PT-141 Legal Status: Approval, Research Use, and Regulatory Notes
FDA-approved as Vyleesi for HSDD in premenopausal women (2019). Prescription required. Available by auto-injector. Not approved for male sexual dysfunction. Also available as a research peptide.
Direct Answer
PT-141 (bremelanotide) is FDA-approved for hypoactive sexual desire disorder in premenopausal women (Vyleesi), providing a regulatory anchor for sexual health research. Phase 3 data in women is solid; male sexual dysfunction data is earlier-stage. For melanocortin-pathway sexual health research, this is the best-evidenced starting point.
- Evidence grade
- Level A
- Research status
- FDA Approved
- Category
- Sexual Health
- Best for
- Hypoactive sexual desire disorder (women), sexual dysfunction research, melanocortin pathway
Legal and Regulatory Status
FDA-approved as Vyleesi for HSDD in premenopausal women (2019). Prescription required. Available by auto-injector. Not approved for male sexual dysfunction. Also available as a research peptide.
Approval Stage
PT-141 is listed as FDA Approved. Approved uses, if any, are indication-specific and do not automatically apply to other claims.
Compliance Notes
- Contraindicated in uncontrolled hypertension
- May cause transient BP increase
- Limit to 8 doses per month
- Risk of hyperpigmentation with frequent use
- Nausea may be significant
Evidence Page
For the complete evidence review, see the main PT-141 guide linked below.
Evidence Snapshot
| Evidence grade | Level A |
|---|---|
| Research status | FDA Approved |
| Best supported outcomes | Female Sexual Desire (Level A), Nausea (Level A), and Male Erectile Function (Level B) |
| Primary citation count | 2 |
| Last reviewed | 2026-06-02 |
Related Guides
How to Cite This Page
ExaminePeptides. "PT-141 Legal Status: Approval, Research Use, and Regulatory Notes." Last reviewed 2026-06-02. https://examinepeptides.com/answers/pt-141-legal-status/
This static answer page is built for fast indexing and direct citation. It summarizes the matching full evidence review and links back to primary sources where the source database includes them.