Chronic Kidney Disease - Pipeline Insight, 2024

This “Chronic Kidney Disease - Pipeline Insight, 2024” report provides comprehensive insights about 76+ companies and 80+ pipeline drugs in Chronic Kidney Disease 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.

Geography Covered

• Global coverage

Chronic Kidney Disease: Understanding

Chronic Kidney Disease: Overview

Chronic Kidney Disease is a condition in which kidneys are damaged and cannot filter blood. As a result, extra fluid and waste from the blood remain in the body, potentially leading to various health issues like heart disease and stroke. Chronic Kidney Disease has various levels of seriousness. It usually gets worse with time though treatment has been shown to slow progression. If left untreated, CKD can progress to kidney failure and early cardiovascular disease.

People with chronic kidney disease may not feel ill or notice any symptoms. CKD signs and symptoms develop over time if kidney damage progresses slowly. Loss of kidney function can cause a buildup of fluid or body waste or electrolyte problems. The most common symptoms of chronic kidney disease include: hypertension, anemia, edema, fatigue, decreased urine output, blood in urine, dark urine, loss of appetite and persistent itchy skin.

Patients feel unwell or have symptoms with mild-to-moderate chronic kidney disease that is, stages 1 to 3. Chronic kidney disease is usually diagnosed by the e GFR test before any symptoms develop. Symptoms tend to develop when chronic kidney disease becomes severe (stage 4) or worse. The symptoms at first tend to be vague and nonspecific, such as feeling tired, having less energy than usual and just not feelingwell.

If the kidney function declines to stage 4 or 5 then various other problems may develop, for example, anaemia and an imbalance of calcium, phosphate and other chemicals in the bloodstream. These can cause various symptoms, such as tiredness due to anaemia, and bone thinning or fractures due to calcium and phosphate imbalance. End-stage kidney failure (stage 5) is eventually fatal unless treated.

Chronic kidney disease is more prevalent in elder population. It is the leading cause of death in the United States. About 37 million US adults are estimated to have chronic kidney disease, and most are undiagnosed. Early stage kidney disease usually has no symptoms, and many people do not know they have CKD until it is very advanced. Kidney disease often gets worse over time and may lead to kidney failure and other health problems, such as stroke or heart attack. Approximately 2 in 1,000 Americans are living with end-stage kidney disease (ESKD), kidney failure that is treated with a kidney transplant or dialysis.

Chronic Kidney Disease- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Chronic Kidney Disease pipeline landscape is provided which includes the disease overview and Chronic Kidney Disease treatment guidelines. The assessment part of the report embraces, in depth Chronic Kidney Disease 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, Chronic Kidney Disease 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 Chronic Kidney Disease R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Kidney Disease.

Chronic Kidney Disease Emerging Drugs Chapters

This segment of the Chronic Kidney Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Chronic Kidney Disease Emerging Drugs

KBP-5074: KBP Biosciences KBP Biosciences’ lead product candidate, KBP-5074, is a potentially best-in-class, next-generation, non-steroidal MRA discovered and developed by KBP’s scientists, is being developed globally to initially treat Stage 3b/4, or moderate-to-severe, CKD patients with uncontrolled hypertension. KBP-5074 selectively binds to recombinant human MRs with much higher affinity than to recombinant human glucocorticoid, progesterone, and androgen receptors, suggesting that KBP-5074 should be effective in blocking the hypertensive and renal tissue damaging effects of aldosterone with reduced risk of pro-diabetic and adverse endocrine effects. In clinical trials conducted to-date, it has demonstrated an ability to lower blood pressure without androgenic effects such as hirsutism, obesity and gynecomastia. The drug is currently being evaluated in Phase III stage of development for the treatment of patients with Uncontrolled Hypertension and Moderate or SevereCKD.

