Mitochondrial biology research
Epitalon Dosage, Protocol & Research Guide
- MW 390.35 g/mol
- CAS 307297-39-8
Dose overview
Every range below is taken from the cited source and carries its evidence grade.
No human dose-finding trial is cited on this page.
Human data and community reports
| Source | Population | Dose | Frequency | Route | Duration | Evidence |
|---|---|---|---|---|---|---|
| Int J Mol Sci 2026 narrative review (doi 10.3390/ijms27198922), synthetic epitalon (not epithalamin)[2] | humanelderly adults with age-related pineal melatonin dysfunction (15 epitalon, 15 epithalamin, 10 placebo per the review) | 0.01 mg[2]intramuscular, dose per day, 10-day course; blinding not clearly described per the review | daily for 10 days | intramuscular | — | Human review or observational reportStudy details from the source: Int J Mol Sci 2026 narrative review (doi 10.3390/ijms27198922), synthetic epitalon (not epithalamin): Korkushko 2007 study, epitalon 0.01 mg/day intramuscularly for 10 days (0.1 mg per course) |
| Same review, Ivko 2020 and Khavinson 2021 studies[2] | humanwomen aged 40-59 (mostly night-shift workers); 40 randomized to placebo or AEDG | 0.5 mg[2]sublingual, sublingual route, not an injection; blinding not specified per the review | daily for 20 days | sublingual | — | Human review or observational reportStudy details from the source: Same review, Ivko 2020 and Khavinson 2021 studies: synthetic AEDG (epitalon) 0.5 mg/day sublingually for 20 days |
| Same review, Khavinson 2002 study[2] | human162 patients (324 eyes) with congenital retinitis pigmentosa vs 46 controls | 5 mcg[2]parabulbar (around the eye); ocular procedure route, dose per eye, not a subcutaneous or intramuscular dose; randomization and blinding unclear per the review | once daily for 10 days | other | — | Human review or observational reportStudy details from the source: Same review, Khavinson 2002 study: epitalon 5.0 mcg per eye once daily parabulbar for 10 days |
Animal data (context only, not a human dose)
Animal figures are shown for context and are never presented as a human dose. Use the converter to see how animal figures scale.
| Source | Species | Dose | Frequency | Route | Duration | Evidence |
|---|---|---|---|---|---|---|
| Spontaneous carcinogenesis study (In Vivo 2006)[3]one-year-old female C3H/He mice injected with Epitalon 0.1 microg, 5 times a week, for 6.5 months | mouse (female C3H/He) | 0.1 mcg[3]injection (route not stated in the abstract); dose per injection, 5 times a week | 5 times a week | other | — | Animal or in-vitro study |
Evidence grades: A approved label, B human trial, C observational, D animal study, E community-reported.
