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PEPLUX

Synthetic ACTH-fragment peptide

Semax

Illustrative PEPLUX product vial in a purple-lit studio
Product illustration

Product form

Nasal spray or subcutaneous injection

The process

Licensed provider review

Semax 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

Semax 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 Semax?

Semax. Whether it is the plain heptapeptide or N-acetyl semax amidate is not yet documented. The dispensing pharmacy must document it before this product can be ordered.

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

Key risks

  • Safety in people has not been established. Without large controlled human trials, its side effects and longer-term risks are not known.
  • FDA says compounded semax may pose a risk of immunogenicity (the immune system reacting to the peptide), and that it has no, or only limited, safety information for the proposed routes of administration.
All risks and who should not use it

FDA status

FDA status for Semax.

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.

Semax 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.

Semax

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

FDA’s documents list it as Semax (heptapeptide).

Semax 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.

Basis
FDA's 503A categories document of April 15, 2026 announced the removal of semax (heptapeptide) 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 semax may pose a risk of immunogenicity and that FDA has no, or limited, safety-related information for the proposed routes of administration.
Checked on
October 13, 2026

How it works

Semax mechanism.

Semax is a synthetic peptide built on a short fragment of adrenocorticotropic hormone (ACTH), with a three-amino-acid tail added to slow its breakdown in the body. Laboratory and animal studies have looked at how it affects signaling in nerve cells.

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

Semax: evidence and limitations.

Most of the published research on semax comes from a small number of laboratories and is in animals and cell systems. The human studies are few and small, and they do not meet the standard needed to show that it works for any use. Its safety and effectiveness in people have not been established. FDA states that it has no, or only limited, safety information for the proposed routes of administration.

Risks

Semax risks and side effects.

  • Safety in people has not been established. Without large controlled human trials, its side effects and longer-term risks are not known.
  • FDA says compounded semax may pose a risk of immunogenicity (the immune system reacting to the peptide), and that it has no, or only limited, safety information for the proposed routes of administration.
  • The nasal form can irritate the lining of the nose. 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

  • The route: this product is listed for nasal and injectable use, and the research behind each route is limited and not interchangeable

  • Every prescription medicine and supplement you take, including anything that acts on the nervous system, because interactions have not been studied

  • Any condition you are being treated for, and any history of allergic or immune reactions to peptide 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 Semax.

What is the FDA status of Semax?
No compounding pathway today. An FDA advisory committee recommendation is not a listing. Semax 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 Semax an approved drug?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. Semax 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 Semax, and what does it not?
Most of the published research on semax comes from a small number of laboratories and is in animals and cell systems. The human studies are few and small, and they do not meet the standard needed to show that it works for any use. Its safety and effectiveness in people have not been established. FDA states that it has no, or only limited, safety information for the proposed routes of administration.
What are the risks of Semax?
Safety in people has not been established. Without large 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 Semax, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Does Semax require baseline labs?
No. Semax does not require baseline labs, though your prescriber may order them based on your history. Baseline labs are included in the price.
What does Semax 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 Semax 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 Semax given?
Nasal spray or 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.

Semax 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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