Epitalon
Epitalon is a synthetic four-amino-acid peptide modeled on a substance your pineal gland already makes. It is one of the most studied compounds in the longevity conversation, and also one of the most misunderstood. This page summarizes what the published literature reports about Epitalon, what has been studied in humans, and where the evidence stops.
Compliance Notice: Important status notice. Epitalon is not FDA approved for any therapeutic use. The FDA placed it on the Category 2 restricted list in September 2023 and removed that designation on April 22, 2026 after the nomination was withdrawn. Removal from Category 2 does not authorize compounding. Epitalon is not on the FDA's 503A bulk drug substances list, so no lawful compounding pathway currently exists pending advisory committee action. Epitalon is not currently listed on the WADA Prohibited List, but WADA updates its list annually and athletes should verify status before any consideration.
Cancer risk notice. Epitalon's primary proposed mechanism involves activation of telomerase, an enzyme that is also active in the majority of human cancers. No human safety studies have been conducted in people with active, suspected, or previously treated malignancy. These are the contraindications identified in the published literature.


Overview
Your pineal gland, the small structure deep in your brain that governs sleep and circadian rhythm, makes its own peptides. Epitalon is a synthetic version of one of them. In laboratory and animal studies, it has been reported to activate telomerase (the enzyme that lengthens telomeres, the protective caps on your chromosomes), restore melatonin production in aged animals, and modulate the genes that keep your body clock running on time.
The claims made for Epitalon outrun the evidence. Here is what the research actually shows. Almost all of that evidence comes from cell studies and animal models. Only two human trials exist. One in patients with retinitis pigmentosa (a degenerative eye condition), one in women investigating sleep and circadian rhythm. Both showed benefit and no serious adverse events. Neither is a Phase 1 safety trial by modern regulatory standards.
So when you hear Epitalon described as an anti-aging peptide, understand what that means. There is a real mechanism, real preclinical data, and real human signal. There is not yet a large randomized trial telling us exactly who benefits, at what dose, for how long, and with what long-term risk profile.

CHEMICAL STRUCTURE & PROPERTIES
- Molecular Formula: C₁₄H₂₂N₄O₉
- Molecular Weight: 390.34 Daltons
- Sequence: Ala-Glu-Asp-Gly (tetrapeptide)
- Origin: Synthetic analog of pineal epithalamin
- CAS Number: 307297-39-8
- Half-life: Short; administered in cycles rather than continuously
- Stability: Lyophilised powder; store at 2°C to 8°C before reconstitution
- Route: Subcutaneous injection
Mechanism of Action
Areas Investigated in
the Research Literature

Current Clinical Evidence
Safety Considerations
Regulatory Status and Legal Considerations
Regulatory information current as of 28 August 2026. This is a summary, not legal or medical advice, and status can change.
FDA Status
- Epitalon is not FDA approved for any therapeutic indication
- The FDA previously placed Epitalon on the Category 2 restricted list in September 2023. As of April 22, 2026, Epitalon is listed as Nominated but Withdrawn from Category 2.
- The FDA Pharmacy Compounding Advisory Committee recommended Epitalon for inclusion on the 503A Bulks List on July 24, 2026. The recommendation is advisory and non-binding; final FDA rulemaking remains pending. Consult current FDA guidance before compounding.
WADA Status
- Epitalon is not currently listed on the WADA Prohibited List
- WADA updates its prohibited list annually and category definitions can evolve
- If you compete in a WADA-regulated sport, verify current status at wada-ama.org before any consideration
- Talk to your sport governing body before considering any compound in this category
Legal Availability
- Research use of Epitalon is legal in the United States
- It is not approved as a therapeutic, which is a different question from legality
- Products sold outside licensed channels carry sterility and purity risks that no authority audits

Conclusion
What the evidence supports
Epitalon is among the most-discussed and least-evidenced compounds in longevity research. The Russian clinical literature reports effects on melatonin rhythm and telomerase activity, and animal work has reported lifespan extension. That work has not been replicated in independent trials, and no human lifespan outcome data exists.
Epitalon is not FDA approved for any therapeutic use. Its removal from the Category 2 restricted list in April 2026 followed the withdrawal of the nomination and does not authorize compounding; it is not on the 503A bulk drug substances list, so no lawful compounding pathway currently exists. This page summarizes the published research and nothing further.
Epitalon SCIENTIFIC
DATA SUMMARY
About this library
This library is published for education. It summarizes published research on compounds studied in this field. Many have no approved medical use, and several cannot lawfully be compounded in the United States. The presence of a page here does not mean Paragon offers that compound. Nothing on these pages is an offer to treat.
This page is general education about a compound studied in this field. Nothing here is medical advice, a recommendation, or an offer to prescribe or supply. A page appearing in this library does not mean Paragon Sports Medicine offers that compound.
Disclaimer: This information is provided for educational purposes only and does not constitute medical advice. Epitalon is not FDA approved for any therapeutic indication and was formerly a Category 2 restricted substance; that designation was withdrawn on 22 April 2026 and its compounding status is pending FDA review. Patients with active, previously treated, or suspected malignancy are not candidates. Patients and researchers should consult with a qualified clinician and ensure regulatory compliance before considering any use of Epitalon.
Statements on this page have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease. Many peptides described here are not FDA approved for the uses discussed, and some cannot lawfully be compounded in the United States. Nothing on this page is medical advice or a recommendation for any individual. Whether any therapy is appropriate depends on your history, your laboratory results, and a clinical evaluation. Individual results vary. This page is published for education. Use of this site does not create a physician-patient relationship.