Reconstitution calculator
- Concentration
- 5 mg/mL
- Volume to draw
- 0.05 mL
- Units on a U-100 syringe
- 5 units
- Draws per vial
- 40
Properties
- CAS
- 307297-39-8
- Molecular weight
- 390.35 g/mol
- Formula
- Not yet recorded
- Sequence
- AEDG
- Aliases
- Epithalon, Epithalamin, Epithalone, Ala-Glu-Asp-Gly
- Vial sizes (mg)
- 10, 25, 50
Storage notes
- Lyophilized
- Not yet recorded from a cited source
- Reconstituted stability (days)
- Not yet recorded from a cited source
Side effects, contraindications and regulatory status
Reported side effects
- Identity: epitalon is the synthetic tetrapeptide Ala-Glu-Asp-Gly; epithalamin is a pineal-derived polypeptide extract. A 2026 narrative review says the two "should not be considered interchangeable" (Int J Mol Sci 2026).[2] Observational
- The same review states human safety data on epitalon are minimal and that none of the human studies were dedicated prospective safety studies (Int J Mol Sci 2026).[2] Observational
- Same review: in the intramuscular epitalon study (epitalon n=15) no apparent adverse effects were reported but adverse-event methods were limited; in the sublingual AEDG study adverse-event data were not systematically reported.[2] Observational
- FDA evaluation of epitalon (free base and acetate), briefing document dated 2026-05-12: FDA concludes there are no clinical data to support safety in humans, and notes a particular immunogenicity risk for subcutaneous injection.[4] Regulator or expert-panel statement
- Same FDA document: nonclinical studies were too limited in scope and duration to inform safety; FDA notes epitalon has been shown to activate telomerase and that longer telomeres are generally associated with increased cancer risk.[4] Regulator or expert-panel statement
- In one-year-old female C3H/He mice injected with epitalon 0.1 mcg 5 times a week for 6.5 months, the authors report no toxic effect (In Vivo 2006). Animal study, not human data.[3] Animal study
Regulatory status
Listed in the 'nominated but withdrawn' table of the FDA bulk-substance safety-risk page (current 2026-04-22); FDA identified no safety information for the proposed route. Checked 2026-10-20.[1] Source
Report any adverse reaction to a qualified healthcare professional.
What the research says
Summaries of the cited studies, each with its evidence grade.
Int J Mol Sci 2026 narrative review (doi 10.3390/ijms27198922), synthetic epitalon (not epithalamin)[2]
Int J Mol Sci 2026 narrative review (doi 10.3390/ijms27198922), synthetic epitalon (not epithalamin): Korkushko 2007 study, epitalon 0.01 mg/day intramuscularly for 10 days (0.1 mg per course)
Spontaneous carcinogenesis study (In Vivo 2006)[3]
Spontaneous carcinogenesis study (In Vivo 2006): one-year-old female C3H/He mice injected with Epitalon 0.1 microg, 5 times a week, for 6.5 months
Compare vial sizes
| Size | Price | Doses available from the vial Calculated | Cost per dose Calculated |
|---|---|---|---|
| 50 mg | $74.99 | — | — |
Cost per dose uses the listed partner price and the reference dose cited on this page. Prices change; check the product page.
Calculated from a default of 2 mL water (adjustable).
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Frequently asked questions
What dose figures are published for Epitalon?
Cited figures on this page: 0.01 mg daily for 10 days, intramuscular, dose per day, 10-day course; blinding not clearly described per the review [2] (Human review or observational report, evidence grade C); 0.5 mg daily for 20 days, sublingual, sublingual route, not an injection; blinding not specified per the review [2] (Human review or observational report, evidence grade C); 5 mcg once daily for 10 days, parabulbar (around the eye); ocular procedure route, dose per eye, not a subcutaneous or intramuscular dose; randomization and blinding unclear per the review [2] (Human review or observational report, evidence grade C). These are summaries of published sources, not medical advice. Each figure links to its source in the references.
What study duration is cited for Epitalon?
The cited duration is 1.4 weeks, with no off period stated (Human review or observational report). It describes the source, not a recommendation.
What is the regulatory status of Epitalon?
Listed in the 'nominated but withdrawn' table of the FDA bulk-substance safety-risk page (current 2026-04-22); FDA identified no safety information for the proposed route. Checked 2026-10-20.
Compound facts
What is the molecular weight of Epitalon?
What is the CAS number of Epitalon?
How is Epitalon stored in the laboratory?
References
Numbered sources used on this page. Markers in the text link here.
- fda.gov
- Int J Mol Sci 2026 narrative review (doi 10.3390/ijms27198922), synthetic epitalon (not epithalamin) pmc.ncbi.nlm.nih.gov Observational
- Spontaneous carcinogenesis study (In Vivo 2006) pubmed.ncbi.nlm.nih.gov Animal study
- fda.gov Regulator or expert-panel statement
Vial sizes and protocols
50 mgPartner size
Available from Pepcore
Supplied as research material for laboratory use only.
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