Peptide dossier, updated Nov 2, 2026

PT-141 (Bremelanotide)

Bremelanotide acetate, brand name Vyleesi. PT-141 is the name used by research-chemical sellers. A melanocortin receptor agonist given as an injection under the skin. FDA approved it in 2019 for one use: low sexual desire in premenopausal women with a specific diagnosis. The same compound is sold online as “PT-141” for other purposes. This page lays out what each source actually says.

See all 16 verified records for PT-141 (Bremelanotide) on the Records page

In plain terms

Approved for: Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) that is not due to another medical or psychiatric condition, relationship problems or a medication (Vyleesi label). No other use is approved.

What it is: A synthetic peptide that activates melanocortin receptors, given as an under-the-skin injection as needed.

What it is said to do, and by whom:

FDA, through the label: approved for the use above; contraindicated in uncontrolled hypertension or known cardiovascular disease; warns of a temporary rise in blood pressure after each dose and of focal skin darkening.
Trial investigators, 2019: in two 24-week trials of 1,267 randomized women, desire scores rose 0.35 points more than placebo and distress fell 0.33 points more (integrated results); nausea, flushing and headache were common.
Sellers of “research” PT-141: FDA’s August 2026 letters say products sold this way are unapproved new drugs.

How strong the evidence is: Randomized phase 3 data exist for the approved use, with modest average effects and frequent nausea. A published re-analysis argues the drug is generally not useful. We found no randomized data for the other uses promoted online.

FDA approval

Approved

Vyleesi, NDA 210557, original approval Jun 21, 2019 (Drugs@FDA through openFDA). Current FDA label (supplement 5, approved Oct 22, 2026): revised 10/2026, marketed by Cosette Pharmaceuticals.

Label contraindication

Heart and blood pressure

Uncontrolled hypertension or known cardiovascular disease. The label also says it is not recommended in patients at high risk for cardiovascular disease. No boxed warning on the label we read.

FDA warning letters, Aug 2026

Two letters name it

FDA told two companies that PT-141 products they sold as “research peptides” are unapproved new drugs.

FDA safety-risk page

Not listed

We read the page on Nov 1, 2026 and did not find bremelanotide on it.

HHS enforcement, Oct 30

Not covered

The draft policy’s covered list names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. PT-141 is not one of them. Draft policy. Not binding.

FDA advisory panel, July

Not reviewed

FDA’s Federal Register notice for the July 23–24 meeting lists seven peptides. PT-141 is not among them.

WADA prohibited list

Not named

We searched the text of WADA’s 2026 list and found no entry for bremelanotide or PT-141. That is a search of one file, not a ruling that it is permitted.

FDA approval and label

The approval dates are from Drugs@FDA through the openFDA API. Label content is paraphrased from FDA’s October 2026 label PDF; the label governs.

