---
title: "Is PT-141 (Bremelanotide) FDA Approved?"
url: https://www.primaralabs.com/answers/is-pt-141-fda-approved
source: Primara Labs, markdown mirror of the HTML page
---

# Is PT-141 FDA approved?

Yes, for one named use. As of 23 September 2026, bremelanotide, the compound called PT-141, is US FDA approved as a branded injection for acquired, generalized hypoactive sexual desire disorder in premenopausal women. The EMA has no record of it, and its Philippine registration could not be read.

Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.

Updated 23 September 2026

01

## The US approval

US FDA: "Approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women". Drugs@FDA records Vyleesi (NDA210557, approved 21 June 2019).

The label limits the indication: it is not indicated for postmenopausal women or for men, and not to enhance sexual performance. The approval covers that branded medicine only.

02

## Europe and the Philippines

EMA: "No record found" for bremelanotide or its US brand in the EMA medicines report, which covers central authorisations only.

Searches of fda.gov.ph for "bremelanotide" and "PT-141" on 23 September 2026 returned no advisory, and the registration record could not be read from the verification portal.

03

## The evidence behind the approval

The Research Desk rates bremelanotide's evidence as phase 3 human, from the two 24-week RECONNECT phase 3 trials in premenopausal women. Those trials and their adverse events are summarised on the Trial Explorer.

04

## What the trials found, and the side effects

In RECONNECT (studies 301 and 302), a phase 3 trial of bremelanotide in premenopausal women with hypoactive sexual desire disorder (n=1,267), the FSFI desire domain score difference from placebo was +0.30 points on study 301, 1.75 mg and +0.42 points on study 302, 1.75 mg over 24 weeks (Kingsberg SA et al. Obstet Gynecol 2019 (RECONNECT)).

Across the development programme, focal skin darkening was rare at labelled use but occurred in more than a third of people given up to 16 consecutive daily doses, and small, transient blood pressure rises were seen on ambulatory monitoring.

This is general information, not legal advice.

Sources

## Where every figure comes from

1.  [US FDA record for Bremelanotide](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557) · checked 23 September 2026
2.  [EMA record for Bremelanotide](https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx) · checked 23 September 2026
3.  [FDA Philippines site search, bremelanotide](https://www.fda.gov.ph/?s=bremelanotide) · checked 23 September 2026

Last reviewed 23 September 2026

Read next

## Related pages

-   [PT-141 10mg](https://www.primaralabs.com/marketplace/pt-141-10mg)
-   [RECONNECT on the Trial Explorer](https://www.primaralabs.com/research/trials/reconnect)
-   [Regulatory Status Tracker: bremelanotide](https://www.primaralabs.com/research/status#bremelanotide)

-   [How does PT-141 work?](https://www.primaralabs.com/answers/how-does-pt-141-work)
-   [Which research peptides are FDA approved?](https://www.primaralabs.com/answers/which-research-peptides-are-fda-approved)