Chronic Kidney Disease: Pipeline Review, 2024

Chronic kidney disease, also known as chronic kidney failure, refers to the progressive condition, where there is a gradual loss of kidney function. Advanced kidney disease may cause dangerous levels of fluids and wastes to build up in the body. Chronic kidney disease can progress to the next stage, which is end-stage renal disease. Some of the symptoms of chronic kidney disease include:

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  • Hypertension
  
  
  • Nausea and Loss of Appetite
  
  
  • Fatigue and Weakness
  
  
  • Others
  
  
  
  

Epidemiology:

Chronic kidney disease is caused by a number of other closely associated diseases such as diabetes, hypertension, cardiovascular diseases, and obesity. In recent years, there has been an increase in the prevalence of chronic kidney disease across several key countries, including the U.S.

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Proportion of Adults in the U.S., Impacted by Chronic Kidney Disease, 2023

According to data published by the Centers for Disease Control and Prevention (CDC) in 2023, the prevalence of chronic kidney disease is significantly higher in people aged 65 and above than in people in the age groups of 45-64 or 18-44.

Therapeutic Assessment:

In a number of patients, chronic kidney disease is diagnosed when the individual undergoes routine testing for another disease or condition. However, the main test for chronic kidney disease is a blood test that measures the levels of a waste product called creatinine in the blood. Some of the medications for the treatment of chronic kidney disease includes angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (ARBs), sodium-glucose cotransporter-2 (SGLT2) inhibitors, and diuretics (water pills).

Key Products:

Some of the drugs that have received approval from the U.S. FDA includes Farxiga (dapagliflozin), Jardiance (empagliflozin), KERENDIA (finerenone), and others. Similarly, all the above mentioned drugs have received the approval from the European Medicines Agency (EMA).

Major Players in Chronic Kidney Disease:

In terms of the key companies present in the chronic kidney disease treatment market, some of them are, AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Bayer, and other companies.

Chronic Kidney Disease Treatment Market Overview:

Chronic kidney disease is a widespread disorder that impacts a substantial proportion of the global population. Hence, a number of established and emerging players are focusing on the development of innovative therapeutics for this disease. For instance, AstraZeneca's product Farxiga (dapagliflozin) registered global revenues of USD 5.96 billion in 2023.

Pipeline Analysis:

Overview of the Pipeline:

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In terms of the current distribution of pipeline candidates, more than 75% of the drugs under clinical trials belong to Phase 1, Phase 2, and Phase 3 collectively.

Pipeline By Mechanism of Action:

In recent times, there has been an increased attention towards the development of newer therapeutics that have a novel mechanism of action. Some of the previously approved drugs for chronic kidney disease, that are still currently present in the clinical trials for expanded label approvals for newer clinical indications are the sodium-glucose transport protein 2 (SGLT2) inhibitors. Some of the drugs under the clinical trials with novel mechanism of actions are as follows:

• Inhibition of Aldosterone Synthase: Some of the recent pipeline drugs that have demonstrated favorable clinical trial results are the candidates who inhibit aldosterone synthase. Drugs belonging to this class, favorably inhibit the aldosterone synthase, an enzyme that controls the sodium homeostasis and hence, controls the final rate limiting steps in aldosterone synthesis. Heightened levels of aldosterone levels can lead to chronic kidney disease, and these drugs limit the levels of aldosterone.


• Restoration of Normal Levels of KLK1: Certain pipeline drugs such as DiaMedica Therapeutics, Inc.’s DM199 function through the restoration of the normal levels of KLK1 and stimulation of nitric oxide and prostaglandin production that aids in the blood flow and the decline in the oxidative stress, inflammation and renal fibrosis in the kidneys.

Pipeline By Route of Administration:

A majority of the drugs under the clinical trials for chronic kidney disease are administered orally. This is because, these drugs, if approved by the regulatory agencies have to be used for a longer time duration by the patients and it will be easier for them to be taken orally. Some of the pipeline drugs that can be taken through the oral route of administration are CR845 by Cara Therapeutics.

Pipeline By Molecule Type:

The majority of the players engaged in the clinical trials for Chronic Kidney Disease treatment have focused on the development of the small molecule drugs. Some of the players with small molecule drugs in their product pipelines for Chronic Kidney Disease includes the emerging company of Axial Therapeutics.

