Chronic Kidney Disease Clinical Trial Pipeline | 75+ Companies Pioneering the Future of Treatment

Major pharmaceutical companies are working to advance the pipeline space and unlock the future growth potential of the Chronic Kidney Disease treatment landscape.

DelveInsight's 'Chronic Kidney Disease Pipeline Insight 2024' report provides comprehensive global coverage of pipeline Chronic Kidney Disease therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Chronic Kidney Disease pipeline domain.

For Chronic Kidney Disease emerging drugs, the 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.

Key Takeaways from the Chronic Kidney Disease Pipeline Report
• DelveInsight's Chronic Kidney Disease Pipeline analysis depicts a robust space with 75+ active players working to develop 80+ pipeline drugs for Chronic Kidney Disease treatment.
• The leading Chronic Kidney Disease companies include AstraZeneca, Eli Lilly and Company, Shandong Suncadia Medicine, Boehringer Ingelheim, AdAlta, Alebund Pharmaceuticals, SCOHIA PHARMA, DiaMedica Therapeutics, Roche, MC2 Therapeutics, Allena Pharmaceuticals, Regulus Therapeutics, UnicoCell Biomed, Regeneron Pharmaceuticals, ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, KBP Biosciences, Kibow Pharma, Cincor Pharma, Lexicon Pharmaceuticals, Sanofi, and others are evaluating their lead assets to improve the Chronic Kidney Disease treatment landscape.
• Key Chronic Kidney Disease pipeline therapies in various stages of development include Renal Autologous Cell Therapy, Bardoxolone methyl, Ziltivekimab, Semaglutide, JARDIANCE, KBP-5074, KT-301, CIN-107, Zibotentan, ALLN-346, DM199, DM199, and others.
• In January 2025, the FDA approved a new indication for semaglutide to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, according to Novo Nordisk.
• On November 11, 2024, Unicycive Therapeutics announced that the U.S. 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 patients on dialysis.

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Chronic Kidney Disease Overview
Chronic Kidney Disease (CKD) is a progressive condition in which the kidneys become damaged and lose their ability to effectively filter blood. As a result, excess fluid and waste accumulate in the body, increasing the risk of serious health complications such as heart disease and stroke. CKD varies in severity, typically worsening over time. While there is no cure, timely treatment can slow its progression. If left unmanaged, CKD can lead to kidney failure and an increased risk of cardiovascular disease.

In its early stages (Stages 1-3), CKD often goes unnoticed, as many patients experience no symptoms. It is usually detected through estimated glomerular filtration rate (eGFR) tests before any noticeable signs develop. Symptoms generally emerge in more advanced stages (Stage 4 or beyond) and may include fatigue, low energy levels, and an overall sense of feeling unwell.

CKD occurs due to a gradual decline in kidney function, resulting in damage to the kidneys. As the disease progresses, the remaining functional glomeruli adapt and compensate to maintain normal kidney function for as long as possible. However, this adaptation leads to increased pressure and hyperfiltration, triggering the release of cytokines and growth factors, which cause hypertrophy and hyperplasia. Over time, the excessive strain on the glomeruli results in increased permeability and proteinuria, with elevated protein levels in the proximal tubules further exacerbating kidney damage.

Since CKD often presents no symptoms in its early stages, routine testing is essential for early detection. Blood and urine tests are commonly used to assess kidney function, measuring levels of compounds such as GFR and protein, which indicate kidney impairment. Higher values in these tests typically suggest more severe CKD.

While CKD has no definitive cure, various treatments can help manage symptoms and slow disease progression. The treatment approach depends on the disease stage and focuses on preserving kidney function. Medications can help control underlying conditions contributing to CKD, such as diabetes, high blood pressure, high cholesterol, and anemia. Kidney transplant recipients, who represent a subset of CKD patients, remain at high risk of disease progression and require careful management. Although advances in immunosuppressive therapies have improved transplant outcomes, long-term graft survival and patient prognosis remain key challenges.

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Chronic Kidney Disease Treatment Analysis: Drug Profile
Baxdrostat : AstraZeneca
Baxdrostat, a highly potent inhibitor of aldosterone synthase, exhibits greater selectivity for aldosterone synthase compared to existing ASIs. Initial studies in cynomolgus monkeys demonstrated its ability to decrease aldosterone production, prompting further investigation in humans. The mechanism of action of baxdrostat involves inhibiting the enzyme aldosterone synthase, which is responsible for the final step in aldosterone biosynthesis. By selectively blocking this enzyme, baxdrostat reduces aldosterone levels, leading to decreased sodium reabsorption and fluid retention, ultimately lowering blood pressure. The drug is currently being evaluated in the Phase III stage of development for the treatment of patients with CKD.

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 the Phase III stage of development to treat patients with moderate to severe chronic kidney disease.

BI-685509: Boehringer Ingelheim
BI 685509 is a novel small soluble guanylate cyclase (sGC) molecule activator that exhibits an in vitro profile consistent with that of an sGC activator. BI 685509 reduced proteinuria and glomerulosclerosis in the ZSF1 rat, a model of diabetic kidney disease (DKD), and reduced tubulointerstitial fibrosis in a 7-day unilateral ureteral obstruction model in rats. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of Chronic Kidney Disease.

PXL770: Poxel SA
PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). Currently, the drug is in the Phase I stage of Clinical trial evaluation for the treatment of Autosomal Dominant Polycystic Kidney Disease.

Key Chronic Kidney Disease Therapies and Companies
• Baxdrostat : AstraZeneca
• Ziltivekimab: Novo Nordisk
• BI-685509: Boehringer Ingelheim
• PXL770: Poxel SA
• Renal Autologous Cell Therapy (REACT): ProKidney
• Bardoxolone methyl: Reata Pharmaceuticals, Inc.
• Ziltivekimab: Novo Nordisk A/S
• 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

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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
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Chronic Kidney Disease Pipeline Report
• Coverage: Global
• Key Chronic Kidney Disease Companies: AstraZeneca, Eli Lilly and Company, Shandong Suncadia Medicine, Boehringer Ingelheim, AdAlta, Alebund Pharmaceuticals, SCOHIA PHARMA, DiaMedica Therapeutics, Roche, MC2 Therapeutics, Allena Pharmaceuticals, Regulus Therapeutics, UnicoCell Biomed, Regeneron Pharmaceuticals, ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, KBP Biosciences, Kibow Pharma, Cincor Pharma, Lexicon Pharmaceuticals, Sanofi, and others.
• Key Chronic Kidney Disease Pipeline Therapies: Renal Autologous Cell Therapy, Bardoxolone methyl, Ziltivekimab, Semaglutide, JARDIANCE, KBP-5074, KT-301, CIN-107, Zibotentan, ALLN-346, DM199, DM199, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Chronic Kidney Disease Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Chronic Kidney Disease Pipeline Therapeutics
6. Chronic Kidney Disease Pipeline: Late-Stage Products (Phase III)
7. Chronic Kidney Disease Pipeline: Late-Stage Products (Phase III)
8. Chronic Kidney Disease Pipeline: Mid-Stage Products (Phase II)
9. 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

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This release was published on openPR.