Research guide / PT-141

What is PT-141? A Complete Research Guide.

Updated August 2026 · 10 minute read

PT-141 is the developmental name for bremelanotide, a melanocortin receptor agonist. It is one of the few peptides in this hub with a completed Phase 3 programme and a real FDA approval — but the approval is narrow, and this guide keeps that boundary exact.

Research information only. This article summarises published research and regulatory records. It is not medical advice, a dosing guide, or a recommendation to use any product. The approved medicine (Vyleesi) and unapproved research material are different regulatory categories.

01 / Overview

What is PT-141?

PT-141 is the code name for bremelanotide, a synthetic cyclic heptapeptide that activates melanocortin receptors. It was developed by Palatin Technologies and approved by the U.S. FDA in June 2019 under the brand name Vyleesi — a subcutaneous autoinjector for one specific condition: acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women.[2]

The approval boundary matters. The FDA label states Vyleesi is not indicated for HSDD in postmenopausal women or in men, and is not indicated to enhance sexual performance. It is contraindicated in uncontrolled hypertension or known cardiovascular disease, limited to one dose per 24 hours, and not recommended beyond 8 doses per month.[3]

PT-141 is widely discussed online for uses far beyond this approved indication — including in men. None of those uses has a completed, positive randomised trial programme behind it. The sections below keep the approved evidence and the unapproved claims clearly separated.

View the PT-141 research listing

02 / Mechanism

How does PT-141 work?

Bremelanotide is a melanocortin receptor agonist. Its approved mechanism is central: it acts on melanocortin-4 receptors (MC4R) in the brain, which are involved in sexual desire pathways. This distinguishes it from drugs that act on blood flow or peripheral tissues.[3]

Aspect	What research reports	Research relevance
MC4R agonism	Bremelanotide activates melanocortin-4 receptors in the central nervous system.	The basis of its approved effect on sexual desire in the studied population.
Central, not vascular	Its mechanism acts on brain desire pathways rather than peripheral blood flow.	Distinguishes it from PDE5 inhibitors such as sildenafil.
Cardiovascular effects	Transient blood-pressure increase and heart-rate decrease after each dose.	Why the label contraindicates uncontrolled hypertension and cardiovascular disease.

The label also records off-target pharmacology: bremelanotide transiently raises blood pressure and lowers heart rate after each dose, and can cause focal hyperpigmentation with repeated use. These are documented drug effects, not theoretical concerns.

03 / Published evidence

Peer-reviewed findings

The pivotal evidence is the RECONNECT programme: two identical Phase 3, randomised, double-blind, placebo-controlled trials published in Obstetrics & Gynecology in 2019. Together they randomised 1,267 premenopausal women with HSDD to bremelanotide 1.75 mg or placebo, self-administered subcutaneously as needed over 24 weeks.[1]

Both trials met their co-primary endpoints: women on bremelanotide had statistically significant increases in sexual desire scores (study 301: +0.30; study 302: +0.42; both P<.001 versus placebo) and statistically significant reductions in distress related to low desire. The absolute effect sizes were modest — a point the authors and FDA reviewers both noted.[1]

Most participants were white (85.6%), from U.S. sites (96.6%), with a mean age of 39. The trials excluded men, postmenopausal women, and people with uncontrolled cardiovascular risk — so the results say nothing about those groups.[1]

The FDA approved Vyleesi on June 21, 2019 on the basis of this programme. The approval is real, but its scope is exactly the studied population: premenopausal women with acquired, generalised HSDD.[3]

04 / Trial registry

The registered trial programme

Unlike most peptides in this hub, bremelanotide has a completed, registered Phase 3 programme. The table below summarises the key records.

Study	Identifier	Population	Outcome
RECONNECT Study 301	NCT02333071	Premenopausal women with HSDD, 24 weeks	Significant desire increase and distress reduction vs placebo
RECONNECT Study 302	NCT02338960	Premenopausal women with HSDD, 24 weeks	Significant desire increase and distress reduction vs placebo
Open-label extension	Part of the RECONNECT programme	Completers of the core phase	Longer-term tolerability data; uncontrolled design

Registry and publication figures reflect the records reviewed for this August 2026 update. The programme studied one indication in one population; no registered programme exists for men or for performance enhancement.[1], [4]

Afiya Labs lists a PT-141 reference material for laboratory research. The catalogue entry is not a medicine listing and is not presented as suitable for human use. The FDA-approved medicine Vyleesi is a separate, prescription-only product.

See the PT-141 catalogue entry

Shop PT-141 pen

05 / Safety evidence

What safety evidence exists?

In the RECONNECT trials, the most common adverse reactions were nausea, flushing, injection-site reactions, headache, and vomiting. Nausea was the most frequent and led some participants to discontinue.[1], [3]

The FDA label carries specific warnings: a transient increase in blood pressure and decrease in heart rate after each dose (usually resolving within 12 hours), contraindication in uncontrolled hypertension or known cardiovascular disease, and focal hyperpigmentation reported with repeated dosing. Dosing is limited to once per 24 hours and no more than 8 doses per month.[3]

Separately, the FDA places bremelanotide (PT-141) in Category 2 of its interim compounding policy — bulk substances that may present significant safety risks in compounding. The approved drug and compounded/research material are regulated differently.[5]

06 / Regulators

Status in the US, Europe, and UAE

United States

Bremelanotide is FDA-approved as Vyleesi (NDA 210557, June 21, 2019) — only for acquired, generalised HSDD in premenopausal women. It is not approved for men, postmenopausal women, or performance enhancement. Separately, the FDA lists bremelanotide in Category 2 of its interim compounding policy (potential significant safety risks for compounded versions).[2], [3], [5]

European Union

Bremelanotide does not hold an EU marketing authorisation. Vyleesi is a U.S.-only approval.

United Arab Emirates

The Emirates Drug Establishment maintains the UAE's public registered medical product directory. We did not rely on a directory search to infer approval, non-approval, legality, availability, or permission for use of any specific product; those questions require confirmation from the EDE. Approved medicines in the UAE are dispensed through licensed channels.[6]

07 / Quick answers

Frequently asked questions

Is PT-141 an approved medicine?

The molecule — bremelanotide — is FDA-approved as Vyleesi, but only for acquired, generalised hypoactive sexual desire disorder in premenopausal women. It is not approved for men, for postmenopausal women, or to enhance sexual performance.

Is PT-141 the same as bremelanotide?

Yes. PT-141 was the developmental code name; bremelanotide is the generic name; Vyleesi is the U.S. brand name of the approved autoinjector.

What did the Phase 3 trials show?

Two identical 24-week trials in 1,267 premenopausal women showed statistically significant increases in sexual desire and reductions in related distress versus placebo. The absolute effect sizes were modest, and the population studied was narrow.

Does PT-141 work for men?

There is no completed, positive randomised trial programme in men, and the FDA label explicitly states Vyleesi is not indicated for use in men. Claims about male use are not supported by registration-quality evidence.

What are the main safety concerns?

Documented effects include nausea, flushing, injection-site reactions, transient blood-pressure increases with heart-rate decreases, and focal hyperpigmentation with repeated use. It is contraindicated in uncontrolled hypertension or known cardiovascular disease.

What does the UAE directory show?

It is a public register of medical products. This guide does not turn a directory search result — or the absence of one — into a claim about approval, legality, or permitted use. The EDE is the appropriate authority for a current determination.

08 / Sources