Peptide dossier, updated Nov 2, 2026

Pinealon

Pinealon, the three-amino-acid peptide Glu-Asp-Arg (EDR). A tripeptide promoted as a brain and anti-aging “bioregulator.” We found no approval, registered trial or enforcement action for it. The published research is small and comes almost entirely from one Russian research program. This page lays out what each source actually says.

See all 6 verified records for Pinealon on the Records page

In plain terms

Approved for: Nothing that we found. It is not an FDA-approved drug, and ClinicalTrials.gov lists no study of it.

What it is: A tiny synthetic peptide of three amino acids (glutamic acid, aspartic acid, arginine).

What it is said to do, and by whom:

Researchers, 2011 and 2012: in cells and in rats, it reduced oxidative stress and, in rat offspring exposed to high homocysteine in the womb, improved learning.
Researchers, 2015: in 32 people aged 41 to 83 with several illnesses and an organic brain syndrome, pinealon and another tripeptide improved “biological age” indicators; the authors recommend them as geroprotectors.
We did not collect sellers’ claims for this compound.

How strong the evidence is: Very weak. A handful of cell and animal studies and one small human report, all from the same research program. We found no randomized human trial and no independent replication.

Regulatory record

None found

We found no FDA approval, safety-risk listing or warning letter that names pinealon. Absence is not proven; FDA’s letters cannot be searched by peptide.

HHS enforcement, Oct 30

Not covered

The draft policy’s covered list names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Pinealon is not one of them. Draft policy. Not binding.

FDA advisory panel, July

Not reviewed

FDA’s Federal Register notice for the July 23–24 meeting lists seven peptides. Pinealon is not among them.

WADA prohibited list

Not named

We searched the text of WADA’s 2026 list and found no entry for pinealon. That is a search of one file, not a ruling that it is permitted.

Registered trials

None

ClinicalTrials.gov returns no study for pinealon as of Nov 2, 2026.

Human evidence

One small report

PubMed returns 22 results. The one human study we read enrolled 32 people and was not controlled as far as the abstract says.

Published research

PubMed returns 22 results for pinealon as of Nov 2, 2026, many in Russian-language journals. We read the abstracts of the papers below.

What the papers show

Cells, 2011. Pinealon limited reactive oxygen species in brain, immune and tumor-derived cell cultures and shifted their cell cycle. The authors say it may interact with the cell’s DNA. This is a laboratory study. Rejuvenation Res PubMed
Rat offspring, 2012. Pregnant rats fed excess methionine produced offspring with learning problems; pinealon given during pregnancy improved the offspring’s spatial learning and made their cerebellar neurons more resistant to oxidative stress. Animal study. Int J Clin Exp Med PubMed
Small human group, 2015. 32 people aged 41 to 83 with several chronic conditions and an organic brain syndrome received pinealon or vesugen. The authors report an anabolic effect and better “biological age” indicators, found pro-oxidant activity on one test and reduced blood progenitor cell markers, and recommend the peptides as geroprotectors. The abstract does not describe a control group. Adv Gerontol PubMed
Review, 2013. Compares polypeptide complexes (cortexin, cerebrolysin) with short peptides including pinealon, semax and cortagen in older adults. We read the abstract only. Adv Gerontol PubMed

Read with care

The papers share authors and institutes linked to one program. We found no independent replication.
“Biological age” indicators are not a clinical outcome.
The 2015 authors themselves note that the peptide showed a pro-oxidant effect on one test.
We read abstracts, not full text, funding or disclosures.

Regulatory status

What we looked for, and what we found.

What we found

WADA, 2026. No entry for pinealon in the text we searched.
FDA safety-risk page. We read the page on Nov 1, 2026 and did not find pinealon on it. FDA page

What we did not find

We found no FDA, EU or Russian registration, briefing document or enforcement action for pinealon.
We did not search Russian drug or supplement registers.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; Pinealon is not one of them
The draft policy’s appendix names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The policy is a draft and not FDA approval. We read the appendix through a text extraction.
Federal Register Docket HHS policy appendix BakerHostetler summary
July 23–24, 2026Regulatory
FDA advisory committee meets on seven peptides; Pinealon is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list Pinealon.
Federal Register notice Holland & Knight summary
2015Literature
32-person report on pinealon and vesugen and biological age
Published in Adv Gerontol.
PubMed
2011Literature
Cell study: pinealon limits reactive oxygen species
Published in Rejuvenation Res.
PubMed

Still not covered

Left off rather than guessed:

HHS policy: we read the draft policy appendix through a text extraction, not as the original PDF layout. It names six covered peptides and not pinealon.
FDA review: we found no FDA briefing document or advisory committee evaluation for pinealon. FDA’s notice for the July meeting does not name it.
Regulatory status outside the US: not found. The Russian drug and supplement registers were not searched.
Human evidence: one small report read by abstract. We did not read the Russian-language papers in full.
Warning letters: we found none that name pinealon.
Patents and SEC filings: not researched for this dossier.
Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
Unread items: full text of most papers; EU and other non-US regulators and registries; WADA lists for years other than 2026; FDA warning letters beyond those listed, which rest on web searches.