PT-141 (bremelanotide)
Also called bremelanotide, bremelanotide acetate, Vyleesi1
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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
At a glance
| What it is | A synthetic cyclic peptide of seven amino acids that activates melanocortin receptors1 |
|---|---|
| Brand | Vyleesi, a single-dose autoinjector used under the skin. Now sold by Cosette Pharmaceuticals1, 3, 11 |
| Approved for | Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Not for men, women after menopause, or to boost sexual performance1 |
| Best evidence | Two 24-week phase 3 trials, 1,267 women. Small gains in desire and less distress versus placebo4 |
| Not shown | More satisfying sex in phase 3. Benefit in men, which was tested only in small early studies1, 8 |
| Legal status | FDA-approved prescription drug. Compounding is legal only within federal pharmacy rules, and those products are not FDA-reviewed1, 14 |
| In sport | Not named on WADA's 2026 list. Ask your anti-doping agency before use18 |
| Main risks | Nausea, flushing, headache, a short rise in blood pressure, and dark patches on the skin with frequent use1 |
| Typical cost | Drugs.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
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 VyleesiMolecular 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.

The end acid group. Melanotan II has an amide here instead
- 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.
FDA-approved. Two 24-week phase 3 trials, 1,267 women. Small gains over placebo
Two phase 3 trials, 1,267 women, found no difference from placebo. One phase 2 trial found a gain
Small early studies of a nasal spray. Dropped in 2008 over blood pressure
One short trial with tirzepatide, reported by the company, not yet peer-reviewed
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
| Use | Study | Model | Finding |
|---|---|---|---|
| HSDD | RECONNECT, Kingsberg 20194 | Two RCTs n=1,267 | 24 weeks, used as needed. Desire score up 0.30 and 0.42 more than placebo; distress score down 0.37 and 0.29 more |
| HSDD | Vyleesi label1 | Same trials | No significant difference in satisfying sexual events. 18% stopped for side effects, vs 2% on placebo |
| HSDD | Simon 20195 | Open extension 684 entered | 52 more weeks on the drug. Scores kept improving, but only 272 finished. No placebo group |
| Female sexual dysfunction | Clayton, phase 2b6 | Human RCT n=327 | 12 weeks. At the two higher doses, satisfying events rose 0.7 and 0.8 a month vs 0.2 on placebo |
| Erections | Molinoff 2003 review8 | Early human small | PT-141 caused dose-related erections in healthy men and men with ED |
| Weight | Palatin 202513 | Human RCT 96 randomized | A 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.
| Goal | Human evidence | Result |
|---|---|---|
| Low desire, before menopause | Two phase 3 RCTs, 1,267 women | Small gains in desire, less distress. Approved use |
| Low desire, after menopause | No phase 3 trial | Not approved |
| Erections | Small early studies | Erections rose, but the program stopped over blood pressure |
| Weight loss | One short company trial | More 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 dose | Vyleesi: 1.75 mg injected under the skin of the abdomen or thigh, as needed, at least 45 minutes before expected sexual activity1 |
|---|---|
| Label limits | No more than one dose in 24 hours and no more than eight a month. Stop after 8 weeks if there is no improvement1 |
| Form | A 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 | |
|---|---|---|
| Structure | Same ring, acid at the end | Same ring, amide at the end |
| Sold for | Low sexual desire | Tanning |
| Approved | Yes, FDA 2019, HSDD in premenopausal women | No approval found anywhere |
| US compounding | Allowed within pharmacy rules, as an approved-drug ingredient | No lawful route. On FDA's "nominated but withdrawn" list, with a note on immune reactions and case reports of melanoma |
| Skin darkening | A side effect, 1% at label use | The 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
All options and prices
MoveWell sells no peptides. Checked November 1, 2026
Brand, with a prescription
| Option | Form | Price | Notes |
|---|---|---|---|
| Vyleesi | 1.75 mg autoinjectors, cartons of 4 or 2 | About $930 to $956 for 4, cash17 | Co-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
Legal status history
Newest first.
- Current statusFDA-approved as Vyleesi for acquired, generalized HSDD in premenopausal women. Not approved for men or after menopause. Not named on WADA's list.1, 18
- No new approved use pending that we could find. Combination studies with other drugs are early.13
- HHS peptide compounding policy covers six other peptides. Bremelanotide isn't one; as an approved-drug ingredient it already has a compounding route.14, 20
- FDA approves updated labeling on use in specific populations, based on the breastfeeding study it required.3
- FDA warning letters to "research use only" peptide sellers name PT-141 among their products.16
- Palatin reports a phase 2 weight trial of bremelanotide with tirzepatide.13
- Palatin sells Vyleesi to Cosette Pharmaceuticals.11
- AMAG and Palatin end their license, and the rights return to Palatin.23
- FDA approves Vyleesi, from AMAG Pharmaceuticals, and requires pregnancy and breastfeeding studies.2
- Palatin drops the nasal spray after FDA questions about blood pressure spikes raised in 2007.9
- Early studies in men with the nasal spray are published.8
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
- 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
- FDA. Approval letter, NDA 210557, VYLEESI, AMAG Pharmaceuticals (Jun 21, 2019). fda.gov
- FDA. Supplement approval letter, NDA 210557/S-005, Cosette Pharmaceuticals (Oct 22, 2026). fda.gov
- 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
- 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
- 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
- Kling J. New drug improves sex drive, at least on paper. MDedge (Oct 25, 2019). Link
- 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
- Drug Store News. Palatin to cut staff, cancel work on ED drug (May 15, 2008). Link
- Hadley ME, Dorr RT. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides 2006;27(4):921–930. Link
- Palatin Technologies. Form 8-K exhibit 99.1: sale of Vyleesi to Cosette Pharmaceuticals (Dec 20, 2023). sec.gov
- Palatin Technologies. Press release on a bremelanotide and PDE5 inhibitor co-formulation for erectile dysfunction (Aug 10, 2023). sec.gov
- Palatin Technologies. Bremelanotide co-administered with tirzepatide meets primary endpoint in phase 2 obesity study (Mar 31, 2025). sec.gov
- FDA. FD&C Act provisions that apply to human drug compounding (section 503A bulk drug substances and essentially copies). fda.gov
- FDA. Compounded drug products that are essentially copies of a commercially available drug product under section 503A, guidance (Jan 2018). fda.gov
- 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
- Drugs.com. Vyleesi prices, coupons, copay cards and patient assistance (checked Nov 1, 2026). drugs.com
- World Anti-Doping Agency. 2026 Prohibited List (copy hosted by SEGAS). PDF
- FDA. Certain bulk drug substances for use in compounding that may present significant safety risks (current as of Apr 22, 2026). fda.gov
- HHS. 503A peptide enforcement discretion policy, Appendix B (Oct 28, 2026). hhs.gov
- Healio. FDA approves Vyleesi for women with low sexual desire (Jun 21, 2019). Link
- 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
- 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.