PT-141 (bremelanotide)

Also called bremelanotide, bremelanotide acetate, Vyleesi1

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2D structure of bremelanotide, a ring of six amino acids with an acetylated norleucine attached
PT-141 molecular structureFull structure and downloads
StatusFDA-approved
Evidence5/5Approved for low desire in premenopausal women. Small benefit over placebo
Status nowFDA-approved prescription drug, sold as Vyleesi. It is approved only for acquired, generalized low sexual desire with distress in women before menopause. It is not approved for men.1, 2
LatestOctober 22, 2026: FDA approved label updates on use in specific populations, based on a breastfeeding study it had required.3 August 24, 2026: FDA warning letters to "research use only" sellers named PT-141 among their products.16
NextNo new approved use is pending that we could find. The maker of the original molecule is testing it with other drugs, in early trials. Full history

PT-141 is bremelanotide, a lab-made ring-shaped peptide that switches on melanocortin receptors in the brain. FDA approved it in 2019, as the Vyleesi autoinjector, for premenopausal women with low sexual desire that causes distress.1, 2 In two 24-week trials of 1,267 women, desire rose and distress fell a little more than on placebo, but the number of satisfying sexual events did not differ.1, 4 About 4 in 10 women had nausea.1 It is a close chemical relative of the unapproved tanning peptide melanotan II.10, 22 It is not approved for men, and "PT-141" vials sold for research are not the approved drug.1, 16

See every peptide's status in the regulatory tracker

In this guide
  1. Status and summary
  2. At a glance
  3. Where to get it
  4. Molecular structure
  5. What it is
  6. How it works
  7. Evidence map
  8. By goal
  9. How it's used
  10. Side effects
  11. Compared with
  12. Stacks
  13. Myths vs evidence
  14. All options and prices
  15. Legal status history
  16. FAQ
  17. References

At a glance

What it isA synthetic cyclic peptide of seven amino acids that activates melanocortin receptors1
BrandVyleesi, a single-dose autoinjector used under the skin. Now sold by Cosette Pharmaceuticals1, 3, 11
Approved forAcquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Not for men, women after menopause, or to boost sexual performance1
Best evidenceTwo 24-week phase 3 trials, 1,267 women. Small gains in desire and less distress versus placebo4
Not shownMore satisfying sex in phase 3. Benefit in men, which was tested only in small early studies1, 8
Legal statusFDA-approved prescription drug. Compounding is legal only within federal pharmacy rules, and those products are not FDA-reviewed1, 14
In sportNot named on WADA's 2026 list. Ask your anti-doping agency before use18
Main risksNausea, flushing, headache, a short rise in blood pressure, and dark patches on the skin with frequent use1
Typical costDrugs.com lists about $930 to $956 cash for four autoinjectors. A maker co-pay program may cut this with commercial insurance17

Where to get it

MoveWell sells no peptides. All options and prices

Prescription, brandVyleesi

The approved product. Needs a prescription for its labeled use. The maker offers a co-pay program for people with commercial insurance.1, 17

See Vyleesi
Not FDA-reviewedCompounded sprays and injections

A licensed pharmacy may compound bremelanotide for a named patient, within limits. These products, doses and routes have not been through FDA review.14, 15

Why
Outside the lawResearch vials

In August 2026 FDA warned online sellers whose "research use only" products included PT-141.16

Why

Molecular structure

Six amino acids closed into a ring, with a seventh, norleucine, hanging off and capped with an acetyl group. The ring is shut by a bond between the side chains of aspartic acid and lysine.

PT-141 molecular structure: a ring of six amino acids, Asp-His-D-Phe-Arg-Trp-Lys, with acetyl-norleucine attached and the end carboxylic acid highlighted

The end acid group. Melanotan II has an amide here instead

AcNlenorleucineDAspHHisfD-PheRArgWTrpKLys
Sequence
Ac-Nle-cyclo(Asp-His-D-Phe-Arg-Trp-Lys)-OH
Length
7 amino acids, 6 in the ring
Formula
C50H68N14O10
Weight
1,025.2 g/mol
Salt
Acetate
Form
1.75 mg in 0.3 mL, single-dose autoinjector

Sequence, formula, weight and salt from the Vyleesi label, for the free base.1 Drawn from that sequence; the formula we computed matches the label. Swapping the end acid for an amide gives melanotan II's formula, C50H69N15O9.

