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Diabetic nephropathy is a serious kidney complication of diabetes that progressively impairs renal function and can lead to end‑stage renal disease. According to Lu Zhang et al., 2025, in 2021, there were an estimated 107.6 million prevalent cases globally. According to the diabetic nephropathy pipeline analysis by Expert Market Research, the pipeline includes novel agents targeting inflammation, fibrosis, and renal protection, alongside established classes like SGLT2 inhibitors and emerging biologics. The growing focus on precision therapies, early intervention, and innovative mechanisms is expected to drive market expansion in the coming years.
Major companies involved in the diabetic nephropathy pipeline analysis include Daewoong Pharmaceutical Co. Ltd., Biocity Biopharmaceutics Co., Ltd., and others.
Leading drugs currently in the pipeline include DWP16001, WAL0921, Dapagliflozin (Forxiga) + SC0062, and others.
The pipeline expansion is driven by the rising development of SGLT2 inhibitors, novel anti-fibrotic agents, and combination therapies. The increased clinical trials and regulatory approvals are expected to accelerate market growth in the coming years.
The Diabetic Nephropathy Pipeline Analysis Report by Expert Market Research gives comprehensive insights into diabetic nephropathy therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for diabetic nephropathy. The diabetic nephropathy report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The diabetic nephropathy pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with diabetic nephropathy treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to diabetic nephropathy.

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Diabetic nephropathy is a chronic kidney disorder that develops due to long-standing diabetes. It causes kidney damage through persistently high blood glucose levels, elevated blood pressure, and protein leakage into the urine. Over time, this condition can lead to decreased kidney function, chronic kidney disease, and potential kidney failure. Early diagnosis and careful management are essential to slow disease progression and prevent severe complications.
Diabetic nephropathy treatments aim to manage blood glucose and blood pressure effectively, using medications such as SGLT2 inhibitors, ACE inhibitors, angiotensin II receptor blockers, and Finerenone to preserve kidney function and slow disease progression. In the drug pipeline, Finerenone, approved in March 2023, shows significant promise by preventing renal fibrosis, reducing kidney function decline, and lowering the risk of heart failure hospitalization in patients with type 2 diabetes-associated kidney disease.
Diabetic nephropathy remains a major global health challenge, fueled by the rising burden of diabetes mellitus. According to Lu Zhang et al., 2025, there were 107.6 million prevalent cases of diabetic nephropathy worldwide in 2021. As per Krishna S. Upadhye et al., 2024, diabetes affects 10.5% of adults aged 20–79 globally, with 537 million cases reported in 2021, projected to reach 643 million by 2030. DKD prevalence varies regionally, affecting 38.8% of diagnosed patients in China, 34.4% in India, and 15.3% of type 2 diabetes patients in Japan. These trends emphasize the urgent need for innovative therapeutic solutions.
This section of the report covers the analysis of diabetic nephropathy drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The diabetic nephropathy pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total diabetic nephropathy clinical trials, with 47%, highlighting strong clinical development and potential near-term approvals. Phase IV follows with 24%, reflecting established treatments driving market stability. Phase I and phase III each hold 13%, supporting innovation and advanced therapy validation. Collectively, these phases demonstrate robust pipeline growth, fostering innovation, expanding treatment options, and positively impacting the diabetic nephropathy landscape.
The drug molecule categories covered under the diabetic nephropathy pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The diabetic nephropathy report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for diabetic nephropathy. Melanocortin receptor agonists are emerging as a novel drug class in the diabetic nephropathy pipeline. For instance, bremelanotide, a selective melanocortin receptor agonist, is under Phase IIb investigation. It has demonstrated reductions in urine protein to creatinine ratio, stabilization of estimated glomerular filtration rate, and improvements in podocyte function, representing a potential disease-modifying therapy for patients with type 2 diabetic nephropathy.
The EMR report for the diabetic nephropathy pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed diabetic nephropathy therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in diabetic nephropathy clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for diabetic nephropathy. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of diabetic nephropathy drug candidates.
DWP16001, also known as enavogliflozin, is a novel selective sodium-glucose cotransporter 2 (SGLT2) inhibitor being developed by Daewoong Pharmaceutical Co., Ltd. This Phase 3 study aims to evaluate the efficacy and safety of DWP16001 in patients with type 2 diabetic nephropathy and moderate renal impairment (CKD stage 3). The study is examining its ability to reduce hyperglycemia through dose-dependent glucosuria while monitoring renal function and overall safety in a randomized, double-blind, placebo-controlled setting. The trial is expected to enroll 348 participants and includes an open-label extension to gather long-term data.
WAL0921 is a first-in-class, humanized monoclonal antibody sponsored by Walden Biosciences, currently undergoing Phase 2 evaluation in patients with glomerular kidney diseases, including diabetic nephropathy. This adaptive, multi-center, randomized, double-blind study is examining the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921. The drug is designed to bind soluble urokinase plasminogen activator receptor (suPAR), inhibiting its pro-inflammatory effects on podocytes, thereby reducing proteinuria and slowing kidney disease progression. Subjects are receiving intravenous infusions every two weeks for seven doses and will be followed for 24 weeks post-treatment.
Dapagliflozin and SC0062 are being evaluated in the ASPIRE-1 Phase 2 trial, sponsored by University Medical Center Groningen. This study is examining the nephroprotective effects of dapagliflozin, a selective SGLT2 inhibitor, in combination with SC0062, a highly selective ETA receptor antagonist. The trial is testing whether this combination mitigates fluid retention and ketogenesis in adults with type 1 diabetes and chronic kidney disease. Participants are randomized to receive SC0062, dapagliflozin, or their combination over 24 weeks to assess safety, efficacy, and complementary mechanisms of action.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Diabetic Nephropathy Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for diabetic nephropathy. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into diabetic nephropathy collaborations, regulatory environments, and potential growth opportunities.
Diabetic Nephropathy Epidemiology Forecast
Diabetes Drugs Market Size, Share and Growth Analysis Report
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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