Chronic kidney disease is the slow loss of kidney function over time. The kidneys filter wastes and excess fluids from the blood. Advanced chronic kidney disease can cause dangerous levels of fluid, electrolytes, and wastes to build up in the body.

Chronic kidney disease’s main causes are age, diabetes, high blood pressure, heart disease, smoking, obesity, and high cholesterol.

Chronic kidney disease in a severe condition presents with leg swelling, feeling tired, vomiting, loss of appetite, puffiness around the eyes, and dry and itchy skin.

Urine examination, blood tests, imaging tests, and finally kidney biopsies are used to diagnose chronic kidney disease. The screening includes the estimated GFR, serum creatinine levels, and urine albumin-to-creatinine ratio. Kidney ultrasonography, the nuclear medicine MAG3 scan, and dimercaptosuccinic acid scans are suggested to define the underlying pathologic changes of the kidney. A biopsy is recommended to determine the cause of the disease.

Chronic kidney disease is treated depending on the cause and its severity. Treatment aims at reducing the signs and symptoms, reducing complications, and slowing the progression of the disease. Antihypertensive agents are recommended as first-line agents. Anti-cholesteremic agents, anemia treatment including iron supplementation, and calcitrol for vitamin D deficiency are recommended and implemented with lifestyle modifications including weight loss, reduced sodium intake, and reduced protein supplementation.

The pipeline of Chronic kidney Disease treatment market consists of a great variable of drugs. Nuclear Factor Erythroid 2–Related Factor 2 (NRF2) Activators, Calcium-Sensing Receptor (CaSR) Modulators, Protein C Enzyme Activators, Endothelin A Receptor Antagonists, Mineralocorticoid Receptor (MR) Antagonists, and some others are the most highlighted class of this indication. Ongoing research and current trials have the potential to change the market.

More than 75 key players, including pharma giants such as Amgen, AstraZeneca, Bayer, Bristol Myers Squibb Co, Sanofi, and others are working to bring novel therapies that overcome the roadblocks of chronic kidney disease treatment pipeline.

Report Highlights

Global Insight Service’s, “Chronic Kidney Disease – Drug Pipeline Landscape, 2023,” an overview of the Chronic Kidney Disease pipeline drugs. This report covers detailed insights on Chronic Kidney Disease drugs under development, assessment by target, mechanism of action, route of administration and molecule type. Product pipeline by companies, stage of development and key regulatory designations, deals and milestones have been presented to gain insights and thus help industry participants for decision making. Chronic Kidney Disease pipeline report helps gaining insights on drugs which are under development stage of drug development process across globally. Global Insight Services aims to cover all the drug attributes, deals, regulatory milestones and all the upcoming milestones.

Recent Developments

In May 2022, the US Food and Drug Administration (FDA) granted Fast Track Designation to AB002 of Aronora Inc for the treatment of Chronic Kidney Disease.

In July 2021, Reata Pharmaceuticals and Kyowa Kirin has strategic collaboration of Bardoxolone methyl in the treatment of CKD in Japan.

In October 2019, Reata Pharmaceuticals Inc. reacquired the rights of bardoxolone from Abbvie.
In June 2020, CSL Behring acquired biotech company Vitaeris along with its important product candidate Clazakizumab.

In January 2023, AstraZeneca to acquire CinCor Pharma to access global rights to CIN-107, a novel aldosterone synthase inhibitor in development for chronic kidney disease.

Key Products

Bardoxolone methyl is being developed for the treatment of chronic kidney disease. Reata Pharmaceuticals entered into collaboration agreement with Abbott to develop and commercialise bardoxolone methyl for the treatment of chronic kidney disease outside the U.S. Reata Pharmaceuticals and Kyowa Kirin has strategic collaboration of Bardoxolone methyl in the treatment of CKD in Japan. Reata Pharmaceuticals Inc. reacquired the rights of bardoxolone from Abbvie.

Clazakizumab is a humanized recombinant monoclonal antibody targeting interleukin-6 (IL-6) for the potential treatment of chronic kidney disease. The CSL Behring and Vitaeris entered into a strategic partnership in 2017 to expedite the development of clazakizumab with the option for CSL Behring to acquire Vitaeris.

AB002 (E-WE thrombin), is a first-in-class protein C activator enzyme which is under development for the treatment of chronic kidney disease. In May 2022, the US Food and Drug Administration (FDA) granted Fast Track Designation to AB002 of Aronora Inc for the treatment of chronic kidney disease.