What it is

Melanocortins are hormones, such as α-MSH, that act on a family of receptors involved in skin color, appetite and sexual behavior. Bremelanotide is a synthetic analog of α-MSH, built as a small ring.1, 8

Its story starts with melanotan II, a tanning peptide made at the University of Arizona. In a 1996 pilot study of three men, melanotan II caused spontaneous erections.22 Palatin Technologies then developed PT-141, which melanotan II's inventors describe as an analog of it.10 The two differ at one end: bremelanotide ends in an acid group, where melanotan II ends in an amide.1, 22 See our melanotan II guide.

Palatin first tested a nasal spray, in men and women. In 2007 FDA raised questions about blood pressure spikes, and in 2008 Palatin dropped that program.9 It came back as an injection under the skin for women. AMAG Pharmaceuticals won approval on June 21, 2019, and FDA called it "another treatment option" for the condition.2, 21 AMAG handed the rights back to Palatin in 2020,23 and in December 2023 Palatin sold Vyleesi to Cosette Pharmaceuticals.11

Palatin also licensed it to partners for China and South Korea.11 We found no approval in Europe or the UK.

How it works

  • Melanocortin receptors. It switches on several melanocortin receptors. At the approved dose, the label says the MC1 and MC4 receptors matter most.1
  • Mainly in the brain. Its developers noted that its target receptors are found mainly in the central nervous system. In rats it switched on nerve cells in the hypothalamus.8
  • Unknown in HSDD. The label says "the mechanism by which VYLEESI improves HSDD in women is unknown."1
  • Fast and short. Blood levels peak about 1 hour after an injection, and the half-life is about 2.7 hours.1
  • Skin color. MC1 receptors control skin pigment, which helps explain the dark patches seen with frequent use.1

Evidence map

Each claimed use is graded separately. A grade measures how much evidence exists, not whether the result was good news.

Low desire, premenopausal women

FDA-approved. Two 24-week phase 3 trials, 1,267 women. Small gains over placebo

More satisfying sex

Two phase 3 trials, 1,267 women, found no difference from placebo. One phase 2 trial found a gain

Erectile dysfunction

Small early studies of a nasal spray. Dropped in 2008 over blood pressure

Weight loss

One short trial with tirzepatide, reported by the company, not yet peer-reviewed

Desire after menopause

No phase 3 trial. The label excludes this group

Scale: 5 FDA-approved, 4 strong human, 3 limited human, 2 animal or lab only, 1 anecdotal

Key studies

UseStudyModelFinding
HSDDRECONNECT, Kingsberg 20194Two RCTs n=1,26724 weeks, used as needed. Desire score up 0.30 and 0.42 more than placebo; distress score down 0.37 and 0.29 more
HSDDVyleesi label1Same trialsNo significant difference in satisfying sexual events. 18% stopped for side effects, vs 2% on placebo
HSDDSimon 20195Open extension 684 entered52 more weeks on the drug. Scores kept improving, but only 272 finished. No placebo group
Female sexual dysfunctionClayton, phase 2b6Human RCT n=32712 weeks. At the two higher doses, satisfying events rose 0.7 and 0.8 a month vs 0.2 on placebo
ErectionsMolinoff 2003 review8Early human smallPT-141 caused dose-related erections in healthy men and men with ED
WeightPalatin 202513Human RCT 96 randomizedA 4-week tirzepatide run-in, then 4 weeks randomized. With tirzepatide, weight fell 4.4% vs 1.6% on placebo. Company press release

Both groups in the phase 3 trials passed the threshold for a meaningful change in desire, so the drug's added benefit is hard to judge in daily life.7 The trials ran in women before menopause, with HSDD not caused by illness, medicines or relationship problems.1

By goal

Pick your goal to see what the evidence supports.

GoalHuman evidenceResult
Low desire, before menopauseTwo phase 3 RCTs, 1,267 womenSmall gains in desire, less distress. Approved use
Low desire, after menopauseNo phase 3 trialNot approved
ErectionsSmall early studiesErections rose, but the program stopped over blood pressure
Weight lossOne short company trialMore people lost 5% or more than on tirzepatide alone. Not peer-reviewed

Sources: Vyleesi label,1 Kingsberg 2019,4 Molinoff 2003,8 Palatin.13

How it's used

We don't give doses. For reference, the FDA label sets one for its approved use only.

Label doseVyleesi: 1.75 mg injected under the skin of the abdomen or thigh, as needed, at least 45 minutes before expected sexual activity1
Label limitsNo more than one dose in 24 hours and no more than eight a month. Stop after 8 weeks if there is no improvement1
FormA prefilled single-dose autoinjector1

Your prescriber decides whether it suits you. Compounded nasal sprays and other doses have not been tested against these label results.

