Epitalon (Epithalon)
One human study reported a good clinical result in more than 90% of people treated with Epitalon for an inherited eye disease (PMID 12195242; checked 24 Aug 2026). It studied 162 people with retinitis pigmentosa (same source and date). The control group had 46 people (same source and date). The paper names no funder. A second study used a random draw (DOI 10.1134/S2079057021010380; checked 24 Aug 2026). It measured blood and urine markers tied to melatonin after AEDG under the tongue (same source and date). Neither study measured how long people lived.
Which names and identifiers belong to Epitalon?
GSRS gives three names: EPITALON, EPITHALON, and ALA-GLU-ASP-GLY (GSRS; checked 24 Aug 2026). The chain has four parts: Ala-Glu-Asp-Gly.
This page covers the free base under UNII O65P17785G and CAS 307297-39-8. The US FDA gives the acetate a different CAS, 307297-40-1 (US FDA briefing; checked 24 Aug 2026).
Epithalone is another spelling in material shown in the US FDA report. GSRS does not list it. Epithalamin is an extract from the pineal gland and is a different drug.
What did the controlled retinal study measure?
The paper studied 162 people with retinitis pigmentosa (PMID 12195242; checked 24 Aug 2026). They were aged 18 to 72 (same source and date). The control group had 46 people (same source and date). All others got Epitalon next to the eye. The paper does not say the groups were random or the test was blind.
| Measure | Epitalon group | Control group | Primary source | Checked |
|---|---|---|---|---|
| Positive clinical effect | More than 90% | Improved visual functions in 31.5% | PMID 12195242 | 24 Aug 2026 |
| First-neuron ERG amplitude | 22.4 ± 1.7 to 27.3 ± 1.6 µV; p < 0.05 | 19.9 ± 1.1 to 18.8 ± 1.1 µV | PMID 12195242 | 24 Aug 2026 |
| Second-neuron ERG amplitude | 150.8 ± 9.9 to 210.6 ± 11.5 µV; p < 0.05 | 160.4 ± 10.1 to 165.3 ± 10.2 µV | PMID 12195242 | 24 Aug 2026 |
The drug was put next to the eye, a route called parabulbar. It was not put under the skin. The study names no funder.
What did the randomized circadian study measure?
The study had 75 women (DOI 10.1134/S2079057021010380; checked 24 Aug 2026). They were aged 40 to 59 (same source and date). They worked night shifts (same source and date). A group of 35 had values in the normal range for their age (same source and date). The other 40 had low melatonin (same source and date). They were put by chance into placebo and AEDG groups. AEDG was used under the tongue.
| Biomarker result after AEDG | Comparison | Primary identifier | Checked |
|---|---|---|---|
| Urinary 6-SMT increased 1.7-fold | Publisher abstract | DOI 10.1134/S2079057021010380 | 24 Aug 2026 |
| Cry2 expression increased twofold | Versus pretreatment; p < 0.05 | World Heart Journal 13(1):189-191 | 24 Aug 2026 |
| Cry2 expression was 1.2-fold higher | Versus placebo; p < 0.05 | World Heart Journal 13(1):189-191 | 24 Aug 2026 |
| Csnk1e expression decreased 2.1-fold | Versus pretreatment; p < 0.05 | World Heart Journal 13(1):189-191 | 24 Aug 2026 |
| Csnk1e expression decreased 1.8-fold | Versus placebo; p < 0.05 | World Heart Journal 13(1):189-191 | 24 Aug 2026 |
The free publisher abstract names no funder. The related full paper has no funding note. Its authors state that they had no conflict.
Which human claims remain unmeasured?
Neither human study measured lifespan, survival, or telomere length in people (checked 24 Aug 2026). PMID 22451889 reports death rates for Epithalamin, not Epitalon. The US FDA says the extract and the short peptide are two different drugs.
The study with a random draw did not test sleep. Exact ClinicalTrials.gov searches for Epitalon, Epithalon, and ALA-GLU-ASP-GLY found no records (checked 24 Aug 2026).
What safety record did the sources and US FDA provide?
| Source | Accessible safety record | Checked |
|---|---|---|
| PMID 12195242 | No treated patient had clinical worsening, side reactions, complications, or other side effects | 24 Aug 2026 |
| DOI 10.1134/S2079057021010380 | The report did not publish adverse-event data | 24 Aug 2026 |
| US FDA briefing | Its FAERS search through 8 Dec 2025 found no reports | 24 Aug 2026 |
| US FDA briefing | Its food and supplement complaint search through 5 Dec 2025 found no cases | 24 Aug 2026 |
The US FDA says not all events are sent in. It does not treat zero reports as proof of safety. The US FDA also found no human safety study of Epitalon used under the skin.
What does evidence tier B mean here?
One human study tested the eye. One used a random draw and measured genes tied to the body clock. The entry keeps tier B (checked 24 Aug 2026). The tier does not set its status with a public body.
What is the recorded EU status?
The EU Commission index has no entry for Epitalon or Epithalon (Union Register index; checked 24 Aug 2026). It does not settle records held by each country. The EU field stays unclear.
When was Epitalon first observed in a product?
No dated product test or record of use is linked here (checked 24 Aug 2026). The first_observed field is null. It is not part of the separate 2011-02 group in the live data.
What does this register entry cover?
This entry covers the free base and its human data. It does not merge the acetate or Epithalamin into this record. No full guide is live yet.