Clinical Trials

Multiple clinical trials evaluate pterostilbene across Phase 1 safety evaluations to Phase 2 and Phase 3 efficacy studies targeting metabolic, neurological, renal, and oncological conditions, including hyperlipidemia, acute kidney injury, amyotrophic lateral sclerosis, and endometrial carcinoma. Sponsored by academic institutions, health systems, and industry partners, this body of research encompasses a mix of completed, active, and recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07579429 RECRUITING
Clonal Cytopenia of Undetermined Significance; Myelodysplastic Syndrome
University of Colorado, Denver
2026-05-20 PHASE2
NCT04562831 ACTIVE_NOT_RECRUITING
Amyotrophic Lateral Sclerosis
Haukeland University Hospital
2020-10-07
NCT05095571 RECRUITING
Amyotrophic Lateral Sclerosis
Haukeland University Hospital
2021-10-07
NCT07024966 RECRUITING
Oxidative Stress; Physical Activity; Antioxidant Effect
Fundació Eurecat
2025-08-01
NCT06289140 COMPLETED
Biological Availability
Fundació Eurecat
2024-03-11
NCT04342975 COMPLETED
AKI
Mayo Clinic
2020-12-01 PHASE2
NCT03671811 ACTIVE_NOT_RECRUITING
Atypical Endometrial Hyperplasia; Endometrial Carcinoma
City of Hope Medical Center
2019-01-21 PHASE2
NCT05561075 COMPLETED
Biological Availability
Fundació Eurecat
2022-10-20
NCT04841499 COMPLETED
Menopause
University of South Alabama
2021-04-05
NCT03635411 UNKNOWN
Recovery of Function
Elysium Health
2018-12-06 PHASE1
NCT03754842 COMPLETED
Muscle Injury
University of Aarhus
2019-02-12
NCT03176628 COMPLETED
Acute Kidney Injury
Massachusetts General Hospital
2017-11-01
NCT03176628 Completed
Acute Kidney Injury
Massachusetts General Hospital|Elysium Health
2017-11-01 Not Applicable
NCT01267227 COMPLETED
Hyperlipidemia; Blood Pressure; Oxidative Stress
University of Mississippi Medical Center
2010-12 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pterostilbene functions as a lipophilic stilbenoid that activates sirtuin 1 and peroxisome proliferator-activated receptor alpha while scavenging reactive oxygen species, thereby suppressing nuclear factor-kappa B signaling and modulating downstream inflammatory cascades. This molecular action attenuates cellular oxidative damage and pro-inflammatory cytokine release, supporting its potential therapeutic utility in trial-studied conditions including acute kidney injury, hyperlipidemia, and amyotrophic lateral sclerosis.

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.