Ziltivekimab: Novo Nordisk Ziltivekimab is a proprietary anti-interleukin-6 ligand monoclonal antibody (anti-IL6 mAb), targeting residual inflammatory cardiovascular risk in patients living with advanced chronic kidney disease (CKD). Ziltivekimab is being developed a therapy intended to reduce the risk of major cardiovascular adverse events in chronic kidney disease (CKD) patients with atherosclerotic cardiovascular disease (ASCVD) and inflammation. Patients who are diagnosed with moderate to severe CKD and have ASCVD and inflammation are at risk for an adverse cardiovascular event at a high rate and there are no approved therapies to prevent this risk. The proinflammatory cytokine, interleukin-6 (IL-6) has been shown to be an independent, causal factor of ASCVD with evidence generated from human genetic studies and preclinical studies. The drug is being evaluated in Phase III stage of development to treat patients with moderate to severe chronic kidneydisease.

US-APR2020: Kibow Pharma US-APR2020 is a natural probiotics formulation that metabolizes nitrogenous waste, which generally diffuses from the circulating bloodstream into the bowel. When these waste products accumulate in high concentrations in the blood, they become highly toxic and can cause severe damage to many organ systems if they are not properly excreted. US-APR2020 utilizes nitrogenous wastes as nutrients. As probiotics grow and multiply, they consume more nitrogenous waste and effectively maintain healthy kidney function.

DM199: Dia Medica Therapeutics DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes, including blood flow, inflammation, fibrosis, oxidative stress, and neurogenesis, via a molecular mechanism that, among other things, increases production of nitric oxide andprostaglandin.

KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. Dia Medica is the first company to have developed and clinically studied a pharmaceutically active recombinant form of the KLK1 protein. The KLK1 protein, in forms produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently in Phase II stage of its development for the treatment of patients with chronic kidneydisease.

AL-01211: Ace Link Therapeutics AL01211 is a proprietary, non-brain penetrant GCS inhibitor with excellent potency (single-digit nanomolar IC50), great selectivity, and other favorable drug properties that support once-daily oral administration. AL01211 offers a much-needed oral small molecule therapy as an alternative to enzyme replacement therapy for Fabry disease that require frequent intravenous infusions. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of Autosomal Dominant Polycystic KidneyDisease.

Chronic Kidney Disease: Therapeutic Assessment

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

Major Players in Chronic Kidney Disease

There are approx. 76+ key companies which are developing the therapies for Chronic Kidney Disease. The companies which have their Chronic Kidney Disease drug candidates in the most advanced stage, i.e. phase III include, KBP Biosciences.

Phases

This report covers around 80+ 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

Chronic Kidney Disease 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.

Chronic Kidney Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Kidney Disease 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 Chronic Kidney Disease drugs.

Chronic Kidney Disease Report Insights

• Chronic Kidney Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Chronic Kidney Disease 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 Chronic Kidney Disease drugs?
• How many Chronic Kidney Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Kidney Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Kidney Disease 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 Chronic Kidney Disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Boehringer Ingelheim
• Eli Lilly and Company
• Reata Pharmaceuticals
• Novo Nordisk
• Prokidney
• KBP Biosciences
• Dia MedicaTherapeutics
• Kibow Pharma
• AstraZeneca
• XORTX Therapeutics
• Ionis Pharmaceuticals
• Merck Sharp & Dohme
• Disc Medicine
• Roche
• CinCor Pharma
• Galapagos NV
• Bayer
• Sentien Biotechnologies, Inc.
• MISSION Therapeutics
• Ace LinkTherapeutics

Key Products

• Bardoxolone methyl
• Empagliflozin
• Ziltivekimab
• KBP-5074
• Renal Autologous Cell Therapy
• DM199
• US-APR2020
• XRx-008
• Zibotentan
• BI 690517
• MK-2060
• ION532
• DISC-0974
• Pirfenidone
• Baxdrostat
• GLPG2737
• Runcaciguat
• SBI-101
• MTX652
• AL-01211

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