만성 신장 질환 : 경쟁 구도 및 임상시험 분석(2026년)

DelveInsight's, "Chronic Kidney Disease - Competitive Landscape and Clinical Trial Analysis, 2026," report provides comprehensive insights about 90+ companies and 100+ drugs in Chronic Kidney Disease Competitive landscape. It 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 (CKD) is a long-term and progressive disorder characterized by persistent impairment of kidney structure or function. It is associated with a gradual reduction in the ability of the kidneys to remove metabolic waste, regulate fluid and electrolyte balance, and maintain overall physiological homeostasis. Research from the Global Burden of Disease (GBD) Study has demonstrated that CKD represents a substantial and growing global health burden, with diabetic kidney disease accounting for a major proportion of CKD-related disability. The increasing prevalence of diabetes, hypertension, obesity, and ageing populations continues to contribute significantly to the rising burden of CKD worldwide.

CKD often develops silently, particularly during its early stages, and may remain undiagnosed until substantial loss of kidney function has occurred. Progressive CKD is associated with several important complications, including cardiovascular disease, anemia, mineral and bone disorders, electrolyte abnormalities, and fluid overload. As kidney function declines further, patients may progress to kidney failure and require kidney replacement therapy, such as dialysis or kidney transplantation. Research has also highlighted considerable disparities in CKD burden and access to kidney care across countries and regions, emphasizing the need for improved early detection and healthcare strategies.

The management of CKD focuses on identifying the underlying cause, slowing disease progression, reducing cardiovascular risk, and managing associated complications. Evidence-based strategies include effective control of blood pressure and diabetes, reduction of albuminuria, and the use of kidney-protective pharmacological therapies where clinically appropriate. Early diagnosis is particularly important because timely intervention can delay disease progression and potentially reduce the need for dialysis or transplantation. Consequently, recent research increasingly emphasizes population-level prevention, screening of high-risk individuals, and equitable access to effective CKD care as essential components of addressing the growing global burden of the disease.

Report Highlights:

• In August 2026, Vertex Pharmaceuticals announced the completion of patient enrollment in AGLOW, a Phase 2 proof-of-concept clinical study evaluating VX-407 for Autosomal Dominant Polycystic Kidney Disease (ADPKD).
• In July 2026, Arnatar Therapeutics announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) cleared its clinical trial application for ART5, a first-in-class up-regulating antisense oligonucleotide (ASO) designed to restore polycystin-1 production for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The Company expects to initiate a first-in-human single ascending dose study in healthy volunteers in the third quarter of 2026, followed by a Phase Ib study in patients with ADPKD in the first half of 2027.
• In June 2026, SCYNEXIS, Inc. announced the initiation of a Phase I study of SCY-770, a first-in-class, potent and direct AMP-activated protein kinase (AMPK) activator being developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The study will evaluate the pharmacokinetics and food effect of two dosing regimens to support dose selection for a planned Phase II proof-of-concept study in patients with ADPKD.
• In June 2026, Rege Nephro Co., Ltd. announced the completion of a first-close fundraising of USD 7.6 million (JPY 1.22 billion), with the financing expected to reach USD 10.6 million following the final second close. The proceeds will support the commercialization and global licensing activities of RN-014, a small-molecule therapy for autosomal dominant polycystic kidney disease (ADPKD), which has reached the last patient last visit milestone in its Phase IIa clinical trial.
• In June 2026, Unicycive Therapeutics announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The FDA cited deficiencies at a third-party manufacturing facility and did not identify new concerns regarding the drug's safety or efficacy or request additional clinical data.
• In May 2026, Bayer announced that the FDA accepted its supplemental New Drug Application (sNDA) and granted Priority Review to KERENDIA(R) (finerenone) for the treatment of adults with type 1 diabetes and chronic kidney disease (CKD). The application was supported by the Phase III FINE-ONE study, in which finerenone demonstrated an approximately 25% reduction in urine albumin-to-creatinine ratio compared with placebo over six months.
• In March 2026, SCYNEXIS, Inc. announced the acquisition of PXL770 from Poxel SA for a total potential consideration of up to USD 196 million. Under the agreement, Poxel received an upfront payment of USD 8 million, with up to USD 8 million in near-term development milestone payments and up to USD 180 million in commercial milestone payments. SCYNEXIS is developing PXL770, subsequently designated SCY-770, as a potential treatment for autosomal dominant polycystic kidney disease.
• In March 2026, R1 Therapeutics launched with an oversubscribed USD 77.5 million Series A financing round to advance AP306, a first-in-class pan-phosphate transporter inhibitor for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The company secured exclusive rights outside Greater China and planned to initiate mid-stage clinical development of AP306 in 2026.

