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PEPLUX

Mitochondrial-derived peptide

MOTS-c

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

The process

Licensed provider review

MOTS-c 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

MOTS-c 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 MOTS-c?

MOTS-c (mitochondrial open reading frame of the 12S rRNA type-c), a mitochondrial-derived peptide.

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

Key risks

  • Safety in people has not been established. Controlled trials of MOTS-c given to people as a medicine are lacking, so its side effects and longer-term risks are not known.
  • FDA says compounded MOTS-c may pose a significant risk of immunogenicity (the immune system reacting to the peptide), and that it lacks important information on whether MOTS-c would cause harm in people.
All risks and who should not use it

FDA status

FDA status for MOTS-c.

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.

MOTS-c 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.

MOTS-c

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

MOTS-c 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 nomination was withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee recommended it on July 23, 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 MOTS-c (listed by FDA as MOTs-C) from Category 2, effective seven days later, because its nomination was 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 MOTS-c may pose a significant risk of immunogenicity, that FDA has not identified any human exposure data on drug products containing it, and that FDA lacks important information on whether it would cause harm in people.
Checked on
October 13, 2026

How it works

MOTS-c mechanism.

MOTS-c is a short peptide of 16 amino acids encoded in the mitochondrial genome rather than in the cell nucleus. Researchers have studied it as a signaling molecule that may carry messages from mitochondria to the rest of the cell, including the cell nucleus. This work has been done mostly in cultured cells and in mice.

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

MOTS-c: evidence and limitations.

Almost all of the published work on MOTS-c is in cell culture and rodents. The human studies that exist mostly measure the MOTS-c the body makes on its own; they do not test it as a medicine. FDA states that it has not identified human exposure data on drug products containing MOTS-c. Its safety and effectiveness in people have not been established, and animal results do not show what will happen in a person.

Risks

MOTS-c risks and side effects.

  • Safety in people has not been established. Controlled trials of MOTS-c given to people as a medicine are lacking, so its side effects and longer-term risks are not known.
  • FDA says compounded MOTS-c may pose a significant risk of immunogenicity (the immune system reacting to the peptide), and that it lacks important information on whether MOTS-c would cause harm in people.
  • 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

Prohibited under the WADA code.

  • Prohibited at all times under WADA class S4.4.1 (activators of AMP-activated protein kinase).

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 MOTS-c.

What is the FDA status of MOTS-c?
No compounding pathway today. An FDA advisory committee recommendation is not a listing. MOTS-c 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 nomination was withdrawn, but removal is not a listing. FDA's Pharmacy Compounding Advisory Committee recommended it on July 23, 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 MOTS-c an approved drug?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. MOTS-c 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 MOTS-c, and what does it not?
Almost all of the published work on MOTS-c is in cell culture and rodents. The human studies that exist mostly measure the MOTS-c the body makes on its own; they do not test it as a medicine. FDA states that it has not identified human exposure data on drug products containing MOTS-c. Its safety and effectiveness in people have not been established, and animal results do not show what will happen in a person.
What are the risks of MOTS-c?
Safety in people has not been established. Controlled trials of MOTS-c given to people as a medicine are lacking, so its side effects and longer-term risks are not known. The full list of side effects, and of who should not use MOTS-c, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Does MOTS-c require baseline labs?
No. MOTS-c does not require baseline labs, though your prescriber may order them based on your history. Baseline labs are included in the price.
What does MOTS-c 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 MOTS-c prohibited in sport?
Prohibited at all times under WADA class S4.4.1 (activators of AMP-activated protein kinase). 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 MOTS-c 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.

MOTS-c 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

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