DrugsCompanyPhase Molecule TypeMoARoA
Bardoxolone Methyl Reata Pharmaceuticals IncFiling RejectedSmall MoleculeNuclear Factor Erythroid 2–Related Factor 2 (NRF2) ActivatorOral
ParsabivAmgenPhase IIISmall MoleculeCalcium-Sensing Receptor (CaSR) ModulatorIntravenous
AB002Aronora IncPhase IIEnzymeProtein C Enzyme ActivatorIntravenous
SC0062Biocity Biopharmaceutics Co LtdPhase ISmall MoleculeEndothelin A Receptor AntagonistOral

Figure: Number of Drugs for The Treatment of Chronic Kidney Disease Under Each Stage of Development

Methodology

The research process includes extensive secondary research on public domain and other authentic sources carried out to add or update the pipeline products information. The secondary research sources include, but are not limited to company websites, annual reports, financial reports, company pipeline chart, investor presentations and SEC filings, journals and conferences, clinical trials registries.

Scope

The pipeline landscape report consists of pipeline product based on several stages of development ranging from discovery to Pre-Registration. The report provides a review of pipeline therapeutics for Chronic Kidney Disease (Hormonal Disorders) by companies based on information derived from company and industry-specific sources. The pipeline report covers assessment of Chronic Kidney Disease (Hormonal Disorders) therapeutics by mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. Comprehensive profiles of the pipeline products with details such as company overview, development stage; molecule type, target, mechanism of action, route of administration, dosage form, regulatory designations, key deals and key upcoming milestones.

Reasons to Buy

Helps to find and recognize significant therapeutics under development for chronic kidney disease.

Thorough understanding of chronic kidney disease pipeline structure and helps in developing corrective measures for pipeline projects.

Effective R&D strategies can be developed with deep knowledge on competitor information, analysis, and insights.

Plan of collaborations from various industry partners that have role in some or the other stage of drug development like contract manufacturing, co-development, contract research organization and commercialization etc.

Helps to create in-licensing and out-licensing opportunities by identifying prospective partners with attractive projects to expand business potential and scope.

Frequently Asked Questions

• What is Chronic Kidney Disease?
• What are the Causes, Signs and Symptoms of Chronic Kidney Disease?
• How is Chronic Kidney Disease diagnosed?
• What are the most common treatments available for Chronic Kidney Disease?
• How many/which companies are developing Chronic Kidney Disease drugs?
• How many Chronic Kidney Disease drugs are under development by each company and their stage of development?
• How many emerging drugs are in late-stage, mid-stage and early-stage of development for the Chronic Kidney Disease treatment?
• What are the key collaborations, mergers and acquisitions, licensing activities related to the Chronic Kidney Disease therapeutics?
• What are the molecule types, target, mechanism of action and route of administration of emerging drugs under development for the treatment of Chronic Kidney Disease?
• What are the clinical studies available for Chronic Kidney Disease and their status?
• What are the key regulatory designations that have been granted to the treatment emerging drugs?
• What are the key upcoming milestones for Chronic Kidney Disease drugs?

Table of Contents

List of Tables
List of Figures

1. Introduction
1.1 Chronic Kidney Disease – Pipeline Drugs, 2023 – Coverage

2. Disease Overview – Chronic Kidney Disease
2.1 Causes
2.2 Signs and Symptoms
2.3 Diagnosis
2.4 Disease Management

3. Chronic Kidney Disease– Pipeline Drugs Development – Overview
3.1 Comparative Analysis by Stage of Development
3.2 Number of Products under Development by Companies, 2023
3.3 Products under Development by Companies, 2023

4. Assessment of Therapeutics
4.1 Assessment by Target
4.2 Assessment by Mechanism of Action
4.3 Assessment by Molecule Type
4.3 Assessment by Route of Administration

