Epithalon is a lab made chain of four amino acids, the small building blocks that proteins are made from, and short chains like this are called peptides. It is also written Epitalon, the chain reads Ala-Glu-Asp-Gly, which spells out as alanine, glutamic acid, aspartic acid and glycine, it weighs 390.35, and it is listed in the public chemical database PubChem under identifier 219042. Where it came from decides everything else about it. Somebody took a ground up cow pineal gland extract called Epithalamin, read off which amino acids were in it, and built four of them into a chain, which makes the chain an imitation of that extract rather than the extract itself. The United States Food and Drug Administration states in a footnote of its briefing document that it considers the two different substances, the extract being a polypeptide complex pulled out of animal pineal gland. The famous human results, the life extension ones, were produced by the extract. Not by this chain.
What it is supposed to do
The selling story is telomeres, the protective caps on the ends of your chromosomes that shorten each time a cell divides. In a 2003 dish experiment from the inventor's own group, adding Epithalon to human fetal cells that had no telomerase, the enzyme that rebuilds those caps, switched that enzyme on and the caps got longer. The concentration is not in the abstract and the entry's author could only recover it from the Food and Drug Administration's reading of the full paper: 50 nanograms in a millilitre of fluid for four days, in cells from fetal lung. A group at Brunel University London, which declared no competing interests, repeated the result in normal human cells at 1.0 micrograms per millilitre daily for three weeks. In two breast cancer lines the caps lengthened too, at 0.1 to 1.0 micrograms per millilitre daily for four days, but by a different route the authors call cancer cell specific. Every bit of that is cells in a dish. The entry's author found no study that has measured telomere length or telomerase activity in a human being given this compound.
What people take it for
The claims in circulation are longer life and protection against cancer, and each one traces to something other than this chain: the human survival figures to the cow gland extract, the tumour results to mice. The one condition the Food and Drug Administration formally evaluated was insomnia, and it found no publication on efficacy in insomnia patients and no study using the injection under the skin that was proposed to it. The entry's author searched and found none either. The only randomised study of the chain itself in people was run in women working night shifts and measured a melatonin breakdown product in urine, and that publication measured no sleep outcome at all.
The dose question
What circulates
10 mg a dose under the skin, 50 or 100 mg a course, one to two times a year
What was studied
0.5 mg a day, sprayed under the tongue
Ivko 2021, 20 women on a 20 day spray, the only randomised study of the four unit chain
Twenty times the only dose the four unit chain has been given a person, and by a route no published study was found using. Trace the 10 mg and it lands on the 2003 extract trial, whose St Petersburg arm gave 10 mg into muscle daily for 10 days, 100 mg a course, digit for digit the circulating schedule. The agent in that trial was Epithalamin, a bovine pineal extract that FDA states is a different substance, and no vendor or clinic page was found deriving the 10 mg from any study of the chain itself.
Reported because it is what people use. Nothing here recommends any amount.
How long it lasts
I could not find one, in any species. The entry's author found no pharmacokinetic study of this compound at all, which is the kind of study that measures where a dose goes and how fast it disappears, so how long a dose lasts, whether the intact four unit chain survives being sprayed under the tongue or injected under the skin, and what fraction of it reaches any tissue are all unmeasured.
Route studied
In people, three published studies: two sprays under the tongue in night shift workers, and one injection into the tissue around the eyeball. The only one of the three with a dose I could point to is 0.5 mg a day for 20 days under the tongue. In mice, injected under the skin, 1.0 microgram per mouse on five consecutive days each month.
Route used
Injected under the skin, at home. The entry's author found no published study giving it to a human by that route, and it is the route the whole community convention runs on.
How to check you have the right molecule
The check here is a name rather than a number on a laboratory report, because one letter separates the thing being sold from the thing the research is about. Epithalon, also written Epitalon, is the lab made four unit chain: weight 390.35, reading alanine, glutamic acid, aspartic acid, glycine, PubChem identifier 219042. Epithalamin is a polypeptide complex extracted from animal pineal gland, and the Food and Drug Administration states it considers the two different substances. So read what the seller cites, not only what the label says. If the page points you at the 266 person survival study, go to PubMed and pull up 14523363 yourself: the words Epitalon, Epithalon and Ala-Glu-Asp-Gly appear nowhere in that paper. The entry's author could not find this compound on ClinicalTrials.gov at all, by term or by intervention, so a trial number offered as support is worth checking. No approved product exists in any market the agency checked, and there is no European Medicines Agency authorisation.
The costly mistake is the one letter. The 266 person survival trial, the 4.1 fold mortality figure and the Kiev follow up are all real research on real patients, and every bit of it was done with Epithalamin, the cow pineal extract. The 266 person trial gave it into muscle; the Kiev follow up does not state a route. In that trial 20 patients were given both extracts every year for six years against a control group of 22, and the arm on the extract alone, 24 patients, had a six year death rate of 45.8 percent against 81.8 percent in the control group. Real randomisation, real numbers, different substance. The 10 mg figure comes from the same paper: its St Petersburg arm gave 10 mg into muscle daily for 10 days, 100 mg a course, which is the circulating Russian schedule digit for digit, and its Kiev arm gave 10 mg into muscle in five doses, 50 mg a course, which is the other circulating one. The entry's author found no vendor or clinic page that derives that 10 mg from any study of the four unit chain.
What is known about harm
There is very little to report, and that is the finding. The Food and Drug Administration identified no repeat dosing toxicity study and no two year cancer study in any form, noted that the once a month schedule in the best mouse study exposed those animals for about 5.5 months at most, and concluded there are no clinical data supporting human safety, singling out the injection under the skin for the risk of an immune reaction to clumped material and impurities. The mechanism people buy it for is the same thing the agency raises as a hazard: lengthening those chromosome caps continuously for life could let cells escape the point where they should stop dividing and turn cancerous, and the independent Brunel work watched the caps lengthen in two breast cancer lines by a route the authors call cancer cell specific. In the mouse lifespan study, leukaemia came down 6.0 fold, while chromosome damage in the bone marrow and the loss of the reproductive cycle also moved.
Everything on this page is a summary. The citations, the studies and the reasoning live in the full entry.