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Epitalon

Tetrapeptide. Epitalon is not FDA approved for any use.

Also called:EpithalonepithalaminN-acetyl epitalon
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated Strongest evidence: Human RCT evidence, 4 of 4
StatusPCAC voted 7–5 for 503A (Jul 2026)Removed from FDA Category 2 on 15 Apr 2026. PCAC voted 7–5 for the 503A list (Jul 2026); not finalized.WADA status unclearFull legal history

Key facts

How we verify
Class
Tetrapeptide
Also called
Epithalon, epithalamin
Vial sizes sold
10 mg, 50 mg, 100 mg
Community-reported sizes
Half-life
Not found
No published half-life found (PubMed search, 2 Oct 2026)
FDA status
Not approved
Off Category 2, 15 Apr 2026
PCAC vote
7–5 for 503A
Jul 2026, not final
WADA
Unclear
Not named on the 2026 list
Everything on Epitalon

Epitalon guides

Evidence at a glance

Human and animal counts are PubMed records from our evidence ledger (search counts, not studies we reviewed). The grade is the strongest design among the studies we summarised for that goal: a human randomized trial outweighs any number of animal studies.

Epitalon: studies by condition
ConditionHuman studiesAnimal studiesStudies we summarisedEvidence grade
Any condition (no goal ledger yet)Not in our ledgerNot in our ledger13Human RCT evidence, 4 of 4Neuro endocrinology letters 2002, PMID 12195242

Grades follow our evidence scale. Summarised studies come from our evidence file, each quote checked against the abstract or label.

Common stacks

Epitalon is often sold pre-mixed or combined with other peptides. No controlled study has tested these combinations; the pages below cover the math and what each part has been studied for.

Common questions

Is Epitalon FDA approved?

No. Epitalon is not FDA approved for any use. The FDA removed it from Category 2 on 15 Apr 2026. Its advisory committee voted 7–5 in July 2026 to add it to the 503A compounding list. That vote is not final.

How much water goes in a 10 mg vial?

That choice only changes the concentration. With 2 mL, the vial is 5 mg/mL. The calculator converts any amount to syringe units. It does the math only and does not suggest a dose.

Sources

  1. 1Certain bulk drug substances for use in compounding that may present significant safety risks (Category 2; 'nominated but withdrawn' table, content current as of 22 Apr 2026)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  2. 2Pharmacy Compounding Advisory Committee meeting, 23–24 Jul 2026 (agenda and materials)U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  3. 3US search volume and year-over-year trend, Google Keyword Planner export (Jun–Aug 2026 vs 2025)Peptigraph research · 2026peptigraph.com/methodology/Accessed 1 Oct 2026
  4. 4World Anti-Doping Code International Standard Prohibited List 2026World Anti-Doping Agency · 2026wada-ama.orgAccessed 2 Oct 2026
  5. 5United States: No FDA-approved product found: Drugs@FDA (openFDA) search for active ingredient "epitalon" returned no matches on 2 Oct 2026.U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026
  6. 6US compounding: Epitalon was removed from FDA's 503A category 2 after the nominators withdrew; FDA announced a PCAC consultation on 24 July 2026.U.S. Food and Drug Administration · 2026fda.govAccessed 2 Oct 2026
  7. 7Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa.Neuro endocrinology letters · 2002PMID 12195242Accessed 2 Oct 2026
  8. 8PubMed search: (epitalon[tiab] OR epithalon[tiab] OR epithalamin[tiab]) (165 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  9. 9PubMed search: (epitalon[tiab] OR epithalon[tiab] OR epithalamin[tiab]) AND (humans[mh] OR patients[tiab] OR randomized[tiab]) (58 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  10. 10PubMed search: (epitalon[tiab] OR epithalon[tiab] OR epithalamin[tiab]) AND (half-life[tiab] OR pharmacokinetic*[tiab]) (0 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  11. 11PubMed search: epitalon[tiab] AND (mice[tiab] OR rats[tiab] OR "life span"[tiab] OR lifespan[tiab]) (31 results)PubMed · 2026pubmed.ncbi.nlm.nih.govAccessed 2 Oct 2026
  12. 12Advisory committee backs 6 of 7 peptides for the 503A listNCPA · 2026ncpa.org
  13. 13FDA gives notice that 12 peptides will be removed from Category 2 (nominations withdrawn)FDA · 2026fda.govAccessed 2 Oct 2026

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