PT-141: where it stands with the FDA, and what it costs
FDA-approved as Vyleesi for one use in premenopausal women; clinics also prescribe compounded bremelanotide.
Prices by form:injections (85)nasal spray (33)troches (5)
Go to clinicLowest per monthPT-141 tablets (2mg)
Everlife · from $65/mo
Go to clinicLowest at a clinic we link toPT-141 injection (5ml)
HealthRX · $170/mo
Where PT-141 stands today
Bremelanotide (PT-141) is FDA-approved as VYLEESI (NDA 210557, approved June 21, 2019; now held by Cosette), a 1.75 mg subcutaneous autoinjector for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Section 503A allows a bulk substance with no monograph if it is a component of an FDA-approved drug (FDA's guidance quotes this condition), so bremelanotide does not depend on the bulks list or FDA's categories, and FDA has placed it in none. It is not on the 503B bulks list or in any 503B category.
FDA-approved products
VYLEESI (bremelanotide injection) autoinjector, 1.75 mg/0.3 mL, Cosette Pharmaceuticals (current holder; originally approved to AMAG Pharmaceuticals), approved 2019-06-21 (NDA 210557). Prescription (marketed); indicated for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
“VYLEESI (AUTOINJECTOR) BREMELANOTIDE ACETATE EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) SOLUTION;SUBCUTANEOUS Prescription ... 06/21/2019 ORIG-1 Approval”
For pharmacies compounding one patient's prescription (section 503A)
Not in any 503A category and not on the 503A bulks list; not needed, because bremelanotide acetate is the active ingredient of an FDA-approved drug (Vyleesi), the 503A route for a substance without a monograph.
“(2) If such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary of the Department of Health and Human Services (Secretary);”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
FDA warnings, recalls and letters
Invalid Date: Import Alert 66-41 (detention without physical examination of unapproved new drugs promoted in the US) still lists 'PT 141 Peptide' from CanLab Research; entry predates 2023 but the alert is in force. (CanLab Research, Quebec, Canada (listed under Import Alert 66-41)).
“Desc: PT 141 Peptide”
24 August 2026: Five warning letters dated 24 Aug 2026 to research-peptide sellers; each names PT-141 (bremelanotide) and tesamorelin as unapproved new drugs (the sellers' products have no approved application); NuScience also sold a tesamorelin/ipamorelin blend. (NuScience Peptides LLC (online 'research peptide' seller); same-day letters to Royal Peptides, Peak Performance Peptides, Peptide Partners and TXP Innovations dba Tex Peptides name PT-141 and tesamorelin too).
“Based on our review, “GLP-2 Tirz Peptide,” “GLP-1 Sema Research Peptide,” “GLP-3 RT (Retatrutide) Research Peptide,” “Survodutide,” “Mazdutide,” “PT-141 Peptide (Bremelanotide),” “Tesamorelin Research Peptide,” “Tesamorelin Ipamorelin Blend,” and “Bacteriostatic water for Peptides (BAC Water)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).”
Our reading
A 503A pharmacy may compound bremelanotide (injection or nasal spray) for a patient-specific prescription, subject to 503A's other conditions, including not regularly compounding copies of the commercially available Vyleesi; use in men or for erectile dysfunction is off-label. A 503B facility has no route from bulk unless the drug is on FDA's shortage list.
Every source above was checked again on 14 November 2026.
What 124 clinics charge
- EverlifePT-141 tablets (2mg)from $65/mo
- ImmortalsPT-141from $73/mo
- TRT KingdomPT-141$89/mo
- EdgeRxPT-141 troches (1mg)$99/mo
- HealSendPT-141 nasal spray$99/mo
What PT-141 is
- What it is
- Melanocortin receptor agonist
- How it works
- Activates melanocortin receptors in the brain involved in sexual desire.
- How it is given
- Subcutaneous injection; also sold as nasal sprays and troches
- Also called
- bremelanotide, Vyleesi
PT-141 side by side
About PT-141
Is PT-141 FDA-approved?
Only as Vyleesi, for hypoactive sexual desire disorder in premenopausal women. What online clinics usually sell is compounded PT-141, which the FDA has not approved.
Is PT-141 legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. Bremelanotide (PT-141) is FDA-approved as VYLEESI (NDA 210557, approved June 21, 2019; now held by Cosette), a 1.75 mg subcutaneous autoinjector for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Section 503A allows a bulk substance with no monograph if it is a component of an FDA-approved drug (FDA's guidance quotes this condition), so bremelanotide does not depend on the bulks list or FDA's categories, and FDA has placed it in none. It is not on the 503B bulks list or in any 503B category.
How much does PT-141 cost?
124 clinics publish a price. The lowest that compares per month is from $65/mo at Everlife, and the middle of 87 clinics' lowest monthly prices is about $203. What a month buys differs by clinic, so each price lists what it includes. every PT-141 price
What forms does PT-141 come in?
Clinics sell it as injection (85 prices), nasal spray (33 prices), other (25 prices), troches (5 prices), tablets (1 price), capsules (1 price).