Moderate and Severe Chronic Kidney Disease - Pipeline Insight, 2024

This “Moderate and Severe Chronic Kidney Disease - Pipeline Insight, 2024,” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Moderate and Severe 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

Moderate and Severe Chronic Kidney Disease Understanding

Moderate and Severe 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. 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.

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

Moderate and Severe Chronic Kidney Disease Emerging Drugs Chapters

This segment of the Moderate and Severe 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.

Moderate and Severe Chronic Kidney Disease Emerging Drugs

Bardoxolone methyl: Reata Pharmaceuticals Bardoxolone methyl is an Nrf2 activator currently being investigated in clinical trials for the treatment of patients with different forms of chronic kidney disease. Inflammation - initiated by a variety of pathogenic processes, including diabetes, systemic hypertension, IgA deposition, and genetic mutations - drives kidney function decline. At the physiological level, chronic activation of pro-inflammatory pathways in the kidney cells leads to a reduction in the glomerular filtration rate (GFR). In March 2021, Reata Pharmaceuticals announced that it had submitted a New Drug Application (NDA) for bardoxolone methyl (bardoxolone), its leading product, to the FDA. Bardoxolone’s NDA application was supported by efficacy and safety clinical data from the multi-center, Phase III CARDINAL trial. Results showed that bardoxolone significantly improved glomerular filtration rate (GFR) compared to placebo, and its adverse events were mild and moderate.

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.

CLBS201: Caladrius Biosciences CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for chronic kidney disease (“CKD”) in patients not yet requiring dialysis. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression of the disease or even reverse the course of CKD. The company has initiated a Phase I/II proof-of-concept study of CLBS201 in a moderate to severe CKDpopulation.

Moderate and Severe Chronic Kidney Disease: Therapeutic Assessment

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

Major Players in Moderate and Severe Chronic Kidney Disease

There are approx. 50+ key companies which are developing the therapies for Moderate and Severe Chronic Kidney Disease. The companies which have their Moderate and Severe Chronic Kidney Disease drug candidates in the most advanced stage, i.e. preregistration include, Reata Pharmaceuticals.

Phases

This report covers around 50+ 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

Moderate and Severe 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

• Intravenous
• Oral
• Parenteral
• Subcutaneous

Molecule Type

Products have been categorized under various Molecule types such as

• Antibody
• Cell therapy
• Enzyme
• Gene therapy
• Peptide
• Recombinant proteins
• Small Molecule

Product Type

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

Moderate and Severe 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 Moderate and Severe 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 Moderate and Severe Chronic Kidney Disease drugs.

Moderate and Severe Chronic Kidney Disease Report Insights

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

Moderate and Severe 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 Moderate and Severe Chronic Kidney Disease drugs?
• How many Moderate and Severe 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 Moderate and Severe Chronic Kidney Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Moderate and Severe 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 Moderate and Severe Chronic Kidney Disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Reata Pharmaceuticals
• KBP Biosciences
• Eli Lilly and Company
• Novo Nordisk
• Prokidney
• Boryung Pharmaceutical
• Boehringer Ingelheim
• Cadila Healthcare Limited
• AM-Pharma
• Dia MedicaTherapeutics
• Allena Pharmaceuticals
• AstraZeneca
• Kibow Pharma
• Bayer
• Roche
• Caladrius Biosciences
• Unico CellBiomed
• Pharmicell
• Scohia Pharma
• Unicycive Therapeutics
• Senda Biosciences
• Sarfez Pharmaceuticals
• Rege Nephro
• Orgenesis
• Oisin Biotechnologies

Key Products

• Bardoxolone methyl
• KBP-5074
• Dulaglutide
• Ziltivekimab
• Semaglutide
• Renal Autologous Cell Therapy
• Fimasartan
• Empagliflozin
• Desidustat
• Ilofotase alfa
• DM199
• ALLN-346
• Zibotentan
• Verinurad
• US-APR2020
• Runcaciguat
• Pirfenidone
• BI-685509
• Cotadutide
• AZD9977
• AZD5718
• CLBS201
• ELIXCYTE
• MEDI8367
• Cellgram-CKD
• AZD8233
• BI 764198

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