No safety dataEpitalon is not FDA-approved.[1] The FDA concluded "there are no clinical data to support the safety of epitalon (free base) or epitalon acetate when used in humans."[4] The calculator does arithmetic only.
What is the epitalon peptide?
Epitalon is the synthetic tetrapeptide Ala-Glu-Asp-Gly (AEDG). It is not the same as epithalamin, a polypeptide extract of the pineal gland.[15][4]
- Sequence
- H-Ala-Glu-Asp-Gly-OH (AEDG)[15]
- Formula and weight
- C14H22N4O9, 390.35 g/mol; acetate salt 450.40 g/mol
- Spelling
- Also written epithalon
- Not the same as
- Epithalamin. The FDA "considers epitalon and epithalamin as different substances".[4]
Regulatory status in November 2026
The FDA recommended against compounding epitalon; HHS then chose not to act against compounded injections under its 2026 policy.
| Date | What happened |
|---|---|
| Sept 29, 2023 | Placed in 503A Category 2[3] |
| Apr 22, 2026 | Removed after the nominations were withdrawn; listed in FDA's "nominated but withdrawn" safety table, which says the agency "lacks sufficient information to know whether the drug would cause harm"[2] |
| July 24, 2026[4][5] | FDA proposes not adding epitalon to the 503A bulks list, reviewing it for insomnia |
| Oct 30, 2026[6] | HHS policy covers epitalon acetate as injections under the skin or into muscle "dispensed in intermittent courses" |
- The cancer question. FDA: "from the mechanistic standpoint, epitalon has the potential to be carcinogenic. Specifically, epitalon has been shown to activate telomerase and lengthen telomeres, and longer telomeres are generally associated with increased risk for cancer."[4] That is a theoretical concern from laboratory findings, not an observed human result.
- HHS's view: "the limited controlled human exposure reported no side effects".[6]
- Enforcement. A 2020 warning letter listed epitalon as ineligible for compounding,[7] and a January 2026 letter to an outsourcing facility cited "Epithalon" products missing required label statements.[8]
- Sport: not named on the WADA 2026 list.[13] From 2027 the list names "peptides" in general under S0.[14]
Epitalon dosage: what the human studies used
The human evidence is a few small Russian studies; none tested injections, and the one placebo-controlled study used a spray under the tongue.
| Study | People | Amount and route studied | Reported |
|---|---|---|---|
| Ivko 2020/2021[9] | 40 women aged 40–50 with low melatonin, randomized to epitalon or placebo | Spray under the tongue, about 0.5 mg a day for 20 days (per FDA) | Urinary melatonin metabolite rose 1.7-fold; no safety data reported |
| Khavinson 2002[10] | People with retinitis pigmentosa; number not in abstract | Not stated in abstract | "Positive clinical effect in 90% of the cases"; no adverse event data in abstract |
| Korkushko 2007[11] | Elderly people; number not in abstract | Not stated in abstract | Night melatonin rose in those with low pineal function; "no side effects" per abstract |
The FDA found no human pharmacokinetic data, no adverse event reports through December 2025, and no human study of injection under the skin.[4] A 2026 early-phase study of a skin serum containing epitalon and other ingredients is registered with no results.[12]
Epitalon peptide dosage chart (concentration only)
No injectable dose has been tested, so this chart shows only what each unit holds. At 390.35 g/mol, 100 mcg is 256 nmol.
| Vial + liquid | mg/mL | mcg per unit | nmol per unit | Units per 100 mcg |
|---|---|---|---|---|
| 2 mg + 1 mL | 2 | 20 | 51.24 | 5 |
| 2 mg + 2 mL | 1 | 10 | 25.62 | 10 |
| 2 mg + 3 mL | 0.667 | 6.67 | 17.08 | 15 |
| 5 mg + 1 mL | 5 | 50 | 128.09 | 2 |
| 5 mg + 2 mL | 2.5 | 25 | 64.05 | 4 |
| 5 mg + 3 mL | 1.667 | 16.67 | 42.7 | 6 |
| 10 mg + 1 mL | 10 | 100 | 256.18 | 1 |
| 10 mg + 2 mL | 5 | 50 | 128.09 | 2 |
| 10 mg + 3 mL | 3.333 | 33.33 | 85.39 | 3 |
Example arithmetic: a 10 mg vial with 2 mL holds 50 mcg per unit, so 1 mg is 20 units. For mg-based amounts, use the peptide calculator in mg.
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- Thymosin alpha-1Approved in Italy Thymalfasin (Zadaxin). Not approved in the U.S.; 2025 sepsis trial negative.
- KisspeptinNot approved Reproductive-hormone signal. Kisspeptin-10 is on FDA Category 2.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
- TB-500Not approved A 7-amino-acid fragment of thymosin beta-4. No human trials of TB-500 itself.
- BPC-157 + TB-500 blendNot approved Two peptides in one vial: the arithmetic of a fixed ratio.
- TesamorelinFDA-approved Egrifta SV and Egrifta WR. Labeled doses, diluents and volumes.
Frequently asked questions
What is the epitalon dosage?
Does epitalon lengthen telomeres in people?
No human study has shown that. The FDA cites laboratory findings that it activates telomerase and lengthens telomeres, and raises that as a possible cancer risk.[4]
Is epitalon the same as epithalamin?
No. Epitalon is a synthetic four-amino-acid peptide; epithalamin is an extract of the pineal gland. The FDA treats them as different substances.[4]
Is epitalon FDA-approved?
No. It has no FDA application.[1]
Sources
- openFDA Drugs@FDA searches for AOD-9604, KPV, epitalon, semax, selank, cagrilintide, melanotan and NAD (no application found)
- Certain bulk drug substances for use in compounding that may present significant safety risks
- Bulk drug substances nominated for use in compounding under section 503A (category lists)
- FDA briefing document: epitalon-related bulk drug substances
- Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026
- Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances (91 FR 68526)
- Warning letter: Tailor Made Compounding LLC
- Warning letter: GenoGenix LLC (503B outsourcing facility)
- Ivko OM et al. AEDG peptide (epitalon) and melatonin secretion in women (Adv Gerontol 2020;33:429–435)
- Khavinson V et al. Epitalon in retinitis pigmentosa (Neuro Endocrinol Lett 2002;23:365–8)
- Korkushko OV et al. Pineal peptide preparations and melatonin in elderly people (Adv Gerontol 2007;20:74–85)
- NCT07888595: topical multi-peptide serum including epitalon (early phase 1, registered 2026)
- World Anti-Doping Code: Prohibited List 2026
- Athlete advisory: what's new on the 2027 WADA Prohibited List
- PubChem CID 219042: epitalon (AEDG)