Item	Detail	Source
Original approval	Jun 21, 2019 (NDA 210557)	Drugs@FDA NDA210557
Later supplements	Two labeling supplements: Oct 23, 2020 (label revised 10/2020) and Oct 22, 2026 (label revised 10/2026). A word-by-word comparison of the two label texts shows these changes in 2026: the marketer (Cosette Pharmaceuticals instead of Palatin Technologies); a lactation section reporting a 10-woman study (relative infant dose 0.132%) in place of “no information”; removal of the pregnancy-registry language; and new package codes. The warnings, contraindication, dosing and trial sections are unchanged. A text comparison cannot see images or layout.	2026 label (PDF) 2020 label (PDF)
Dosing	1.75 mg injected under the skin, as needed, at least 45 minutes before anticipated sexual activity; no more than one dose in 24 hours; more than 8 doses a month is not recommended.	2026 label (PDF)
Limitations of Use	Not indicated for HSDD in postmenopausal women or in men, and not indicated to enhance sexual performance.	2026 label (PDF)
Indication	Premenopausal women with acquired, generalized HSDD, as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, or a medication or drug substance.	2026 label (PDF)
Warnings, as headed	Transient increase in blood pressure and decrease in heart rate after each dose, usually resolving within 12 hours. Focal hyperpigmentation, reported by 1% of patients dosed up to 8 times a month, with higher risk in patients with darker skin and with daily dosing; resolution was not confirmed in some patients. In a separate study, 38% developed focal hyperpigmentation after 8 consecutive daily doses and a further 14% of those continuing for 8 more days. Nausea was reported by 40% and led 8% to stop. In the label’s pooled trial data, 18% of drug-treated and 2% of placebo patients stopped because of adverse reactions.	2026 label (PDF)
Contraindication	Uncontrolled hypertension or known cardiovascular disease.	2026 label (PDF)
Efficacy results in the label	Desire score, mean change: 0.5 vs 0.2 on placebo (study 1) and 0.6 vs 0.2 (study 2). Distress score: -0.7 vs -0.4 in both. The label says there was no significant difference in satisfying sexual events, a secondary endpoint. Early discontinuation during the 24 weeks: 40% vs 13% (study 1) and 39% vs 25% (study 2).	2026 label (PDF)
Pregnancy, interactions, liver	Animal studies suggest possible fetal harm, so the label advises contraception and stopping if pregnancy is suspected. It may slow absorption of oral drugs and may sharply lower oral naltrexone levels (avoid together). One case of acute hepatitis in the open-label extension; the label says the drug’s role could not be excluded.	2026 label (PDF)

Registered trials

ClinicalTrials.gov returns 10 studies for bremelanotide as of Nov 2, 2026. We opened the records below. Registry entries are written by sponsors and are not reviewed for scientific merit.

Registry	Study	Status	What the record says
NCT02333071	RECONNECT study 301, phase 3, premenopausal women with HSDD	Completed, Jun 2017	Enrollment on the registry: 723. Results posted. The label and the paper report 1,267 women randomized across studies 301 and 302; the registry figure is higher and we did not establish why.
NCT02338960	RECONNECT study 302, phase 3	Completed, Jun 2017	Enrollment on the registry: 714. Results posted.
NCT01382719	Phase 2, women with female sexual arousal disorder and/or HSDD	Completed, Sep 2012	Enrollment: 612. Results posted. We did not read them.
NCT06867835	Phase 4, single dose of Vyleesi in lactating women to measure drug concentration in milk	Completed, Nov 15, 2025	10 enrolled. No results posted.
NCT06565611	Phase 2, bremelanotide co-administered with tirzepatide	Active, not recruiting	Phase 2 study of bremelanotide co-administered with tirzepatide for the treatment of obesity. 108 enrolled (estimated). The registry’s estimated completion date, Mar 31, 2025, has passed.

Other records we saw include a phase 4 study of the melanocortin-4 receptor in HSDD (40 enrolled, results posted) and a pilot in diabetic kidney disease (16 enrolled); we did not open them.

Published research

PubMed returns 110 results for bremelanotide as of Nov 2, 2026. We read the abstracts of the papers below.

What the papers show

RECONNECT phase 3, 2019. Two identical placebo-controlled trials of 1.75 mg as needed for 24 weeks; 1,267 randomized, 1,202 in the efficacy analysis. Desire score change versus placebo: 0.30 (study 301) and 0.42 (study 302); distress change: -0.37 and -0.29. Nausea, flushing and headache occurred in 10% or more. Sponsored by Palatin Technologies and AMAG Pharmaceuticals. Obstet Gynecol PubMed
Open-label extension, 2019. 684 of 856 eligible patients enrolled; 272 completed 52 weeks. Nausea 40.4%, flushing 20.6%, headache 12.0%. No new safety signals were reported. Obstet Gynecol PubMed
Safety review, 2022. 3,500 subjects in 43 studies. In the double-blind phase 3 data: nausea 40.0% versus 1.3% on placebo, flushing 20.3% versus 1.3%, headache 11.3% versus 1.9%. Focal hyperpigmentation was rare at label dosing but occurred in more than one-third of subjects after up to 16 consecutive daily doses. Small, transient blood pressure rises were seen. J Womens Health PubMed
Re-analysis, 2021. A single-author meta-analysis using FDA application data reports that 72.72% of protocol-listed outcomes went unreported in the main paper, that discontinuation for adverse events was higher on bremelanotide (OR 11.98), and that participants who completed the trial were less likely to join the extension. The author concludes the drug is generally not useful. A published commentary disputes it. J Sex Res PubMed J Sex Res PubMed

