Clinical Trials

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.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Kaempferol functions as an inverse agonist of estrogen-related receptors ERRα and ERRγ while inhibiting topoisomerase I-catalyzed DNA religation and fatty acid synthase activity, thereby disrupting receptor-mediated transcription and lipogenic signaling pathways. This target modulation downregulates cellular bioenergetics and cellular proliferation, providing a mechanistically relevant rationale for its clinical exploration in mitochondrial health, skin biophysical maintenance, and peri-implant tissue healing.

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.