PT-141 (Bremelanotide) (Vyleesi)
What to know about PT-141 (Bremelanotide) — also sold as Vyleesi: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
PT-141 (Bremelanotide) (brand names: Vyleesi) is classified as Low risk (2 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved (Vyleesi) for HSDD. Not TGA registered in Australia.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (2 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
Risk Profile
FDA approved (Vyleesi) for HSDD. Not TGA registered in Australia.
How PT-141 (Bremelanotide) is regulated
PT-141 (Bremelanotide) is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
Clinical Evidence
- FDA Approval of Vyleesi (bremelanotide) for HSDD (2019)
FDA approved bremelanotide (Vyleesi) for hypoactive sexual desire disorder in premenopausal women. Subcutaneous injection. Not TGA-registered in Australia.
FDA approval — definitive for US market
- RECONNECT Phase 3 Trial — Bremelanotide for HSDD (2019)
Phase 3 RCT demonstrating efficacy of bremelanotide for HSDD. Published in Obstetrics & Gynecology.
Peer-reviewed phase 3 trial in major journal
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.