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.
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.