A synthetic four-amino-acid peptide studied for aging, mainly in animal and small human studies.
Key takeaway
Epitalon is a tetrapeptide based on a pineal gland extract. Research, largely from one group of labs, has looked at telomeres and aging in animals.
At a glance
| FDA status | Not FDA-approved |
|---|---|
| 503A compounding | No 503A pathway: nomination withdrawn after FDA safety review |
| Body areas | Cellular energy & aging, Brain, mood & sleep |
| Through ScriptMates | Information only |
| Open questions | None noted |
What is epitalon?
Epitalon is a tetrapeptide based on a pineal gland extract. Research, largely from one group of labs, has looked at telomeres and aging in animals.
FDA says it has not identified safety information for the proposed routes and has concerns about aggregation and impurities.
Dosage forms
No FDA-approved dosage form. A standardized dosage form for human use was not confirmed from the sources below.
Is epitalon FDA-approved?
Not FDA-approved. Epitalon was nominated for the 503A bulks list and placed in Category 2 over safety concerns; the nomination was later withdrawn. FDA notes it has no, or only limited, safety information for the proposed uses.
Can it be prescribed through ScriptMates?
No 503A pathway: nomination withdrawn after FDA safety review. A partner pharmacy lists it, but it has no lawful 503A pathway today (nomination withdrawn after FDA safety review).
Sources
- FDA: Bulk substances that may present significant safety risks (Category 2 and withdrawn nominations)
- FDA: Bulk drug substances nominated under 503A, Categories 1–3 (May 14, 2026)
Checked October 27, 2026. FDA updates these pages, so confirm before relying on them.