Epitalon

Not FDA-approved Evidence grade C — small or uncontrolled human studies / case series Updated 2026-10-20

This page describes published research and public regulatory records. It is not medical advice. SoluneFit does not sell, supply, or recommend any compound. The SoluneFit app includes a private, on-device tracker for people who want a record of what they and their clinician have already decided — the app neither suggests compounds nor doses.

Also known as: epithalon, epitalone, Ala-Glu-Asp-Gly, AEDG, AEDG peptide, epitalon acetate.

Regulatory status

Not approved and not a component of any FDA-approved drug. FDA's briefing for the 24 July 2026 PCAC proposed NOT adding epitalon (free base or acetate) to the 503A bulks list, citing poor characterisation, no human safety data, immunogenicity risk and no evidence in insomnia [1][2]; PCAC outcome UNVERIFIED: FDA has posted no minutes or vote summary as of 2026-10-20 (non-FDA reports describe a non-binding vote for inclusion, rulemaking pending). FDA's compounding-risk page lists it as nominated then withdrawn [3]. FDA cited a pharmacy for compounding epitalon as an ineligible bulk substance with no approved application (warning letter, 2020) [5].

What it is

Synthetic tetrapeptide (Ala-Glu-Asp-Gly) modelled on epithalamin, a bovine pineal-gland extract.

A four-amino-acid peptide developed in Russia from work on a pineal-gland extract and promoted for ageing, sleep and melatonin. Human data are a few small Russian studies; FDA treats it as a different substance from the extract epithalamin.

What the published research shows

FDA counts three small human studies (sublingual spray in 40 women; retinitis pigmentosa) plus Russian reviews; several submitted papers were on the extract epithalamin, not epitalon. No insomnia trials.

Published human studies and reports (these describe trial populations, not SoluneFit claims):

Women aged 40-50 with low melatonin output (Ivko et al. 2021, as summarised by FDA): 40 randomised to placebo or sublingual epitalon spray, 3 sprays twice daily for 20 days (0.5 mg/day); urinary melatonin metabolite rose 1.7-fold; FDA notes small size, short duration and no sleep outcomes.
Retinitis pigmentosa (Khavinson et al. 2002): Rat model plus patients with degenerative retinal disease; the authors reported a positive clinical effect in 90 % of cases. FDA gives no patient numbers or dose.
Compounding nominations (withdrawn): SC injection at 10 mg/mL or 3 mg/mL; FDA evaluated only insomnia.

Mechanism, as reported

Not established. Animal and cell studies report effects on melatonin and telomerase activity, but how it works is unknown.

Practical record

Studied routes: subcutaneous, sublingual.
Typical supply: No approved product. Sold as 10-50 mg 'research' vials, 3-3.3 mg capsules and oral spray (FDA). The nominator cited the Russian Pharmacopoeia; FDA did not confirm any approval.
Reconstitution: Limited water solubility; FDA notes 3 mg/mL may not be achievable. In solution stable 2-7 days at 4 °C (supplier data cited by FDA).
Storage: Lyophilised powder stable about 3 weeks at room temperature; desiccated below -18 °C long term (supplier data cited by FDA).

Safety signals on record

Reported adverse events: No adequate human safety data; a Russian abstract claimed no side effects in elderly people without giving methods. No reports in FDA's adverse-event or food-complaint databases.
Contraindications: None established (no label).
Interactions: None documented.
Notes: FDA raises a theoretical cancer concern: epitalon is reported to switch on telomerase and lengthen telomeres, and lifelong exposure might help cells escape normal ageing; the mouse tumour studies were too short to settle this. Also flagged for immunogenicity with injection.

Sources

General wellness education, not medical advice. Unapproved compounds have no established dosing, purity standard, or safety profile.

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