5. Drug Profiles
5.1 Late-Stage Drugs – Filing- Rejected
5.1.1 Bardoxolone methyl
5.2 Clinical Stage Drugs – Phase III
5.2.1 Apixaban
5.2.2 Clazakizumab
5.2.3 Fimasartan
5.2.4 Finerenone
5.2.5 GZ427397
5.2.6 Imlifidase
5.2.7 KBP-5074
5.2.8 Parsabiv
5.2.9 React
5.2.10 Semaglutide
5.2.11 Sodium Zirconium Cyclosilicate
5.2.12 Ziltivekimab
5.3 Clinical Stage Drugs – Phase II
5.3.1 AB002
5.3.2 ALLN-346
5.3.3 Apabetalone
5.3.4 AT-1501
5.3.5 AZD5718
5.3.6 AZD9977 + Dapagliflozin
5.3.7 BAY1213790
5.3.8 BI 685509
5.3.9 BI 690517
5.3.10 BIVV020
5.3.11 CIN-107
5.3.12 Cotadutide
5.3.13 DCR-PHXC
5.3.14 DM199
5.3.15 DMX-200
5.3.16 Elixcyte
5.3.17 Epclusa
5.3.18 Esbriet
5.3.19 Fesomersen
5.3.20 Finerenone + Empagliflozin
5.3.21 FR104
5.3.22 HB-101
5.3.23 Isatuximab
5.3.24 Ixazomib
5.3.25 KT-301
5.3.26 LIS1
5.3.27 MIC-Lx Cell Therapy
5.3.28 MK-2060
5.3.29 REGN5459
5.3.30 Runcaciguat
5.3.31 SCO-792
5.3.32 SEG101
5.3.33 SNF472
5.3.34 TX200-TR101
5.3.35 Verinurad
5.3.36 Zepatier
5.3.37 Zibotentan + Dapagliflozin
5.4 Clinical Stage Drugs – Phase I
5.4.1 AMY-101
5.4.2 Apraglutide
5.4.3 AR882
5.4.4 AZD2373
5.4.5 Aztreonam-Avibactam
5.4.6 Belzutifan
5.4.7 BIV009
5.4.8 BMS-986259
5.4.9 Cellgram-CKD
5.4.10 DAG181
5.4.11 DDO-3055
5.4.12 LSTA201
5.4.13 MEDI8367
5.4.14 Pirfenidone
5.4.15 Plazomicin
5.4.16 PXS-5382
5.4.17 RMC-035
5.4.18 SC0062
5.4.19 Tirzepatide
5.4.20 TUM012
5.5 Early-Stage Drugs – Preclinical
5.5.1 AVX420
5.5.2 AZD4831
5.5.3 CAR Peptide
5.5.4 CKD-349
5.5.5 Drug for Chronic Kidney Disease
5.5.6 Drug for Chronic Kidney Disease
5.5.7 EVs
5.5.8 HLSC-Evs
5.5.9 HR17031
5.5.10 HRS-1780
5.5.11 INV 100
5.5.12 MSCKD
5.5.13 MZ-301
5.5.14 NovRD
5.5.15 NP-251
5.5.16 OB-001
5.5.17 RBT-2
5.5.18 REDX12271
5.5.19 REGEND003
5.5.20 SCO-116
5.5.21 Telomere therapy
5.5.22 Tilvestamab
5.5.23 TPX-200
5.5.24 TXR-1208
5.5.25 TXR-1210
5.5.26 VM507
5.6 Early-Stage Drugs – Discovery
5.6.1 Drug for Chronic Kidney Disease
5.6.2 Drug for Chronic Kidney Disease
5.6.3 Drug for Chronic Kidney Disease
5.6.4 Drug for Chronic Kidney Disease
5.6.5 Drug for Chronic Kidney Disease
5.6.6 JB-101
5.6.7 JB-201
5.6.8 RBr07
5.6.9 SBI-101
5.6.10 TRPC6 Antagonist
5.7 Unknown Stage Drugs
5.7.1 SZ007

