Clinical Trials

Several clinical trials are currently evaluating conditions associated with this compound profile, including uterine corpus carcinoma, Lynch syndrome, type 2 diabetes mellitus, vestibular disorders, and acute pediatric asthma exacerbations. Spanning early-stage research—incorporating Phase 1/Phase 2, Phase 2, and unspecified protocols—these studies are sponsored by academic, governmental, and pharmaceutical entities, such as the National Cancer Institute and Vanderbilt University Medical Center. Portfolio recruitment statuses reflect trials that are currently either withdrawn or not yet recruiting.

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NCT04662164 Withdrawn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)

Check the Kaempferide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a bioactive natural flavonol, kaempferide interacts with cellular signaling enzymes to attenuate pro-inflammatory cytokine production and mitigate oxidative stress cascades. By suppressing these key biochemical pathways, the compound inhibits uncontrolled cellular proliferation and tissue inflammation, which is clinically relevant for evaluating its efficacy in inflammatory lung conditions like acute asthma, metabolic dysfunction in diabetes, and gynecologic malignancies including uterine corpus carcinoma.

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.