Pipeline By Company:

In terms of pipeline drugs for Chronic Kidney Disease treatment, the number of these drugs in the advanced stages of clinical studies are limited. A number of the companies with pipeline candidates for Chronic Kidney Disease treatment, are emerging biopharmaceutical companies that based in the U.S. Some of the companies with pipeline drugs are Yamo Pharmaceuticals, Curemark, and Astrogen, Inc.

Clinical Trial Insights:

Ongoing Clinical Trials: Some of the key pipeline candidates under clinical trials are as follows:

Phase 1:

• HRS-1780: Shandong Suncadia Medicine Co., Ltd.


• DISC-0974: Disc Medicine


• TS-143: Taisho Pharmaceutical Co., Ltd.


• KBP-5074: KBP Biosciences

Phase 2:

• KBP-5074: KBP Biosciences Co., Ltd.


• DM199: DiaMedica Therapeutics, Inc.


• CR845: Cara Therapeutics


• BAY3283142: Bayer


• KT-301: Kibow Biotech

Phase 3:

• BI 690517: Boehringer Ingelheim International GmbH
  
  
  
  • Study Description: This study is open to patients suffering or not suffering from diabetes. Furthermore, this study is open to participants consuming other medications for chronic kidney disease such as angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), and sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study is a multicenter, international, randomized, and double-blind, placebo-controlled clinical trial for BI 690517. The study type of this clinical trial is interventional, and the primary purpose is treatment. The allocation and interventional model is randomized and parallel assignment respectively. The masking of this study is quadruple.
  
  
  
  


• PA21: Vifor Fresenius Medical Care Renal Pharma

Future Trial Prospects:

• August 2024: EASi-KIDNEY, a trial that will evaluate Boehringer Ingelheim’s candidate of BI 690517, is currently in Phase 3 of clinical trials and have not yet begun the recruitment of patients.


• April 2024: Vertex Pharmaceuticals Incorporated announced the advancement of Inaxaplin (VX-147) into Phase 3 portion of the global Phase 2/3 pivotal clinical trial in APOL1-mediated kidney disease (AMKD).

Regulatory Landscape:

• FDA and EMA Approvals: In recent times, the regulatory agencies of U.S. FDA and EMA, have approved drugs for the treatment of chronic kidney disease. For instance, in September 2023, Jardiance (empagliflozin) was approved by the U.S. FDA


• Orphan Drug Designations: In the current scenario, there has been limited Orphan Drug Designations (ODD) to drugs for chronic kidney disease. However, several companies have such as XORTX and Unicycive Therapeutics have received Orphan Drug Designations (ODD) for autosomal dominant polycystic kidney disease (ADPKD).


• Market Authorization Challenges: Despite the substantial patient burden of chronic kidney disease, the number of drugs solely approved for this condition are limited. The costs associated with these drugs may lead to limited reimbursement coverage and higher copay for the patient, leading to challenges in terms of their widespread marketing and launch.

Report Scope

• A thorough assessment of the pipeline products by areas such as development stage; route of administration; drug class; indication; sponsor; molecule type and drug target


• Comprehensive profiles of the pipeline products with details such as company overview; product description; R&D status; development activities; mechanism of action; molecule type; development stage; indications; funding and route of administration


• Overview of dormant and discontinued pipeline products


• Key insights about the epidemiology of conditions being treated by the pipeline products and overview of the addressable or current market for the pipeline products


• Overview of the latest developments; news articles, press releases, and relevant conferences

Report Methodology

• All pipeline reports are built through the analysis of data primarily collected through credible desk research sources. Secondary research is supplemented by interviews conducted with key opinion leaders.


• Desk research sources include global and regional clinical trials databases; annual reports, websites, press releases & investor presentations of companies; white papers; news articles; reports published by industry associations; articles/reports published on databases such as NCBI, ResearchGate; internal databases

Reasons to Buy this Report

• Develop effective growth strategies based on a comprehensive overview of the R&D activity and pipeline products for Chronic Kidney Disease


• Identify emerging players or competition in the market based on pipeline products and develop strategies to counter the emergence of these players


• Identify the focus of leading players about R&D for Chronic Kidney Disease


• Identify potential companies from a partnership or acquisition point of view based on current synergy in R&D activities or strategies to diversify R&D focus to drive growth in business

Analyze the reasons behind dormant and discontinued products to make changes in the R&D focus if necessary