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ItalianoHistory and Development
The story of PT-141 covers three decades, two quite different goals and several changes of owner.
An Accidental Discovery
In the 1980s, scientists at the University of Arizona in Tucson made synthetic versions of alpha-MSH, hoping to tan the skin and perhaps protect it from sunlight. One of them, Melanotan II, was tried in small groups of men in the 1990s. Besides darker skin, some of the volunteers reported erections that came on without any stimulation.
Palatin Takes Over
The US company Palatin Technologies, based in New Jersey, decided to develop the sexual effect on its own. It produced a close relative of the tanning peptide, coded PT-141. In the early 2000s it was tested as a nasal spray in men with erectile dysfunction, including men who had not done well on sildenafil, and in small groups of women.
A Setback in 2008
Larger trials showed that the nasal spray could push up blood pressure. In 2008 Palatin stopped developing it for erectile dysfunction, and for several years bremelanotide largely dropped out of the news.
A New Start for Women
Palatin came back with an injection under the skin, which produced steadier levels in the blood, and focused on women with low sexual desire. A dose-finding trial in several hundred premenopausal women was followed by two large phase 3 trials, together known as RECONNECT, which ran from 2015 to 2016.
Approval as Vyleesi
In 2017 Palatin licensed the North American rights to AMAG Pharmaceuticals, which applied for approval. On 21 June 2019 the US Food and Drug Administration approved bremelanotide, sold as Vyleesi, for premenopausal women with acquired, generalised hypoactive sexual desire disorder. It was only the second medicine ever approved for this condition.
Since Then
Palatin took the rights back from AMAG in 2020 and sold Vyleesi to Cosette Pharmaceuticals in December 2023. Licensing deals were also signed for China and South Korea. No approval has been granted in Europe, and some researchers now ask whether the drug could help men with low desire.