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FP-014 is a ready-to-use, subcutaneous, long-acting injectable formulation of triptorelin mesylate developed by Foresee Pharmaceuticals. It utilizes a proprietary Stabilized Injectable Formulation (SIF) technology, incorporating N-methyl-2-pyrrolidone (NMP) and poly(D,L-lactide-co-glycolide) (PLGA) to provide controlled and sustained release of the active ingredient. As a gonadotropin-releasing hormone (GnRH) agonist, triptorelin works by initially stimulating but subsequently desensitizing the pituitary GnRH receptors, leading to a profound reduction in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion. This suppression results in the reduction of serum testosterone to castrate levels (< 50 ng/dL), which is the primary goal of androgen ablation therapy in patients with advanced or metastatic prostate cancer. FP-014 is currently being evaluated in Phase 3 clinical trials (KATANA studies) for three-month (11.25 mg) and six-month (22.5 mg) administration schedules.
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