Compounds
Epitalon Dosage: What Protocols Use
Epitalon dosage, answered honestly: the 5 to 10 mg a day that sellers and clinics list was never tested. The doses actually studied in mice, monkeys and a few small human reports, a labeled mouse-to-human conversion, and why we give no reconstitution example.
Published October 18, 2026 · 7 min read
Key takeaways
- There is no established human dose of epitalon. The protocols sellers and clinics use, 5 to 10 mg a day by injection or by mouth, often in cycles, were never tested in anyone.
- The only placebo-controlled human study used 0.5 mg a day as a sublingual spray for 20 days in about 20 women and measured a urine melatonin marker, not aging or sleep. One or two days at the seller dose add up to that entire course.
- The lifespan claims come from mice given about 1 microgram each (roughly 30 to 40 mcg/kg) on 5 days a month. Converted by body surface area, that is about 0.17 to 0.23 mg for a 70 kg adult: our arithmetic, not a dose.
- Nobody has measured how long epitalon lasts in human blood or how much of any route is absorbed, so no schedule has a pharmacological basis.
- This page gives no reconstitution example or units table: no US pharmacy may compound epitalon in October 2026, so there is no legal product to measure.
The direct answer: there is no studied human dose of epitalon that a protocol could be built on. The charts sellers and clinics circulate, 5 to 10 mg a day by injection or by mouth, sometimes repeated every few months, match no study. What exists is a handful of animal doses, one small placebo-controlled human study at 0.5 mg a day under the tongue, and an eye-injection report at micrograms per day. This page sets those side by side. Our epitalon profile covers the evidence, risks and legal status; our epitalon vs sermorelin comparison covers the peptide in the same market that a licensed pharmacy can actually dispense.
The studied doses
| Study | Dose, route and frequency | Subjects and duration | What was measured |
|---|---|---|---|
| Anisimov 2003, lifespan | 1 microgram per mouse (about 30 to 40 mcg/kg), under the skin, 5 consecutive days every month | 54 female SHR mice per group, from 3 months of age until death | Mean lifespan unchanged; longest-lived 10% lived 13.3% longer; maximum lifespan 12.3% longer (Anisimov 2003) |
| Anisimov 2001, lifespan | 0.1 microgram per mouse, under the skin, 5 consecutive days every month | Female CBA mice, from 6 months of age until death | Mean survival 5.3% longer; fewer spontaneous tumors (Anisimov 2001) |
| Goncharova 2001, melatonin | 2 mcg/kg into muscle, daily | Young and old female rhesus monkeys, 10 days | Evening melatonin up more than 4-fold in old monkeys; sleep not recorded (FDA epitalon review 2026) |
| Night-shift study (Ivko) | 0.5 mg a day as a sublingual spray (3 sprays twice a day) or placebo | About 20 women aged 40 to 50 with low melatonin output on each arm, 20 days | Urinary melatonin metabolite up 1.7-fold; no change on placebo; sleep and safety not reported (Ivko 2020) (FDA epitalon review 2026) |
| Retinitis pigmentosa | 5 micrograms per eye, injected beside the eye (parabulbar), daily | 162 patients aged 18 to 72, 10 days, compared with conventional treatment | 'Positive clinical effect in 90% of the cases', reported by the developers (Khavinson 2002) (Araj 2025) |
| Human pharmacokinetic studies | None | None | Half-life, absorption and distribution never measured in people (FDA epitalon review 2026) |
Four things matter in reading that table.
The human doses are small and short. The sublingual study gave 10 mg in total over 20 days. The eye study gave 50 micrograms per eye over 10 days, by a route nobody uses for longevity.
The animal doses were intermittent. The mice were injected 5 days a month, not daily, which FDA calculated as at most about 22 weeks of exposure over their lives (FDA epitalon review 2026).
Nobody tested a dose range. Each study used one fixed dose, so there is no evidence that more does more, or that less does less.
The outcomes were markers. No dose in the table was tied to an aging, disease or sleep outcome in a person.
