Peptides / Sexual health and hormones

Synthetic analog · 7 amino acids · 1,025.2 Da

Bremelanotide (PT-141)

ApprovedNot banned in sport

PT-141, also called bremelanotide, is a peptide that acts on melanocortin receptors, approved by the FDA in 2019 as Vyleesi for low sexual desire in premenopausal women. Studies in people tested it on sexual function and tracked side effects. PepBank shows 100 results on PT-141 from 20 studies in people, and 27 from animal and lab studies. The strongest evidence is a randomized trial in people. Data as of 2026-10-30.

Also known as PT 141, PT-141, PT-141 free base, PT141, Bremelanotida, Bremelanotide and 2 more

7 amino acids, from first to lastXDHFRWK

Evidence level: Large trials in people100 of 128 results come from studies in people, including randomized trials.

Results in people

100

78% of 128 results

Results in animals

14% of 128 results

Results in lab cells

7% of 128 results

From computer models

under 1% of 128 results

Overview

Bremelanotide (PT-141) at a glance

What it is	Synthetic analog, 7 amino acids
Approval	Approved in the US (Vyleesi, 2019)
In sport	Not listed as banned by WADA
Studies	32 studies with results. 28 of them gave PT-141, with 128 results. 100 in people18 in animals9 in lab cells1 from computer models
Best study in people	Randomized controlled trial with 1,247 people (2019)
Clinical trials	10 registered: 1 active or planned, 4 with posted results
Community use	Low sexual desire in premenopausal women (the approved use); Sexual desire and erectile support in men (off label); Used with a PDE5 inhibitor such as sildenafil (reported by one wiki)

The science

What is PT-141?

Cyclic melanocortin receptor agonist peptide. FDA-approved in 2019 as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women.

Amino acids in one chain

The history of PT-141

2003
The oldest paper on PT-141 in PepBank is from 2003.
2006February
A registered trial of PT-141 started (NCT00425256).
2019June
FDA approved Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) with 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. Not indicated for postmenopausal women, men, or to enhance sexual performance.

Bremelanotide (PT-141) structure and chemistry

The key facts about the molecule. Long codes are in the closed section below.

Sequence, 7 amino acidsFrom the first amino acid to the last

X1−DHF+R5W+K

Darker means more water-repelling+ and − show charge in the bodyOutlined: changed amino acid

Structure

Bremelanotide (PT-141) is a synthetic analog of 7 amino acids, with a ring, 4 changed amino acids.

Formula

C₅₀H₆₈N₁₄O₁₀

Molecular weight

1,025.2 g/mol

CAS number

189691-06-3

Targets

Melanocortin receptor 4 (gene MC4R): agonistEvidence: approved-drug labelMelanocyte-stimulating hormone receptor (gene MC1R): agonistEvidence: approved-drug labelMelanocortin receptor 3 (gene MC3R): agonistEvidence: approved-drug label

Development

Palatin Technologies (developer; sponsor of the phase 2 and phase 3 trials); AMAG Pharmaceuticals, Inc was the applicant at FDA approval in 2019; NDA 210557 is now listed under Cosette (Drugs@FDA). Highest phase: past the trial stage (see status).

Identifiers

PubChem 9941379, ChEMBL CHEMBL2070241, UNII 6Y24O4F92S, DrugBank DB11653, KEGG D06569, IUPHAR 10408, PDB 7F55

Full sequence, SMILES and InChIKey

Three-letter sequence
Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH

InChIKey
FFHBJDQSGDNCIV-MFVUMRCOSA-N

SMILES
CCCC[C@@H](C(=O)N[C@H]1CC(=O)NCCCC[C@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H](NC(=O)[C@@H](NC1=O)CC2=CN=CN2)CC3=CC=CC=C3)CCCN=C(N)N)CC4=CNC5=CC=CC=C54)C(=O)O)NC(=O)C

See charge, composition and 3D structure on the Scientific page

The evidence

What PT-141 studies show

Results grouped by what the studies measured. Each card shows where its results come from.

