Novo Nordisk’s OZEMPIC Approval Heat Up the Chronic Kidney Disease Therapeutic Market | DelveInsight

GlobeNewswire On February 19, 2025 23:00 IST

The FDA’s recent approval of OZEMPIC highlights the expanding use of GLP-1 drugs beyond diabetes and weight management. Novo Nordisk’s blockbuster medication has gained another label expansion, now authorized for treating chronic kidney disease.

New York, USA, Feb. 19, 2025 (GLOBE NEWSWIRE) — Novo Nordisk’s OZEMPIC Approval Heat Up the Chronic Kidney Disease Therapeutic Market | DelveInsight

Chronic kidney disease (CKD) is a long-term condition marked by structural or functional kidney impairments lasting more than three months, reducing the kidneys’ ability to filter blood efficiently. It is categorized into five stages, with worsening severity potentially resulting in kidney failure (Stage 5) and an elevated risk of cardiovascular complications. If left untreated, CKD can advance to End-stage Renal Disease (ESRD), often requiring dialysis or a kidney transplant.

As per DelveInsight analysis, in 2023, approximately 82 million prevalent cases of CKD and nearly 14 million total diagnosed prevalent cases of CKD were diagnosed in the 7MM. These cases are projected to increase further during the forecast period (2025-2034), due to the increasing geriatric population. In 2023, the US accounted for the highest number of diagnosed prevalent cases of CKD among the 7MM, representing approximately 26% of the total diagnosed prevalent cases of CKD.

The treatment landscape for CKD comprises various pharmacological therapies designed to manage complications and slow disease progression, though no existing medications can reverse the condition. The CKD treatment market is segmented by drug class, including Erythropoietin Stimulating Agents (ESAs), Angiotensin-Converting Enzyme Inhibitors (ACE-Is), Angiotensin Receptor Blockers (ARBs), antidiabetic medications, treatments for Secondary Hyperparathyroidism (SHPT), and urate-lowering therapies.

Several FDA-approved medications play a crucial role in CKD treatment, each offering distinct benefits. FARXIGA (dapagliflozin) and INVOKANA (canagliflozin), both SGLT2 inhibitors, help slow kidney disease progression in adults with or without type 2 diabetes by enhancing urinary glucose excretion through the inhibition of glucose reabsorption. KERENDIA (finerenone), a nonsteroidal mineralocorticoid receptor antagonist (MRA), is approved to lower the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular complications in CKD patients with type 2 diabetes. These treatments reflect an advancing, targeted strategy for CKD management, addressing both renal and cardiovascular health.

Learn more about the CKD treatment landscape @ Drugs for Chronic Kidney Disease Treatment

Recently in January 2025, the FDA approved Novo Nordisk’s OZEMPIC for chronic kidney disease. The approval of OZEMPIC for chronic kidney disease marks a significant milestone, making it the first GLP-1 receptor agonist indicated for this condition and the most broadly approved drug in its class. Originally authorized in 2017 for glycemic control in type 2 diabetes, OZEMPIC received FDA approval in 2020 to lower the risk of major cardiovascular events in adults with T2D and established heart disease. Its active ingredient, semaglutide, later expanded into weight management under the brand WEGOVY in 2021, which also gained approval last year for reducing cardiovascular risk.

OZEMPIC, available in 0.5 mg, 1 mg, and 2 mg doses, is an injectable prescription medication designed to improve blood sugar control in adults with type 2 diabetes when combined with diet and exercise. Additionally, it helps lower the risk of serious cardiovascular events—such as heart attack, stroke, or death—in adults with T2D and existing heart disease. The drug also slows the progression of kidney disease, reduces the likelihood of kidney failure (end-stage kidney disease), and decreases the risk of death from cardiovascular disease in adults with T2D and CKD. Its safety and effectiveness in children remain unverified.

This FDA approval is backed by the results of the FLOW phase IIIb kidney trial, which assessed the effects of once-weekly OZEMPIC injections on kidney and cardiovascular outcomes in adults with T2D and CKD. The study met its primary objective, demonstrating that a 1 mg dose of OZEMPIC reduced the relative risk of kidney disease progression, kidney failure, and cardiovascular-related death by 24% (with an absolute risk reduction of 4.9% over three years) compared to a placebo, alongside standard care.

To know more about CKD treatment options, visit @ New Treatment for Chronic Kidney Disease

The treatment pipeline for CKD features several promising therapies, including ziltivekimab (Novo Nordisk), zibotentan/dapagliflozin (AstraZeneca), Vicadrostat (BI 690517) + Empagliflozin (Boehringer Ingelheim), Lorundrostat (Mineralys Therapeutics), and others, are currently in advanced development stages. These emerging therapies have the potential to enhance treatment outcomes significantly and fill existing gaps in patient care.

Discover which therapies are expected to grab major CKD market share @ Chronic Kidney Disease Market Report

Ziltivekimab is a fully human monoclonal antibody designed to inhibit IL-6, reducing systemic inflammation linked to atherosclerosis. With an extended half-life, it allows for once-monthly subcutaneous dosing. Currently, in Phase III trials for patients with chronic kidney disease, Ziltivekimab became part of Novo Nordisk’s portfolio after the company acquired Corvidia Therapeutics in June 2020 for USD 2.1 billion. As part of the deal, Novo Nordisk paid USD 725 million upfront, gaining access to Corvidia’s lead candidate and strengthening its cardio-renal therapy pipeline.

Zibotentan, a potent endothelin A receptor antagonist, is being combined with dapagliflozin, a powerful SGLT2 inhibitor, to form a synergistic treatment for CKD with high proteinuria. This combination is designed to enhance kidney protection, lower proteinuria levels, and offer cardiovascular benefits by targeting key disease mechanisms, potentially reducing mortality and delaying the progression to ESKD. Currently in Phase III trials, the therapy showed promising outcomes at ASN 2023, with Phase IIb data revealing a significant reduction in albuminuria compared to dapagliflozin alone, further supporting its continued development for CKD patients with high proteinuria. These findings were simultaneously published in The Lancet.

BI 690517, developed by Boehringer Ingelheim, is an innovative and highly selective aldosterone synthase inhibitor (ASi) aimed at slowing kidney damage progression and lowering cardiovascular risks in CKD patients. Currently undergoing evaluation in the Phase III EASi-KIDNEY trial, it is being tested alongside empagliflozin, an SGLT2 inhibitor, to enhance renal protection. In November 2023, Boehringer Ingelheim presented promising Phase II results at ASN Kidney Week, highlighting BI 690517 as a potentially significant treatment for CKD. The drug received Fast Track Designation from the US FDA in October 2022.

Discover more about drugs for CKD in development @ Chronic Kidney Disease Clinical Trials

The anticipated launch of these emerging therapies for CKD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the CKD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for CKD in the 7MM is expected to grow from USD 4.6 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by the launch of emerging therapies during the forecast period (2025–2034).

DelveInsight’s latest published market report titled as Chronic Kidney Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the CKD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential. The CKD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

Total Prevalent Cases of CKD
Total Diagnosed Prevalent Cases of CKD
Gender-specific Diagnosed Prevalent Cases of CKD
Age-specific Diagnosed Prevalent Cases of CKD
Stage-specific Diagnosed Prevalent Cases of CKD
Complication-specific Diagnosed Prevalent Cases of CKD
Etiology-specific Diagnosed Prevalent Cases of CKD

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM CKD market. Highlights include:

10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert’s Opinion
Access and Reimbursement

Download this CKD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs’ opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the CKD market. Also, stay abreast of the mitigating factors to improve your market position in the CKD therapeutic space.

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