Hyperphosphatemia, characterized by elevated serum phosphate levels, is commonly observed in chronic kidney disease (CKD) and is associated with increased mortality in dialysis patients. According to Zhongcheng Fan et al., 2025, CKD affects approximately 8%-16% of the global population, driving a significant patient pool at risk of hyperphosphatemia. Current therapies focus on phosphate binders, dietary management, and novel agents targeting phosphate absorption. Growing attention is being given to developing safer and more effective treatments, driven by rising CKD prevalence and associated complications. According to the hyperphosphatemia pipeline analysis by Expert Market Research, the drug pipeline is expected to witness robust growth in the coming years.
Major companies involved in the hyperphosphatemia pipeline analysis include Taisho Pharmaceutical Co., Ltd., Alebund Pharmaceuticals, and others.
Leading drugs currently in the pipeline include AP301, JMKX003002, AP306, and others.
The pipeline is set to expand with innovative phosphate binders and targeted therapies, driven by rising chronic kidney disease prevalence, improved drug delivery mechanisms, and increased investment in clinical trials.
The Hyperphosphatemia Pipeline Insight Report by Expert Market Research gives comprehensive insights into hyperphosphatemia therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for hyperphosphatemia. The hyperphosphatemia report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The hyperphosphatemia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with hyperphosphatemia treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to hyperphosphatemia.
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Hyperphosphatemia is a medical condition characterized by elevated phosphorus levels in the blood, primarily resulting from impaired kidney function. When the kidneys fail to excrete phosphate efficiently, it accumulates, causing disruptions in calcium-phosphate balance, potentially leading to cardiovascular complications and bone disorders. This condition commonly occurs in patients with chronic kidney disease, especially those on dialysis, as their kidneys are unable to maintain normal phosphate homeostasis.
Hyperphosphatemia treatments focus on reducing serum phosphate levels through dietary phosphate restriction, phosphate binders, and novel absorption inhibitors. These approaches aim to manage phosphorus levels, prevent complications, and improve patient outcomes in chronic kidney disease. For instance, in September 2023, Kyowa Kirin received approval in Japan for Phozevel® (tenapanor hydrochloride) for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis. The drug works locally in the gut to reduce phosphate absorption, providing a new, effective treatment option with a favorable safety profile.
According to Zhongcheng Fan et al., 2025, hyperphosphatemia is commonly observed in chronic kidney disease (CKD), which has a global prevalence of 8%-16%, and is associated with higher mortality among dialysis patients. As per Umesh B. Khanna et al., 2025, the incidence of hyperphosphatemia in the general population is around 12%, while in patients with end-stage renal disease (ESRD), it ranges from 50% to 74%, increasing progressively with advancing CKD stages. According to Fabiana Baggio Nerbass et al., 2023, a study of 13,792 hemodialysis patients in Brazil revealed regional differences, with the South reporting the highest prevalence at 41.2%. These epidemiological insights underscore the need for targeted drug development in this area.
This section of the report covers the analysis of hyperphosphatemia drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The hyperphosphatemia pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phases II and III cover a major share of the total hyperphosphatemia clinical trials, with 50% each. The strong presence of drugs in advanced phases highlights robust clinical development, which can expand therapeutic options, and drive growth in the hyperphosphatemia market.
The drug molecule categories covered under the hyperphosphatemia pipeline analysis include small molecules, monoclonal antibodies and peptides. The hyperphosphatemia report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hyperphosphatemia. Chemical-based therapies are advancing in the treatment of hyperphosphatemia to manage elevated serum phosphorus levels in patients with chronic kidney disease on hemodialysis. For instance, in July 2023, Shanghai Fosun Pharmaceutical (Fosun Pharma) announced that its New Drug Application for Tenapanor Hydrochloride Tablets, a first-in-class oral intestinal sodium/hydrogen exchanger 3 (NHE3) inhibitor, was accepted for review by the National Medical Products Administration in China. Tenapanor works by reducing intestinal sodium absorption, increasing water content in the intestinal lumen, and promoting bowel movements, thereby effectively lowering serum phosphorus levels in hemodialysis patients.
The EMR report for the hyperphosphatemia pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hyperphosphatemia therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hyperphosphatemia clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for hyperphosphatemia. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of hyperphosphatemia drug candidates.
AP301 is a novel iron-based phosphate binder being sponsored by Alebund Pharmaceuticals. This Phase 3 study is aiming to evaluate its efficacy and safety in patients with hyperphosphatemia undergoing maintenance dialysis in the U.S. and China. The study is examining whether AP301 can lower blood phosphate levels, impact serum calcium, calcium-phosphate product, and parathyroid hormone levels, and improve quality of life. AP301 works by binding phosphate in the gastrointestinal tract without systemic absorption. It is administered orally three times daily, with doses adjusted based on blood phosphate levels, providing high tolerability and reduced pill burden.
JMKX003002 is an oral drug being developed by Jemincare for managing hyperphosphatemia in end-stage renal disease patients undergoing hemodialysis. This Phase 2a, multicenter, randomized, open-label, active drug-controlled study is evaluating the efficacy and safety of JMKX003002, aiming to reduce serum phosphorus levels with sustained effect and improved patient compliance. The study is examining the drug’s ability to control hyperphosphatemia compared with Sevelamer carbonate. JMKX003002 is designed to enhance phosphorus reduction while improving overall quality of life through convenient oral administration.
AP306 is an oral phosphate transporter inhibitor targeting NaPi-IIb, PiT-1, and PiT-2, developed by Alebund Pharmaceuticals. It is under a global rights agreement with Chugai Pharmaceutical. This Phase 2b study is evaluating the safety, tolerability, and serum phosphate-lowering effect of fixed doses of AP306 in patients receiving maintenance hemodialysis with hyperphosphatemia. Participants are taking AP306 or a placebo three times daily for 12 weeks, while discontinuing other phosphate-lowering drugs. The trial is examining whether AP306 effectively reduces blood phosphate levels and monitors any adverse effects, supporting its potential as a targeted oral therapy.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Hyperphosphatemia Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for hyperphosphatemia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into hyperphosphatemia collaborations, regulatory environments, and potential growth opportunities.
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