Several clinical trials are evaluating kaempferol across diverse therapeutic applications, including healthy dietary biomarkers, female sexual dysfunction, mitochondrial health and pharmacokinetics, skin biophysical properties, and peri-implant bone healing. Sponsored by academic institutions, these early-stage studies—designated as Phase 1 or Not Applicable—reflect a mix of completed protocols and active recruitment.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07322406 | RECRUITING | No Disease; Mitochondria Health; Longevity; Pharmacokinetics and Biological Absorption of Kaempferol in Healthy Adult; Healthy Volunteers |
University of Pittsburgh |
2025-12-09 | |
| NCT07458334 | RECRUITING | Skin Biophysical Properties |
Kaohsiung Medical University Chung-Ho Memorial Hospital |
2026-02-09 | |
| NCT07156799 | COMPLETED | Peri-implant Bone Healing and Osseointegration |
Al-Azhar University |
2023-06-05 | |
| NCT06060691 | COMPLETED | Female Sexual Dysfunction |
Deraya University |
2023-09-20 | PHASE1 |
| NCT05073523 | Completed | Healthy |
Chalmers University of Technology |
2021-09-27 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2026-03-23)
Check the
Kaempferol
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.