# Bremelanotide (PT-141): FDA Status, Research and Uses

> Bremelanotide (PT-141): FDA approval as Vyleesi, the exact label indication, label safety data, studies, compounding rules and WADA status.

- Canonical URL: https://livingpluspeptides.com/peptides/bremelanotide-pt-141/
- Last updated: October 25, 2026
- Publisher: Living+

Bremelanotide (PT-141) is a synthetic cyclic peptide that activates melanocortin receptors. FDA approved it in 2019 as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) that causes marked distress or interpersonal difficulty and is not due to another condition, relationship problems or a drug. It was also studied for erectile dysfunction in men [1, 2, 6, 7].

## Regulatory status

- FDA approved: Yes: [Vyleesi (DailyMed label)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf)
- 503A compounding: [Component of an FDA-approved drug](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act). Active ingredient of Vyleesi (NDA 210557, approved June 21, 2019). No FDA 503A category list names bremelanotide. A 2020 FDA warning letter (inspection in 2018, before approval) listed it as ineligible.
- 503B bulks list: [Not nominated](https://www.fda.gov/media/94164/download). Not on the FDA 503B nominated substances list (updated March 21, 2025).
- WADA prohibited: [No](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (Not named on the 2026 List)
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22bremelanotide%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [DailyMed: VYLEESI label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf), [FDA: Vyleesi approval package, NDA 210557](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000Approv.pdf), [Drugs@FDA: NDA 210557](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557), [FDA: Bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act), [FDA: 503B nominated bulk drug substances list (March 21, 2025)](https://www.fda.gov/media/94164/download), [FDA warning letter naming PT-141 (Aug 24, 2026)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026), [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA drug shortages query: bremelanotide](https://api.fda.gov/drug/shortages.json?search=generic_name:%22bremelanotide%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Melanocortin receptor agonist [1]
- Amino-acid length: 7 amino acids (cyclic heptapeptide) [1]
- Half-life: About 2.7 hours after a subcutaneous dose (label) [1]
- Route used in studies: Subcutaneous (label); intranasal in early studies [1, 5, 6]
- First studied: Human studies published in 2004 [6]

## How it works

Bremelanotide is a short, ring-shaped peptide made of 7 amino acids. The Vyleesi label calls it a synthetic, cyclic heptapeptide and a melanocortin receptor agonist. It is a lab-made analog of alpha-melanocyte stimulating hormone, a natural hormone that acts on melanocortin receptors [1, 5].

The label says bremelanotide activates several receptor subtypes and does not pick just one. In order of potency they are MC1R, MC4R, MC3R, MC5R and MC2R. At the approved dose, binding to MC1R and MC4R matters most. Nerve cells that carry MC4R are found in many areas of the central nervous system [1].

The label states plainly that the way Vyleesi improves HSDD in women is unknown. In a small early study in women, measured vaginal blood flow did not change after a dose, even though more women reported moderate or high desire [1, 5].

MC1R sits on pigment cells in the skin. When bremelanotide binds there, it can raise melanin and darken the skin. This is why the label lists focal hyperpigmentation as a warning [1].

