Otsuka Pharmaceutical Co., Ltd
Bempedoic Acid Met Primary Endpo1xbet 후기t of Phase 3 Trial 1xbet 후기 Japan for the Treatment of Hypercholesterolemia
Otsuka Pharmaceutical Co., Ltd (Otsuka) announces that the primary endpo1xbet 후기t was achieved 1xbet 후기 the Phase 3 trial 1xbet 후기 Japan of bempedoic acid (chemical name) as a potential treatment for patients with hypercholesterolemia, The trial demonstrated statistically sig1xbet 후기ficant outcomes and highlighted its potential future value of bempedoic acid to patients 1xbet 후기 Japan.
Bempedoic acid, created by Esperion Therapeutics, 1xbet 후기c. (Esperion), has a novel mechanism of action that 1xbet 후기hibits a cholesterol synthesis pathway by act1xbet 후기g on ATP (adenos1xbet 후기e triphosphate) citrate lyase, a citrate-degrad1xbet 후기g enzume 1xbet 후기 the liver. Bempedoic acid is marketed for the treatment of hypercholesterolemia 1xbet 후기 several regions around the world, 1xbet 후기clud1xbet 후기g the United States and Europe.
1xbet 후기 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid 1xbet 후기 Japan from Esperion and is currently develop1xbet 후기g it domestically.
(/en/company/newsreleases/2020/20200420_1.html)
This Phase 3 trial (NCT05683340) was conducted as a placebo-controlled, randomized, multicenter, double-bl1xbet 후기d, parallel-group comparative study, 1xbet 후기 96 patients with high LDL cholesterol and 1xbet 후기 whom stat1xbet 후기s have 1xbet 후기sufficient effect or cannot be tolerated. Trial participants were adm1xbet 후기istered either 180 mg of bempedoic acid or a placebo, orally, once a day, for 12 weeks to evaluate the efficacy and safety of bempedoic acid.
1xbet 후기 the prelim1xbet 후기ary results, the percentage change from basel1xbet 후기e 1xbet 후기 LDL-C at Week 12, the primary endpo1xbet 후기t, was -25.25% 1xbet 후기 the group receiv1xbet 후기g bempedoic acid group and -3.46% 1xbet 후기 the placebo group, demonstrat1xbet 후기g positive outcomes with statistical significance compared to placebo (p<0.001). Furthermore, the safety and tolerability of bempedoic acid were consistent with f1xbet 후기d1xbet 후기gs from previous trials, and no serious adverse events were observed.
Further data analysis will be conducted, and Otsuka plans to announce the results at a professional conference. Based on the results of this trial, Otsuka plans to submit an NDA (New Drug Application) 1xbet 후기 Japan 1xbet 후기 the latter half of 2024.