Biomed Peptides Logo
    Back to blog

    Epitalon Peptide: A Provider's Guide to Identity, Regulatory Context, and Supply

    Short answer: Epitalon (also spelled Epithalon or Epithalone) is the synthetic tetrapeptide Ala-Glu-Asp-Gly (AEDG). PubChem lists it as CID 219042, molecular formula C14H22N4O9, molecular weight ≈390.35 g/mol, CAS 307297-39-8 (PubChem). It was synthesized based on the amino acid composition of Epithalamin, a bovine pineal gland extract (Araj et al., 2025). Biomed Peptides lists EPITALON in 10 mg and 50 mg lyophilized vials for verified, licensed providers only.

    This guide covers identity, the 2026 regulatory picture, supply format, documentation, and access. Clinical decisions stay with the prescribing clinician.

    What is the Epitalon peptide?

    Sequence and structure

    Epitalon is one of the smallest peptides in a typical clinic catalog. It has just four residues, and two of them (glutamic acid and aspartic acid) carry acidic side chains.

    Attribute Value
    Name Epitalon (Epithalon, Epithalone)
    Sequence (3-letter) Ala-Glu-Asp-Gly
    Sequence (1-letter) AEDG
    Chemical name (PubChem synonym) L-alanyl-L-glutamyl-L-aspartyl-glycine
    Length 4 amino acids
    Molecular formula C14H22N4O9
    Molecular weight ≈390.35 g/mol
    CAS (as listed in PubChem) 307297-39-8
    PubChem CID 219042

    Origin: Epithalamin vs. Epitalon

    The two names are easy to mix up, but they refer to different things:

    • Epithalamin is a polypeptide extract prepared from bovine pineal glands.
    • Epitalon is a single, defined synthetic tetrapeptide. It "was synthesized based on the amino acids composition of Epithalamin," according to a 2025 review in the International Journal of Molecular Sciences (Araj et al., 2025).

    The same review notes that, despite a large body of biological research, "the quantity of physico-chemical and structural investigations of this peptide remains quite limited" (Araj et al., 2025). That gives practices one more reason to rely on lot-specific analytical documentation instead of general claims.

    PubChem lists "Epithalamin" among the synonyms on the Epitalon record (PubChem). Catalogs and COAs should use the defined tetrapeptide name and sequence, so it's clear the vial contains AEDG and not a tissue extract.

    Regulatory context in 2026

    Epitalon's regulatory status changed during 2026. Here's what the primary sources say, in order.

    FDA's 503A category pages

    • FDA's significant-safety-risks page lists Epitalon under "Bulk drug substances nominated but withdrawn," meaning it was previously in category 2 and the nominators withdrew their nominations. It's marked current as of April 22, 2026 (FDA).
    • FDA's 503A nominations list (updated May 14, 2026) does not name Epitalon in category 1, 2, or 3 (FDA nominations list).

    HHS enforcement-discretion notice (October 2026)

    On October 30, 2026, HHS published a Federal Register notice of availability for an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." Under it, HHS "does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A," while FDA develops the 503A bulks list through rulemaking (Federal Register). The notice calls the document a draft, invites comments for two weeks after publication, and says HHS may revisit the policy.

    According to a law-firm analysis of the policy, Epitalon (acetate) is one of six peptides in Appendix A. Enforcement discretion applies only when all of the policy's listed conditions are met (McDermott). The conditions that bear directly on sourcing and documentation include:

    • The bulk drug substance comes from a section 510-registered facility and has a valid COA.
    • The original manufacturer is FDA-registered, and its physical facility location appears on the COA. Any repacker or reseller must document its own validation of the manufacturer and the COA.
    • The compounded product contains a single active ingredient.
    • Labeling carries the statement "This is a compounded drug product. Not for resale."

    The policy also has identity, route, and reporting conditions. The policy text is hosted on HHS's website, and the Federal Register notice links to it. Your compounding pharmacist should review the current version before relying on it. The policy doesn't add Epitalon to the 503A bulks list or make it FDA-approved (McDermott). The notice itself reminds readers that compounded drugs are not FDA-approved (Federal Register). For pathway background, see what a 503A pharmacy is and peptide compounding pharmacy.

    How Epitalon is supplied to clinics

    Lyophilized vial format and sizes

    Epitalon ships as a lyophilized (freeze-dried) powder in a sealed vial. The Biomed Peptides lyophilized catalog lists:

    • EPITALON, 10 mg vial
    • EPITALON, 50 mg vial

    Both strengths contain the same AEDG tetrapeptide in different fill amounts. Pricing appears only after a provider account is approved.

    Storage pointers

    • Keep vials sealed, dry, and protected from light. Follow the product label first.
    • Don't store peptides in solution long term. Bachem notes they "may slowly undergo chemical degradation" and recommends keeping them as a lyophilizate in a tightly closed container, below −15 °C for longer storage, with lower temperatures preferred. Refrigeration at 4 °C is acceptable for short-term use (Bachem).
    • Let a cold vial reach room temperature before opening, because peptides are hygroscopic and absorbed moisture "reduces the overall peptide content" (Bachem).
    • Use the diluent named on the labeling. See bacteriostatic water for peptides.

    Our lyophilized peptides storage guide covers receiving, cold storage, and rotation in detail.

    Documentation to request for Epitalon

    • Lot-specific COA with mass spectrometry identity matching ≈390 Da for the free tetrapeptide, and HPLC purity with the method stated
    • Peptide content and counter-ion (for example, acetate), which is how a lot reconciles the labeled mg with the powder's actual composition (Bachem)
    • Original manufacturer name and facility location, plus registration details
    • Endotoxin results where applicable
    • Labeled storage conditions and expiration

    Our peptide COA and third-party testing guide shows how to read each section and match it to the vial.

    How providers get access to Epitalon

    Biomed Peptides supplies physician-use product only to licensed healthcare providers and GPOs. We don't sell to patients or consumers.

    1. Submit the provider application.
    2. Our team verifies your credentials, usually within 24–48 hours.
    3. Approved accounts can view pricing, the full catalog, and lot documentation.
    4. Order for office use or patient-specific fulfillment, with shipping to all 50 states.

    Source Epitalon for your practice

    Licensed practices can apply for provider access to view EPITALON pricing and lot COAs for the 10 mg and 50 mg vials, or browse the lyophilized catalog.

    FAQ

    What is the Epitalon peptide?

    Epitalon is the synthetic tetrapeptide Ala-Glu-Asp-Gly (AEDG). PubChem lists it as CID 219042 with a molecular weight of about 390.35 g/mol.

    Is Epithalon the same as Epitalon?

    Yes. Epitalon, Epithalon, and Epithalone are spelling variants of the same AEDG tetrapeptide. Epithalamin is different: it's the bovine pineal extract whose amino acid composition Epitalon was based on.

    What is Epitalon's 503A regulatory status?

    FDA lists Epitalon among substances previously in category 2 whose nominations were withdrawn (page current April 22, 2026). In October 2026, HHS published notice of a draft enforcement-discretion policy that, per published analyses, names Epitalon (acetate) among six peptides, subject to specific conditions. Confirm the current status with your compounding pharmacist.

    What vial sizes does Biomed Peptides list for Epitalon?

    EPITALON is listed in 10 mg and 50 mg lyophilized vials. Pricing is visible to approved provider accounts.

    What should an Epitalon COA show?

    Mass spectrometry identity matching about 390 Da, HPLC purity, peptide content and counter-ion, the original manufacturer and facility location, endotoxin results where applicable, and labeled storage and expiration.

    Sources

    Frequently Asked Questions

    Quick answers related to this article.

    Back to all articles