Alebund Pharmaceuticals Completes Enrollment in Global Phase III Trial for Hyperphosphatemia Drug AP301

Alebund Pharmaceuticals Completes Enrollment in Global Phase III Trial for Hyperphosphatemia Drug AP301

By, Admin 8 May 2026

Alebund Pharmaceuticals has completed patient enrollment in the global Phase III pivotal clinical trial of AP301, a next-generation phosphate binder being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

The milestone marks a major step forward in the company’s global regulatory strategy and positions AP301 closer to potential approval in both the United States and China.

Global Phase III Trial Enrolls 282 Patients

The multi-regional Phase III study, known as RESPOND-2, enrolled 282 dialysis-dependent CKD patients with hyperphosphatemia across the United States and China.

The trial included:

  • 138 patients in the United States
  • 144 patients in China

The study is being led by Geoffrey A. Block in the US, while Xiaoqiang Ding serves as the China principal investigator.

RESPOND-2 is designed as a randomized, double-blind, multi-regional Phase III study evaluating the efficacy and safety of AP301 in CKD patients aged 12 years and older undergoing maintenance dialysis.

What Makes AP301 Different?

AP301 is a novel fiber-iron-based phosphate binder designed to address several limitations associated with existing therapies. According to Alebund Pharmaceuticals, the therapy aims to provide:

  • Higher phosphate-binding capacity
  • Improved gastrointestinal tolerability
  • Minimal risk of iron overload
  • Lower pill burden
  • No chewing requirement before swallowing

The company believes these features could improve patient adherence and help patients achieve better long-term phosphate control.

Why Hyperphosphatemia Matters in CKD?

Hyperphosphatemia is one of the most common and dangerous complications in chronic kidney disease patients. The condition affects:

  • Approximately 95% of dialysis-dependent CKD patients
  • Around 15% of non-dialysis CKD patients

Persistently elevated phosphate levels are associated with serious complications such as:

  • Vascular calcification
  • Secondary hyperparathyroidism
  • Renal osteodystrophy
  • Cardiovascular disease
  • Increased mortality risk

For dialysis patients, dialysis alone is often insufficient to remove excess phosphorus from the body, making phosphate binders a critical part of long-term disease management.

Existing Treatments Still Face Major Challenges

Current phosphate binders are widely used but remain associated with several problems, including:

  • Gastrointestinal side effects
  • High pill burden
  • Poor treatment adherence

As a result, phosphate control rates remain low globally. According to Dialysis Outcomes and Practice Patterns Study (DOPPS) data:

  • 76% of dialysis patients in China fail to achieve target phosphate levels
  • 52% of patients in the US remain uncontrolled
  • 39% of patients in Japan also fail to meet treatment goals

The China Dialysis Calcification Study further reported that only 40.1% of Chinese dialysis patients achieve recommended phosphate targets.

Strong Results from Earlier China Phase III Study

AP301 has already demonstrated promising efficacy and safety in the completed China pivotal Phase III study, RESPOND-1. The trial randomized 474 patients across 50 investigational sites in China and was led by Li Zuo.

Key findings included:

  • AP301 demonstrated non-inferiority to Sevelamer Carbonate at Week 12
  • Greater long-term phosphate reduction at Week 52
  • Higher phosphate target attainment rates
  • Lower average daily dose requirements compared to sevelamer carbonate

At Week 52:

  • AP301 achieved a 66.7% phosphate target attainment rate
  • Sevelamer carbonate achieved 58.6%
  • AP301 required a lower daily dose

The treatment also showed durable phosphate reduction over the full study period.

Safety Profile Appears Favorable

According to the company, AP301 was generally safe and well tolerated. The most common adverse events included:

  • Discoloured feces
  • Mild diarrhoea

Importantly, no safety signals related to iron accumulation were observed during the 52-week treatment period.

Diarrhoea was typically mild, occurred early in treatment, and rarely caused discontinuation.

FDA and China NDA Plans

Based on existing clinical data, US Food and Drug Administration has agreed that RESPOND-2 can serve as the single pivotal study supporting potential US registration for AP301.

Meanwhile, Alebund has also aligned with National Medical Products Administration and plans to submit a New Drug Application in China in the near future.

According to Jin Tian, completing enrollment on schedule reflects the company’s growing capability in global clinical development and registrational studies.

Growing Market Opportunity

The market for phosphate-lowering therapies is expected to expand significantly over the coming decade. According to China Insights Consultancy estimates:

  • China’s serum phosphorus-lowering drug market could reach RMB 10 billion by 2035
  • The global market could reach approximately USD 6 billion

As CKD prevalence continues to rise globally, demand for more tolerable and effective phosphate binders is expected to increase substantially.

Alebund Expands Kidney Disease Pipeline

Founded in Shanghai in 2018, Alebund Pharmaceuticals focuses on therapies targeting kidney diseases, CKD complications, and chronic conditions.

The progress of AP301 highlights the company’s broader strategy of developing innovative renal therapies capable of addressing major unmet clinical needs in dialysis care and chronic kidney disease management.

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