Evidence Snapshot
What this grade covers
A for canonical sequence identity; C for selected cell and animal findings (oxidative-stress, hypoxia, and gene-expression studies); D/E for human cognition, stress adaptation, anti-aging, Alzheimer disease, safety, approval, or dosing.
Regulatory Context
No FDA-approved Pinealon medicine was identified. Human-use claims depend largely on secondary or foreign-language reports that require source-level verification.
Research Takeaway
Pinealon is the synthetic tripeptide Glu-Asp-Arg, also described as EDR; it is distinct from Epitalon, which is a different tetrapeptide sequence.
Evidence boundary: Evidence for Epitalon or other Khavinson peptides must not be transferred to Pinealon.
See all 6 evidence claims →Quick Summary
Pinealon is a short tripeptide commonly identified as Glu-Asp-Arg (EDR). Most direct evidence is preclinical and comes from a narrow, frequently Russian-language research lineage.
Mechanism & Research Overview
The originating literature proposes effects on stress responses, gene expression, antioxidant systems, and neuronal survival. These hypotheses remain experimental and are not tied to a validated clinical receptor mechanism.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Pinealon is the synthetic tripeptide Glu-Asp-Arg, also described as EDR; it is distinct from Epitalon, which is a different tetrapeptide sequence.
Does not establish
Evidence boundary: Evidence for Epitalon or other Khavinson peptides must not be transferred to Pinealon.
Sources: Pinealon, ROS, Cell Survival, and Cell-Cycle Effects; Penetration of short fluorescence-labeled peptides into the nucleus in HeLa cells and in vitro specific interaction of the peptides with deoxyribooligonucleotides and DNA
Supported
Preclinical studies report antioxidant, antihypoxic, gene-regulatory, or neurobiological effects of Pinealon/EDR in cells and animal models.
Does not establish
Evidence boundary: These findings do not establish clinically meaningful cognitive or neuroprotective efficacy in humans.
Sources: Pinealon, ROS, Cell Survival, and Cell-Cycle Effects; Penetration of short fluorescence-labeled peptides into the nucleus in HeLa cells and in vitro specific interaction of the peptides with deoxyribooligonucleotides and DNA; Investigation of antihypoxic properties of short peptides; Neuroepigenetic review of ultrashort peptides (2022)
Supported
No FDA-approved drug product named Pinealon was identified in the Drugs@FDA search performed for this frozen package.
Does not establish
Evidence boundary: This does not address marketing status in other countries or laboratory research use.
Supported
The cited evidence does not establish a modern controlled human safety database, long-term adverse-event incidence, or therapeutic window for Pinealon.
Does not establish
Evidence boundary: Small or historical observations summarized in reviews cannot establish comprehensive safety.
Sources: Pinealon, ROS, Cell Survival, and Cell-Cycle Effects; Investigation of antihypoxic properties of short peptides; EDR Peptide: Possible Mechanism of Gene Expression and Protein Synthesis Regulation Involved in the Pathogenesis of Alzheimer's Disease
Supported
The frozen evidence does not support presenting Pinealon as a proven treatment for Alzheimer's disease, cognitive decline, anti-aging, or neuroregeneration.
Does not establish
Evidence boundary: Mechanistic gene-expression hypotheses and animal findings are not equivalent to randomized clinical efficacy.
Sources: Pinealon, ROS, Cell Survival, and Cell-Cycle Effects; Investigation of antihypoxic properties of short peptides; EDR Peptide: Possible Mechanism of Gene Expression and Protein Synthesis Regulation Involved in the Pathogenesis of Alzheimer's Disease
Supported
Only dosing from an identifiable named study may be displayed with its original study context; no consumer dosing, reconstitution, injection, or nootropic regimen is permitted.
Does not establish
Evidence boundary: Historical or preclinical exposure cannot be generalized into a current treatment recommendation.
Sources: Investigation of antihypoxic properties of short peptides; EDR Peptide: Possible Mechanism of Gene Expression and Protein Synthesis Regulation Involved in the Pathogenesis of Alzheimer's Disease
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Direct modern human trial evidence is sparse and was not verified in sufficient detail for clinical claims.Safety Consideration
Much of the literature comes from one research lineage and includes Russian-language sources.Safety Consideration
Pinealon must remain distinct from Cortexin and other cerebral-cortex extracts or peptide mixtures.Safety Consideration
Important uncertainties include: cell-cycle and proliferative effects; context-dependent oxidative or pro-oxidant activity; altered hematopoietic markers reported in a small combined Pinealon/Vesugen study; neurologic, psychiatric, sleep, seizure, and autonomic effects; unknown tumor and genomic effects; unknown hepatic, renal, cardiovascular, reproductive, pregnancy, pediatric, and developmental effects; product identity, purity, aggregation, immunogenicity, sterility, endotoxin, and route-specific exposure; and unknown long-term or repeated-course safety.
