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Epithalon

Also known as: Epitalon, AEDG Tetrapeptide, AEDG Peptide

Research Only

Molecular Formula

C14 H22 N4 O9 Fr Ba

Molecular Weight

390.35 Da (Free Base; Acetate ~450.40 Da)

Half-Life

Unknown in humans (human pharmacokinetics and elimination half-life have not been established)

Sequence

H-Ala-Glu-Asp-Gly-OH

Clinical Applications & Evidence

Mechanism of Action

In experimental models, Epitalon upregulates hTERT expression and telomerase activity, binds specific histone proteins (H1.3) to induce heterochromatin decondensation, and stimulates pineal gland melatonin synthesis. A 2025 in-vitro study observed telomere elongation in normal and breast-cancer cell lines, underscoring unresolved theoretical questions regarding telomerase activation in oncogenesis.

Investigated Uses

  • hTERT & telomerase regulation (Preclinical cell-culture research; unproven anti-aging efficacy in humans)
  • Circadian rhythm & melatonin research (Investigational — sublingual & animal models; unproven for clinical insomnia)
  • Retinitis pigmentosa (Investigational parabulbar pilot study; 2010 FDA orphan drug designation was subsequently withdrawn)
  • Geroprotective & neuroendocrine research (Preclinical animal models; historical human longevity data evaluated crude bovine Epithalamin, not synthetic Epitalon)
Early Clinical / Animal Models

Regulatory & Safety Status

FDA Status

Research Only

WADA / Athletic Status

Prohibited at All Times (WADA S4.4.1)

Known Side Effects

Human adverse-event frequency and safety profile remain uncharacterized in controlled clinical trialsHuman subcutaneous safety, long-term toxicity, immunogenicity, and carcinogenicity are unstudiedTheoretical risk of telomerase activation in latent or active malignancies

Contraindications

  • WADA-tested athletes (Prohibited at all times under S0 Non-Approved Substances)
  • Active malignancy or history of cancer (Precautionary exclusion due to theoretical telomerase concerns)
  • Pregnancy and lactation (Unstudied safety profile)

Drug Interactions

  • Melatonin and immunomodulating agents (Theoretical overlap; clinical drug interactions have not been systematically studied)

Citations & Clinical Trials

Biogerontology Epitalon Telomere Elongation in Normal and Cancer Cell Lines (Biogerontology 2025) PubMed Clinical Study of Epithalon in Retinitis Pigmentosa (2002) FDA FDA Briefing Document: Epitalon — PCAC Meeting (July 24, 2026) Alzheimer's Drug Discovery Foundation Epithalamin and Epithalon Evidence Review International Journal of Molecular Sciences Overview of Epitalon: Bioactive Pineal Tetrapeptide (Review 2025)