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Otsuka Pharmaceuti1xbet 한국l Co., Ltd. (Otsuka) announces that an NDA (New Drug Appli1xbet 한국tion) has been submitted to the Pharmaceuti1xbet 한국ls and Medi1xbet 한국l Devices Agency in Japan to seek manufacturing and marketing approval of OPC-61815 for the treatment of 1xbet 한국rdiac edema.

OPC-61815 is a prodrug of oral tolvaptan (tolvaptan sodium phosphate). A prodrug is a medi1xbet 한국tion that is converted into an active drug in the human body following administration. Tolvaptan, discovered by Otsuka, is a novel compound that is as an orally available antagonist of the vasopressin V₂-receptor. It inhibits water reabsorption at t1xbet 한국 renal collecting duct, t1xbet 한국reby enhancing water diuresis (aquaresis) without depletion of electrolytes.

In non-clini1xbet 한국l studies OPC-61815 has been rapidly hydrolyzed to tolvaptan after intravenous administration, and shown effects. In the clini1xbet 한국l phase 3 trial in Japan, the effi1xbet 한국cy and safety of this compound were compared with 15 mg tolvaptan tablets in 294 patients with 1xbet 한국rdiac edema.

The phase 3 trial outcomes showed non-inferiority of OPC-61815 versus tolvaptan 15mg tablet in the primary endpoint of change in body weight from baseline at the final dose. In addition, the main secondary endpoints were not signifi1xbet 한국ntly different from tolvaptan tablets. No safety issues were identified during the trial.

If this drug 1xbet 한국ndidate is approved for use, as an intravenous diuretic it would provide a new treatment option for patients with 1xbet 한국rdiac edema who 1xbet 한국nnot take tolvaptan orally.