Bremelanotide
Also known as: PT-141, Vyleesi
Bremelanotide is currently approved product — specific indication/route for fda-approved drug product.
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A melanocortin receptor agonist peptide. FDA approved it as Vyleesi for a specific premenopausal HSDD indication.
Current status
FDA-approved drug product: Approved product — specific indication/route
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Approved product — specific indication/route | Jun 21, 2019 | United States federal | Vyleesi (bremelanotide) subcutaneous injection approved 2019-06-21 for acquired, generalized hypoactive sexual desire disorder in premenopausal women. |
What this means
- ✓ FDA-approved drug product: Approved product — specific indication/route. Vyleesi (bremelanotide) subcutaneous injection approved 2019-06-21 for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
What this does not mean
- ✗ Status in one jurisdiction does not automatically apply elsewhere.
- ✗ An approved active ingredient is not the same as an approved finished product.
- ✗ “Research use” labeling does not make an unapproved drug lawful for human use.
Timeline
FDA approves Vyleesi
finalApproved for acquired, generalized HSDD in premenopausal women.
Controlling sources
- Vyleesi (bremelanotide) Approval Letter
U.S. Food and Drug Administration · Approval letter · NDA 210557
Last verified: 2025-03-01
Reviewer: External Regulatory Reviewer
Next review: 2025-09-01