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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 3 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 phosphate control.
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.
The FDA designated this trial as the single pivotal study supporting U.S. registration of AP301. Chief Medical Officer Jin Tian called it "an important milestone in the global registrational development of AP301."
By 2035, the global serum phosphorus-lowering product market is forecasted to reach USD 6 billion, while Alebund plans to submit a New Drug Application in China in the near future.