Pinealon peptide

Summary

Pinealon is a synthetic tripeptide, a chain of three amino acids (Glu-Asp-Arg), developed at the St. Petersburg Institute of Bioregulation and Gerontology and sold in Russia as a dietary supplement for brain function. Its evidence consists of rat and cell culture studies (cells grown in a dish) from the developing group, including protection of rat offspring from prenatal hyperhomocysteinemia (high levels of the amino acid homocysteine before birth); no randomized human trial has been indexed, so PeptideAgent grades it animal-only. It has never been reviewed by FDA, is not an approved drug anywhere, and is prohibited in sport under WADA section S0, the anti-doping ban on unapproved substances.

What is Pinealon?

Pinealon is a synthetic tripeptide (Glu-Asp-Arg) from the Khavinson family of short peptide bioregulators. It is also known as EDR peptide, Glu-Asp-Arg, L-glutamyl-L-aspartyl-L-arginine, Khavinson peptide, Pinealon peptide.

How does it work?

The developers propose that short peptides such as Pinealon enter cells and the nucleus and bind DNA to modulate gene expression, including genes involved in neuronal differentiation, antioxidant defense, and the pathogenesis of Alzheimer's disease. In rat neurons it reduced reactive oxygen species accumulation and necrosis under oxidative stress. These proposals rest on in vitro, molecular modeling, and rodent work from a single research group and have not been independently confirmed or tested in humans.

Pinealon benefits: what the evidence shows

Published evidence comes from the Khavinson group in St. Petersburg. In rats with methionine induced hyperhomocysteinemia during pregnancy, Pinealon improved spatial orientation and learning in the offspring and reduced reactive oxygen species and necrotic cells in isolated cerebellar neurons. A 2020 review describes proposed effects on gene expression relevant to Alzheimer's disease based on cell and computational work. A Russian language review reports use of short peptides in older people, but no randomized controlled trial has been indexed and no independent laboratory has replicated the findings.

Human evidence

No indexed randomized controlled trial identified. A 2013 Russian language review from the developing group describes neuroprotective use of peptide bioregulators including short peptides in people of various ages, but design details are not available in an indexed abstract and it is not a controlled trial. No pharmacokinetic or safety study in humans has been published.

Animal evidence

In pregnant rats loaded with dietary methionine to induce hyperhomocysteinemia, Pinealon administration improved the offspring's spatial orientation and learning ability and decreased reactive oxygen species accumulation and the number of necrotic cells among isolated cerebellar neurons. In vitro work from the same group reports antioxidant and neuroprotective effects in neuronal cultures.

Key studies

Conditions studied

Is Pinealon legal in the United States?

FDA and compounding status

Pinealon has never been nominated to or reviewed for the FDA 503A or 503B bulks lists and does not appear on the FDA Category 2 page (current as of April 22, 2026). It is not a component of any approved drug, so a 503A pharmacy has no lawful basis to compound it. It is not an FDA approved drug and is sold in Russia only as a supplement, not a medicine.

WADA status

WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.

Regulatory timeline

No regulatory events recorded.

Full tracker for Pinealon or the category-wide tracker.

What published studies of Pinealon used

Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.

Not established in human literature. Rat studies used research doses with no established human equivalent. Russian supplement labeling for Pinealon capsules is not based on any published dose finding study.

Routes reported

Pinealon side effects

Side effects

Interactions

Contraindications

How do people access Pinealon legally?

Typical cost: Not available through licensed US channels. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity.

• Rules by state
• Verified provider directory

Compare Pinealon

• Pinealon vs epitalon

What's actually offered, and what that means for you

Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make pinealon lawful. Pinealon is not FDA approved and not on the 503A bulks list, so a pharmacy has no lawful basis to compound it. [4] [8]

Enforcement is uneven. FDA mostly acts through warning letters to compounders and online sellers, Category 2 safety listings, and import alerts that let it detain shipments, rather than stopping every pharmacy. State pharmacy boards oversee pharmacies day to day, and their rules differ. [4] [6] [9] [10] [11]

What changes for you

• No FDA review of the product: FDA does not check a compounded drug's safety, effectiveness, or quality before it is sold. [6]
• Identity, purity, sterility, and dose accuracy can vary from batch to batch. [4]
• Insurance rarely covers it, so you usually pay cash.
• For tested athletes, pinealon is prohibited at all times on the WADA list, whatever the source. [7]

What to check

These checks lower some risks, but they do not make an unlawfully compounded product lawful or safe. Check for:

• A 503A pharmacy licensed in your state (your state board of pharmacy publishes license lookups). [6]
• A real evaluation by a licensed prescriber, not just an online form.
• A certificate of analysis for the specific batch.

Frequently asked questions

Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.

Sources

Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.