Bremelanotide

Bremelanotide API 

Bremelanotide is a synthetic melanocortin receptor agonist developed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. As the first centrally acting therapy specifically approved for HSDD, Bremelanotide represents a significant advancement in female sexual health.

Approved by the U.S. FDA in 2019 under the brand name Vyleesi, Bremelanotide offers an on-demand, non-hormonal solution for women experiencing persistent lack of sexual desire, which cannot be explained by medical, psychological, or relationship issues.

Our Bremelanotide API is produced through solid-phase peptide synthesis (SPPS), ensuring high purity, low impurities, and consistency suitable for clinical and commercial injectable formulations.

Mechanism of Action

Bremelanotide works by activating melanocortin receptors, particularly MC4R (melanocortin-4 receptor) in the central nervous system. This activation is believed to modulate pathways in the hypothalamus that are involved in sexual arousal and desire.

Key effects include:

• Enhanced dopaminergic signaling, promoting sexual interest

• Suppression of inhibitory pathways affecting libido

• Central nervous system modulation without relying on sex hormones (non-estrogenic, non-testosterone)

This mechanism makes Bremelanotide distinct from traditional hormonal therapies and suitable for a wider population of women.

Clinical Research & Outcomes

Bremelanotide has been evaluated in multiple Phase 2 and Phase 3 clinical trials, involving thousands of women diagnosed with HSDD.

Key findings include:

• Statistically significant improvement in sexual desire scores (measured by FSFI-d)

• Reduction in distress related to low sexual desire (measured by FSDS-DAO)

• Rapid onset of action (within hours), allowing on-demand use prior to sexual activity

• Demonstrated efficacy in women with and without comorbid conditions (e.g., depression, anxiety)

In clinical studies, up to 25%–35% of patients experienced meaningful improvement versus placebo.

Safety and Tolerability

• The most common side effects include nausea, flushing, and headache—generally mild and self-limiting.

• Unlike earlier melanocortin agents, Bremelanotide is not associated with significant increases in blood pressure or heart rate in most patients.

• As an on-demand treatment, it avoids chronic hormone exposure and can be used flexibly.

Manufacturing and Quality

Our Bremelanotide API:

• Is synthesized using advanced SPPS with high efficiency

• Meets strict international standards for purity, identity, and residual solvents

• Is suitable for injectable formulation (such as prefilled autoinjector pens)

• Available in pilot and commercial-scale batches, supporting both R&D and market supply

Therapeutic Potential

Beyond HSDD, Bremelanotide’s mechanism has prompted interest in other areas of sexual and neuroendocrine modulation, including:

• Male sexual dysfunction

• Mood-related disorders

• Appetite and energy regulation (via melanocortin system)

Its well-characterized peptide profile and central nervous activity continue to support potential development in adjacent therapeutic areas.