Read with care

The pivotal and safety papers were sponsored by the manufacturers. The re-analysis is by one outside author and is contested.
The trials enrolled premenopausal women, mostly white (85.6%) and in the United States (96.6%). They tell us nothing about men or about other uses sold online.
We read abstracts, not full text.

FDA warning letters

We found three FDA warning letters that name PT-141 or bremelanotide. None is a finding about the substance. This rests on web searches.

Recipient	Date	Letter	What it says
NuScience Peptides LLC	Aug 24, 2026	Warning letter 733652	FDA says products including “PT-141 Peptide (Bremelanotide)”, among others, are unapproved new drugs. We read the letter text.
Royal Peptides LLC	Aug 24, 2026	Warning letter 734884	FDA says products including “PT-141”, among others, are unapproved new drugs under section 505(a). We read the letter text.
Tailor Made Compounding LLC, a compounding pharmacy	Apr 1, 2020	Warning letter 594743	FDA says an inspection found the firm compounding with a list of substances that includes Bremelanotide (PT-141), and that drugs made from them were not eligible for the section 503A exemptions. We read the letter text.

A warning letter is FDA’s statement about one firm’s conduct on one date. It is not a finding about the substance. FDA’s list of letters cannot be searched by peptide, so other letters could exist that we did not find. The 2026 letters concern companies selling products as “research” peptides, not the approved Vyleesi.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; PT-141 is not one of them
The draft policy’s appendix names six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. The policy is a draft and not FDA approval. We read the appendix through a text extraction.
Federal Register Docket HHS policy appendix BakerHostetler summary
Aug 24, 2026Enforcement
FDA sends warning letters to two companies selling PT-141 products as unapproved new drugs
The letters are to NuScience Peptides LLC and Royal Peptides LLC.
NuScience Royal Peptides
July 23–24, 2026Regulatory
FDA advisory committee meets on seven peptides; PT-141 is not among them
The committee recommended six of the seven, all nonbinding. FDA’s notice of the meeting does not list PT-141.
Federal Register notice Holland & Knight summary
Apr 1, 2020Enforcement
FDA warning letter to a compounding pharmacy names Bremelanotide (PT-141) among its compounded substances
The letter says drugs the firm compounded from these bulk substances were not eligible for the 503A exemptions.
Warning letter 594743
2019Literature
RECONNECT phase 3 results published
Two 24-week placebo-controlled trials, 1,267 women randomized. Sponsored by Palatin and AMAG.
PubMed
Jun 21, 2019Approval
FDA approves Vyleesi (NDA 210557)
Original approval date per Drugs@FDA through openFDA.
Drugs@FDA NDA210557

Still not covered

Left off rather than guessed:

HHS policy: we read the draft policy appendix through a text extraction, not as the original PDF layout. It names six covered peptides and not PT-141.
FDA review: we found no FDA briefing document or advisory committee evaluation for PT-141. FDA’s notice for the July meeting does not name it.
The 2026 supplement: we compared label texts and found the changes above; we did not read FDA’s approval letter or review of it. We read the whole 2026 label text.
FDA review documents: we did not read the 2019 review package, only the label.
Trial enrollment counts: the label and the paper agree on 1,267 randomized (635 drug, 632 placebo). ClinicalTrials.gov lists 723 and 714 enrolled, which sum to more. We did not establish why.
Use in men: not approved. We did not review the male studies from the 2000s.
Patents and SEC filings: not researched for this dossier.
Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
Unread items: full text of most papers; EU and other non-US regulators and registries; WADA lists for years other than 2026; FDA warning letters beyond those listed, which rest on web searches.