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PEPLUX

Synthetic tetrapeptide

Epitalon

Also called Epithalon.

Illustrative PEPLUX product vial in a purple-lit studio
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Subcutaneous injection

The process

Licensed provider review

Epitalon cost

$229 per month

*If medically eligible.
Medication
Included
Clinician visit
Included
Baseline labs
Included
Lab retests
Included when ordered by your provider
Shipping
Included
Patient portal access
Included
Care-team chat support
Included

Considering more than one product?

  • Two products prescribed together: $349 per month
  • Three products prescribed together: $479 per month
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Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

FDA status, checked on October 13, 2026

Epitalon is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Order now

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.

Prescription products require an online evaluation with a licensed provider. Not all patients qualify.

States served: not yet confirmed. How state availability works

What is Epitalon?

Epitalon (Ala-Glu-Asp-Gly), a synthetic tetrapeptide. Not epithalamin, the pineal gland extract.

Adults who want to discuss epitalon with a licensed provider after reading its regulatory status, and who accept that any decision to prescribe it rests on limited laboratory and animal research, not on evidence that it is safe or effective in people.

Key risks

  • Safety in people has not been established. Without controlled human trials, its side effects and longer-term risks are not known.
  • FDA says compounded epitalon may pose a risk of immunogenicity (the immune system reacting to the peptide), and that it has not identified safety information for the proposed route of administration.
All risks and who should not use it

FDA status

FDA status for Epitalon.

Rendered from our regulatory records, which cite FDA, Federal Register and label documents directly. Each record shows the date we last checked it.

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

Epitalon is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

An FDA advisory committee recommendation is not a listing. Nothing changes unless FDA publishes a final rule.

Epitalon

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

Epitalon is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee recommended it on July 24, 2026. A recommendation is not a listing: nothing changes unless FDA publishes a final rule.

Epitalon (also spelled epithalon) is not the same substance as epithalamin. This record covers epitalon only.

Basis
FDA's 503A categories document of April 15, 2026 announced the removal of epitalon from Category 2, effective seven days later, because its nominations were withdrawn. It has no entry in FDA's current 503A or 503B category documents, it is not on the 503A bulks list (21 CFR 216.23) or the 503B bulks list, and it is not a component of an FDA-approved drug. FDA's safety page says compounded epitalon may pose a risk of immunogenicity, and that FDA has not identified safety-related information for the proposed route of administration, so it lacks sufficient information to know whether it would cause harm in people.
Checked on
October 13, 2026

How it works

Epitalon mechanism.

Epitalon is a synthetic peptide of four amino acids (alanine, glutamic acid, aspartic acid and glycine). It was developed by researchers studying epithalamin, a pineal gland extract, but it is a different, fully synthetic substance. Laboratory and animal studies have looked at its effects on gene expression in cells and tissues.

That describes what the molecule does in the body. It is not a claim about what it will do for you.

What the evidence supports

Epitalon: evidence and limitations.

Most of the published research on epitalon comes from a small number of laboratories, largely one research group, and much of it has not been independently replicated. The work is mainly in cell culture and animals. The few human reports are small and do not meet the standard of a modern controlled trial. FDA states that it lacks enough information to know whether epitalon would cause harm in people. Its safety and effectiveness in people have not been established.

Risks

Epitalon risks and side effects.

  • Safety in people has not been established. Without controlled human trials, its side effects and longer-term risks are not known.
  • FDA says compounded epitalon may pose a risk of immunogenicity (the immune system reacting to the peptide), and that it has not identified safety information for the proposed route of administration.
  • Injection under the skin can cause redness, swelling, pain or bruising at the site, and infection if the injection technique or the product is not sterile.
  • Not for use during pregnancy or breastfeeding, or by anyone under 18, because there is no safety information for these groups.
  • Stop and seek medical care for signs of an allergic reaction, such as hives, swelling of the face or throat, or difficulty breathing.

This information is educational and is not medical advice. It does not establish a provider–patient relationship.

Clinical review

What your prescriber will consider.

These are decision factors a licensed provider weighs when deciding whether this product is appropriate for you. They are not instructions, and there is no dosing protocol on this page.

  • What you hope to change, how you and the provider would judge it, and whether a better-studied option should come first

  • That safety and effectiveness in people have not been established, and what that means for you

  • Every prescription medicine and supplement you take, because interactions have not been studied

  • Any history of allergic or immune reactions to injected medicines

  • Whether you are subject to sport drug testing, and how anti-doping rules apply to this substance

PEPLUX does not publish self-administration protocols. Dose, frequency and duration are set by your prescriber against your own history and reviewed over time.

Lot documents

What a certificate of analysis should cover.

When a pharmacy is named, each lot's certificate of analysis is expected to cover the tests below. No certificate exists or is published yet.

  • Potency
  • Sterility
  • Endotoxin
  • pH

Sport and anti-doping

WADA status.

  • Not named on the WADA 2026 Prohibited List. Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed.

The list is revised every year. If you compete, check the current list and your federation’s own rules.

Straight answers

Common questions about Epitalon.

What is the FDA status of Epitalon?
No compounding pathway today. An FDA advisory committee recommendation is not a listing. Epitalon is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 in April 2026 after the nominations were withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee recommended it on July 24, 2026. A recommendation is not a listing: nothing changes unless FDA publishes a final rule. Checked against primary sources on October 13, 2026.
Is compounded Epitalon an approved drug?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. Epitalon is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established. PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.
What does the evidence support for Epitalon, and what does it not?
Most of the published research on epitalon comes from a small number of laboratories, largely one research group, and much of it has not been independently replicated. The work is mainly in cell culture and animals. The few human reports are small and do not meet the standard of a modern controlled trial. FDA states that it lacks enough information to know whether epitalon would cause harm in people. Its safety and effectiveness in people have not been established.
What are the risks of Epitalon?
Safety in people has not been established. Without controlled human trials, its side effects and longer-term risks are not known. The full list of side effects, and of who should not use Epitalon, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Does Epitalon require baseline labs?
No. Epitalon does not require baseline labs, though your prescriber may order them based on your history. Baseline labs are included in the price.
What does Epitalon cost?
$229 per month. Medication: included. Clinician visit: included. Baseline labs: included. Lab retests: included when ordered by your provider. Shipping: included. Patient portal access: included. Care-team chat support: included. *If medically eligible.
Is Epitalon prohibited in sport?
Not named on the WADA 2026 Prohibited List. Not named on the 2026 list. Whether the S0 class (substances with no government approval for human therapeutic use) reaches it has not been confirmed.
How is Epitalon given?
Subcutaneous injection. Your prescriber decides whether it is appropriate for you and sets the regimen. PEPLUX does not publish dosing.

Next step

A licensed provider reviews every request.

Epitalon is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.

Order now

No compounding pathway today. An FDA advisory committee recommendation is not a listing.

*If medically eligible.

Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.

Also offered

Other products.

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