Large trials in people100 of 128 results come from studies in people, including randomized trials.

Sexual and women's health

52 results · 38 in people · 12 animal · 2 lab

In premenopausal women with low sexual desire, bremelanotide raised desire scores more than placebo. Obstetrics and gynecology, 2019

Top results

In premenopausal women with low sexual desire, bremelanotide raised desire scores more than placebo. (Obstetrics and gynecology, 2019)
In female rats, PT‑141 did not change how rewarding sex was perceived. (Proceedings of the National Academy of Sciences of the United States of America, 2004)
In premenopausal women with sexual dysfunction, bremelanotide led to more satisfying sexual events per month than placebo. (Women's health, 2016)

Heart and blood vessels

6 results · 6 in people

In premenopausal women, bremelanotide 1.25 mg raised systolic blood pressure slightly more than placebo for a short time after dosing. Journal of hypertension, 2017

Top results

In premenopausal women, bremelanotide 1.25 mg raised systolic blood pressure slightly more than placebo for a short time after dosing. (Journal of hypertension, 2017)
In premenopausal women, bremelanotide 1.75 mg slowed the heart rate a little in the first hours after dosing. (Journal of hypertension, 2017)
In healthy adults, bremelanotide nasal doses did not cause significant drops in blood pressure. (Clinical therapeutics, 2017)

Sex hormones and fertility

4 results · 4 in people

In women with low sexual desire, bremelanotide raised levels of the hormone LH over 300 minutes. Journal of the Endocrine Society, 2022

Top results

In women with low sexual desire, bremelanotide raised levels of the hormone LH over 300 minutes. (Journal of the Endocrine Society, 2022)
In women with low sexual desire, bremelanotide raised levels of the hormone FSH over 300 minutes. (Journal of the Endocrine Society, 2022)
In women with low sexual desire, bremelanotide did not change estradiol levels. (Journal of the Endocrine Society, 2022)

Weight and appetite

4 results · 4 in people

In obese women, bremelanotide lowered daily calorie intake by about 400 kcal compared with placebo. Diabetes, obesity & metabolism, 2022

Top results

In obese women, bremelanotide lowered daily calorie intake by about 400 kcal compared with placebo. (Diabetes, obesity & metabolism, 2022)
In obese women, bremelanotide caused more weight loss than placebo after 16 days. (Diabetes, obesity & metabolism, 2022)
In obese women, bremelanotide lowered total calorie intake more than placebo over short treatment periods. (Diabetes, obesity & metabolism, 2022)

Skin, hair and wounds

2 results · 2 in people

Patchy skin darkening was rare when bremelanotide was used as the label says. Journal of women's health, 2022

Top results

Patchy skin darkening was rare when bremelanotide was used as the label says. (Journal of women's health, 2022)
Patchy skin darkening occurred in more than one-third of people after up to 16 days of daily bremelanotide. (Journal of women's health, 2022)

Survival and serious illness

1 result · 1 in people

No deaths were reported in the bremelanotide trials. Journal of women's health, 2022

Top results

No deaths were reported in the bremelanotide trials. (Journal of women's health, 2022)

All 32 PT-141 studies by area Open the Scientific page

Key PT-141 studies

Studies in people come first, then studies in animals and in the lab.

People
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials
Kingsberg et al. 2019 · Obstetrics and gynecology · 1,247 people · cited by 95
6 results
People
Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial
Clayton et al. 2016 · Women's health (London, England) · cited by 58
6 results
People
Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder
Revicki et al. 2020 · Journal of patient-reported outcomes · cited by 5
1 result
People
Safety Profile of Bremelanotide Across the Clinical Development Program
Clayton et al. 2022 · Journal of women's health (2002) · 1,247 people · cited by 6
14 results
People
Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide
Simon et al. 2022 · Journal of women's health (2002) · 1,202 people · cited by 6
6 results

All 32 Bremelanotide (PT-141) studies

PT-141 clinical trials

ClinicalTrials.gov lists 10 trials of PT-141. 1 is active or planned, and 4 have posted results. PepBank does not show trial results.

