{"shortAnswer":"Bremelanotide is FDA-approved as Vyleesi, with a prescription, for one use: low sexual desire in women before menopause. The evidence grade is moderate-human, and the benefit was small. It is not approved for men or to boost sex. PT-141 sold online for research is not legal.","url":"https://peptideindex.ai/compound/bremelanotide","status":"fda-approved","statusCheckedAt":"2026-10-25T06:26:00.803Z","statusStale":false,"regulatoryAsOf":"2026-10-24","verified":"2026-10-25T17:34:43.212Z","primarySourceUrl":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210557Orig1s005ltr.pdf","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"45b77f8b-d9d0-4953-9036-e646c11c36c5","object":"compound","slug":"bremelanotide","name":"Bremelanotide","attrs":{"name":"Bremelanotide","class":"melanocortin","access":[{"type":"approved-product","detail":"Approved by FDA and sold with a prescription as a single-use pen for a shot under the skin, used as needed before sex.","indication":"Low sexual desire that causes distress in women before menopause, not due to another illness, a relationship problem or a drug. Not for men, for women after menopause, or to improve sexual performance.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","brand_names":["Vyleesi"],"manufacturer":"Cosette Pharmaceuticals, Inc."},{"type":"lawful-compounding","detail":"Under section 503A, a pharmacy may make it for one patient with a prescription. It may not make copies of an approved drug such as Vyleesi regularly or in large amounts.","source_url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize"}],"dosing":"From the Vyleesi label. One 1.75 mg shot under the skin of the belly or thigh, as needed, at least 45 minutes before sex. No more than one dose in 24 hours. More than 8 doses a month is not recommended. Stop after 8 weeks if there is no improvement. The prescriber decides if it fits.","trials":[],"aliases":["Vyleesi","PT-141"],"summary":"A prescription shot for low sexual desire in women who have not gone through menopause. FDA approved it as Vyleesi in 2019.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557","tier":"primary","type":"regulatory","title":"Drugs@FDA: Vyleesi, new drug application 210557"},{"n":2,"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","tier":"primary","type":"label","title":"DailyMed: Vyleesi prescribing information, revised March 2024"},{"n":3,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf","tier":"primary","type":"label","title":"Drugs@FDA: Vyleesi prescribing information, revised October 2020"},{"n":4,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210557Orig1s000ltr.pdf","tier":"primary","type":"regulatory","title":"FDA approval letter for Vyleesi, 21 June 2019"},{"n":5,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210557Orig1s005ltr.pdf","tier":"primary","type":"regulatory","title":"FDA approval letter for a Vyleesi label change, supplement 005, October 2026"},{"n":6,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":7,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances under evaluation, Category 1 and Category 2 lists"},{"n":8,"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances that may present significant safety risks, Category 2"},{"n":9,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":10,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":11,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":12,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":13,"url":"https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers","tier":"legal-analysis","type":"legal-analysis","title":"Sheppard Mullin: FDA warning letters to unlawful peptide sellers, 2026"},{"n":14,"url":"https://www.afslaw.com/perspectives/alerts/ruo-ined-five-peptide-vendors-learn-research-use-only-not-legal-strategy","tier":"legal-analysis","type":"legal-analysis","title":"ArentFox Schiff: research-use-only labels are not a legal strategy, 2026"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/31599840/","tier":"peer-reviewed","type":"rct","title":"Bremelanotide for low sexual desire: two phase 3 trials, 2019"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/31599847/","tier":"peer-reviewed","type":"human-trial","title":"Long-term safety and benefit of bremelanotide: 52-week open-label follow-up, 2019"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/27181790/","tier":"peer-reviewed","type":"rct","title":"Bremelanotide in women before menopause: a 12-week dose-finding trial, 2016"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/35147466/","tier":"peer-reviewed","type":"human-trial","title":"Safety of bremelanotide across its clinical program, 2022"},{"n":19,"url":"https://pubmed.ncbi.nlm.nih.gov/33678061/","tier":"peer-reviewed","type":"human-trial","title":"Re-analysis of the two phase 3 bremelanotide trials, 