The body clears bremelanotide fast. After one dose under the skin, its average half-life is about 2.7 hours. It is broken down by splitting the bonds between its amino acids [1].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: RECONNECT Studies 301 and 302 (Kingsberg et al.) | 2019 | 1,267 premenopausal women with HSDD randomized | Two identical phase 3, randomized, double-blind, placebo-controlled trials, 24 weeks | Women on bremelanotide 1.75 mg as needed had statistically significant gains in desire scores and drops in distress scores versus placebo. Nausea, flushing and headache were more common [3]. | [Source](https://pubmed.ncbi.nlm.nih.gov/31599840/) |
| Human trial: Ambulatory blood pressure trial (White et al.) | 2017 | 397 premenopausal women with female sexual dysfunction | Randomized, double-blind, placebo-controlled, parallel-arm | Small, short-lived rises in systolic blood pressure with lower heart rate were seen in the first 4 hours after dosing [8]. | [Source](https://pubmed.ncbi.nlm.nih.gov/27977473/) |
| Human trial: Phase 2b dose-finding trial (Clayton et al.) | 2016 | 327 premenopausal women with female sexual dysfunction (efficacy set) | Randomized, placebo-controlled, 12 weeks, three subcutaneous doses | The pooled 1.25 and 1.75 mg groups had more satisfying sexual events per month than placebo. Side effects were nausea, flushing and headache [4]. | [Source](https://pubmed.ncbi.nlm.nih.gov/27181790/) |
| Human trial: Single intranasal dose in women with arousal disorder (Diamond et al.) | 2006 | 18 premenopausal women with female sexual arousal disorder | Randomized, double-blind, placebo-controlled crossover | More women reported moderate or high desire after bremelanotide than placebo. Measured vaginal blood flow did not change [5]. | [Source](https://pubmed.ncbi.nlm.nih.gov/16839319/) |
| Human trial: Intranasal PT-141 with sildenafil (Diamond et al.) | 2005 | 19 men with erectile dysfunction | Randomized crossover, placebo spray and placebo tablet arms | Studied for erectile dysfunction. Erectile response with PT-141 plus sildenafil was greater than with sildenafil alone [7]. | [Source](https://pubmed.ncbi.nlm.nih.gov/15833522/) |
| Human trial: First intranasal PT-141 studies in men (Diamond et al.) | 2004 | Healthy men and men with mild to moderate erectile dysfunction | Double-blind, placebo-controlled safety and pharmacokinetic studies | Studied for erectile dysfunction. Erections versus placebo were seen at doses above 7 mg. Flushing and nausea were the most common side effects [6]. | [Source](https://pubmed.ncbi.nlm.nih.gov/14963471/) |

## Doses used in studies

Label dosing for the approved use: the Vyleesi label gives 1.75 mg under the skin of the abdomen or thigh, as needed, at least 45 minutes before expected sexual activity. It says not to take more than one dose within 24 hours, and that more than 8 doses per month is not recommended [1].

The phase 2b trial tested 0.75, 1.25 and 1.75 mg under the skin, as desired, over 12 weeks [4]. A study in women with arousal disorder used a single 20 mg intranasal dose [5]. Early studies in men tested intranasal doses, with erectile effects seen above 7 mg, and 7.5 mg combined with 25 mg sildenafil [6, 7].

**Dosing is set by a licensed provider.**

## Side effects and safety

Blood pressure: the label says Vyleesi briefly raises blood pressure and lowers heart rate after each dose. In studies, systolic pressure rose by up to 6 mmHg and diastolic by up to 3 mmHg, peaking 2 to 4 hours after the dose, and usually returned to baseline within 12 hours. Vyleesi is contraindicated in people with uncontrolled high blood pressure or known cardiovascular disease [1].

Nausea and other common effects: in the phase 3 trials, nausea was reported by 40% of patients, 13% needed anti-nausea medicine, and 8% stopped the trials because of it. Flushing occurred in 20% and headache in 11%. The most common side effects (over 4%) were nausea, flushing, injection site reactions, headache and vomiting [1].

Skin darkening: focal hyperpigmentation of the face, gums or breasts was reported in 1% of patients using up to 8 doses per month. In another study, 38% developed it after daily dosing for 8 days. The label says clearing was not confirmed in all patients after stopping [1].

Drug interaction: the label says Vyleesi may sharply lower blood levels of naltrexone taken by mouth. People using oral naltrexone for alcohol or opioid addiction should avoid Vyleesi [1].

Products sold online as "PT-141" are not Vyleesi. FDA has called PT-141 products from online sellers unapproved new drugs [11, 14].

- [FDA warning letter to an online seller naming PT-141 (Bremelanotide) as an unapproved new drug](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) (2026-08-24)
- [FDA Import Alert 66-41: unapproved new drugs promoted in the U.S. (includes a PT 141 Peptide entry)](https://www.accessdata.fda.gov/cms_ia/importalert_190.html) (2020-03-21)

## Legal and regulatory status

- 2026-10-23: FDA approved a Vyleesi labeling supplement (S-005) that updates Section 8, Use in Specific Populations, based on a final postmarketing study report [10]. [Source](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210557Orig1s005ltr.pdf)
- 2026-08-24: FDA issued a warning letter to an online seller stating that its PT-141 (Bremelanotide) product is an unapproved new drug, despite research use only labels [11]. [Source](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)
- 2026-01-01: The WADA 2026 Prohibited List took effect. Bremelanotide is not named on it [13]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2020-04-01: An FDA warning letter to a compounding pharmacy listed Bremelanotide (PT-141) among bulk substances it said did not meet section 503A. The inspection took place in 2018, before Vyleesi was approved [15]. [Source](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)
- 2019-06-21: FDA approved Vyleesi (bremelanotide) injection, NDA 210557, as a new molecular entity [2, 9]. [Source](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000Approv.pdf)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-bremelanotide-pt-141).

