Cognitive · Investigational
Pinealon
No lawful US pathway
01 · Overview
Pinealon is a synthetic tripeptide (Glu-Asp-Arg, also called EDR) developed as part of the Khavinson peptide bioregulator series, designed to mimic endogenous short peptides proposed to regulate gene expression in neural tissues. Its developers hypothesize that it enters cells and binds histone proteins or nucleic acids, influencing pathways such as MAPK/ERK, apoptosis proteins, and antioxidant enzymes (PMID 33396470).
Pinealon has been studied primarily in the context of age-related decline and neurodegenerative models.
02 · Research summary & key findings
A review by the developing group summarizes cell and animal studies in which the EDR peptide reduced neuronal apoptosis and preserved dendritic spines in neuron cultures from Alzheimer and Huntington disease mouse models (PMID 33396470). In aged rats exposed to hypoxia or hypothermia, pinealon altered brain neurotransmitter levels and oxidative markers, with effects generally weaker than Cortexin (PMID 28509493). Human evidence is limited to small Russian studies, such as an uncontrolled study of 32 older adults with organic brain syndrome reporting improved biological age indicators (PMID 26390612). Placebo-controlled trials in international peer-reviewed journals are lacking.
03 · Regulatory status
Pinealon is in the investigational stage. While preclinical and early-phase data exist, it has not received regulatory approval for clinical use in the United States.
No lawful pathway today
Pinealon is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding. If you are working on the goal it is studied for, a licensed clinician can tell you what is lawfully available, which may be something else.
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Looking for a lawful, clinician-prescribed option for cognitive support?
Pinealon is an investigational compound, is not FDA-approved, and has no lawful US compounding pathway, so we do not offer it and no clinician we work with will prescribe it. Products sold online as “research chemicals” are not made or tested to the standards required of medicines. If you are working on cognitive support, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Subcutaneous injection
- Oral
References
- [1][EFFECT OF SYNTHETIC PEPTIDES ON AGING OF PATIENTS WITH CHRONIC POLYMORBIDITY AND ORGANIC BRAIN SYNDROME OF THE CENTRAL NERVOUS SYSTEM IN REMISSION] Adv Gerontol, 2015. PMID 26390612
- [2][Pinealon and Cortexin influence on behavior and neurochemical processes in 18-month aged rats within hypoxia and hypothermia] Adv Gerontol, 2015. PMID 28509493
- [3]EDR Peptide: Possible Mechanism of Gene Expression and Protein Synthesis Regulation Involved in the Pathogenesis of Alzheimer's Disease Molecules, 2020. PMID 33396470
Primary literature
- PubMed: "Pinealon"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Pinealon"
Registered interventional and observational studies, including status and phase.
- PubChem: "Pinealon"
Chemical structure, molecular properties, and bioactivity data.
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