Side effects and who should avoid it

  • Nausea. 40% on the drug vs 1.3% on placebo. About 13% needed anti-nausea medicine and 8% stopped because of it. It usually eased by the second dose.1
  • Other common effects. Flushing in 20%, injection-site reactions in 13% and headache in 11%.1
  • Blood pressure. Each dose briefly raises blood pressure, by up to about 6 points systolic, and slows the heart rate. It usually settles within 12 hours.1
  • Dark skin patches. Seen in 1% at up to eight doses a month, and in 38% of people given eight daily doses in a separate study. Face, gums and breasts were affected, and the patches did not always fade. Darker skin raises the risk.1
  • Drug interactions. It can slow stomach emptying and sharply lower levels of oral naltrexone, so the label says to avoid it with naltrexone used for alcohol or opioid dependence.1
  • Pregnancy. Animal data suggest possible harm. The label advises effective contraception and stopping if pregnancy is suspected.1 FDA required a pregnancy registry and a breastfeeding study at approval.2, 3
  • Who should avoid it. People with uncontrolled high blood pressure or known heart disease, and anyone at high cardiovascular risk.1
  • Unapproved products. Research vials and nasal sprays have no FDA check on content or dose. The nasal program was stopped over blood pressure spikes.9, 16

Compared with

PT-141 (bremelanotide)Melanotan II
StructureSame ring, acid at the endSame ring, amide at the end
Sold forLow sexual desireTanning
ApprovedYes, FDA 2019, HSDD in premenopausal womenNo approval found anywhere
US compoundingAllowed within pharmacy rules, as an approved-drug ingredientNo lawful route. On FDA's "nominated but withdrawn" list, with a note on immune reactions and case reports of melanoma
Skin darkeningA side effect, 1% at label useThe intended effect

Sources: Vyleesi label,1 Hadley and Dorr 2006,10 Dorr 1996,22 FDA compounding rules,14 FDA safety-risks list.19 See our melanotan II guide and our KPV guide, a small piece of α-MSH.

Stacks

PT-141 is often discussed alongside Viagra-type drugs. Palatin planned a single injection that combines the two for men who don't respond to those drugs, but we found no published results.12 It is also mixed online with melanotan II, which adds an unapproved drug with its own skin and blood pressure risks. In 2025 Palatin reported a short phase 2 trial with tirzepatide for weight; that combination isn't approved.13

Myths vs evidence

ClaimPT-141 is "female Viagra"
EvidenceIt acts mainly on receptors in the brain, and in phase 3 it didn't increase satisfying sexual events. The gains were in desire and distress scores.1, 4
ClaimIt's FDA-approved, so it works for anyone's libido
EvidenceIt's approved only for premenopausal women with HSDD. The label says it is not for men, women after menopause or boosting performance.1
ClaimResearch-grade PT-141 is the same as Vyleesi
EvidenceResearch vials have no FDA quality check, and FDA has warned sellers of "research use only" PT-141.16
ClaimA nasal spray is gentler than the injection
EvidenceThe nasal program was stopped after blood pressure spikes. No nasal product is approved.1, 9
ClaimIt's basically melanotan II, so melanotan II works the same way
EvidenceThey are close relatives, but only bremelanotide went through phase 3 trials and FDA review. We found no approval for melanotan II anywhere, and FDA's compounding list cites case reports of melanoma and other serious harms.10, 19
ClaimIt has no real side effects
EvidenceNausea hit 40%, and 18% stopped the drug in trials because of side effects.1

All options and prices

MoveWell sells no peptides. Checked November 1, 2026

Brand, with a prescription

OptionFormPriceNotes
Vyleesi1.75 mg autoinjectors, cartons of 4 or 2About $930 to $956 for 4, cash17Co-pay program for commercial insurance; as little as $0 for eligible patients, per the maker17

Cash prices vary by pharmacy. Insurance coverage depends on your plan and diagnosis.

Compounded bremelanotide

Federal law lets a licensed 503A pharmacy compound from an ingredient that is part of an FDA-approved drug, for a named patient's prescription.14 Bremelanotide qualifies because it is the active ingredient in Vyleesi.1 Pharmacies may not regularly or in large amounts make what are essentially copies of an approved drug.14, 15 Compounded drugs are not FDA-approved, and the nasal sprays and doses sold by clinics were not the products tested in the trials. We don't link compounded versions. It isn't part of the 2026 HHS peptide policy, which it doesn't need.20

Research use only products

We don't list sellers. In August 2026 FDA warned five peptide sellers, whose products included PT-141, that a "research use only" label doesn't excuse products clearly meant for people.16

FAQ

Is PT-141 FDA-approved?

