Brain & sleep Pineal tetrapeptide (Ala-Glu-Asp-Gly)
Epitalon
Regulatory status
Status at a glance
503A compounding status
Advisory committee voted to include
FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in favor of adding this substance to the 503A bulks list. PCAC votes are non-binding recommendations; FDA and HHS make the final decision, and the substance is not on the bulks list unless FDA adds it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Epitalon is a synthetic four-amino acid peptide based on a pineal-gland extract, sold on the "research peptide" market for anti-aging and sleep. Its human evidence is limited to older studies from a single Russian research group, not independently replicated. As of 2026 it is not FDA-approved, though a 2026 FDA advisory committee gave a non-binding favorable vote toward allowing it to be compounded.
At a glance
- FDA status
- Non-FDA-approved peptide sold in the wellness/gray market
- What it is
- Synthetic pineal tetrapeptide (Ala-Glu-Asp-Gly) marketed for longevity
- Research
- Human evidence is sparse, dated, and from a single non-independent source
- Compounding status
- A 2026 FDA advisory vote was favorable but non-binding; not yet compoundable on that basis
- Evidence strength
- Low research
Summary
Epitalon is a synthetic four-amino acid peptide sold for anti-aging and sleep. See what limited human research exists and where it stands with the FDA in 2026.
What is epitalon?
Epitalon (also spelled epithalon) is a synthetic four-amino acid peptide derived from epithalamin, a natural extract of the pineal gland. It is sold through wellness and "research peptide" channels for anti-aging, longevity, and sleep, often described as a "peptide bioregulator." It is not an approved medicine.
How does it work?
Epitalon is proposed to:
- Help restore the body's melatonin rhythm
- Act as an antioxidant
- Influence gene expression, including claims of activating telomerase (an enzyme linked to cellular aging)
These mechanistic claims rest on cell-culture and animal work, with the telomerase findings coming from laboratory systems. This describes the proposed mechanism, separate from demonstrated benefit in people.
Is it FDA-approved?
Safety note
Status: Non-FDA-approved peptide sold in the wellness/gray market
Category: Wellness and performance · Primary body area: Brain & sleep
No. Epitalon is not approved by the FDA for any use. In July 2026 the FDA's Pharmacy Compounding Advisory Committee gave epitalon a narrow, non-binding favorable vote toward the 503A compounding list. Because that vote is only a recommendation and the FDA has not completed formal rulemaking, epitalon is not currently on the list and cannot be legally compounded by U.S. pharmacies on that basis.
What does the research show?
Editor’s note
Evidence strength: Low research
The human data are sparse, dated, single-source, and not independently replicated, so any longevity or wellness benefit is unestablished.
The human evidence is limited and single-source. The main human reports come from one Russian research group and include older studies on melatonin rhythm and age-related conditions; these are generally small, largely non-English, and not independently replicated with modern randomization and blinding. No independent, large, modern trial establishes a longevity or wellness benefit. The telomerase and lifespan claims rest mainly on laboratory and animal work.
Sources: reports from the originating research group are indexed on PubMed, including a human-cell telomerase study (Khavinson et al., 2003, DOI 10.1023/a:1025493705728), an animal lifespan study (Anisimov et al., 2002, DOI 10.1023/a:1021104819170), and a review of the group's aging work (Khavinson, 2002, PubMed PMID 12374906); and reporting on the July 2026 FDA advisory committee vote (AJMC). This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- PMID 12374906
- [2]
- [3]
- [4]
- [5]
- [6]
- [7]
- [8]
- [9]
- [10]
- [11]
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