Bremelanotide
Also: Vyleesi · PT-141
- Status
- Approved
- Evidence
- Moderate
- Field
Neuromodulatory
1
What it is
An FDA-approved on-demand injection for hypoactive sexual desire disorder in premenopausal women. The research-chemical name PT-141 is the same scaffold used off-label and in unregulated products — those are not the approved drug.
2
How it works
Melanocortin receptor agonist (MC4R, some MC3R). Central melanocortin signaling can increase sexual desire; this is distinct from vascular PDE5 drugs.
3
The evidence
Two phase 3 trials (RECONNECT) supported modest improvements on desire and distress scores versus placebo, with nausea as the lead adverse event and a blood-pressure/heart-rate warning.
4
Sourcing
FDA-approved as Vyleesi. Prescription. Unregulated PT-141 vials sold as research chemicals are a different risk stack (identity, sterility, dose).
Prescription Vyleesi, on-demand subcutaneous injection, through a clinician. PT-141 is the research-chemical name for the same scaffold — that vial is not the approved drug.
Same four pathways as the Sourcing guide.
5
Will insurance pay?
Often poorly covered. Many plans treat HSDD pharmacotherapy as non-essential. Expect cash-pay or a manufacturer program. Prior auth, when it exists, is indication-specific (premenopausal HSDD).
6
Grey market
PT-141 / bremelanotide research vials are a staple of peptide shops and tanning forums. Dose, sterility, and blood-pressure risk are unsupervised in that channel.
Strand does not list vendors. See the grey market.
7
Risks
Nausea is common. Transient blood-pressure increase and heart-rate decrease: do not use in uncontrolled hypertension or known cardiovascular disease per label. Focal hyperpigmentation and nausea-related discontinuation occur.
- Nausea is common and can be treatment-limiting.
- Transient blood-pressure increase and heart-rate decrease: not for uncontrolled hypertension or known CVD per label.
- Focal hyperpigmentation. Unregulated PT-141 adds identity and infection risk.
8
Papers
RECONNECT · 2019 · Obstet Gynecol
Kingsberg et al. Bremelanotide for the treatment of hypoactive sexual desire disorder. PMID 31599840.
FDA prescribing information.
Related
- Melanotan II — Research
- Kisspeptin-10 — Investigational