Bremelanotide is the active ingredient of one FDA-approved prescription drug, Vyleesi, approved on June 21, 2019 under new drug application NDA 210557. That approval covers a single product with a single route, and no intranasal bremelanotide product has ever been approved: Drugs@FDA holds exactly one application. A vial or a spray sold as PT-141 for laboratory work is not that approved drug, and on August 24, 2026 FDA said so in writing to five sellers. This piece is the paperwork behind each of those statements, as of September 23, 2026.

Is PT-141 FDA approved? One molecule, one application

PT-141 and bremelanotide name the same molecule: PT-141 was the developmental code, bremelanotide is the international nonproprietary name, Vyleesi is the brand. Where the molecule sits in the melanocortin family, and how one terminal group separates it from melanotan II, is covered in one parent, three analogues. This piece stays on the regulatory record.

Drugs@FDA holds exactly one bremelanotide application: number 210557, active ingredient BREMELANOTIDE ACETATE, product VYLEESI (AUTOINJECTOR), marketing status Prescription, listed as both a reference listed drug and a reference standard. The original approval, ORIG-1, is dated June 21, 2019 and classified "Type 1 - New Molecular Entity" under a standard review priority. One supplement has been approved since: SUPPL-2, on October 23, 2020, a labeling change.

The approval letter names the applicant of the day.

"NDA 210557 / NDA APPROVAL / AMAG Pharmaceuticals, Inc" "We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling."FDA approval letter, NDA 210557, June 21, 2019, Reference ID 4452852

The applicant shown in Drugs@FDA today is Cosette Pharmaceuticals, Inc., also the firm named on the current structured product listing, effective November 13, 2025. Drugs@FDA displays only the current holder, and we found no primary document for the steps between AMAG and Cosette. Regard that chain as an open question rather than a fact.

What Vyleesi is: the route and the indication on the record

Drugs@FDA records one route for the one product.

"Dosage Form/Route: SOLUTION;SUBCUTANEOUS"Drugs@FDA overview record, NDA 210557

The approved labeling carries one indication, reproduced here once and only as a regulatory fact.

"VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)… Limitations of Use VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance."FDA-approved labeling for Vyleesi, current structured product listing

Those two fields are the whole of what has been approved. Neither is guidance, and this site publishes none. The route is quoted because it is the one fact separating the approved product from every other material carrying the molecule's name.

Has an intranasal bremelanotide product ever been approved?

No. A query of Drugs@FDA across bremelanotide as a generic name and as an active ingredient returns one application, NDA 210557, with one product and one route: no intranasal application, no discontinued intranasal product, none withdrawn. "Bremelanotide nasal spray" describes a development program that was abandoned, not a drug that reached the market.

FDA's multi-discipline review for NDA 210557 states why. The passage below is an optical-character reading of a scanned memo, and the broken spacing is the source's.

"The initial clinical studies in women were conducted via the intranasal route with safety determination based on intranasal formulation use in males. However, due to variable systemic exposure via the intranasal route, the applicants' current treatment paradigm in women with HSDD, is as needed bremelanotide…"FDA, NDA 210557 Multi-discipline Review, 2019

Variable systemic exposure is the stated reason. A second thread runs beside it: FDA's clinical team and the Division of Cardiovascular and Renal Products identified increases in systolic and diastolic blood pressure of roughly 4 mmHg and asked the applicant to run an ambulatory blood-pressure monitoring study, published in J Hypertens in 2017 (PMID 27977473). The earlier male program was closed outright: most nonclinical work ran under IND 61706, and "IND 61706 was withdrawn in 2017". The female program ran under IND 64119, opened in 2001, whose own initial clinical studies were also intranasal.

Peer-reviewed work corroborates the blood-pressure thread. A 2022 review in Neurol Int explains why the pivotal program wrote blood-pressure exclusion criteria into its design.

"This measure was included in response to safety concerns associated with earlier studies of intranasal bremelanotide treatment. Specifically, melanocortin receptor agonists, such as bremelanotide, may cause increases in BP."Edinoff AN et al., *Neurol Int*, 2022 (PMID 35076581)

A review abstract that contradicts the label

Here is a trap worth naming. That same 2022 review carries a sentence in its abstract stating that bremelanotide is administered intranasally or by the approved route. It is inconsistent with the approved labeling, which records one route, and with Drugs@FDA, which holds one application. Read that sentence as an error in a secondary source, not as evidence that an intranasal product exists.

