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Alebund Pharmaceuticals Announces Completion of Patient Enrollment in Global Phase III Pivotal Multi-Regional Clinical Trial of AP301 for Hyperphosphatemia
The trial enrolled 282 dialysis patients, exceeding the original target, and will support U.S. registration of AP301, Alebund said.
- On Wednesday, May 6, 2026, Alebund Pharmaceuticals Limited announced completion of patient enrollment in the global Phase III pivotal trial for AP301, a novel fiber-iron-based phosphate binder treating hyperphosphatemia.
- Hyperphosphatemia affects approximately 95% of dialysis-dependent chronic kidney disease patients, yet existing phosphate binders frequently cause poor compliance due to gastrointestinal side effects and high pill burdens limiting effective treatment.
- Dr. Geoffrey A. Block of U.S. Renal Care and Professor Xiaoqiang Ding of Zhongshan Hospital, Fudan University, led the trial enrolling 282 chronic kidney disease patients on maintenance dialysis—138 in the United States and 144 in China.
- FDA agreement designated this trial as the single pivotal study supporting U.S. registration of AP301. Chief Medical Officer Jin Tian called enrollment completion "an important milestone in the global registrational development of AP301."
- Following trial completion, Alebund plans to submit a New Drug Application in China in the near future. Global market for serum phosphorus-lowering products is forecasted to reach USD 6 billion by 2035, positioning AP301 in a high-growth sector.
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Alebund Pharmaceuticals Announces Completion of Patient Enrollment in Global Phase III Pivotal Multi-Regional Clinical Trial of AP301 for Hyperphosphatemia
SHANGHAI, May 6, 2026 /PRNewswire/ -- Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, today announced the completion of patient enrollment…
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Leaning Left9Leaning Right6Center18Last UpdatedBias Distribution55% Center
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