Research Areas Being Studied
Research areas discussed on this page reflect the Cognitive / Neuro category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Pinealon and Biological-Age Indicators in Locomotive Workers ():
- Pinealon and Vesugen in 32 People With Polymorbidity and Organic Brain Syndrome ():
- Pinealon and Vesugen in Professional Truck Drivers ():
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Pinealon and Biological-Age Indicators in Locomotive Workers | A report involving locomotive workers described changes in biological-age and adaptation indicators after Pinealon use. The abstract does not provide the modern trial details needed to establish randomization, blinding, allocation concealment, validated clinical endpoints, complete adverse-event reporting, or durable benefit. | ||||
| Pinealon and Vesugen in 32 People With Polymorbidity and Organic Brain Syndrome | A 32-person study of Pinealon and Vesugen in participants with polymorbidity and organic brain syndrome reported changes in biological-age indicators, but also reported pro-oxidant activity and reduced circulating CD34-positive hematopoietic markers. The small sample, mixed compounds, unclear control methods, surrogate endpoints, and concerning laboratory signals prevent anti-aging, geroprotective, or safety claims, and prevent attribution to either compound alone. | ||||
| Pinealon and Vesugen in Professional Truck Drivers | A study of professional truck drivers and metal-worker controls reported the best psychoadaptive effect with combined Pinealon and Vesugen. Combination exposure, occupational confounding, unclear treatment allocation, and subjective endpoints prevent attribution of this result to either compound alone. |
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Pinealon and Cortexin influence on behavior and lipid peroxidation in aged rats under stress | 2015 | 18-month-old rats under stress models | The study compared Pinealon and Cortexin in aged rats exposed to hypoxia or hypothermia and reported differences in behavior and oxidative-stress measures. | Pinealon must remain distinct from Cortexin; this animal comparison does not support human use. | |
| Pinealon protects rat offspring from prenatal hyperhomocysteinemia | 2012 | Rat prenatal hyperhomocysteinemia model | Pinealon improved selected cognitive and biochemical outcomes in rat offspring exposed to prenatal hyperhomocysteinemia. | Animal developmental model; translation, dose equivalence, and long-term safety are unknown. | |
| Penetration of short fluorescence-labeled peptides into the nucleus in HeLa cells and in vitro specific interaction of the peptides with deoxyribooligonucleotides and DNA | 2011 | The study included fluorescently labeled Pinealon (Glu-Asp-Arg) and reported cellular or nuclear penetration and interactions with nucleic-acid targets in vitro. | |||
| Investigation of antihypoxic properties of short peptides | 2008 | Rat hypobaric and prenatal hypoxia models | Pinealon was studied in experimental hypoxia models and showed neurobiological effects under those conditions. The findings are preclinical. | Russian-language animal study from a narrow research lineage; no human clinical inference is warranted. | |
| EDR-DNA Interaction | A biophysical study examined EDR-DNA interaction using molecular-docking and structural methods. This supports a mechanistic hypothesis only, not a validated human receptor, pharmacodynamic biomarker, or disease-modifying mechanism. | ||||
| Pinealon, ROS, Cell Survival, and Cell-Cycle Effects | Laboratory studies reported that EDR/Pinealon reduced reactive-oxygen-species accumulation and necrotic cell death in selected neural and non-neural cell systems and altered ERK activation and cell-cycle behavior. These findings do not establish antioxidant therapy, neuroprotection, or clinical safety in humans, and cell-cycle effects create unresolved proliferative and oncologic questions. |
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Drugs@FDA: FDA-Approved Drugs Database | 2026 | Current Drugs@FDA name searches performed for this frozen package did not identify approved drug products under the names AHK-Cu, FOXO4-DRI, Pinealon, or Mechano Growth Factor. A negative name search does not exclude differently named products but establishes that no approval was identified under these research names. | |||
| FDA 503A Bulk Drug Substances Categories, Updated May 14, 2026 | 2026 | Cardiogen, Cortagen, Pinealon, and Vesugen were not identified in FDA's current 503A nominated bulk-drug-substance category document, updated May 14, 2026. Absence from that document is not approval, a safety determination, or authorization to compound. | |||
| ClinicalTrials.gov Search Portal | No modern registered interventional development program for Cardiogen, Cortagen, Pinealon, or Vesugen was identified in the reviewed ClinicalTrials.gov searches. | ||||
| PubChem Pinealon Record | PubChem's Pinealon compound record establishes the identity of the synthetic tripeptide Glu-Asp-Arg (EDR). Used for identity verification only, not efficacy evidence. |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Neuroepigenetic review of ultrashort peptides (2022) | 2022 | Review discussing neuroepigenetic mechanisms proposed for ultrashort peptides, including EDR/Pinealon, in the context of gene-expression regulation. | |||
| EDR Peptide: Possible Mechanism of Gene Expression and Protein Synthesis Regulation Involved in the Pathogenesis of Alzheimer's Disease | 2020 | Review of EDR/Pinealon research | The review discusses EDR/Pinealon mechanisms and summarizes preclinical and limited human observations. The evidence is not comparable to modern large randomized clinical trials. | The article is a secondary synthesis from the originating research group and does not establish clinical efficacy. | |
| Neuroprotective effects of peptide bioregulators in people of elderly and old age | 2013 | Narrative review of older adults and experimental models | The paper summarizes reported clinical use of peptide preparations, including Pinealon, in older adults, but provides limited modern trial detail in the English abstract. | Original-language and underlying primary reports require manual verification before any human-efficacy claim. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Content pending review. Last updated 2026-07-30.
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