Solid bars are dates that happened. Hatched bars are planned dates. Data from ClinicalTrials.gov.

1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Phase 3completed723 people

2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Phase 3completed714 people

Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

Phase 4completed40 people

All 4 Bremelanotide (PT-141) trials

Status and safety

Is PT-141 approved?

FDA

United States

Approved

Vyleesi, since 2019.

EMA

European Union

Not approved

No approved medicine contains it.

WADA

Sport

Not banned

Not on the 2026 Prohibited List.

Yes. Approved in the US (Vyleesi, 2019). The FDA label for Vyleesi says: “Premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) with 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” No central EU authorisation (EMA). Not listed as banned by WADA.

Laws and labels change, so check the regulator for the current status.

PT-141 side effects and safety

PepBank has 42 safety results from studies of PT-141. 40 of them come from studies in people.

Safety results from studies (42)

More women had nausea with bremelanotide than with placebo in two trials. (Obstetrics and gynecology, 2019)
In phase 3 trials, nausea was more common with bremelanotide than with placebo. (Journal of women's health, 2022)
In premenopausal women, bremelanotide 1.25 mg raised systolic blood pressure slightly more than placebo for a short time after dosing. (Journal of hypertension, 2017)
In healthy adults, bremelanotide nasal doses, with or without alcohol, were generally well tolerated in this small study. (Clinical therapeutics, 2017)
In men with erectile dysfunction, PT‑141 plus sildenafil caused no new side effects and no more or worse side effects than sildenafil alone. (Urology, 2005)
Nasal PT‑141 was reported as safe and well tolerated in both studies. (International journal of impotence research, 2004)
In premenopausal women, nausea was reported as a side effect of bremelanotide. The abstract gives no numbers. (Women's health, 2016)
Injected PT‑141 was reported as safe and well tolerated in both studies. (International journal of impotence research, 2004)
Of 684 women who joined the year-long extension, 272 finished it. The abstract does not give reasons. (Obstetrics and gynecology, 2019)
More women had flushing with bremelanotide than with placebo in two trials. (Obstetrics and gynecology, 2019)
More women had headache with bremelanotide than with placebo in two trials. (Obstetrics and gynecology, 2019)
In two trials of bremelanotide in premenopausal women, most side effects were mild or moderate. (Obstetrics and gynecology, 2019)
In phase 3 trials, flushing was more common with bremelanotide than with placebo. (Journal of women's health, 2022)
In phase 3 trials, headache was more common with bremelanotide than with placebo. (Journal of women's health, 2022)
In phase 3 trials, injection site reactions were more common with bremelanotide than with placebo. (Journal of women's health, 2022)
In premenopausal women, bremelanotide 1.75 mg raised systolic blood pressure slightly more than placebo for a short time after dosing. (Journal of hypertension, 2017)
In premenopausal women, bremelanotide also raised diastolic blood pressure slightly, to a similar degree as systolic. (Journal of hypertension, 2017)
In premenopausal women, bremelanotide 1.75 mg slowed the heart rate a little in the first hours after dosing. (Journal of hypertension, 2017)
In premenopausal women, twenty-six stopped because of blood pressure rises, and the share was similar in all four groups, placebo included. (Journal of hypertension, 2017)
In healthy adults, bremelanotide nasal doses did not cause significant drops in blood pressure. (Clinical therapeutics, 2017)
In healthy adults, bremelanotide did not cause more side effects than placebo in this small study. (Clinical therapeutics, 2017)
In healthy adults in this small study, nobody stopped taking part because of side effects. (Clinical therapeutics, 2017)
In healthy adults, check-ups, heart tracings and lab tests showed no important changes. (Clinical therapeutics, 2017)
In healthy adults, no serious side effects linked to the drug were reported. (Clinical therapeutics, 2017)

See every safety result on the Scientific page

Doses studied (17 shown)

The doses that these studies used. They are not recommendations.

