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DS-9001 is a recombinant protein drug designed as an *anti-PCSK9 Anticalin Albumod*[1][3]. Its mechanism of action is inhibition of PCSK9 (proprotein convertase subtilisin/kexin type 9), a protein that regulates LDL receptor degradation, with the therapeutic goal to lower LDL cholesterol levels[1][3]. It was developed for the treatment of dyslipidemia and other lipid disorders. DS-9001 is an engineered fusion protein classified as an Anticalin— a small, high-affinity binding protein based on the lipocalin structure, fused with albumod for plasma half-life extension. Its primary indication was dyslipidemia, targeting patients with hypercholesterolemia through PCSK9 inhibition[1][3][9]. The originator and principal developer was Pieris Pharmaceuticals, while Daiichi Sankyo subsequently was involved in clinical development and commercialization[1][3][9]. Clinical development was discontinued after phase 1 trials[1][9].
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