Chronic Kidney Disease: Company and Product Profiles (Marketed Therapies)

1. Company Overview: AstraZeneca

AstraZeneca is a UK-based global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines across major therapeutic areas, including oncology, cardiovascular, renal and metabolic diseases, respiratory and immunology, and rare diseases. The company has established a significant presence in CKD and cardiorenal disease management through its portfolio of medicines targeting disease progression and associated cardiovascular complications.

Product Description: Farxiga (Dapagliflozin)

Farxiga (dapagliflozin) is an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor developed by AstraZeneca. It selectively inhibits SGLT2 in the proximal renal tubules, reducing sodium and glucose reabsorption and promoting natriuresis and glucosuria. These effects help reduce intraglomerular pressure and provide kidney-protective benefits that can slow CKD progression. Farxiga received US FDA approval for the treatment of CKD on April 30, 2021. It is indicated to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease (ESKD), cardiovascular death, and hospitalization for heart failure in adults with CKD at risk of disease progression.

2. Company Overview: Boehringer Ingelheim/ Eli Lilly and Company

Boehringer Ingelheim is a Germany-based, research-driven global pharmaceutical company focused on developing innovative therapies across cardiometabolic, renal, respiratory, immunology, oncology, and other therapeutic areas. The company has a strong presence in cardiorenal medicine and has expanded its portfolio to address the interconnected risks of CKD, cardiovascular disease, and metabolic disorders.

Eli Lilly and Company is a US-based global pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines across diabetes, obesity, cardiovascular and renal diseases, oncology, immunology, and neuroscience. The company has a strong presence in cardiometabolic medicine and collaborates with Boehringer Ingelheim on the development and commercialization of Jardiance (empagliflozin), a major therapy within the SGLT2 inhibitor class. Through this collaboration, Eli Lilly has expanded its presence in chronic kidney disease (CKD) by supporting the development of therapies that address kidney disease progression and associated cardiovascular risks.

Product Description: Jardiance (Empagliflozin)

Jardiance (empagliflozin) is an oral SGLT2 inhibitor developed by Boehringer Ingelheim and Eli Lilly. It selectively inhibits SGLT2 in the proximal renal tubules, decreasing renal reabsorption of glucose and sodium and contributing to restoration of tubuloglomerular feedback and reduction of intraglomerular pressure. These effects provide kidney-protective benefits and help slow CKD progression. Jardiance received US FDA approval for its CKD indication on September 22, 2023. It is indicated to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with CKD at risk of progression.

3. Company Overview: Bayer

Bayer is a Germany-based global life sciences company with a major pharmaceutical business focused on developing innovative therapies across cardiovascular and renal diseases, oncology, immunology, and other therapeutic areas. The company has expanded its renal portfolio through targeted therapies designed to address underlying mechanisms contributing to progressive kidney damage and associated cardiovascular complications.

Product Description: Kerendia (Finerenone)

Kerendia (finerenone) is an oral, non-steroidal mineralocorticoid receptor antagonist developed by Bayer. It selectively blocks the mineralocorticoid receptor, reducing receptor overactivation associated with inflammation and fibrosis in the kidneys and cardiovascular system, thereby helping limit progressive kidney damage and cardiorenal complications. Kerendia received US FDA approval on July 9, 2021, for CKD associated with Type 2 diabetes. It is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with Type 2 diabetes.

Chronic Kidney Disease: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Jiangsu Hengrui Pharmaceuticals

Jiangsu Hengrui Pharmaceuticals is a China-based pharmaceutical company focused on the research, development, manufacturing, and commercialization of innovative medicines across multiple therapeutic areas, including oncology, immunology, cardiovascular and metabolic diseases, and other major disease areas. The company has established a broad research and development infrastructure and is expanding its innovative drug portfolio through in-house discovery and clinical development programs. With an increasing focus on novel therapies for chronic diseases, Jiangsu Hengrui Pharmaceuticals continues to advance products addressing significant unmet medical needs in China and international markets.

Product Description: HRS-1780

HRS-1780 is an investigational, selective non-steroidal mineralocorticoid receptor antagonist (MRA) being developed for the treatment of chronic kidney disease (CKD). By selectively blocking mineralocorticoid receptor activation, HRS-1780 is intended to reduce pathological processes associated with CKD progression, including proteinuria and progressive renal function decline. In a Phase II study, HRS-1780 demonstrated a dose-dependent reduction in albuminuria, with placebo-corrected reductions in urinary albumin-to-creatinine ratio (UACR) of 29.9% and 53.5% at Week 13 with the 10 mg and 20 mg doses, respectively. HRS-1780 is currently being evaluated in a multicenter, randomized, double-blind, placebo-controlled Phase III trial in adults with CKD, with the objective of assessing its efficacy and safety in delaying renal function decline when administered alongside standard treatment. A Phase I pharmacokinetic study in subjects with mild and moderate renal impairment also showed no significant differences in the overall pharmacokinetic and safety profiles compared with healthy subjects, supporting its further clinical development in CKD. Currently, the drug is in Phase III stage of its development for CKD.