Dose as reported	Class	Species	Route	Duration	Design	Source
1.75 mg	Human	human	subcutaneous	24 weeks	Randomized trial in people · n = 1,202	Kingsberg 2019
1.25 and 1.75 mg pooled	Human	human	subcutaneous	12 weeks	Randomized trial in people	Clayton 2016
1.75 mg	Human	human	subcutaneous	24 weeks	Randomized trial in people · n = 1,202	Simon 2022
1.25 mg	Human	human	subcutaneous	Not reported	Randomized trial in people · n = 397	White 2017
1.75 mg	Human	human	subcutaneous	Not reported	Randomized trial in people · n = 397	White 2017
0.75, 1.25 and 1.75 mg	Human	human	subcutaneous	Not reported	Randomized trial in people · n = 397	White 2017
1.75 mg	Human	human	subcutaneous	Not reported	Randomized trial in people · n = 31	2022
20 mg	Human	human	intranasal	7 days	Randomized trial in people · n = 24	Clayton 2017
7.5 mg	Human	human	intranasal	Not reported	Randomized trial in people · n = 19	Diamond 2005
20 mg	Human	human	intranasal	single dose	Randomized trial in people · n = 18	Diamond 2006
>7 mg	Human	human	intranasal	Not reported	Randomized trial in people	Diamond 2004
0.75, 1.25 and 1.75 mg	Human	human	subcutaneous	12 weeks	Randomized trial in people	Clayton 2016
>1.0 mg (tested 0.3 to 10 mg)	Human	human	subcutaneous	Not reported	Randomized trial in people	Rosen 2004
4 mg	Human	human	subcutaneous	Not reported	Randomized trial in people	Rosen 2004
6 mg	Human	human	subcutaneous	Not reported	Randomized trial in people	Rosen 2004
1.75 mg	Human	human	Not reported	Not reported	Randomized trial in people	Althof 2019
1 µM	Lab	rabbit	Not reported	Not reported	Study on tissue taken from a body	Aughton 2008

From the community

How people use it

What people report online. It comes from forums and guides, not from studies.

Community-reported. Not tested in trials.

PT-141 is the research name of bremelanotide, sold as Vyleesi for low sexual desire in premenopausal women. Community sources report that some people, including men, use it off label by subcutaneous injection before sex, often at lower amounts than the label to limit nausea.

Reported routines and cautions

What people use it for

Low sexual desire in premenopausal women (the approved use)S1
Sexual desire and erectile support in men (off label)S2S4
Used with a PDE5 inhibitor such as sildenafil (reported by one wiki)S2

Reported regimens

Regimens that community sources report for PT-141 (bremelanotide). Community-reported, not tested in trials.
Context	Route	Amount	How often	How long	Agreement	Sources
Vyleesi label: premenopausal women with hypoactive sexual desire disorder (HSDD)Official label dosing of an approved product	subcutaneous injectionabdomen or thigh, with a prefilled autoinjector	1.75 mg per dose	as needed, at least 45 minutes before sexual activity; not more than one dose in 24 hours	not more than 8 doses per month	single source (official label)	S1
Off-label use, lower than the label amount to limit nausea	subcutaneous injection	0.5 to 1 mg per dose	as needed, about 60 minutes before activity	on demand	single source: a wiki that carries seller rankings and compiles forum reports that cannot be checked	S2
Off-label use in men, sometimes with a PDE5 inhibitor	subcutaneous injection	1 to 2 mg per dose	as needed, 1 to 2 hours before activity	on demand	single source: a wiki that carries seller rankings and compiles forum reports that cannot be checked	S2
Nasal spray (the wiki calls it niche)	intranasalThe wiki says some compounding pharmacies offer a spray and that absorption is variable.	1 to 2 mg per dose	as needed	on demand	single source: a wiki that carries seller rankings; it calls this route niche and says absorption is variable	S2

