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Mitochondrial & longevity

Epitalon (Epithalon)

Also known as Epithalon, Epithalone, Epitalone, AEDG, Ala-Glu-Asp-Gly

Limited human dataTier C applies to the molecule only. The injected 5 to 10 mg/day clinic dosing is convention only (anecdotal and preclinical tier). No human or animal study used that dose, route and schedule. Do not upgrade.

Synthetic pineal-derived tetrapeptide (investigational geroprotector, or 'peptide bioregulator'). It has no approved drug class.

Not FDA-approved. Not on FDA's 503A category lists (May 14, 2026). Source, May 14, 2026

Identity. Epitalon is the synthetic tetrapeptide Ala-Glu-Asp-Gly (AEDG). It was designed from the amino-acid composition of Epithalamin, a bovine pineal-gland extract. It is not Epithalamin, which is a multi-peptide extract. The 12-year randomized mortality study in elderly coronary patients (PMID 17426848) tested epithalamine, not epitalon, and must never be cited as epitalon evidence. Published human work comes almost entirely from the St. Petersburg Institute of Bioregulation and Gerontology (Khavinson group) and reaches us through secondary reviews. No independent replication was found. The FDA withdrawn-nominations table lists it as 'epitalon'. FDA and the PCAC evaluated 'free base' and 'acetate' separately, so the salt form and whether the labeled mg is gross or net peptide matter. The formulary vial amount is 10 mg, and epitalon also appears in a blend. Single-agent epitalon doses on this page do not apply to the blend. No blend dosing is given until the pharmacy label states mg of epitalon per vial or per mL and lists every component.

At a glance

These dosages are a helpful guide, not a prescription. Every clinician is expected to do their own due diligence before prescribing.

  1. Start

    0.5 mg/day sublingual (placebo-controlled study, women)1

    Human study
Frequency
daily1
Route
sublingual1
Course
20 days1
Study routes were sublingual and parabulbar, not subcutaneous; no trial supports subcutaneous milligram dosing, and no dose-finding data exist.
Calculate this dose

Dosing detail

Human studies

Human study

  • Patients with retinal degeneration (retinitis pigmentosa per the Frontiers review; n=162 examined, ages 18 to 72 per the IJMS review; the review does not split treated from control), St. Petersburg Institute of Bioregulation and Gerontology; treated group vs conventional-treatment control

    5.0 ug per eye1

    Route
    parabulbar injection
    Frequency
    not stated; 10 consecutive days
    Duration
    10 consecutive days
    n
    162
    Design
    Clinical trial with a conventional-treatment control group (not placebo), as described in a secondary review. The primary paper is not identified.
    Source quote
    Each patient received 5.0 µg of Epitalon per eye, injected parabulbarly for 10 consecutive days. The control group was treated with conventional methods for 2002 (antisclerotic agents, vasodilators, and angioprotectors). None of the Epitalon-treated patients reported side effects.

    Finding. Reported improvement in visual acuity (+0.15-0.20 on average) and visual fields; no side effects reported by treated patients. This safety statement applies only to the microgram parabulbar regimen.

  • Women studied for circadian rhythm and melatonin production; placebo and control cohorts (n=75 per the IJMS review)

    0.5 mg/day1

    Route
    sublingual
    Frequency
    daily
    Duration
    20 days
    n
    75
    Design
    Placebo-controlled human study, as described in a secondary review. The primary paper is not identified.
    Source quote
    Epitalon was delivered sublingually for a duration of 20 days at a dose of 0.5 mg/day. ... Epitalon was observed to enhance this parameter by 1.6 times relative to the placebo group.

    Finding. Urinary 6-sulfatoxymelatonin rose 1.6-fold vs placebo. Clock expression fell 1.8-fold vs placebo. Cry2 doubled vs pre-treatment (not vs placebo). Csnk1e fell (comparator not stated). No endpoint is a clinical outcome.

What clinics and vendors publish

These ranges come from clinic and vendor publications, not studies.

Clinic-reportedCommunity-reported

Every practice source is a commercial clinic, telehealth, or compiled-wiki page. No peer-reviewed review or professional-society document gives a clinical-practice dose. Practice doses are in mg per day, whereas the two human-study regimens are 5 ug per eye and 0.5 mg per day. No dose-finding or pharmacokinetic study links them, and the sources state that no dose-finding studies have been published. Treat these as convention, not evidence.