2. Company Overview: Boehringer Ingelheim

Boehringer Ingelheim is a Germany-based, research-driven global pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines for human and animal health. Its human pharmaceutical business has a strong focus on cardiometabolic and renal diseases, oncology, immunology, respiratory diseases, and mental health. The company has established a significant presence in chronic kidney disease (CKD) and related cardiorenal diseases, with a research strategy focused on addressing disease progression and reducing long-term complications. Through its internal research capabilities and strategic collaborations, Boehringer Ingelheim continues to advance innovative therapies targeting key biological pathways involved in chronic and progressive diseases.

Product Description: Vicadrostat

Vicadrostat (BI 690517) is an investigational, potent, and highly selective aldosterone synthase inhibitor being developed by Boehringer Ingelheim for the treatment of chronic kidney disease (CKD). The therapy is designed to inhibit the production of aldosterone, a hormone implicated in inflammation, fibrosis, and progressive cardiorenal damage. By reducing excessive aldosterone activity, vicadrostat has the potential to address pathways associated with CKD progression and reduce albuminuria. Clinical studies have demonstrated that vicadrostat, including when evaluated in combination with empagliflozin, can reduce urinary albumin-to-creatinine ratio (UACR) in patients with CKD. Vicadrostat is currently being evaluated in the Phase III EASi-KIDNEY(TM) clinical trial, which is assessing its efficacy and safety in combination with empagliflozin in patients with CKD at risk of disease progression, representing an advanced-stage therapeutic approach targeting residual cardiorenal risk.

3. Company Overview: Novo Nordisk

Novo Nordisk is a Denmark-based global healthcare company focused primarily on the discovery, development, and commercialization of innovative therapies for chronic diseases. The company has established a strong presence in diabetes, obesity, cardiovascular disease, and other serious chronic conditions, while continuing to expand its research activities into related therapeutic areas, including chronic kidney disease (CKD). With an extensive global research and development network, Novo Nordisk focuses on developing novel peptide- and hormone-based therapies to address interconnected cardiometabolic and renal diseases. The company leverages its expertise in incretin-based medicines and metabolic disease management to develop treatments targeting major unmet medical needs across global markets.

Product Description: NNC0519-0130

NNC0519-0130 is an investigational once-weekly subcutaneous therapy being developed by Novo Nordisk that targets the GLP-1 receptor (glucagon-like peptide-1 receptor) and the GIP receptor (glucose-dependent insulinotropic polypeptide receptor) as a dual agonist.The candidate is being evaluated in a randomized, placebo- and active-controlled, proof-of-concept and dose-finding Phase II study (NCT06717698), which is assessing its efficacy, safety, and pharmacokinetics, including its potential to reduce kidney damage and improve kidney function. The study compares different doses of NNC0519-0130 with semaglutide 1.0 mg and placebo and is expected to enroll approximately 465 participants.

4. Company Overview: Ingenia Therapeutics

Ingenia Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies targeting vascular and endothelial dysfunction. The company's research platform is centered on the TIE2 signaling pathway, which plays a critical role in maintaining vascular integrity, endothelial stability, and tissue homeostasis. Ingenia Therapeutics is advancing its pipeline across diseases associated with vascular dysfunction and aims to develop novel therapies that address underlying disease mechanisms rather than only managing disease symptoms. Through its TIE2-targeted therapeutic platform, the company is expanding its clinical development activities into nephrology and other areas with significant unmet medical needs.

Product Description: IGT-303

IGT-303 is an investigational, first-in-class TIE2-targeted therapy being developed by Ingenia Therapeutics for the treatment of chronic kidney disease (CKD), including diabetic kidney disease (DKD). The therapy is designed to directly activate the TIE2 signaling pathway, which plays an important role in maintaining endothelial function and vascular integrity. By activating TIE2, IGT-303 aims to address vascular dysfunction and endothelial damage, key pathological processes associated with CKD progression. IGT-303 is currently being evaluated in a Phase I/IIa clinical trial to assess its safety, tolerability, pharmacokinetics, and potential therapeutic effects in patients with CKD, representing a novel disease-modifying approach targeting the vascular component of kidney disease.

5. Company Overview: AstraZeneca

AstraZeneca is a UK-based global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines across major therapeutic areas, including oncology, cardiovascular, renal and metabolic diseases, respiratory and immunology, and rare diseases. The company has established a strong presence in chronic kidney disease (CKD) and related cardiometabolic conditions through a broad research and development portfolio targeting disease progression and associated complications. AstraZeneca continues to expand its pipeline through internally discovered and clinically developed therapies designed to address significant unmet needs across diverse patient populations worldwide.

