS