- subcutaneous
PT-141 (Bremelanotide)
Bremelanotide (Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH)
PT-141 (Bremelanotide) at a glance
Not on either FDA listHow studies gave it
Injected into the fat under the skin
Evidence on this page
3 peer-reviewed papers, published 2019 to 2022
FDA compounding lists
It appears on neither of the two FDA compounding tables.
What it is
A cyclic heptapeptide melanocortin receptor agonist, FDA-approved in 2019 as Vyleesi for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. PT-141 is a synthetic analog of alpha-MSH and an active metabolite of Melanotan II, differing by the absence of the C-terminal amide. Its therapeutic effect is attributed primarily to MC4R activation in the hypothalamic medial preoptic area, increasing dopamine release in neural circuits governing sexual desire. It is the first and only on-demand injectable treatment approved for HSDD.
Published research
Bremelanotide was evaluated in two randomized, double-blind, placebo-controlled phase III trials (RECONNECT, Studies 301 and 302) enrolling over 1,200 premenopausal women with HSDD. Both trials met their co-primary endpoints, demonstrating statistically significant improvement in sexual desire (eDiary) and reduction in distress (FSDS-DAO) compared to placebo.
The drug's mechanism involves MC3R/MC4R activation in the CNS, increasing dopaminergic tone in the medial preoptic area. Pharmacokinetics show ~100% subcutaneous bioavailability, Tmax of ~1 hour, 21% protein binding, and elimination via urine (65%) and feces (23%). Nausea severity diminishes with repeated use (21% at first dose, ~3% thereafter).
What the terms on this page mean9 termsHide
- receptor
- A docking point on a cell. A molecule that fits it can switch a process on or off inside that cell.
- agonist
- A molecule that binds a receptor and switches it on.
- analog
- A molecule built to copy a natural one with a deliberate change, usually to make it last longer or bind more tightly.
- MSH
- Melanocyte-stimulating hormone, involved in skin pigment and in appetite signalling.
- double-blind
- Neither the participants nor the researchers know who received the real substance.
- placebo-controlled
- Part of the group receives an inactive substitute for comparison.
- pharmacokinetics
- How fast the body absorbs a substance, where it goes, and how it clears it out.
- subcutaneous
- Into the fat layer just under the skin.
- bioavailability
- The share of a dose that reaches the bloodstream intact.
Compounding status
Not on either FDA list- FDA listing
- PT-141 (Bremelanotide) appears on neither FDA's category 2 table nor its table of withdrawn nominations.
- What that means
- Absence from both lists is not permission to compound. Section 503A allows a bulk drug substance only where a USP or NF monograph exists, or the substance is a component of an FDA-approved drug product, or it appears on the 503A bulks list.
Source: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA. Content current as of 2026-04-22; read 2026-09-05. This describes what a compounding pharmacy may supply. It is not advice about your own use.
Also given subcutaneous
- RetatrutideRetatrutide (LY3437943)Not on either FDA list
- SelankSelank (Thr-Lys-Pro-Arg-Pro-Gly-Pro) — Synthetic Tuftsin AnalogNomination withdrawn
- SemaglutideSemaglutide (acylated GLP-1(7-37) analog)Not on either FDA list
- SermorelinSermorelin Acetate (GRF 1-29 NH₂)Not on either FDA list
- SS-31 (Elamipretide)SS-31 (Elamipretide / Forzinity / Bendavia / MTP-131)Not on either FDA list
- TB-500Thymosin Beta-4 FragmentNomination withdrawn
Where this came from3 referencesHide
Each one was resolved at PubMed and confirmed to be the work this page cites. Author, title, journal and year come from the PubMed record, not from the page text.
- Bremelanotide: First Approval
Dhillon S, Keam SJ. Drugs (2019). PMID 31429064.
- Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder
Mayer D, Lynch SE. The Annals of pharmacotherapy (2020). PMID 31893927.
- The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women
Pfaus JG, et al.. CNS spectrums (2022). PMID 33455598.
About this page
Reviewed 2026-08-11. This page reports what published studies and FDA documents say. It carries no dose, cycle length or stack, and it does not tell you whether a substance is appropriate for you. Side-effect reports circulating on forums are self-reported rather than measured, so they are not republished here.
See the editorial policy for how corrections are handled.