Moderate and Severe Chronic Kidney Disease Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight

(Albany, USA) DelveInsight's "Moderate and Severe Chronic Kidney Disease Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Moderate and Severe Chronic Kidney Disease market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

The moderate and severe chronic kidney disease market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as Novo Nordisk, Prokidney, Boryung Pharmaceutical, Boehringer Ingelheim, Cadila Healthcare Limited, and AM-Pharma. These industry pioneers are transforming treatment strategies and redefining the future of Moderate and Severe Chronic Kidney Disease, bringing new hope to patients worldwide.

For emerging moderate and severe chronic kidney disease drugs, the Moderate and Severe Chronic Kidney Disease pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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Key Takeaways from the Moderate and Severe Chronic Kidney Disease Pipeline Report
• DelveInsight's moderate and severe chronic kidney disease pipeline analysis depicts a robust space with 50+ active players working to develop 50+ pipeline drugs for Moderate and Severe Chronic Kidney Disease treatment.
• The leading moderate and severe chronic kidney disease companies include Reata Pharmaceuticals, KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical, Boehringer Ingelheim, Cadila Healthcare Limited, AM-Pharma, DiaMedica Therapeutics, Allena Pharmaceuticals, AstraZeneca, Kibow Pharma, Bayer, Roche, Caladrius Biosciences, UnicoCell Biomed, Pharmicell, Scohia Pharma, Unicycive Therapeutics, Senda Biosciences, Sarfez Pharmaceuticals, Rege Nephro, Orgenesis, Oisin Biotechnologies, and others are evaluating their lead assets to improve the Moderate and Severe Chronic Kidney Disease treatment landscape.
• Key moderate and severe chronic kidney disease pipeline therapies in various stages of development include 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, and others.
• In March 2025, Nasdaq-listed scPharmaceuticals received FDA approval for a supplemental new drug application (sNDA) for FUROSCIX (furosemide injection). This approval expands the drug's use to treat edema in patients with chronic kidney disease, marking a significant advancement in scPharmaceuticals' portfolio for cardiorenal conditions.
• In March 2025, the FDA approved an expanded indication for furosemide injection (Furoscix; scPharmaceuticals, Inc.) to treat edema in adult patients with chronic kidney disease, including nephrotic syndrome. The expanded treatment is expected to be available by April 2025. This approval follows the FDA's acceptance of the supplemental new drug application in July 2024.
• In November 2024, Unicycive Therapeutics (Nasdaq: UNCY) announced that the FDA has accepted its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), with a PDUFA target action date of June 28, 2025. If approved, OLC could significantly improve treatment for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.

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Moderate and Severe Chronic Kidney Disease Overview
Chronic Kidney Disease (CKD) occurs when the kidneys are damaged and can no longer effectively filter waste and excess fluid from the blood. This buildup can lead to serious complications, including heart disease and stroke. CKD progresses gradually and varies in severity, but timely treatment can help slow its progression. Without intervention, it may lead to kidney failure and early cardiovascular problems. In the early stages (1 to 3), many patients may not notice any symptoms and are often diagnosed through an eGFR test. As the disease advances to stage 4 or beyond, symptoms such as fatigue, low energy, and a general feeling of being unwell become more apparent.

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Moderate and Severe Chronic Kidney Disease Treatment Analysis: Drug Profile
Bardoxolone methyl: Reata Pharmaceuticals
Bardoxolone methyl is an Nrf2 activator under clinical investigation for various forms of chronic kidney disease (CKD). Kidney inflammation caused by conditions such as diabetes, hypertension, IgA deposition, and genetic mutations contributes to declining glomerular filtration rate (GFR). Bardoxolone targets these pro-inflammatory pathways to preserve kidney function. In March 2022, Reata Pharmaceuticals submitted a New Drug Application (NDA) to the FDA, supported by results from the Phase III CARDINAL trial. The trial demonstrated that bardoxolone significantly improved GFR compared to placebo, with a favorable safety profile marked by mostly mild to moderate adverse events.

KBP-5074: KBP Biosciences
KBP-5074, developed by KBP Biosciences, is a next-generation, non-steroidal mineralocorticoid receptor antagonist (MRA) in development for Stage 3b/4 CKD patients with uncontrolled hypertension. It binds selectively to mineralocorticoid receptors with minimal activity at other hormone receptors, potentially reducing endocrine side effects. Clinical trials have shown KBP-5074 effectively lowers blood pressure without androgenic side effects like hirsutism, obesity, or gynecomastia. The drug is currently in Phase III development for treating moderate-to-severe CKD with uncontrolled hypertension.

Key Moderate and Severe Chronic Kidney Disease Therapies and Companies
• Bardoxolone methyl: Reata Pharmaceuticals
• KBP-5074: KBP Biosciences
• Ziltivekimab: Novo Nordisk
• CLBS201: Caladrius Biosciences
• Renal Autologous Cell Therapy (REACT): ProKidney
• Bardoxolone methyl: Reata Pharmaceuticals, Inc.
• Ziltivekimab/Semaglutide: Novo Nordisk A/S
• JARDIANCE (empagliflozin): Boehringer Ingelheim/Eli Lilly and Company
• KBP-5074: KBP Biosciences
• KT-301: Kibow Pharma
• CIN-107 (Baxdrostat): Cincor Pharma
• Zibotentan: AstraZeneca
• ALLN-346: Allena Pharmaceuticals
• DM199: DiaMedica Therapeutics Inc
• Sotagliflozin: Lexicon Pharmaceuticals/Sanofi

Learn more about the novel and emerging moderate and severe chronic kidney disease pipeline therapies @ https://www.delveinsight.com/report-store/moderate-and-severe-chronic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Moderate and Severe Chronic Kidney Disease Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Intravenous
• Oral
• Parenteral
• Subcutaneous

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

Scope of the Moderate and Severe Chronic Kidney Disease Pipeline Report
• Coverage: Global
• Key Moderate and Severe Chronic Kidney Disease Companies: Reata Pharmaceuticals, KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical, Boehringer Ingelheim, Cadila Healthcare Limited, AM-Pharma, DiaMedica Therapeutics, Allena Pharmaceuticals, AstraZeneca, Kibow Pharma, Bayer, Roche, Caladrius Biosciences, UnicoCell Biomed, Pharmicell, Scohia Pharma, Unicycive Therapeutics, Senda Biosciences, Sarfez Pharmaceuticals, Rege Nephro, Orgenesis, Oisin Biotechnologies, and others.
• Key Moderate and Severe Chronic Kidney Disease Pipeline Therapies: 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, and others.

Dive deep into rich insights for drugs used for moderate and severe chronic kidney disease treatment; visit @ https://www.delveinsight.com/report-store/moderate-and-severe-chronic-kidney-disease-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Table of Contents
1. Introduction
2. Executive Summary
3. Moderate and Severe Chronic Kidney Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Moderate and Severe Chronic Kidney Disease Pipeline Therapeutics
6. Moderate and Severe Chronic Kidney Disease Pipeline: Late-Stage Products (Phase III)
7. Moderate and Severe Chronic Kidney Disease Pipeline: Late-Stage Products (Phase III)
8. Moderate and Severe Chronic Kidney Disease Pipeline: Mid-Stage Products (Phase II)
9. Moderate and Severe Chronic Kidney Disease Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
https://www.delveinsight.com/ats-conference-coverage

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.