Clinical Trials

Numerous clinical trials, ranging from Phase 1 to Phase 4 alongside non-interventional dietary studies, evaluate the physiological and therapeutic potential of spermidine across diverse healthy and clinical cohorts. Conducted by academic institutions—such as the University of Oxford, Medical University Innsbruck, and University Hospital Bonn—and industry entities like Chrysea Labs Lda, these studies encompass completed, active non-recruiting, and actively recruiting protocols. The investigations examine varied endpoints including healthy aging, venous disease, major depression, vaccine-induced immune memory response, periodontitis, endothelial autophagy reactivation, and mortality risk.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07202403 ENROLLING_BY_INVITATION
Aging; Longevity
Atria Research and Global Health Institute (ARGHI)
 2025-09
NCT07383311 RECRUITING
Mild Cognitive Impairment Due to Alzheimer's Disease; Subjective Cognitive Decline (SCD)
University Medicine Greifswald
 2025-10-28
NCT07058974 ACTIVE_NOT_RECRUITING
Smokers; Former Smokers
Icahn School of Medicine at Mount Sinai
 2025-08-12 PHASE1
NCT07662330 RECRUITING
Obesity & Overweight; Hyperlipidemia
Shanghai 10th People's Hospital
 2026-01-01
NCT07675200 RECRUITING
Autophagy; Healthy Aging
Nutraland USA, Inc.
 2026-01-09
NCT06186102 COMPLETED
Ischemic Heart Disease; Myocardial Infarction; Cardiovascular Diseases; Hypertensive Heart Disease; Hypertension; Diastolic Dysfunction; Obesity; Metabolic Syndrome; Diabetes Mellitus, Type 2; Dietary Habits; Inflammation; Quality of Life; Cognition Disorder; Cognitive Impairment
University of Aarhus
 2024-01-01 PHASE2
NCT07035626 RECRUITING
Radiation-induced Xerostomia
West China Hospital
 2025-06-25 PHASE1; PHASE2
NCT06792916 COMPLETED
Peridontitis
Luca Ramaglia
 2025-01-25 PHASE4
NCT04405388 UNKNOWN
Hypertension
Medical University of Graz
 2020-02-25 PHASE3
NCT05926557 COMPLETED
Peri-implant Mucositis; Mucositis Oral
Federico II University
 2023-07-01
NCT05128331 UNKNOWN
Heart Failure, Diastolic
University Medicine Greifswald
 2021-08-11
NCT05459961 UNKNOWN
Healthy Subjects
Chrysea Labs Lda
 2022-08-14
NCT06017219 UNKNOWN
Healthy Subjects
Chrysea Labs Lda
 2023-05-05
NCT05421546 COMPLETED
COVID-19; Vaccine Reaction
University of Oxford
 2022-08-01
NCT06017219 Active not recruiting
Healthy Subjects
Chrysea Labs Lda
 2023-05-05 Not Applicable
NCT05421546 Completed
COVID-19|Vaccine Reaction
University of Oxford
 2022-08-01 Not Applicable
NCT06249620 COMPLETED
Healthy
Industrial Farmacéutica Cantabria, S.A.
 2022-04-19
NCT04823806 UNKNOWN
Depression; Healthy
University Hospital, Bonn
 2020-12-01
NCT04138134 Active not recruiting
Venous Disease
Neuromed IRCCS|Principal investigator: Giacomo Frati|Co-investigator: Francesco Pompeo
 2022-02-01 --
NCT05017428 COMPLETED
Postprandial Inflammation
University of California, Davis
 2021-04-08
NCT04823806 Active not recruiting
Depression|Healthy
University Hospital Bonn
 2020-12-01 Not Applicable
NCT02855918 Completed
Major Depression
University Hospital Montpellier|Institut National de la Santé Et de la Recherche Médicale France|Sys2Diag Mixt laboratory CNRS/Alcediag Montpellier
 2016-09-23 Not Applicable

(data from https://clinicaltrials.gov, updated on 2025-10-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Spermidine acts as an endogenous polyamine that modulates acetyltransferases such as EP300, promoting the deacetylation of essential autophagy factors to stimulate cytoprotective macroautophagy. By accelerating intracellular protein degradation and organelle clearance through activated autophagic flux, this compound maintains cellular homeostasis, supporting vascular endothelial function, immune memory enhancement, and healthy aging in clinical settings.

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.