Reported side effects

nausea (40% of patients in the label's trials; 13% needed anti-nausea medicine)S1 S4
flushingS1 S4
headache, vomiting, injection-site reactionsS1
short rise in blood pressure and fall in heart rate after a doseS1
focal skin darkening (hyperpigmentation), including face, gums and breastsS1

Reported benefits (claims, not shown in trials)

more sexual desire and arousalS1 S4

Cautions

The label lists uncontrolled hypertension or known cardiovascular disease as a contraindication and says Vyleesi is not recommended in patients at high risk for cardiovascular disease.S1
The label says blood pressure rises after each dose and usually returns to normal within 12 hours. It gives the 24-hour gap between doses partly because close doses may add to the effect on blood pressure.S1
The label reports focal hyperpigmentation in 1% of patients and says the risk is higher in patients with darker skin and with daily dosing.S1
Amounts for men and for nasal use come from community wikis, not from the label. The label does not cover them.S1S2

Status notes

Vyleesi (bremelanotide) is an FDA-approved injection for premenopausal women with HSDD. The label says it is not indicated for postmenopausal women or for men, and not to enhance sexual performance.S1

Community sources

S1VYLEESI (bremelanotide) injection - prescribing information (opens in a new tab)dailymed.nlm.nih.gov
S2PT-141: Community Protocols & Reportspeptideprotocolwiki.comcarries seller links, not linked
S4PT-141 (Bremelanotide) (opens in a new tab)peptide-db.com

Gaps

Only one community wiki (S2) gives off-label amounts; it compiles forum reports that cannot be checked, and it carries seller rankings. No independent source for nasal use. No harm-reduction or regulator page for off-label use was found. A newsletter that gave other amounts (1 to 2 mg, weekly use) was removed because its author sells PT-141 and offers a discount code. Reddit was not used.

Questions and more

Ask a question about PT-141

The answer links to every study it uses.

What does the evidence say about PT-141?Is PT-141 tested in people?Compare with Oxytocin Compare with Melanotan I (afamelanotide)

Sources

Database: PepBank data for PT-141 (data version 308560)
Regulator: FDA status record
Regulator: EMA status record
Regulator: WADA status record
Trial registry: ClinicalTrials.gov
Community: community sources (forums and guides), as summarized in the PepBank community file

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

PepBank is a research reference. Talk to a doctor before you use any peptide.

Ask your AI about PT-141

Bremelanotide (PT-141)

ApprovedNot banned in sport

Also known as PT 141, PT-141, PT-141 free base, PT141, Bremelanotida, Bremelanotide and 2 more

What it is

Synthetic analog, 7 amino acids

Approval

Approved in the US (Vyleesi, 2019)

In sport

Not listed as banned by WADA

Studies

32 studies with results. 28 of them gave PT-141, with 128 results.
100 in people18 in animals9 in lab cells1 from computer models

Best study in people

Randomized controlled trial with 1,247 people (2019)

Clinical trials

10 registered: 1 active or planned, 4 with posted results

Community use

Low sexual desire in premenopausal women (the approved use); Sexual desire and erectile support in men (off label); Used with a PDE5 inhibitor such as sildenafil (reported by one wiki)

