U.S. regulatory status
PT-141 (bremelanotide)
Also known as Bremelanotide, Vyleesi, Bremelanotide acetate
Is PT-141 (bremelanotide) legal right now?
PT-141 (bremelanotide) is a melanocortin receptor agonist peptide that the FDA approved on June 21, 2019 as Vyleesi, a 1.75 mg subcutaneous autoinjector for premenopausal women with acquired, generalized hypoactive sexual desire disorder.
That makes it a prescription-only drug in the United States. Cosette Pharmaceuticals now holds the application, and Vyleesi is still marketed.
Compounding is narrow. Because bremelanotide is a component of an approved drug, a state-licensed 503A pharmacy may compound it for an individual patient’s prescription, using bulk material from an FDA-registered manufacturer, but it may not regularly make essentially copies of Vyleesi (same ingredient, similar strength, same route) unless the prescriber documents a significant difference for that patient.
Selling PT-141 as a “research” peptide is not lawful: on August 24, 2026 the FDA issued warning letters to five online sellers, including Royal Peptides and Peptide Partners, calling their PT-141 products unapproved new drugs. No FDA rulemaking, advisory committee review or other dated decision on bremelanotide is pending.
Restricted: Prescription-only, banned, controlled, or under active FDA enforcement.
Verified Oct 15, 2026 (ET) · status held since Jun 21, 2019
Where it sits in the process
Outside the 503A list process. It is an FDA-approved drug, so the 503A bulks list does not apply to it. The status above says what pharmacies may and may not do.
What changed last
No recorded changes yet - this entry has held one status since it was added.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | Restricted | FDA-approved prescription drug: Vyleesi, NDA 210557, approved Jun 21, 2019. As a component of that drug it may be 503A-compounded for an individual patient, but not as regular copies of Vyleesi while it is marketed. Aug 24, 2026: FDA warning letters to five online “research peptide” sellers name PT-141. |
| Australia (TGA) | Unscheduled | Not individually named in the Poisons Standard (October 2026) and no product on the ARTG; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation (no bremelanotide product in the MHRA Products database); supply as a medicine would be unlicensed. |
| European Union (EMA) | Restricted | No EU marketing authorisation: absent from the Union Register, and EMA’s medicines data lists no application for it. Enforcement against unlicensed supply is handled at member-state level. |
| Canada (Health Canada) | Restricted | No authorized product in the Drug Product Database; Health Canada named bremelanotide among unauthorized injectable peptide drugs seized from Canada Peptide (advisory updated Aug 1, 2025). |
| Sport / anti-doping (WADA) | Unscheduled | Not named on the 2026 or 2027 Prohibited List or the 2027 Monitoring Program; S0 covers only substances with no government approval for human use, and bremelanotide is FDA-approved. |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
FDA warning letters
5 FDA warning letters mention PT-141 (bremelanotide), all dated Aug 24, 2026.
- NuScience Peptides LLC
- Peak Performance Peptides
- Peptide Partners LLC
- Royal Peptides LLC
- TXP Innovations LLC dba Tex Peptides
A warning letter is the FDA telling one company it believes the company broke federal law. It does not change the status above. All warning letters, by compound
Sources & transparency
Sources for this entry
- Drugs@FDA - NDA 210557 (Vyleesi) FDA · primaryApproved June 21, 2019 as a new molecular entity; holder Cosette; marketing status Prescription.
- FDA - Bulk drug substances used in compounding under section 503A FDA · primary503A pharmacies may use bulk substances that are components of FDA-approved drug products where no USP or NF monograph exists.
- FDA guidance - Compounded drug products that are essentially copies of a commercially available drug product under section 503A (Jan 2018) FDA · primaryDefines essentially a copy (same API, similar strength, same route) and the four-prescriptions-a-month enforcement threshold.
- FDA warning letter - Royal Peptides LLC (Aug 24, 2026) FDA · primaryNames “PT-141” among unapproved new drugs sold online as research products.
- FDA warning letter - Peptide Partners LLC (Aug 24, 2026) FDA · primaryNames “PT-141 (Bremelanotide)” among unapproved new drugs sold online.
- Health Canada advisory - Unauthorized injectable peptide drugs seized and sold by Canada Peptide Health Canada · primaryLists bremelanotide among unauthorized injectable peptide drugs. Basis for the Canada row.
- TGA - Australian Register of Therapeutic Goods search: bremelanotide TGA · primaryNo matching results. Basis for the Australia row, with the Poisons Standard October 2026 (F2026L01327).
- MHRA Products database - search: bremelanotide UK gov · primaryNo search results. Basis for the United Kingdom row.
- Union Register of medicinal products (European Commission) EU · primaryNo bremelanotide product. Basis for the European Union row.
- WADA - 2027 Prohibited List (in force Jan 1, 2027) WADA · primaryBremelanotide is not named; S0 applies only to substances with no current government approval for human therapeutic use.
- Last verified by a human
- Oct 15, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
- What we sell
- Nothing. No products, no affiliates, no sponsored placements.
This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
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