Orkedia® is the commercial brand name of Evocalcet Tablets, developed by Kyowa Kirin of Japan. It is a new-generation oral calcimimetic agent. It activates calcium-sensing receptors on parathyroid gland cells to suppress parathyroid hormone secretion and parathyroid cell proliferation, lowering serum PTH levels to control secondary hyperparathyroidism in dialysis patients.
Main Indications
Treatment of secondary hyperparathyroidism in adult chronic kidney disease patients receiving maintenance dialysis.
Clinical Research
Global multicenter phase III pivotal trials fully validated its potent PTH-lowering efficacy for dialysis patients with SHPT;
Head-to-head comparative registration trials confirmed stronger PTH control and lower gastrointestinal adverse reaction rates versus cinacalcet;
Long-term observational cohort studies demonstrated stable sustained serum calcium and phosphorus balance during chronic oral administration;
Dose titration research identified optimal once-daily oral dosing with balanced efficacy and gastrointestinal tolerability;
Chinese domestic registration trials verified favorable safety and efficacy profiles for local Chinese dialysis patient populations.
Common Side Effects
Major severe risk: Hypocalcemia, which may trigger muscle spasm, numbness and arrhythmia;
Common mild adverse reactions: Nausea, vomiting, abdominal distension, diarrhea, headache and fatigue;
Laboratory abnormalities: Transient reduction of serum calcium, rare mild elevation of liver transaminases.
Approval Status in China
Original drug Orkedia® (Evocalcet Tablets) was officially approved for marketing in China in July 2024, with the specification of 2mg, 10 tablets per box. It is currently a prescription drug included in China’s category B medical insurance starting from 2025.
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