Epitalon
Synthetic pineal tetrapeptide (geroprotector candidate)
Status
Not approved
Not approved as a medicine anywhere. In the US it sat in FDA's Category 2 of bulk substances that may present significant safety risks until the compounding nominations were withdrawn and the substance came off that list in April 2026; FDA staff then recommended against adding it to the 503A Bulks List, an advisory committee voted 7 to 4 the other way on 24 July 2026, and adding it would still require formal rulemaking that has not happened.
Evidence
Animal data only
The lifespan, tumour and telomerase findings are from rodents and cell lines; FDA's 2026 review found no published clinical study of epitalon in patients and no safety data in humans.
In sport
WADAProhibited (WADA)
A four-amino-acid peptide derived from a pineal gland extract, sold as an unapproved anti-ageing research chemical. Claims about telomeres and lifespan rest on rodent and cell studies, not human trials.
Structure
4 residuesPoint at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.
Sequence as text
H-A-E-D-G-OH
What it is used for
- Slowing biological ageing and extending lifespan (claimed, unproven)
- Lengthening telomeres and raising telomerase activity (claimed, unproven)
- Restoring melatonin rhythm and improving sleep (claimed, unproven)
- Melatonin metabolite excretion in night-shift workers (studied)
How it works
Epitalon copies the amino acid make-up of epithalamin, an extract of the pineal gland. In cell culture it raises hTERT messenger RNA and telomerase activity, which lengthens telomeres, and in cancer cell lines it also activates the alternative lengthening of telomeres pathway. Animal work reports effects on melatonin synthesis, interleukin-2 messenger RNA and several enzymes. No receptor has been identified and the route by which a four-residue peptide would reach these targets in people is unclear.
How strong the evidence is
Animal data only
Anisimov and colleagues reported that intermittent subcutaneous epitalon in mice reduced spontaneous tumour incidence and extended lifespan, with no sign of genotoxicity in bone marrow. Al-Dulaimi and colleagues (2025) showed dose-dependent telomere lengthening in human cell lines through telomerase upregulation, and through the alternative lengthening pathway in cancer cells. In people, FDA identified only a small unblinded study of sublingual epitalon in 75 night-shift workers that measured a melatonin metabolite and reported no sleep outcomes. FDA concluded there is a lack of evidence of effectiveness and no clinical safety data at all.
Risks and side effects
- No clinical safety data: FDA found no human study reporting safety outcomes for epitalon
- Telomere lengthening is a double-edged mechanism, and FDA raised the concern that chronic exposure could help damaged cells evade senescence and become cancerous
- Risk of immune reactions from peptide aggregation and peptide-related impurities, particularly by injection
- Sold only as a research chemical, so identity, purity, endotoxin load and sterility are unverified
- Prohibited in sport at all times under WADA class S0, which covers substances with no approval by any government health regulator
Regulatory status
Status by country
| Jurisdiction | Status | Source |
|---|---|---|
| USUnited States | No authorised medicine | Source 1 |
| EUEuropean Union | No authorised medicine | Source 7 |
| UKUnited Kingdom | No authorised medicine | Source 8 |
| AUAustralia | No authorised medicine | Source 9 |
| CACanada | No authorised medicine | Source 10 |
Timeline
Sources
- 01Epitalon: FDA Presentation Slides, Pharmacy Compounding Advisory Committee Meeting, July 24, 2026(opens the source in a new tab)
- 02Overview of Epitalon, Highly Bioactive Pineal Tetrapeptide with Promising Properties(opens the source in a new tab)
- 03Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity(opens the source in a new tab)
- 04FDA advisory panel narrowly rejects compounding of one peptide, backs two others(opens the source in a new tab)
- 05Epitalon, CID 219042(opens the source in a new tab)
- 06The 2026 Prohibited List, International Standard(opens the source in a new tab)
- 07Find medicine: centrally authorised medicines(opens the source in a new tab)
- 08MHRA Products: active substances beginning with E(opens the source in a new tab)
- 09Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab)
- 10Think twice before injecting peptides bought online: unauthorized products can seriously harm you(opens the source in a new tab)
Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.