Our arithmetic, labeled as arithmetic
Animal doses are converted to a first estimate of a human-equivalent dose by body surface area, not body weight; for mice, the standard method divides the mg/kg dose by 12.3 (Nair 2016). For a 70 kg adult:
| Mouse dose | Human-equivalent by surface area | For a 70 kg adult | By body weight alone, for comparison |
|---|---|---|---|
| 30 mcg/kg (low end of Anisimov 2003) | about 2.4 mcg/kg | about 0.17 mg per injection day | 2.1 mg |
| 40 mcg/kg (high end of Anisimov 2003) | about 3.3 mcg/kg | about 0.23 mg per injection day | 2.8 mg |
None of those numbers is a dose. The surface-area method is what drug developers use to pick a cautious starting point for a first-in-human safety study, after which they usually divide by a further safety factor of 10 (Nair 2016). It assumes epitalon behaves in people as it does in mice, which nobody has checked.
Set against it, the seller range of 5 to 10 mg a day is about 20 to 60 times the converted mouse dose, taken daily rather than 5 days a month, and 10 to 20 times the human sublingual dose, usually by a different route. The seller numbers are not a cautious extrapolation from the studies. They are unrelated to them.
What sellers and clinics list
| What the charts say | Where the number comes from | Status |
|---|---|---|
| 5 to 10 mg a day, by injection under the skin or by mouth | Websites FDA reviewed (FDA epitalon review 2026) | Never tested in a person |
| Courses in 'cycles', one site saying every 4 months | Same websites | Never compared with any other schedule |
| Vials of 10, 20, 25 or 50 mg; capsules of 3 or 3.3 mg; an oral spray | Product listings, several labeled for research use only | Content, purity and sterility unverified |
| Compounded injections at 10 mg/mL or 3,000 mcg/mL | The two withdrawn nominations to FDA | FDA doubted the free base would dissolve in water at 3 mg/mL |
These are claims, not doses. FDA's reviewers found no clinical study assessing epitalon's safety, no pharmacokinetic data and no repeat-dose toxicity study in animals, so no seller schedule has anything underneath it (FDA epitalon review 2026).
Why there is no reconstitution example or units table
People searching for an epitalon dosage chart usually want one more thing: how much bacteriostatic water to add to a 10 mg vial and how many units to draw. We are not going to give that, for three reasons.
- No pharmacy may make it. Epitalon is not approved, has no USP monograph, is not a component of an approved drug and is not on the 503A bulks list. FDA's advisory committee voted 7 to 4, with 1 abstention, in July 2026 to recommend adding it, against the advice of FDA's reviewers, but FDA has issued no rule (HPM 2026). Our legal tracker follows it.
- The arithmetic would describe an unknown. Reconstitution math assumes the vial holds what the label says. FDA found epitalon poorly characterized, sold as a free base or an acetate salt under one common name, with certificates of analysis that lacked tests for specific impurities and bacterial endotoxins (FDA epitalon review 2026).
- Reconstitution help is what FDA cites. In its 2026 warning letters to research-peptide sellers, FDA pointed to dosing guides, reconstitution calculators and bundled bacteriostatic water as evidence that vials labeled for research were drugs for people.
Our reconstitution calculator and units converter exist for medications a pharmacy has dispensed with a labeled concentration. Epitalon has neither.
Oral, sublingual and nasal forms
The sublingual spray is the only non-injected form tested in people, and it moved a urine marker (Ivko 2020). No one has measured epitalon in the blood after a spray, a capsule or an injection, and a 2025 review notes that short peptides such as epitalon are typically unstable and break down quickly in the body, with no stabilized version yet evaluated (Araj 2025). Capsules sold at 3 to 3.3 mg have no data at all. Nasal epitalon has been studied only in rats, as far as we found.
Bottom line
A truthful epitalon dosage chart has an empty row where the human protocol should be. Above it sit a microgram per mouse 5 days a month, 2 mcg/kg in monkeys for 10 days, micrograms injected beside the eye, and 0.5 mg a day under the tongue for 20 days, each tied to a marker rather than an outcome. The 5 to 10 mg a day on seller charts matches none of them. If you want what epitalon is sold for, the epitalon profile explains where the evidence actually points, and the sermorelin dosage chart shows what a studied, prescribable peptide dose looks like.
Frequently asked questions
+How much epitalon should I take?
No one can answer that from evidence, and we do not recommend any amount. There is no human pharmacokinetic study, no dose-finding trial and no long-term safety study of epitalon. The only placebo-controlled human study used 0.5 mg a day as a sublingual spray for 20 days and measured a urine melatonin marker. In October 2026 no US pharmacy may compound epitalon, so there is no labeled product to dose.
+What is the epitalon dosage per day?