The general point is worth more than the correction. A review summarises a field, is not written by the regulator, and is not updated when the record changes. Whether a product is approved, and by which route, is answered by Drugs@FDA and the approved labeling. A review, however well cited, is downstream of both.

What "component of an approved drug" changes

Because bremelanotide is a component of an FDA-approved drug product, it reaches eligibility under section 503A through that prong rather than through the bulk drug substances list. FDA's own wording of the two prongs, and what each one does and does not permit, is set out in 503A, 503B and research use only, and this piece does not repeat it.

What the lists and the Federal Register actually say

• 21 CFR 216.23, the 503A bulks list itself, names six substances in paragraph (a) and four more in paragraph (b) that FDA considered and did not list. Bremelanotide appears nowhere in the section.
• The Category 2 list, "Bulk Drug Substances That May Present Significant Safety Risks", content current April 22, 2026, names fourteen substances. Several research-chemical peptides are among them, including GHRP-2, GHRP-6, ipamorelin acetate and kisspeptin-10. Bremelanotide and PT-141 are not.
• The 503B bulks list for outsourcing facilities, last updated May 16, 2024, names five substances, each limited to topical or oral use. Bremelanotide is not among them.
• The Federal Register holds exactly two documents naming bremelanotide: a determination of the regulatory review period for patent extension on Vyleesi, published August 20, 2020, and a product-specific guidances availability notice, published March 25, 2021. Neither concerns bulk drug substances. A search for "PT-141" returns two documents, one an energy-sector cybersecurity rule and one an EPA perchlorate proposal.

One question cannot be closed. Whether bremelanotide was ever nominated to the 503A docket is unverified: FDA's Category 1 and Category 3 rosters and the nominations table no longer resolve, returning HTTP 404 as of September 23, 2026. The Federal Register and the surviving Category 2 list both return nothing, so there is no positive evidence of a nomination, and no public way to prove there was none.

Five FDA warning letters named PT-141

On August 24, 2026 FDA's Center for Drug Evaluation and Research issued five warning letters under the subject "Unapproved New Drugs/Misbranded", each naming PT-141, bremelanotide or both among the products at issue. All five were posted on September 1, 2026.

""PT-141 Peptide (Bremelanotide)," … 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)."FDA warning letter to NuScience Peptides LLC, August 24, 2026

What FDA read on those websites to reach that conclusion, and how it handled the sellers' own research-use-only labelling, is the subject of what FDA reads before calling a research product a drug.

Is bremelanotide on the WADA 2026 Prohibited List?

Stated precisely: bremelanotide, PT-141, melanocortin, melanotan, MSH, MC4 and afamelanotide appear zero times in the 26-page 2026 Prohibited List, effective 1 January 2026. There is no melanocortin-agonist class on it.

Absence is not a clearance. Section S0 reaches any pharmacological substance not addressed elsewhere on the list and "with no current approval by any governmental regulatory health authority for human therapeutic use". Bremelanotide holds such an approval, so S0's wording does not capture it on its face; a molecule with no approval anywhere is a different question with a different answer. We checked only the Prohibited List itself, not WADA technical documents, Q&As or the monitoring program, so the verified statement is narrow: not named on the 2026 list. How the catch-all sections operate is covered in the WADA list and peptides.

Status as of September 23, 2026

The bremelanotide and bremelanotide liquid spray we list are research-use-only materials, a lyophilized vial and a 10 mL solution. Neither is Vyleesi, neither is an approved drug, and we publish no use guidance for either.

Sources

• Drugs@FDA overview, NDA 210557 (Vyleesi), FDA
• NDA 210557 approval letter, FDA, June 21, 2019
• Vyleesi (bremelanotide) approved labeling, FDA, 2019
• NDA 210557 Multi-discipline Review, FDA, 2019
• 21 CFR 216.23, bulk drug substances for compounding under section 503A, eCFR
• Bulk drug substances used in compounding under section 503A, FDA
• Certain bulk drug substances that may present significant safety risks (Category 2), FDA, current April 22, 2026
• 503B bulk drug substances list, FDA, updated May 16, 2024
• Determination of Regulatory Review Period for Purposes of Patent Extension; VYLEESI, Federal Register, August 20, 2020
• Warning letter to NuScience Peptides LLC, FDA, August 24, 2026
• Edinoff AN et al., Bremelanotide for Treatment of Female Hypoactive Sexual Desire, Neurol Int, 2022
• WADA 2026 Prohibited List, World Anti-Doping Agency, effective January 1, 2026