Chronic Kidney Disease Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Chronic Kidney Disease Pipeline Insight 2025" report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in the Chronic Kidney Disease pipeline landscape. It covers the Chronic Kidney Disease pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Chronic Kidney Disease pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Chronic Kidney Disease Pipeline Report

* In March 2025, Novo Nordisk A/S announced a study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.
* In March 2025, Bayer organized a phase 2b Dose-finding, Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of BAY 3283142 on Top of Standard of Care in Reducing Albuminuria in Patients With Chronic Kidney Disease.
* In March 2025, Shandong Suncadia Medicine Co., Ltd. conducted a phase II Clinical Study of Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in the Treatment of Patients With Chronic Kidney Disease (Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Design).
* In March 2025, Boehringer Ingelheim conducted this study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart disease.
* In March 2025, Novartis Pharmaceuticals announced the ASSIST study is a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).
* DelveInsight's Chronic Kidney Disease pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for Chronic Kidney Disease treatment.
* The leading Chronic Kidney Disease Companies such as 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 and others.
* Promising Chronic Kidney Disease Pipeline Therapies such as roxadustat, Monofer Registered , AZD5718, Dapagliflozin 10 mg, MEDI8367, AST-120 , and others.

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Chronic Kidney Disease Emerging Drugs 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.

* RGLS8429: Regulus Therapeutics

RGLS8429 is a novel, next-generation oligonucleotide for the treatment of ADPKD designed to inhibit miR-17 and to preferentially target the kidney. Administration of RGLS8429 has shown robust data in preclinical models, where clear improvements in kidney function, size, and other measures of disease severity have been demonstrated along with a superior pharmacologic profile in preclinical studies compared to Regulus' first-generation compound. Currently, the drug is in Phase I for the treatment of Chronic Kidney Disease.

The Chronic Kidney Disease Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Chronic Kidney Disease with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Chronic Kidney Disease Treatment.
* Chronic Kidney Disease Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Chronic Kidney Disease Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Chronic Kidney Disease market

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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 and others.

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

Chronic Kidney Disease Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Scope of the Chronic Kidney Disease Pipeline Report

* Coverage- Global
* 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 and others.
* Chronic Kidney Disease Pipeline Therapies- Roxadustat, Monofer Registered , AZD5718, Dapagliflozin 10 mg, MEDI8367, AST-120 , and others.
* Chronic Kidney Disease Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Chronic Kidney Disease Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Chronic Kidney Disease Pipeline on our website @ Chronic Kidney Disease Emerging Drugs and Companies [https://www.delveinsight.com/sample-request/chronic-kidney-disease-ckd-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Content

* Introduction
* Executive Summary
* Chronic Kidney Disease: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Chronic Kidney Disease- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Baxdrostat : AstraZeneca
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* BI-685509: Boehringer Ingelheim
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* RGLS8429: Regulus Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Chronic Kidney Disease Key Companies
* Chronic Kidney Disease Key Products
* Chronic Kidney Disease- Unmet Needs
* Chronic Kidney Disease- Market Drivers and Barriers
* Chronic Kidney Disease- Future Perspectives and Conclusion
* Chronic Kidney Disease Analyst Views
* Chronic Kidney Disease Key Companies
* Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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