StartClinic-reported
10 mg per injection (clinic protocol). No source states a lower starting dose.
TitrationClinic-reported
No titration schedule is published. Courses use fixed doses.
TypicalClinic-reported
10 mg per night subcutaneously for 10 consecutive nights (clinic protocol); 5 to 10 mg per day for 10 to 20 consecutive days per course (Peptide Protocol Wiki)
CeilingClinic-reported
Per day: 10 mg is the top of the stated 5 to 10 mg per day range. Peptide Protocol Wiki: no publication 'has presented data comparing multiple dose levels' to identify 'an optimal dose, a minimum effective dose, or a maximum tolerated dose'. Per cycle (a practice ceiling derived from the sources' own ranges, not a published limit): 10 mg x 20 days = 200 mg per cycle. The most conservative published spacing is a 4-month rest with at most 3 cycles per year. No study tests repeat-cycle safety.
FrequencyClinic-reported
Once daily during a course
RouteClinic-reported
Subcutaneous in current clinic and vendor protocols. The Peptide Protocol Wiki describes intramuscular as the original Khavinson protocol route. Bioavailability by route is untested. The human studies listed here used parabulbar and sublingual routes.
TimingClinic-reported
Evening or bedtime (clinic protocol: before bed, at least 2 hours after last meal; wiki: evening or before bed preferred).
CycleClinic-reported
Courses of 10 to 20 days, repeated every 4 to 6 months (wiki: 2 to 3 courses per year); one clinic requires a 4-month rest between 10-night cycles, maximum 3 cycles per year. Conservative convention: 4-month minimum rest, no more than 3 cycles per year.
  • Clinic-reportedPharmacy or clinic protocol2
    Epithalon runs for 10 consecutive nightly injections at 10mg per dose
  • Clinic-reportedPharmacy or clinic protocol2
    After each cycle, a 4-month rest is required before starting the next one
  • Clinic-reportedPharmacy or clinic protocol2
    inject before going to bed, at least 2 hours after your last meal
  • Community-reportedOther web source3
    5-10 mg per day
  • Community-reportedOther web source3
    No publication from the Khavinson group or any other laboratory has presented data comparing multiple dose levels
  • Community-reportedOther web source3
    10-20 consecutive days per course; repeat every 4-6 months (2-3 courses per year)
  • Community-reportedOther web source3
    Intramuscular (IM), described as the original Khavinson protocol route

Safety

Serious warnings

  • No FDA label or boxed warning exists. FDA's withdrawn-nominations table states: 'Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration', due to 'the potential for aggregation and peptide-related impurities'. Request a certificate of analysis plus sterility, endotoxin and purity results for each lot.4
  • Preclinical signal: in the breast cancer cell lines 21NT and BT474, epitalon produced telomere extension through ALT activation. In normal cells, telomere extension was dose-dependent via hTERT and telomerase upregulation. Human relevance is unknown, but the finding supports caution in active or recent malignancy.5
  • Safety gap: 'in the analyzed works, information regarding critical issues about this peptide's safety is missing', including short- and long-term toxicity, genotoxic activity, carcinogenic potential, and drug-drug interactions.1
  • The oncologic picture is not uniformly protective. In SHR mice epitalon 'did not influence total spontaneous tumor incidence, but inhibited the development of leukemia (6.0-fold)'. Do not present it as anti-tumor.6

Contraindications

  • Prescriber caution: avoid in active malignancy or recent cancer history. Telomerase and ALT activation were shown in vitro, and human relevance is unknown. Peptide Protocol Wiki: 'Avoid in active cancer due to theoretical concern about telomerase activation promoting cancer cell immortalization'.3
  • Pregnancy and lactation: no human safety data exist in any source reviewed; avoid. This is a conservative judgment, not a sourced contraindication.1

Adverse effects

  • No adverse events were reported at 5 ug per eye parabulbar x 10 days (n=162, conventional-treatment control): 'None of the Epitalon-treated patients reported side effects.' No safety data exist for subcutaneous mg-range dosing.1
  • Review: 'No long-term safety data; no Western RCTs'. The absence of serious adverse events in the Russian literature is 'encouraging but insufficient' given publication bias.7

Monitoring

  • No validated monitoring protocol exists. Frontiers review: 'Telomere length, inflammatory markers, and epigenetic clocks show promise but require validation in peptide intervention contexts.'7
  • Clinical judgment, not sourced guidance: confirm age-appropriate cancer screening is current before a course. Check glucose or HbA1c in diabetic patients or those on insulin or sulfonylureas (old rhesus monkeys showed lower basal glucose and insulin; this is not shown in humans). Counsel the patient to stop and report fever, injection-site reaction or hives. Document the lot COA.8

