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PEPLUX

Growth hormone-releasing hormone analog

Sermorelin

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

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Subcutaneous injection or oral use

The process

Licensed provider review

Sermorelin 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
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In FDA's 503B Category 1: interim enforcement discretion, not the bulks list.

*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 Sermorelin?

Sermorelin acetate.

Adults whose symptoms and baseline IGF-1 lead them to discuss the growth hormone axis with a licensed provider. The provider reviews the subcutaneous or oral formulation separately, with evidence that is limited and cannot be assumed to apply across routes.

Key risks

  • Injection-related effects can include pain, redness or swelling at the site. Allergic reactions can occur; the side-effect profile of an oral tablet cannot be inferred from an injected formulation.
  • Raising growth hormone and IGF-1 may not be appropriate for people with an active cancer or a history of cancer, which is why the prescriber reviews it first.
All risks and who should not use it

FDA status

FDA status for Sermorelin.

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

In FDA's 503B Category 1: interim enforcement discretion, not the bulks list.

Sermorelin

FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.

FDA’s documents list it as Sermorelin Acetate.

Sermorelin acetate is in FDA's 503B Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503B outsourcing facility that compounds it while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Sermorelin does not appear in any of FDA's 503A categories. Compounded sermorelin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.

Basis
FDA's 503B categories document (updated March 21, 2025) lists "Sermorelin Acetate" in Category 1, bulk drug substances under evaluation, marked as a component of an FDA-approved drug. Sermorelin does not appear in Category 1, 2 or 3 of FDA's 503A categories document (updated May 14, 2026). It is not on the 503A bulks list in 21 CFR 216.23 and not on the 503B bulks list. Category 1 is FDA's interim enforcement discretion, not a statutory pathway.
Checked on
October 13, 2026

How it works

Sermorelin mechanism.

Sermorelin is a growth hormone-releasing hormone (GHRH) analog that can signal the pituitary to release growth hormone. Whether a particular formulation delivers the peptide in a way that produces this effect is a separate question. An oral tablet cannot be assumed to behave like a subcutaneous injection.

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

Sermorelin: evidence and limitations.

Evidence for sermorelin in adults is limited and must be interpreted according to the population, route and formulation studied. Evidence from an injected product does not establish the absorption, safety or effectiveness of an oral tablet. Formulation-specific evidence for the listed tablet has not been confirmed, and safety and effectiveness for age-related changes in growth hormone have not been established.

Risks

Sermorelin risks and side effects.

  • Injection-related effects can include pain, redness or swelling at the site. Allergic reactions can occur; the side-effect profile of an oral tablet cannot be inferred from an injected formulation.
  • Raising growth hormone and IGF-1 may not be appropriate for people with an active cancer or a history of cancer, which is why the prescriber reviews it first.
  • Not for anyone with a known allergy to sermorelin.
  • The adverse effects of the listed oral formulation have not been established. Its formulation-specific risks and absorption require review.
  • The safety of compounded sermorelin in adults, particularly over the long term, has not been established.
  • Safety in pregnancy and breastfeeding has not been established.

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.

  • Baseline IGF-1 and a review of your symptoms, not age alone

  • The exact formulation and route, including the unconfirmed evidence for the oral tablet and the limits of transferring injection findings to it

  • Any active or past cancer, which weighs against a therapy that raises growth hormone and IGF-1

  • Whether sleep, training load, or nutrition explain the symptoms first

  • How IGF-1 will be monitored during treatment, and when the prescriber will reassess whether to continue

  • Thyroid function and other hormone results that affect how the pituitary responds

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

Prohibited under the WADA code.

  • Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).

If you compete under an anti-doping authority, or are tested through your employer or federation, tell your prescriber before you start. Sanctions can follow from possession or purchase records alone, without a positive test.

Straight answers

Common questions about Sermorelin.

What is the FDA status of Sermorelin?
In FDA's 503B Category 1: interim enforcement discretion, not the bulks list. Sermorelin acetate is in FDA's 503B Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503B outsourcing facility that compounds it while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Sermorelin does not appear in any of FDA's 503A categories. Compounded sermorelin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold. Checked against primary sources on October 13, 2026.
Is compounded Sermorelin an approved drug?
No. 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.
What does the evidence support for Sermorelin, and what does it not?
Evidence for sermorelin in adults is limited and must be interpreted according to the population, route and formulation studied. Evidence from an injected product does not establish the absorption, safety or effectiveness of an oral tablet. Formulation-specific evidence for the listed tablet has not been confirmed, and safety and effectiveness for age-related changes in growth hormone have not been established.
What are the risks of Sermorelin?
Injection-related effects can include pain, redness or swelling at the site. Allergic reactions can occur; the side-effect profile of an oral tablet cannot be inferred from an injected formulation. The full list of side effects, and of who should not use Sermorelin, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Why does Sermorelin require baseline labs?
Yes. A prescriber reviews baseline labs before a first prescription of Sermorelin. Baseline labs are included in the price.
What does Sermorelin 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 Sermorelin prohibited in sport?
Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors). If you are subject to anti-doping testing, tell your prescriber before you start. Sanctions can follow from possession or purchase records alone, without a positive test.
How is Sermorelin given?
Subcutaneous injection or oral use. 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.

Order now

In FDA's 503B Category 1: interim enforcement discretion, not the bulks list.

*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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