2021"},{"n":20,"url":"https://pubmed.ncbi.nlm.nih.gov/42254382/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review of drug trials for low sexual desire in women, 2026"},{"n":21,"url":"https://alert.psychnews.org/2019/06/fda-approves-medication-to-treat-female.html","tier":"established-news","type":"reference","title":"Psychiatric News: FDA approves Vyleesi, June 2019"},{"n":22,"url":"https://www.upi.com/Health_News/2019/06/21/FDA-approves-drug-to-treat-low-sexual-desire-in-women/9051561157769/","tier":"established-news","type":"reference","title":"UPI: FDA approves Vyleesi, 21 June 2019"},{"n":23,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026","tier":"primary","type":"regulatory","title":"FDA warning letter to an online seller of research-use peptides, 24 August 2026"},{"n":24,"url":"https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize","tier":"primary","type":"regulatory","title":"FDA: policies for compounders as the national GLP-1 supply stabilizes, conditions under section 503A"}],"known_risks":["Nausea is the most common problem. In trials, 40% had nausea on it. On a dummy shot, 1% did. About 1 in 12 quit because of it [^2].","It raises blood pressure and slows the heart for up to 12 hours after each dose. The label says not to use it with high blood pressure that is not under control, or with heart disease [^2].","It can cause dark patches on the face, gums or breasts. This was more likely with darker skin and with daily use. In some people the patches did not go away [^2].","Flushing, headache and reactions where the shot went in were also common. In trials, 18% quit because of unwanted effects. On a dummy shot, 2% did [^2] [^18].","It can slow how fast the stomach empties. That can change how well some pills work, such as naltrexone taken by mouth [^2].","PT-141 sold for research is not made under FDA rules. FDA warns that injected products skip some of the body's defenses against germs and toxins [^9]."],"short_answer":"Bremelanotide is FDA-approved as Vyleesi, with a prescription, for one use: low sexual desire in women before menopause. The evidence grade is moderate-human, and the benefit was small. It is not approved for men or to boost sex. PT-141 sold online for research is not legal.","evidence_grade":"moderate-human","open_questions":["Nobody knows exactly how it raises desire. The label says how it acts on this condition is unknown [^2].","Nobody knows how long the effect of each dose lasts. The label says the best time to take it has not been fully worked out [^2].","Experts disagree on how much it helps. One review of the trial data said people preferred the dummy shot, judged by who stayed in the trials [^19].","Nobody knows its benefit or its risks in men or after menopause. The label does not cover those groups [^2].","In October 2026, FDA approved changes to the label's advice for pregnancy and other groups [^5]. The public label we read does not show those changes yet."],"section_routes":"The legal way to get bremelanotide is a prescription for Vyleesi [^1] [^2]. The label is for women before menopause with low sexual desire that causes distress [^2].\n\nThe label says to stop if there is no improvement after 8 weeks [^2]. It is not for women with high blood pressure that is not under control, or with heart disease [^2].\n\nA pharmacy may also make it, because it is part of an approved drug [^6]. Under section 503A, that is only for one patient with a prescription [^24]. A pharmacy may not make copies of Vyleesi regularly or in large amounts [^24].","regulatory_as_of":"2026-10-24","section_channels":"Outside a prescription, bremelanotide reaches people as PT-141 from online sellers that label it for research use [^9] [^13]. On 24 August 2026, FDA sent warning letters to five such sellers [^9] [^10] [^11] [^12] [^23]. Each letter names PT-141 [^9] [^10] [^11] [^12] [^23].\n\nThe sellers' labels said the products were for research only, or not for people [^9] [^10] [^12] [^23]. FDA said their websites showed the products were meant for people anyway [^9] [^10] [^12] [^23]. It called them unapproved new drugs, and sending them across state lines breaks federal law [^9] [^14]. FDA warns that injected products skip some of the body's defenses against germs and toxins [^9].\n\nNo FDA page we found names bremelanotide at a clinic, an online prescriber, or as a fake or imported product. So this page does not describe those channels.","section_evidence":"The evidence grade is moderate-human: two large trials in women before menopause agree it helps desire a little [^15] [^16]. Experts disagree on whether the gain is worth its known risks [^19].\n\nThe two main trials lasted 24 weeks and included 1,247 women with low desire [^2] [^15]. Women on it scored higher for desire than women on a dummy shot. They also felt less upset about low desire [^15]. The gains were small, on scales that run from about 1 to 6 and from 0 to 4 [^2]. It did not raise the number of satisfying sexual events [^2].