Websites FDA reviewed list 5 to 10 mg a day by injection or by mouth. No study tested those doses. The studied human daily dose was 0.5 mg as a sublingual spray in about 20 women, and the eye study used 5 micrograms per eye a day. One or two days at the seller dose add up to the entire 20-day course in the human study.
+How long is an epitalon cycle?
Cycles are a seller convention, not a studied schedule. Some websites recommend repeating a course every 4 months. In the mouse lifespan studies, epitalon was injected 5 days in a row every month for the rest of the animals' lives; the human reports lasted 10 or 20 days. None of these was compared with any other schedule.
+How do you reconstitute epitalon 10mg?
We do not give reconstitution instructions for epitalon. A 10 mg vial is a research product: no pharmacy may legally prepare epitalon, so the vial has no label anyone stands behind, its content and sterility are unverified, and FDA has treated reconstitution guides and calculators on vendor websites as evidence that such vials are unapproved drugs for people. FDA also questioned whether the free base dissolves in water at the concentrations that were proposed.
+Does sublingual or oral epitalon work?
A sublingual spray at 0.5 mg a day raised a urinary melatonin metabolite 1.7-fold in women with low melatonin output, which shows something was absorbed or acted locally, but no one has measured blood levels after any route. Capsules sold at 3 to 3.3 mg have never been tested, and a 2025 review notes that short peptides like epitalon are typically unstable and break down quickly in the body.
+What dose of epitalon was used in mice?
The main lifespan study gave female mice 1 microgram each, which the authors put at about 30 to 40 mcg/kg, under the skin on 5 consecutive days every month from the age of 3 months until death. Average lifespan did not change; maximum lifespan was 12.3% longer. An earlier study in another strain used 0.1 microgram per mouse on the same monthly schedule.
+Can a doctor prescribe epitalon at a proper dose?
Not in October 2026. Epitalon is not FDA-approved and no 503A pharmacy or 503B outsourcing facility may compound it. FDA's advisory committee voted 7 to 4, with 1 abstention, in July 2026 to recommend adding it to the permitted list, against the advice of FDA's reviewers, but FDA has issued no rule. A prescription cannot make a non-compoundable substance compoundable.
Sources
- StudyAnisimov VN et al. Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice. Biogerontology 2003;4:193-202. (2003)
- StudyAnisimov VN, Khavinson VK, Mikhalski AI, Yashin AI. Effect of synthetic thymic and pineal peptides on biomarkers of ageing, survival and spontaneous tumour incidence in female CBA mice. Mech Ageing Dev 2001;122:41-68. (2001)
- StudyIvko OM et al. AEDG peptide regulates human circadian rhythms genes expression during pineal gland accelerated aging. Adv Gerontol 2020;33:429-35 (in Russian; English edition 2021). (2020)
- StudyKhavinson V et al. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett 2002;23:365-8. (2002)
- ReviewAraj SK, Brzezik J, Madra-Gackowska K, Szeleszczuk L. Overview of Epitalon: highly bioactive pineal tetrapeptide with promising properties. Int J Mol Sci 2025;26:2691. (2025)
- ReviewNair AB, Jacob S. A simple practice guide for dose conversion between animals and human. J Basic Clin Pharm 2016;7:27-31 (Table 1: divide the mouse mg/kg dose by 12.3, from FDA's guidance). (2016)
- RegulatoryFDA. Evaluation of epitalon-related bulk drug substances (epitalon free base and epitalon acetate) for the 503A bulks list, evaluated for insomnia (memo dated May 12, 2026), briefing document for the Pharmacy Compounding Advisory Committee meeting of July 23-24, 2026. Read October 10, 2026. (2026)
- NewsSnow CD, Palmer KL, Bass M. PCAC adds two more bulk drug substances for the 503A list (epitalon, semax; emideltide rejected). FDA Law Blog, July 28, 2026. (2026)
Written by
The Peptide Doctrine Editorial Team
Our editors write from primary sources — peer-reviewed studies, FDA documents and pharmacy records — and grade every claim by the strength of its evidence. See our editorial policy for how articles are researched, reviewed and updated.
Disclosure. The Peptide Doctrine is an independent editorial project. It currently has no sponsor and runs no advertising: we accept no payment for reviews, rankings or placements, we run no affiliate links, and we do not sell or link to "research-use" peptide vendors. Content is educational and is not medical advice.
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