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The FDA has issued warnings to companies that have illegally sold drugs labeled for research purposes or not for human consumption. Some of these products have been sold directly to consumers for human use, even though they were specifically labeled not to be used in humans

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PT-141 was FDA-approved in 2019 under the brand name Vyleesi for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, representing the first melanocortin receptor agonist approved for this indication

is the most-cited primary reference

Immune dysregulation, oxidative stress, mitochondrial dysfunction, and neuroinflammation are central to its pathology