6. Key Regulatory Designations

7. Key Deals

8. Key Upcoming Milestones

9. Key Companies Involved
9.1 Algernon Pharmaceuticals Inc
9.2 Algomedix Inc
9.3 Allena Pharmaceuticals
9.4 Amgen
9.5 Amyndas Pharmaceuticals S.A
9.6 Angiotensin Therapeutics Inc
9.7 Aria Pharmaceuticals
9.8 Aronora Inc
9.9 Arthrosi Therapeutics
9.10 AstraZeneca
9.11 Bayer
9.12 Beijing Continent Pharmaceutical Co Ltd
9.13 BERGENBIO
9.14 Biocity Biopharmaceutics Co Ltd
9.15 Boehringer Ingelheim
9.16 Boryung Pharmaceutical Co Ltd
9.17 Bristol-Myers Squibb
9.18 Ceptur Therapeutics Inc
9.19 Chinook Therapeutics Inc
9.20 Chong Kun Dang Pharmaceutical
9.21 CinCor Pharma Inc
9.22 Cipla USA Inc
9.23 Coegin Pharma AS
9.24 CSL Behring
9.25 DiaMedica Therapeutics Inc
9.26 Dicerna Pharmaceuticals Inc
9.27 Dimerix Ltd
9.28 Eledon Pharmaceuticals
9.29 Eli Lilly and Company
9.30 Evotec SE
9.31 Future Medicine Co Ltd
9.32 Genentech Inc
9.33 Gilead Sciences
9.34 Guard Therapeutics AB
9.35 Hansa Biopharma AB
9.36 Helixmith Co Ltd
9.37 Hookipa Biotech GmbH
9.38 ICoat Medical AB
9.39 Invent Pharmaceuticals Inc
9.40 Ionis Pharmaceuticals Inc
9.41 Jiangsu HengRui Medicine Co Ltd
9.42 Junten Bio Co Ltd
9.43 KBP Biosciences
9.44 Kibow Pharma
9.45 Lisata Therapeutics Inc
9.46 Maze Therapeutics Inc
9.47 MedBiome Inc
9.48 Merck Sharp & Dohme LLC
9.49 Novartis
9.50 NovMetaPharma Co Ltd
9.51 Novo Nordisk A/S
9.52 Oisin Biotechnologies
9.53 Orgenesis Inc
9.54 OrthoTrophix Inc
9.55 OSE Immunotherapeutics
9.56 Pfizer
9.57 Pharmaxis Ltd
9.58 Pharmicell Co Ltd
9.59 Prokidney
9.60 RAGE Biotech Pty Ltd
9.61 Reata Pharmaceuticals Inc
9.62 Redx Pharma Plc
9.63 Regeneron Pharmaceuticals
9.64 Renibus Therapeutics Inc
9.65 Resverlogix Corp
9.66 Sangamo Therapeutics
9.67 Sanifit Therapeutics S. A
9.68 Sanofi
9.69 Sarfez Pharmaceuticals Inc
9.70 Scohia Pharma Inc
9.71 Sentien Biotechnologies Inc
9.72 Shandong Suncadia Medicine Co Ltd
9.73 Sunshine Lake Pharma Co Ltd
9.74 Suzhou Regend Therapeutics Co Ltd
9.75 TagCyx Biotechnologies
9.76 Takeda
9.77 TolerogenixX GmbH
9.78 UnicoCell Biomed CO LTD
9.79 Unicyte AG
9.80 Vascular BioSciences
9.81 VectivBio AG
9.82 Xenothera SAS

