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PEPLUX

Melanocortin receptor agonist

PT-141

Also called Bremelanotide.

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

Product form

Subcutaneous injection or nasal spray

The process

Licensed provider review

PT-141 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

Vyleesi is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Compounded bremelanotide (PT-141) is a different product. It is not FDA-approved, it is not the same as Vyleesi, and FDA has not reviewed it.

The Vyleesi approval does not cover men or enhancing sexual performance.

Order now

Narrow 503A pathway as a component of an FDA-approved drug, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.

*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 PT-141?

Bremelanotide (PT-141). Prescribing is limited to the population on the approved label.

Premenopausal women with acquired, generalized hypoactive sexual desire disorder, the only population on the approved bremelanotide label, who want to discuss it with a licensed provider. It is not prescribed to men, after menopause, or to enhance sexual performance. The provider decides whether it suits you, and whether there is a documented clinical reason for a compounded version rather than the approved product.

Key risks

  • Nausea is the most commonly reported side effect on the approved label, sometimes severe enough to need anti-nausea treatment or to stop. Flushing, injection site reactions, headache and vomiting are also common.
  • Blood pressure rises and heart rate falls for a period after each dose, usually returning to baseline within about 12 hours. It must not be used by anyone with uncontrolled high blood pressure or known cardiovascular disease, and it is not recommended for people at high cardiovascular risk.
All risks and who should not use it

FDA status

FDA status for PT-141.

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

Narrow 503A pathway as a component of an FDA-approved drug, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.

Vyleesi is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Compounded bremelanotide (PT-141) is a different product. It is not FDA-approved, it is not the same as Vyleesi, and FDA has not reviewed it.

The Vyleesi approval does not cover men or enhancing sexual performance.

PT-141

Narrow compounding pathway, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.

FDA’s documents list it as Bremelanotide (PT-141).

Bremelanotide is a component of an FDA-approved drug, so a 503A pharmacy can compound it against a patient-specific prescription under that narrow statutory route. A compounder may not regularly make copies of a commercially available approved drug: a compounded injection of similar strength counts as a copy unless the prescriber documents a significant difference for that patient. There is no 503B route. The approved product is indicated only for premenopausal women with acquired, generalized hypoactive sexual desire disorder, not for men. Compounded bremelanotide is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.

PT-141 is the development name for bremelanotide. They are the same molecule.

Basis
Bremelanotide is not in any category of FDA's 503A or 503B category documents and is not on the 503A bulks list. Its only basis is the 503A route for a bulk drug substance that is a component of an FDA-approved drug (NDA 210557). FDA treats a compounded drug as essentially a copy when it matches a commercially available drug's active ingredient in the same, similar or an easily substitutable strength and can be used by the same route, unless a prescriber documents a significant difference for an identified patient. FDA has said it does not intend to act when a compounder fills four or fewer prescriptions of such a copy in a calendar month. A nasal form differs from the approved injection by route, so the copy test does not reach it, but FDA has not approved any nasal bremelanotide product. FDA warning letters dated August 24, 2026 treated bremelanotide sold for research use as an unapproved new drug.
Checked on
October 13, 2026

How it works

PT-141 mechanism.

Bremelanotide, also known as PT-141, is a synthetic peptide that activates melanocortin receptors. At the levels used clinically, its action at the MC4 receptor, found in many areas of the brain, and the MC1 receptor, found on pigment cells, is the most relevant. How it affects sexual desire is not known.

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

PT-141: evidence and limitations.

The approved bremelanotide injection was evaluated in two 24-week randomized, placebo-controlled trials in premenopausal women with acquired, generalized hypoactive sexual desire disorder. Those results belong to the approved product. Compounded bremelanotide was not part of those trials, and no nasal form of bremelanotide has been approved, so the safety and effectiveness of a compounded injection or nasal spray have not been established.

Risks

PT-141 risks and side effects.

  • Nausea is the most commonly reported side effect on the approved label, sometimes severe enough to need anti-nausea treatment or to stop. Flushing, injection site reactions, headache and vomiting are also common.
  • Blood pressure rises and heart rate falls for a period after each dose, usually returning to baseline within about 12 hours. It must not be used by anyone with uncontrolled high blood pressure or known cardiovascular disease, and it is not recommended for people at high cardiovascular risk.
  • Darkening of the skin in patches, including on the face, gums or breasts, has been reported. It is more likely with darker skin and with more frequent use, and it did not always resolve.
  • It may sharply reduce the effect of oral naltrexone, so it should not be used with naltrexone taken by mouth for alcohol or opioid use disorder.
  • Animal studies suggest a possible risk to a developing fetus, and human pregnancy data are insufficient. The approved label advises stopping if pregnancy is suspected.
  • The safety of compounded bremelanotide, and of any nasal form, has not been established in clinical trials.

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.

  • Whether low sexual desire is acquired, generalized and causing marked distress, and is not better explained by another medical or psychiatric condition, relationship difficulties, or a medicine you take

  • Your blood pressure and cardiovascular risk, assessed before starting and reviewed during treatment

  • Oral medicines that depend on reaching a set level to work, such as antibiotics, or that need to act quickly, such as some pain relief, because bremelanotide may slow stomach emptying

  • Any use of oral naltrexone

  • Pregnancy, plans for pregnancy, and contraception, since the approved label advises effective contraception during treatment

  • Whether the approved product suits you, and whether a documented clinical reason supports a compounded version instead

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.

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

Straight answers

Common questions about PT-141.

What is the FDA status of PT-141?
Narrow 503A pathway as a component of an FDA-approved drug, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved. Bremelanotide is a component of an FDA-approved drug, so a 503A pharmacy can compound it against a patient-specific prescription under that narrow statutory route. A compounder may not regularly make copies of a commercially available approved drug: a compounded injection of similar strength counts as a copy unless the prescriber documents a significant difference for that patient. There is no 503B route. The approved product is indicated only for premenopausal women with acquired, generalized hypoactive sexual desire disorder, not for men. Compounded bremelanotide 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 PT-141 an approved drug?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality. Vyleesi is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Compounded bremelanotide (PT-141) is a different product. It is not FDA-approved, it is not the same as Vyleesi, and FDA has not reviewed it. The Vyleesi approval does not cover men or enhancing sexual performance. 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 PT-141, and what does it not?
The approved bremelanotide injection was evaluated in two 24-week randomized, placebo-controlled trials in premenopausal women with acquired, generalized hypoactive sexual desire disorder. Those results belong to the approved product. Compounded bremelanotide was not part of those trials, and no nasal form of bremelanotide has been approved, so the safety and effectiveness of a compounded injection or nasal spray have not been established.
What are the risks of PT-141?
Nausea is the most commonly reported side effect on the approved label, sometimes severe enough to need anti-nausea treatment or to stop. Flushing, injection site reactions, headache and vomiting are also common. The full list of side effects, and of who should not use PT-141, is in the risks section of this page. Your prescriber reviews your history before deciding whether it is appropriate for you.
Does PT-141 require baseline labs?
No. PT-141 does not require baseline labs, though your prescriber may order them based on your history. Baseline labs are included in the price.
What does PT-141 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 PT-141 prohibited in sport?
Not named on the WADA 2026 Prohibited List.
How is PT-141 given?
Subcutaneous injection or nasal spray. 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.

Vyleesi is FDA-approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Compounded bremelanotide (PT-141) is a different product. It is not FDA-approved, it is not the same as Vyleesi, and FDA has not reviewed it.

The Vyleesi approval does not cover men or enhancing sexual performance.

Order now

Narrow 503A pathway as a component of an FDA-approved drug, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.

*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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