Yes, as Vyleesi, for one use: acquired, generalized low sexual desire that causes distress in women before menopause.

Can men use it?

It isn't approved for men. Early nasal studies in men found more erections, but that program stopped in 2008 over blood pressure concerns.

Is it the same as melanotan II?

No, but they are close. They share the same ring and differ at one end. Bremelanotide is approved; melanotan II is not approved anywhere. See our melanotan II guide.

How well does it work?

In trials, desire rose and distress fell a little more than on placebo. The number of satisfying sexual events did not differ, and many women on placebo also improved.

Is compounded PT-141 legal?

A licensed pharmacy may compound it for a named patient, within federal limits, because it is an approved drug's ingredient. Compounded products are not FDA-reviewed, and research vials are not legal for human use. We link only the approved product.

What dose is used?

We don't give doses. The Vyleesi label's dose for its approved use is 1.75 mg under the skin at least 45 minutes before sex, no more than once a day and eight times a month.

Why does it cause dark patches?

It also acts on the receptor that controls skin pigment. Patches appeared in 1% at label use and in 38% after eight daily doses.

Can athletes use it?

It isn't named on WADA's 2026 list. Check with your anti-doping agency first.

References

23 sources, with links
  1. FDA. VYLEESI (bremelanotide injection) prescribing information, Cosette Pharmaceuticals (rev. 03/2024; section 8 was updated in Oct 2026, see ref. 3), via Drugs.com. drugs.com
  2. FDA. Approval letter, NDA 210557, VYLEESI, AMAG Pharmaceuticals (Jun 21, 2019). fda.gov
  3. FDA. Supplement approval letter, NDA 210557/S-005, Cosette Pharmaceuticals (Oct 22, 2026). fda.gov
  4. Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. Obstet Gynecol 2019;134(5):899–908. PMID 31599840
  5. Simon JA, Kingsberg SA, Portman D, et al. Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder. Obstet Gynecol 2019;134(5):909–917. PMID 31599847
  6. MDedge. Bremelanotide improves female sexual dysfunction (Jun 5, 2013), reporting the phase 2b trial later published as Clayton AH et al., Womens Health (Lond) 2016. Link; PMID 27181790
  7. Kling J. New drug improves sex drive, at least on paper. MDedge (Oct 25, 2019). Link
  8. Molinoff PB, Shadiack AM, Earle D, Diamond LE, Quon CY. PT-141: a melanocortin agonist for the treatment of sexual dysfunction. Ann N Y Acad Sci 2003;994:96–102. PMID 12851303
  9. Drug Store News. Palatin to cut staff, cancel work on ED drug (May 15, 2008). Link
  10. Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides 2006;27(4):921–930. Link
  11. Palatin Technologies. Form 8-K exhibit 99.1: sale of Vyleesi to Cosette Pharmaceuticals (Dec 20, 2023). sec.gov
  12. Palatin Technologies. Press release on a bremelanotide and PDE5 inhibitor co-formulation for erectile dysfunction (Aug 10, 2023). sec.gov
  13. Palatin Technologies. Bremelanotide co-administered with tirzepatide meets primary endpoint in phase 2 obesity study (Mar 31, 2025). sec.gov
  14. FDA. FD&C Act provisions that apply to human drug compounding (section 503A bulk drug substances and essentially copies). fda.gov
  15. FDA. Compounded drug products that are essentially copies of a commercially available drug product under section 503A, guidance (Jan 2018). fda.gov
  16. ArentFox Schiff. RUO-ined: five peptide vendors learn research use only is not a legal strategy (Sep 18, 2026; on FDA warning letters of Aug 24, 2026). Link
  17. Drugs.com. Vyleesi prices, coupons, copay cards and patient assistance (checked Nov 1, 2026). drugs.com
  18. World Anti-Doping Agency. 2026 Prohibited List (copy hosted by SEGAS). PDF
  19. FDA. Certain bulk drug substances for use in compounding that may present significant safety risks (current as of Apr 22, 2026). fda.gov
  20. HHS. 503A peptide enforcement discretion policy, Appendix B (Oct 28, 2026). hhs.gov
  21. Healio. FDA approves Vyleesi for women with low sexual desire (Jun 21, 2019). Link
  22. Dorr RT, Lines R, Levine N, et al. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study (gives its structure, ending in -NH2). Life Sci 1996;58(20):1777–1784. Link
  23. Palatin Technologies. Form 8-K exhibit 99.1: Palatin and AMAG end the Vyleesi license (Jul 27, 2020). sec.gov

This page is for education and is not medical advice. Vyleesi is approved only for acquired, generalized HSDD in premenopausal women. Talk to a clinician before using it.