10. Dormant Drugs
10.1 Inactive Drugs
10.2 Discontinued Drugs

11. Appendix

List of Tables

Table 1.1 Number of Products Under Development for Chronic Kidney Disease
Table 1.2 Number of Products Under Development by Companies
Table 1.3 Products Under Development by Companies
Table 1.4 Products by Targets
Table 1.5 Products by Mechanism of Action
Table 1.6 Products by Molecule Type
Table 1.7 Products by Route of Administration
Table 2.1 Clinical Trial Details – Apixaban/Bristol Myers Squibb Co
Table 2.2 Clinical Trial Details – Clazakizumab/CSL Behring
Table 2.3 Clinical Trial Details – Fimasartan/Boryung Pharmaceutical Co Ltd
Table 2.4 Clinical Trial Details – Finerenone/Bayer
Table 2.5 Clinical Trial Details – GZ427397/Sanofi
Table 2.6 Clinical Trial Details – Imlifidase/Hansa Biopharma AB
Table 2.7 Clinical Trial Details – KBP-5074/KBP Biosciences
Table 2.8 Clinical Trial Details – Parsabiv/Amgen
Table 2.9 Clinical Trial Details – REACT/Prokidney
Table 2.10 Clinical Trial Details – Semaglutide/Novo Nordisk A/S
Table 2.11 Clinical Trial Details – Sodium Zirconium Cyclosilicate/AstraZeneca
Table 2.12 Clinical Trial Details – Ziltivekimab/Novo Nordisk A/S
Table 2.13 Clinical Trial Details – AB002/Aronora Inc
Table 2.14 Clinical Trial Details – ALLN-346/Allena Pharmaceuticals
Table 2.15 Clinical Trial Details – Apabetalone/Resverlogix Corp
Table 2.16 Clinical Trial Details – AT-1501/Eledon Pharmaceuticals
Table 2.17 Clinical Trial Details – AZD5718/AstraZeneca
Table 2.18 Clinical Trial Details – AZD9977 + Dapagliflozin/AstraZeneca
Table 2.19 Clinical Trial Details – BAY1213790/Bayer
Table 2.20 Clinical Trial Details – BI 685509/Boehringer Ingelheim
Table 2.21 Clinical Trial Details – BI 690517/Boehringer Ingelheim
Table 2.22 Clinical Trial Details – BIVV020/Sanofi
Table 2.23 Clinical Trial Details – CIN-107/CinCor Pharma Inc
Table 2.24 Clinical Trial Details – Cotadutide/AstraZeneca
Table 2.25 Clinical Trial Details – DCR-PHXC/Dicerna Pharmaceuticals Inc
Table 2.26 Clinical Trial Details – DM199/DiaMedica Therapeutics Inc
Table 2.27 Clinical Trial Details – ELIXCYTE/UnicoCell Biomed CO LTD
Table 2.28 Clinical Trial Details – Epclusa/Gilead Sciences
Table 2.29 Clinical Trial Details – ESBRIET/Genentech Inc
Table 2.30 Clinical Trial Details – Finerenone + Empagliflozin/Bayer
Table 2.31 Clinical Trial Details – FR104/OSE Immunotherapeutics
Table 2.32 Clinical Trial Details – HB-101 /Hookipa Biotech GmbH
Table 2.33 Clinical Trial Details – Isatuximab/Sanofi
Table 2.34 Clinical Trial Details – Ixazomib/Takeda
Table 2.35 Clinical Trial Details – KT-301/Kibow Pharma
Table 2.36 Clinical Trial Details – LIS1/Xenothera SAS
Table 2.37 Clinical Trial Details – MIC-Lx Cell Therapy/TolerogenixX GmbH
Table 2.38 Clinical Trial Details – MK-2060/Merck Sharp & Dohme LLC
Table 2.39 Clinical Trial Details – REGN5459/Regeneron Pharmaceuticals
Table 2.40 Clinical Trial Details – Runcaciguat/Bayer
Table 2.41 Clinical Trial Details – SEG101/Novartis
Table 2.42 Clinical Trial Details – SNF472/Sanifit Therapeutics S. A
Table 2.43 Clinical Trial Details – TX200-TR101/Sangamo Therapeutics
Table 2.44 Clinical Trial Details – Verinurad/AstraZeneca
Table 2.45 Clinical Trial Details – Zepatier/Merck Sharp & Dohme LLC
Table 2.46 Clinical Trial Details – Zibotentan + Dapagliflozin/AstraZeneca
Table 2.47 Clinical Trial Details – AMY-101/Amyndas Pharmaceuticals S.A
Table 2.48 Clinical Trial Details – Apraglutide/VectivBio AG
Table 2.49 Clinical Trial Details – AR882 /Arthrosi Therapeutics
Table 2.50 Clinical Trial Details – AZD2373/AstraZeneca
Table 2.51 Clinical Trial Details – Aztreonam-Avibactam/Pfizer
Table 2.52 Clinical Trial Details – Belzutifan/Merck Sharp & Dohme LLC
Table 2.53 Clinical Trial Details – BIV009/Sanofi
Table 2.54 Clinical Trial Details – BMS-986259/Bristol-Myers Squibb
Table 2.55 Clinical Trial Details – Cellgram-CKD/Pharmicell Co Ltd
Table 2.56 Clinical Trial Details – DAG181/Sunshine Lake Pharma Co Ltd
Table 2.57 Clinical Trial Details – DDO-3055/Jiangsu HengRui Medicine Co Ltd
Table 2.58 Clinical Trial Details – LSTA201/Lisata Therapeutics Inc
Table 2.59 Clinical Trial Details – Pirfenidone/Beijing Continent Pharmaceutical Co Ltd
Table 2.60 Clinical Trial Details – Plazomicin/Cipla USA Inc
Table 2.61 Clinical Trial Details – SC0062/Biocity Biopharmaceutics Co Ltd
Table 2.62 Clinical Trial Details – Tirzepatide/Eli Lilly and Company
Table 2.63 Clinical Trial Details – CKD-349/Chong Kun Dang Pharmaceutical
Table 2.64 Clinical Trial Details – HR17031/Jiangsu HengRui Medicine Co Ltd
Table 2.65 Clinical Trial Details – HRS-1780/Shandong Suncadia Medicine Co Ltd
Table 3.1 Regulatory Designations
Table 4.1 Inactive Drugs
Table 4.2 Discontinued Drugs

List of Figures

Figure 1.1 Number of Products under Development for Chronic Kidney Disease, 2023
Figure 1.2 Products by Top 5 Targets and Stage of Development for Chronic Kidney Disease, 2023
Figure 1.3 Products by Top 5 Mechanism of Action for Chronic Kidney Disease, 2023
Figure 1.4 Products by Top 5 Molecule Type for Chronic Kidney Disease, 2023
Figure 1.5 Products by Top 5 Route of Administration for Chronic Kidney Disease, 2023

Key Players
Report Segmentation
  • Assessment by Stage of Development
  • Assessment by Companies
  • Assessment by Target
  • Assessment by Mechanism of Action
  • Assessment by Molecule Type
  • Assessment by Route of Administration

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