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Drug intelligence / Profile preview
AM0801 is a biodegradable, melt-extruded controlled-release implant containing 3.6 mg of goserelin, a synthetic decapeptide analogue of gonadotropin-releasing hormone (GnRH). Developed by AMW GmbH, it is designed for the treatment of hormone-sensitive cancers, primarily prostate cancer and breast cancer, as well as certain benign gynecological conditions like endometriosis. As a GnRH agonist, goserelin initially stimulates the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), but continuous administration leads to down-regulation of GnRH receptors, resulting in a profound reduction in sex hormone levels (testosterone in men and estradiol in women). The AM0801 formulation utilizes AMW's proprietary biodegradable polymer matrix to provide sustained therapeutic levels over a one-month period.
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