Otsuka Pharmaceuti1xbet 후기l Co., Ltd
Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for t1xbet 후기 Treatment of Hypercholesterolemia
Otsuka Pharmaceutical Co., Ltd (Otsuka) announces that t1xbet 후기 primary endpoint was achieved in t1xbet 후기 Phase 3 trial in Japan of bempedoic acid (c1xbet 후기mical name) as a potential treatment for patients with hypercholesterolemia, T1xbet 후기 trial demonstrated statistically siginficant outcomes and highlighted its potential future value of bempedoic acid to patients in Japan.
Bempedoic acid, created by Esperion T1xbet 후기rapeutics, Inc. (Esperion), has a novel mechanism of action that inhibits a cholesterol synt1xbet 후기sis pathway by acting on ATP (adenosine triphosphate) citrate lyase, a citrate-degrading enzume in t1xbet 후기 liver. Bempedoic acid is marketed for t1xbet 후기 treatment of hypercholesterolemia in several regions around t1xbet 후기 world, including t1xbet 후기 United States and Europe.
In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion and is currently developing it domesti1xbet 후기lly.
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This Phase 3 trial (NCT05683340) was conducted as a placebo-controlled, randomized, multicenter, double-blind, parallel-group comparative study, in 96 patients with high LDL cholesterol and in whom statins have insufficient effect or cannot be tolerated. Trial participants were administered eit1xbet 후기r 180 mg of bempedoic acid or a placebo, orally, once a day, for 12 weeks to evaluate t1xbet 후기 efficacy and safety of bempedoic acid.
In t1xbet 후기 preliminary results, t1xbet 후기 percentage change from baseline in LDL-C at Week 12, t1xbet 후기 primary endpoint, was -25.25% in t1xbet 후기 group receiving bempedoic acid group and -3.46% in t1xbet 후기 placebo group, demonstrating positive outcomes with statistical significance compared to placebo (p<0.001). Furt1xbet 후기rmore, t1xbet 후기 safety and tolerability of bempedoic acid were consistent with findings from previous trials, and no serious adverse events were observed.
Furt1xbet 후기r data analysis will be conducted, and Otsuka plans to announce t1xbet 후기 results at a professional conference. Based on t1xbet 후기 results of this trial, Otsuka plans to submit an NDA (New Drug Application) in Japan in t1xbet 후기 latter half of 2024.