Dose as reported

Class

Species

Route

Duration

Design

Source

1.75 mg

Human

human

subcutaneous

24 weeks

Randomized trial in people · n = 1,202

Kingsberg 2019

1.25 and 1.75 mg pooled

Human

human

subcutaneous

12 weeks

Randomized trial in people

Clayton 2016

1.75 mg

Human

human

subcutaneous

24 weeks

Randomized trial in people · n = 1,202

Simon 2022

1.25 mg

Human

human

subcutaneous

Not reported

Randomized trial in people · n = 397

White 2017

1.75 mg

Human

human

subcutaneous

Not reported

Randomized trial in people · n = 397

White 2017

0.75, 1.25 and 1.75 mg

Human

human

subcutaneous

Not reported

Randomized trial in people · n = 397

White 2017

1.75 mg

Human

human

subcutaneous

Not reported

Randomized trial in people · n = 31

2022

20 mg

Human

human

intranasal

7 days

Randomized trial in people · n = 24

Clayton 2017

7.5 mg

Human

human

intranasal

Not reported

Randomized trial in people · n = 19

Diamond 2005

20 mg

Human

human

intranasal

single dose

Randomized trial in people · n = 18

Diamond 2006

>7 mg

Human

human

intranasal

Not reported

Randomized trial in people

Diamond 2004

0.75, 1.25 and 1.75 mg

Human

human

subcutaneous

12 weeks

Randomized trial in people

Clayton 2016

>1.0 mg (tested 0.3 to 10 mg)

Human

human

subcutaneous

Not reported

Randomized trial in people

Rosen 2004

4 mg

Human

human

subcutaneous

Not reported

Randomized trial in people

Rosen 2004

6 mg

Human

human

subcutaneous

Not reported

Randomized trial in people

Rosen 2004

1.75 mg

Human

human

Not reported

Randomized trial in people

Althof 2019

1 µM

Lab

rabbit

Not reported

Study on tissue taken from a body

Aughton 2008

Context

Route

Amount

How often

How long

Agreement

Sources

Vyleesi label: premenopausal women with hypoactive sexual desire disorder (HSDD)Official label dosing of an approved product

subcutaneous injectionabdomen or thigh, with a prefilled autoinjector

1.75 mg per dose

as needed, at least 45 minutes before sexual activity; not more than one dose in 24 hours

not more than 8 doses per month

single source (official label)

Off-label use, lower than the label amount to limit nausea

subcutaneous injection

0.5 to 1 mg per dose

as needed, about 60 minutes before activity

on demand

single source: a wiki that carries seller rankings and compiles forum reports that cannot be checked

Off-label use in men, sometimes with a PDE5 inhibitor

subcutaneous injection

1 to 2 mg per dose

as needed, 1 to 2 hours before activity

on demand

single source: a wiki that carries seller rankings and compiles forum reports that cannot be checked

Nasal spray (the wiki calls it niche)

intranasalThe wiki says some compounding pharmacies offer a spray and that absorption is variable.

1 to 2 mg per dose

as needed

on demand

single source: a wiki that carries seller rankings; it calls this route niche and says absorption is variable

Bremelanotide (PT-141)

Bremelanotide (PT-141) at a glance

What is PT-141?

The history of PT-141

Bremelanotide (PT-141) structure and chemistry

What PT-141 studies show

Sexual and women's health

Heart and blood vessels

Sex hormones and fertility

Weight and appetite

Skin, hair and wounds

Survival and serious illness

Key PT-141 studies

PT-141 clinical trials

Is PT-141 approved?

PT-141 side effects and safety

How people use it

What people use it for

Reported regimens

Reported side effects

Reported benefits (claims, not shown in trials)

Cautions

Status notes

Community sources

Ask a question about PT-141

Related peptides

Sources

Bremelanotide (PT-141)

Bremelanotide (PT-141) at a glance

What is PT-141?

The history of PT-141

Bremelanotide (PT-141) structure and chemistry

What PT-141 studies show

Sexual and women's health

Heart and blood vessels

Sex hormones and fertility

Weight and appetite

Skin, hair and wounds

Survival and serious illness

Key PT-141 studies

PT-141 clinical trials

Is PT-141 approved?

PT-141 side effects and safety

How people use it

What people use it for

Reported regimens

Reported side effects

Reported benefits (claims, not shown in trials)

Cautions

Status notes

Community sources

Ask a question about PT-141

Related peptides

Sources