Product Description: AZD4248

AZD4248 is an investigational small-molecule nicotinamide N-methyltransferase (NNMT) inhibitor being developed by AstraZeneca for cardiorenal disease, including chronic kidney disease (CKD). The candidate is currently being evaluated in a Phase I, first-in-human, randomized, single-blind, placebo-controlled clinical trial (NCT07024823) involving healthy participants and patients with CKD and type 2 diabetes. The study is assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD4248 following single and multiple ascending doses, including multiple-dose evaluation in participants with diabetic kidney disease.

Chronic Kidney Disease Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Chronic Kidney Disease Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Chronic Kidney Disease Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Chronic Kidney Disease Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Chronic Kidney Disease Clinical Trial Assessment

• Clinical Trial Analysis
• Clinical Trial Design Analysis
• Sponsor and Geographical Analysis
• Chronic Kidney Disease Clinical Trial Analysis

The report comprises of comparative assessment of clinical trial analysis (by status, development stage, therapy area, enrolled participants by age, study completion year, end point status).

• Chronic Kidney Disease Clinical Trial Design Analysis

The report comprises of comparative assessment of clinical trial design analysis (by allocation, interventional model, enrolled participants by status, masking).

• Sponsor and Geographical Analysis

The report comprises of comparative assessment of sponsor and geographical analysis (by top sponsors, developmental stage, clinical trials sponsored by countries, therapies by countries).

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 and approved drugs?

Key Players

• Boehringer Ingelheim
• Eli Lilly and Company
• Reata Pharmaceuticals
• Novo Nordisk
• KBP Biosciences
• Prokidney
• Bayer
• Novo Nordisk
• Kibow Pharma
• XORTX Therapeutics
• AstraZeneca
• Roche
• AstraZeneca
• MC2 Therapeutics
• AstraZeneca
• Allena Pharmaceuticals
• Boehringer Ingelheim
• Boehringer Ingelheim
• SCOHIA PHARMA
• DiaMedica Therapeutics
• CinCor Pharma
• Galapagos NV
• Boehringer Ingelheim
• Bayer
• Sentien Biotechnologies, Inc.
• Regeneron Pharmaceuticals
• UnicoCell Biomed
• OccuRx
• Pharmicell
• Lisata Therapeutics
• Bayer
• Ionis Pharmaceuticals
• Merck Sharp & Dohme
• Disc Medicine
• Shandong Suncadia Medicine

Key Products

• Empagliflozin
• Dapagliflozin
• Bardoxolone methyl
• Ziltivekimab
• KBP-5074
• Renal Autologous Cell Therapy
• Finerenone
• Semaglutide
• US-APR2020
• XRx-008
• Zibotentan
• Pirfenidone
• Verinurad
• MC2-25
• AZD9977
• ALLN-346
• BI-685509
• BI 764198
• SCO-792
• DM199
• Baxdrostat
• GLPG2737
• BI 690517
• Runcaciguat
• SBI-101
• REGN5459
• ELIXCYTE
• FT011
• Cellgram-CKD
• CLBS201
• BAY3283142
• ION532
• MK-2060

Table of Contents

Introduction

Executive Summary

Chronic Kidney Disease: Overview

• Introduction
• Causes and Risk Factors
• Stages
• Pathophysiology
• Diagnosis
• Treatment and Management

Chronic Kidney Disease -Analytical Perspective: In-depth Commercial Assessment

• Chronic Kidney Disease Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, and development stage)

Chronic Kidney Disease: Company and Product Profiles (Marketed Therapies)

Boehringer Ingelheim/ Eli Lilly and Company

• Company Overview

Jardiance

• Product Description
• Research and Development Activities
• Product Developmental Activities

Chronic Kidney Disease: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

Jiangsu Hengrui Pharmaceuticals

• Company Overview

HRS-1780

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

Novo Nordisk

• Company Overview

NNC0519-0130

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

AstraZeneca

• Company Overview

AZD4248

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical Stage Products

• Comparative Analysis

Discovery Stage Products

• Comparative Analysis

Unknown Stage Products

• Comparative Analysis

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Clinical Trial Assessment

Clinical Trial Analysis

• Assessment by Status
• Assessment by Status and Phase of development
• Assessment by End Point Status
• Assessment by Enrolled Patients by Age
• Assessment by Study Completion Year

Clinical Trial Design Analysis

• Assessment by Allocation of Clinical Trials
• Assessment by Interventional Model of Clinical Trials
• Assessment by Enrolled Patients by Status
• Assessment by Masking of Clinical Trials

Sponsor and Geographical Analysis

• Assessment by Top Sponsors
• Assessment by Total Trials Sponsored by Countries and Phase
• Assessment by Clinical Therapies by Countries

Inactive Products

• Comparative Analysis

Chronic Kidney Disease- Unmet needs

Chronic Kidney Disease - Market drivers and barriers