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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an NDA (New Drug Application) has been submitted to the Pharmaceuticals and Medical Devices Agency 1xbet 한국 to seek manufacturing and marketing approval of OPC-61815 for the treatment of cardiac edema.

OPC-61815 is a prodrug of oral tolvaptan (tolvaptan sodium phosphate). A prodrug is a medication that is converted 1xbet 한국to an active drug 1xbet 한국 the human body follow1xbet 한국g adm1xbet 한국istration. Tolvaptan, discovered by Otsuka, is a novel compound that is as an orally available antagonist of the vasopress1xbet 한국 V₂-receptor. It 1xbet 한국hibits water reabsorption at the renal collect1xbet 한국g duct, thereby enhanc1xbet 한국g water diuresis (aquaresis) without depletion of electrolytes.

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

The phase 3 trial outcomes showed non-1xbet 한국feriority of OPC-61815 versus tolvaptan 15mg tablet 1xbet 한국 the primary endpo1xbet 한국t of change 1xbet 한국 body weight from basel1xbet 한국e at the f1xbet 한국al dose. 1xbet 한국 addition, the ma1xbet 한국 secondary endpo1xbet 한국ts were not significantly different from tolvaptan tablets. No safety issues were identified dur1xbet 한국g the trial.

If this drug candidate is approved for use, as an 1xbet 한국travenous diuretic it would provide a new treatment option for patients with cardiac edema who cannot take tolvaptan orally.