## Frequently asked questions

### Is PT-141 the same as Vyleesi?

PT-141 is another name for bremelanotide, the active ingredient in Vyleesi [1, 5]. Only Vyleesi is FDA approved. Products sold online as PT-141 are not, and FDA has called PT-141 products from online sellers unapproved new drugs [2, 11, 14].

### Is bremelanotide FDA approved?

Yes, as Vyleesi, approved on June 21, 2019. It is approved only for premenopausal women with acquired, generalized HSDD that causes marked distress or interpersonal difficulty and is not due to a medical or psychiatric condition, relationship problems, or a medication or drug [1, 2].

### Is Vyleesi approved for men or after menopause?

No. The label says it is not indicated for HSDD in postmenopausal women or in men, and not indicated to enhance sexual performance [1]. It was studied for erectile dysfunction in men in early trials [6, 7].

### What are the most common side effects of bremelanotide?

On the label, the most common are nausea, flushing, injection site reactions, headache and vomiting. Nausea was reported by 40% of patients in the phase 3 trials [1].

### Does bremelanotide raise blood pressure?

Yes, briefly. The label reports rises of up to 6 mmHg systolic that usually return to baseline within 12 hours, and it is contraindicated with uncontrolled high blood pressure or known cardiovascular disease [1].

### Is research use only PT-141 legal to sell?

FDA has said no when sellers market it for people. In a 2026 warning letter, FDA said research use only labels did not change its finding that the seller's PT-141 product was an unapproved new drug [11].

### Can a compounding pharmacy make bremelanotide?

Section 503A lets pharmacies use bulk substances that are components of FDA-approved drugs when no USP monograph applies, along with other conditions [12]. Bremelanotide is the active ingredient of Vyleesi [1]. Our tracker lists it that way, but no FDA page names it directly.

### Is PT-141 banned in sports?

Bremelanotide is not named on the WADA 2026 Prohibited List [13]. Athletes should check with their anti-doping body before using any product.

### How long does a dose last?

The half-life is about 2.7 hours, but the label says the duration of efficacy after each dose is unknown [1].

## Sources

1. [DailyMed: VYLEESI (bremelanotide injection) label](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf)
2. [FDA: Vyleesi approval package, NDA 210557](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000Approv.pdf)
3. [Kingsberg et al. 2019, Obstet Gynecol (PubMed)](https://pubmed.ncbi.nlm.nih.gov/31599840/)
4. [Clayton et al. 2016, Womens Health (PubMed)](https://pubmed.ncbi.nlm.nih.gov/27181790/)
5. [Diamond et al. 2006, J Sex Med (PubMed)](https://pubmed.ncbi.nlm.nih.gov/16839319/)
6. [Diamond et al. 2004, Int J Impot Res (PubMed)](https://pubmed.ncbi.nlm.nih.gov/14963471/)
7. [Diamond et al. 2005, Urology (PubMed)](https://pubmed.ncbi.nlm.nih.gov/15833522/)
8. [White et al. 2017, J Hypertens (PubMed)](https://pubmed.ncbi.nlm.nih.gov/27977473/)
9. [Drugs@FDA: NDA 210557 (Vyleesi)](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557)
10. [FDA: Vyleesi supplement approval letter S-005 (Oct 2026)](https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210557Orig1s005ltr.pdf)
11. [FDA warning letter to an online peptide seller (Aug 24, 2026)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)
12. [FDA: Bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)
13. [WADA: 2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
14. [FDA: Import Alert 66-41](https://www.accessdata.fda.gov/cms_ia/importalert_190.html)
15. [FDA warning letter to a compounding pharmacy (Apr 1, 2020)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020)

Educational information, not medical advice. This site sells nothing.