Is Bremelanotide authorised in the EU?

No — the EMA marketing-authorisation application was withdrawn by the sponsor in 2019. Not currently available through EU regulatory channels.

Is Bremelanotide the same as PT-141?

Yes — PT-141 is the grey-market / research-chemical name for bremelanotide. The molecule is identical, but PT-141 sold online is not the authorised Vyleesi product and lacks quality controls.

Who makes Bremelanotide?

Palatin Technologies (US) is the originator. Vyleesi is marketed via licensing partnerships.

How is Vyleesi dosed?

On-demand only — one 1.75 mg subcutaneous autoinjector dose, at least 45 minutes before anticipated sexual activity. No more than one dose per 24 hours and eight per month.

Bremelanotide — Peptidepedia

MOLECULAR INFORMATION

Molecular information

Type: Melanocortin (MC1R/MC3R/MC4R) receptor agonist · on-demand subcutaneous

Bremelanotide is a cyclic heptapeptide melanocortin receptor agonist developed by Palatin Technologies, FDA-authorised (2019) under the brand Vyleesi for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. EMA marketing-authorisation application was withdrawn in 2019; no EU authorisation as of writing.

Indications (FDA)

Hypoactive sexual desire disorder (HSDD) — premenopausal women, on-demand
Use is restricted to autoinjector formulation; modest effect size

Why we grade it A

Two pivotal Phase 3 trials supported the FDA authorisation, with replicated modest-but-real effect on validated HSDD endpoints. The EMA withdrawal removes one regulator’s endorsement but does not negate the trial data — hence A rather than S, and unclassified rather than authorised for the EU status.

Regulatory authorisations

US	2019	as Vyleesi

RECONSTITUTION

How to reconstitute

YOU WILL NEED

Bacteriostatic water (BAC water)
Insulin syringes (0.5–1 mL)
Alcohol swabs
Vial of lyophilized peptide
Sterile work surface

PROCEDURE

01Clean the work area and hands thoroughly.
02Calculate the required bacteriostatic-water volume for the desired concentration.
03Draw the calculated BAC water into the syringe.
04Inject the water slowly down the inside wall of the vial — not directly onto the powder cake.
05Gently swirl until fully dissolved. Never shake.
06Store the reconstituted vial refrigerated at 2–8 °C and use within 28 days.

Standard biotech reconstitution procedure. Always use sterile technique. This is research-protocol guidance, not medical advice.

References

RECONNECT (Study 301) 2017

856 participants

HSDD in premenopausal women — significant improvement in Female Sexual Function Index desire domain vs placebo
RECONNECT (Study 302) 2017

875 participants

HSDD replication — confirmed desire-domain improvement at 24 weeks

Frequently asked questions

What is Bremelanotide used for?: FDA-authorised (2019) under Vyleesi for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Not authorised for any other indication.
Is Bremelanotide authorised in the EU?: No — the EMA marketing-authorisation application was withdrawn by the sponsor in 2019. Not currently available through EU regulatory channels.
Is Bremelanotide the same as PT-141?: Yes — PT-141 is the grey-market / research-chemical name for bremelanotide. The molecule is identical, but PT-141 sold online is not the authorised Vyleesi product and lacks quality controls.
Who makes Bremelanotide?: Palatin Technologies (US) is the originator. Vyleesi is marketed via licensing partnerships.
How is Vyleesi dosed?: On-demand only — one 1.75 mg subcutaneous autoinjector dose, at least 45 minutes before anticipated sexual activity. No more than one dose per 24 hours and eight per month.