\n\nMore women on it than on a dummy shot quit before the end. In one trial it was 40% compared with 13% [^2]. A 2021 reanalysis of the data FDA reviewed found similar gains. It said the benefits were modest and the trial reports left many results out [^19].\n\nIn a 52-week follow-up with no dummy shot, 684 women took it, and the gains held [^16]. An earlier 12-week trial in 327 women found similar results [^17]. A 2026 review of nine trials found it among the most studied drugs for this condition. It said differences between trials make them hard to compare [^20].\n\nThese trials tested the approved drug in women. They tell us nothing about PT-141 sold for research, which FDA has not approved [^9].","regulatory_status":"fda-approved","section_what_it_is":"Bremelanotide is a prescription drug. It is a lab-made peptide, a short chain of the building blocks of protein [^2]. It switches on melanocortin receptors, which are signal points in the brain and skin [^2]. The ones in the skin can darken it [^2].\n\nFDA approved it in June 2019 under the brand name Vyleesi [^1] [^4]. It comes as a single-use pen with a shot under the skin of the belly or thigh [^2]. It is used as needed before sex, not every day [^2].\n\nIt is approved for one condition: low sexual desire in women who have not gone through menopause [^2] [^4]. The low desire must cause real distress. It must not come from another illness, a relationship problem or another drug [^2].","section_is_it_legal":"Bremelanotide is FDA-approved: FDA approved it as Vyleesi in June 2019 for low sexual desire in women before menopause [^1] [^4]. That covers Vyleesi, with a prescription, for that one use. It does not cover men, women after menopause, or boosting sex. It does not make PT-141 sold for research legal [^2] [^9]. Checked 24 October 2026.\n\nThere is a gap between the approved use and what sellers offer it for. The label says it is not for men and not to improve sexual performance [^2]. In July 2026, FDA reviewed five seller websites [^9] [^10] [^11] [^12] [^23]. They described PT-141 for arousal, desire, libido and sexual function [^10] [^12] [^23]. One site pointed to a study in men with erection problems [^9]. FDA called every one of those products an unapproved new drug [^9] [^10] [^11] [^12] [^23].\n\nThe drug's maker today is Cosette Pharmaceuticals [^1] [^2]. In October 2026, FDA approved a change to part of its label [^5]. Bremelanotide is not on FDA's Category 1 or Category 2 lists of raw ingredients for compounding [^7] [^8]. Those lists are for ingredients that are not part of an approved drug [^6]. Because bremelanotide is part of Vyleesi, a pharmacy may use it to make a drug [^6]. Under section 503A, that is only for one patient with a prescription [^24]. A pharmacy may not make copies of Vyleesi regularly or in large amounts [^24].","unofficial_channels":[{"type":"research-use-seller","what_it_is":"Sold online as PT-141 labeled for research use or not for people.","enforcement":[{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including PT-141.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including PT-141.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including PT-141 labeled as bremelanotide.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including PT-141 labeled as bremelanotide.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026"},{"date":"2026-08-24","text":"FDA warning letter to an online seller of research-use peptides, including PT-141 labeled as bremelanotide.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026"}],"legal_position":{"text":"FDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026"},"documented_risks":[{"text":"FDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026"},{"text":"FDA says no approved application covers these products, so their safety and benefit for the sellers' uses have not been 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recommendation.","sources":["https://clinicaltrials.gov/api/v2/studies?query.intr=bremelanotide+OR+Vyleesi+OR+PT-141&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf","https://peptideindex.ai/methodology#evidence-grade","https://peptideindex.ai/methodology#short-answer","https://pubmed.ncbi.nlm.nih.gov/31599840/","https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210557Orig1s005ltr.pdf","https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557","https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026"],"verified_at":"2026-10-25T17:34:43.212Z","published_at":"2026-10-25T18:23:26.255Z","parent":null,"children":[],"snapshots":{"trials":{"snapshot_at":"2026-10-25T06:26:06.284Z","stale":false,"notice":"A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}