Hyperphosphatemia - Pipeline Insight, 2025

This “Hyperphosphatemia - Pipeline Insight, 2025” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Hyperphosphatemia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Hyperphosphatemia: Understanding

Hyperphosphatemia: Overview

Hyperphosphatemia is a condition characterized by elevated phosphate levels in the blood, typically defined as a serum phosphate concentration greater than 4.5 mg/dL in adults. Phosphate, an abundant mineral in the body, is predominantly stored in bones as hydroxyapatite and plays a vital role in numerous biological functions, including ATP production, protein phosphorylation, and nucleic acid formation. The regulation of phosphate is a complex process influenced by intestinal absorption, renal excretion, and cellular distribution, with hormonal control by calcitriol, parathyroid hormone (PTH), and fibroblast growth factor 23 (FGF-23). Causes of hyperphosphatemia include chronic kidney disease, excessive phosphate intake, hypoparathyroidism, and certain medications, while disturbances in phosphate metabolism can lead to adverse effects on bone health, kidney function, and overall mineral balance.

Renal failure is the primary cause of hyperphosphatemia, with a glomerular filtration rate (GFR) below 30 mL/min leading to impaired phosphate filtration and elevated serum levels. Other less common causes include excessive phosphate intake, such as from phosphate-containing laxatives or vitamin D intoxication, which increases intestinal phosphate absorption. Conditions like hypoparathyroidism, acromegaly, and thyrotoxicosis can also result in enhanced renal phosphate reabsorption, contributing to hyperphosphatemia. Genetic factors, such as deficiencies leading to hypoparathyroidism, pseudohypoparathyroidism, and decreased FGF-23 activity, may also be implicated. Additionally, pseudohyperphosphatemia, a laboratory artifact seen in patients with hyperglobulinemia, hyperlipidemia, or hyperbilirubinemia, can interfere with phosphate measurement, leading to falsely elevated phosphate levels.

Hyperphosphatemia can result from several pathophysiological mechanisms, including excessive phosphate load, decreased renal excretion, and disorders like hypoparathyroidism and pseudohypoparathyroidism. An excessive phosphate load can arise from massive tissue breakdown, as seen in rhabdomyolysis, tumor lysis syndrome, and hemolysis, where phosphate is released from cells into the bloodstream. Exogenous sources such as phosphate-containing laxatives and vitamin D intoxication also contribute by increasing phosphate absorption. Decreased renal excretion due to chronic kidney disease (CKD) or renal failure impairs phosphate clearance, leading to accumulation, as compensatory mechanisms like fibroblast growth factor 23 (FGF23) and parathyroid hormone (PTH) secretion initially maintain balance but eventually fail. Hypoparathyroidism, either due to parathyroid injury or genetic mutations, impairs phosphate excretion, while pseudohypoparathyroidism involves resistance to PTH, resulting in elevated phosphate levels.

The management of hyperphosphatemia involves several strategies depending on the severity and underlying conditions. For dialysis patients, phosphate levels should be lowered toward the normal range, with no specific target level set, while chronic kidney disease (CKD) patients not on dialysis should maintain serum phosphate levels under 4.5 mg/dL. In cases of acute hyperphosphatemia with good renal function, phosphate excretion can be enhanced with saline infusion and diuretics. Dietary phosphate restriction (800-1000 mg/day) is recommended for both predialysis and dialysis patients. For those with impaired renal function, hemodialysis is necessary, and phosphate binders are used for persistently elevated phosphate levels, including calcium-based binders, magnesium carbonate, and sevelamer. Medications targeting intestinal phosphate transporters, such as nicotinic acid and nicotinamide or tenapanor, can also be considered. In renal replacement therapies, more intensive dialysis may improve phosphate removal. Additionally, managing secondary hyperparathyroidism through vitamin D metabolites and calcium-sensing receptor agonists is crucial. The differential diagnosis includes pseudohyperphosphatemia, vitamin D intoxication, rhabdomyolysis, tumor lysis syndrome, and pseudohypoparathyroidism.

'Hyperphosphatemia- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hyperphosphatemia pipeline landscape is provided which includes the disease overview and Hyperphosphatemia treatment guidelines. The assessment part of the report embraces, in depth Hyperphosphatemia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Hyperphosphatemia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Hyperphosphatemia R&D. The therapies under development are focused on novel approaches to treat/improve Hyperphosphatemia.

Hyperphosphatemia Emerging Drugs Chapters

This segment of the Hyperphosphatemia report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Hyperphosphatemia Emerging Drugs

AP306: Alebund Pharmaceuticals

AP306 is an investigational drug developed by Alebund Pharmaceuticals that represents a novel approach to treating hyperphosphatemia in chronic kidney disease patients. It is the world's first pan-inhibitor of sodium-dependent phosphate transporters. The drug has shown a clinically significant reduction in serum phosphorus levels, with a higher proportion of patients achieving the KDIGO recommended target range compared to traditional phosphate binders like sevelamer carbonate. The drug has received Breakthrough Therapy Designation from NMPA. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Hyperphosphatemia.

Hyperphosphatemia: Therapeutic Assessment

This segment of the report provides insights about the different Hyperphosphatemia drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Hyperphosphatemia

• There are approx. 4+ key companies which are developing the therapies for Hyperphosphatemia. The companies which have their Hyperphosphatemia drug candidates in the most advanced stage, i.e. Phase III include, Shanghai Alebund Pharmaceuticals Limited.

Phases

The report covers around 4+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Hyperphosphatemia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Hyperphosphatemia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Hyperphosphatemia therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hyperphosphatemia drugs.

Hyperphosphatemia Report Insights

• Hyperphosphatemia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Hyperphosphatemia Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Hyperphosphatemia drugs?
• How many Hyperphosphatemia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hyperphosphatemia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hyperphosphatemia therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hyperphosphatemia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Shanghai Alebund Pharmaceuticals Limited
• Taisho Pharmaceutical Co., Ltd.

Jemincare

• Vidasym

Key Products

• VS-505
• TS-172
• JMKX003002
• VS 605

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