Clinical Trials

Numerous clinical trials spanning early phase 1 through phase 4 are investigating Fisetin as a senolytic and anti-inflammatory agent across various therapeutic areas, including age-related conditions, endothelial dysfunction, peripheral arterial disease, sepsis, chronic kidney disease, and frailty. Sponsored by prominent academic institutions such as the Mayo Clinic, these studies encompass a broad spectrum of statuses ranging from actively recruiting and active to completed, suspended, or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06431932 RECRUITING
Multimorbidity; Healthy
Ove Andersen
 2026-03-24 PHASE1; PHASE2
NCT06113016 RECRUITING
Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Early Stage Breast Carcinoma
Jonsson Comprehensive Cancer Center
 2024-07-23 PHASE2
NCT07025226 RECRUITING
Glioma
Mayo Clinic
 2025-08-12 EARLY_PHASE1
NCT05595499 RECRUITING
Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
Jonsson Comprehensive Cancer Center
 2023-03-27 PHASE2
NCT06796374 RECRUITING
Pharmacokinetic Study in Healthy Volunteers
University Medicine Greifswald
 2026-03-31
NCT07676435 RECRUITING
Age-Related Lung Function Decline
Cedars-Sinai Medical Center
 2026-06-17 PHASE2
NCT05758246 RECRUITING
Sepsis; Acute Infection; Organ Failure
University of Minnesota
 2023-08-23 PHASE2
NCT03325322 SUSPENDED
Chronic Kidney Diseases; Diabetes Mellitus; Diabetic Nephropathies
Mayo Clinic
 2018-01-02 PHASE2
NCT07678346 NOT_YET_RECRUITING
Systemic Inflammation (hsCRP); Healthy Aging; Vitality; Healthy Adult Participants
Nutraland USA, Inc.
 2026-07
NCT06819254 RECRUITING
Fatigue
Wake Forest University Health Sciences
 2025-12-09 PHASE4
NCT04733534 ACTIVE_NOT_RECRUITING
Frailty; Childhood Cancer
St. Jude Children's Research Hospital
 2022-06-06 PHASE2
NCT05593588 ACTIVE_NOT_RECRUITING
Common Variable Immunodeficiency; Interstitial Lung Disease Due to Systemic Disease
Avni Joshi
 2023-04-12 PHASE2
NCT06399809 RECRUITING
Peripheral Arterial Disease; Aging; Peripheral Vascular Diseases; Walking, Difficulty; Claudication
Northwestern University
 2024-09-30 PHASE2
NCT03430037 ENROLLING_BY_INVITATION
Frail Elderly Syndrome
Mayo Clinic
 2018-02-06 PHASE2
NCT03675724 ENROLLING_BY_INVITATION
Frail Elderly Syndrome
Mayo Clinic
 2018-11-15 PHASE2
NCT07195318 RECRUITING
Healthy
Ove Andersen
 2025-09-24
NCT06990256 ACTIVE_NOT_RECRUITING
Sleep Disorder; Aging
Huazhong University of Science and Technology
 2025-09-16
NCT04476953 ACTIVE_NOT_RECRUITING
Covid19
Mayo Clinic
 2020-08-03 PHASE2
NCT07279714 COMPLETED
Alzheimer s Disease; Alzheimer Dementia; Alzheimer Dementia (AD); Alzheimer Disease; Mild Cognitive Disorder; Neurocognitive Disorders, Mild; Neurocognitive Disorder
Sunnybrook Health Sciences Centre
 2026-01-27 PHASE2
NCT06133634 ACTIVE_NOT_RECRUITING
Aging; Endothelial Dysfunction; Arterial Stiffness
University of Colorado, Boulder
 2023-09-25 PHASE1; PHASE2
NCT05505747 WITHDRAWN
Meniscus Tear; Meniscus; Derangement; Meniscus Lesion; Meniscus Disorder
Austin V Stone
 2025-07 PHASE2; PHASE3
NCT04815902 UNKNOWN
Osteoarthritis, Knee
Steadman Philippon Research Institute
 2021-05-18 PHASE1; PHASE2
NCT05416515 COMPLETED
Carpal Tunnel Syndrome
Peter C. Amadio, M.D.
 2022-10-09 PHASE2
NCT05025956 UNKNOWN
Femoroacetabular Impingement
Steadman Philippon Research Institute
 2021-10-24 PHASE1; PHASE2
NCT05276895 SUSPENDED
Osteoarthritis
Assiut University
 2022-07-01
NCT04537299 TERMINATED
Covid19; SARS-CoV Infection
Mayo Clinic
 2022-04-29 PHASE2
NCT04770064 WITHDRAWN
Osteoarthritis, Knee
Austin V Stone
 2023-06 PHASE1; PHASE2
NCT04994561 WITHDRAWN
Aging
Vitality in Aging Research Group, Inc.
 2022-06 PHASE1
NCT05758246 Recruiting
Sepsis|Acute Infection|Organ Failure
University of Minnesota
 2023-08-23 Phase 2
NCT04313634 COMPLETED
Healthy
Sundeep Khosla, M.D.
 2020-06-09 PHASE2
NCT05482672 WITHDRAWN
Knee Osteoarthritis; Obese; Depression
Cale Andrew Jacobs, PhD
 2023-04 PHASE2; PHASE3
NCT04210986 COMPLETED
Osteoarthritis, Knee
Steadman Philippon Research Institute
 2020-01-06 PHASE1; PHASE2
NCT04771611 COMPLETED
Covid19; Coronavirus Infection
James L. Kirkland, MD, PhD
 2021-07-14 PHASE2
NCT02909686 COMPLETED
Gulf War Illness
University of Alabama at Birmingham
 2016-07

(data from https://clinicaltrials.gov, updated on 2026-05-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fisetin acts as a potent sirtuin-activating compound that modulates sirtuin enzymes, thereby regulating downstream acetylated protein targets and signaling pathways involved in cellular stress responses, anti-inflammatory cascades, and caloric restriction mimicry. By promoting senolytic activity and clearing senescent cells, this target modulation mitigates tissue dysfunction and systemic inflammation, demonstrating therapeutic relevance across clinical trials investigating age-related frailty, vascular dysfunction, and acute infection.

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>).

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Note: Technical data last updated: Sep 1, 2026.