Interactions

  • No drug-drug interaction data exist. The IJMS review notes that 'information regarding critical issues about this peptide's safety is missing', and calls for studies of 'food-drug and drug-drug interactions'.1
  • Glucose-lowering drugs: there is an animal-only signal of lowered glucose and insulin in old monkeys (PMID 15664732). Human relevance is unknown.8

Handling

Reconstitution

Guidance here comes from commercial sources only, and no manufacturer-specific reconstitution instructions exist. Peptide Protocol Wiki example: 'adding 1 mL of solvent to a 10 mg vial produces a 10 mg/mL solution'. The clinic protocol dissolves a 50 mg vial in 1 mL (50 mg/mL), so the same '20 units' means 10 mg there but 2 mg from a 10 mg vial in 1 mL. See the volume table in the dose math for each strength. Follow the partner pharmacy's label for diluent and beyond-use date.

Storage before mixing

Wiki: lyophilized powder is stored at -20 degrees Celsius or colder, protected from light; 'No formal stability data have been published.' Follow the partner pharmacy's label for the compounded vial.

Storage after mixing

Wiki: 'Use within 2 to 4 weeks (estimated)' with 'No formal stability data have been published.' Clinic protocol: refrigerate, do not freeze, do not leave at room temperature. This is not a regulatory beyond-use date.23

Evidence

There is no FDA-approved product and no Western randomized trial. Human data are small studies from a Russian group: parabulbar 5 ug per eye in retinal disease, and sublingual 0.5 mg/day for melatonin and circadian-gene endpoints. These studies are available only as abstracts or in secondary reviews. Telomere and lifespan claims rest on cell and rodent work. Clinic protocols of 5 to 10 mg per day by injection have no dose-finding trial behind them. Long-term safety data are absent.

Mechanism

Proposed mechanisms come mostly from cell and animal work. They include upregulation of hTERT and telomerase activity with telomere elongation in cultured cells, and restoration of pineal melatonin synthesis and circadian-gene expression. A 2025 review states that these may not be the only mechanisms.15910

Availability

Amounts offered

  • 10 mg

Custom strengths on request.

Blends that include Epitalon (Epithalon)

References

According to PubMed

  1. 1Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising PropertiesInt J Mol Sci (review; full text via PMC11943447), 2025
  2. 2Epithalon Dosage Protocol: The 10-Day Cycle, Reconstitution Guide, and the Exact Schedule We UsePerfect B Aesthetic Medicine (clinic, FNP-BC author; updated Oct 13, 2026), 2026
  3. 3Epitalon: Dosing Protocols and AdministrationPeptide Protocol Wiki (no named author; updated Jan 29, 2026), 2026
  4. 4Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. FDA (Content current as of 04/22/2026), 2026
  5. 5Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activityBiogerontology (in vitro), 2025
  6. 6Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice.Biogerontology 2003 (mouse), 2003
  7. 7Therapeutic peptides in gerontology: mechanisms and applications for healthy agingFront Aging (narrative review; full text via PMC13095733), 2026
  8. 8Pineal peptides restore the age-related disturbances in hormonal functions of the pineal gland and the pancreas.Exp Gerontol 2005 (rhesus monkey), 2005
  9. 9[AEDG peptide regulates human circadian rhythms genes expression during pineal gland accelerated aging]Adv Gerontol (Russian; abstract only), 2020
  10. 10[Normalizing effect of the pineal gland peptides on the daily melatonin rhythm in old monkeys and elderly people]Adv Gerontol (Russian; abstract only; no dose stated), 2007
  11. 11Bulk Drug Substances Used in Compounding Under Section 503A of the FDCAU.S. FDA (Content current as of 05/14/2026); page does not mention epitalon, 2026
  12. 12FDA to Remove 12 Popular Peptides from the Category 2 'Do Not Compound' ListFrier Levitt, April 16, 2026, 2026
  13. 13Bulk-list bound? PCAC backs majority of peptides in two-day public meetingMcDermott Will & Schulte (fetched; July 2026), 2026
  14. 14FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026U.S. FDA (fetched PDF text), 2026
  15. 15Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging.Bull Exp Biol Med 2006 (epithalamine extract, not epitalon), 2006

Last reviewed 2026-10-14. 26 figures checked against their sources. How this works