Pinealon: What It Is and Its U.S. Regulatory Status

What is Pinealon?

Pinealon is a very short synthetic peptide made of three amino acids: glutamic acid, aspartic acid and arginine (Glu-Asp-Arg, sometimes written EDR). It is not FDA-approved for any use, and no product containing it is an approved medicine in the United States.

Pinealon was developed by Vladimir Khavinson and colleagues in St. Petersburg, Russia. Despite its name, it is not a hormone made by the pineal gland. It is a lab-made peptide.

Where it comes from

Pinealon belongs to a group of short peptides that Khavinson's group calls peptide bioregulators. The group proposes that these very small peptides can influence gene activity in specific tissues. Other compounds from the same research program include Epitalon and the thymus extract thymalin.

That idea comes mainly from the group's own laboratory and animal work. It has not been confirmed in large, independent clinical trials.

What the research measured

Published research on Pinealon is limited and comes mostly from laboratory and animal studies by the same research network.

• Cell studies: a 2011 paper in Rejuvenation Research reported that Pinealon reduced the buildup of reactive oxygen species (unstable molecules that can damage cells) and reduced cell death in rat nerve cells, immune cells and a laboratory cell line exposed to oxidative stress.
• Animal studies: a 2012 study in the International Journal of Clinical and Experimental Medicine gave Pinealon to pregnant rats with high homocysteine levels. Their offspring performed better on spatial learning tests than offspring of rats with the same condition that did not receive it, although homocysteine levels themselves did not fall.

Findings in cells and rats do not show that a compound works or is safe in people. We found no large, controlled human trials of Pinealon published in international medical journals, and we did not find independent replications of these results by unrelated research groups.

U.S. regulatory status

Current status: Not FDA-approved.

The FDA has not approved Pinealon as safe and effective for any medical use. Pinealon is not on the 503A bulks list, the list of bulk substances pharmacies may use to compound medicines, and it does not appear in any of the FDA's compounding nomination categories as of the agency's May 14, 2026 update.

Terms such as "bioregulator" are descriptive labels. They are not regulatory categories in the United States, and they do not mean a product has been reviewed by the FDA.

Products sold online as "research chemicals" or labeled "for research purposes only" are not approved medicines, and the FDA has not reviewed their identity, purity or quality.

Documented safety information

There is no FDA label and no FDA safety review for Pinealon. Because controlled human studies are lacking, its side effects, interactions and long-term risks in people are unknown. Products sold under the name are not made under FDA oversight, so their actual content and purity can differ from what the label says.

Why Peptide Labs does not sell Pinealon

Peptide Labs does not sell this compound. This page is general information, not medical advice. Our Peptide Guide exists to explain what these compounds are and how they are regulated, not to supply them.

Anyone with questions about Pinealon, or about memory and brain health, should speak with a licensed healthcare provider, who can explain the current evidence and the legal status in plain terms.

Related reading

See the full list of compound profiles in the Peptide Guide. Other peptides discussed for brain health include Semax and Cerebrolysin. For the legal background, read whether peptides are legal in the U.S.