Chronic Kidney Disease Drugs Market, By Drug Class (ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), B-Blockers, Calcium Channel Blockers, Loop Diuretics, Erythropoiesis-Stimulating Agents (ESAs), Phosphate Binders, Others), By Route of Administration (Oral and Parentral), By Indication (Diabetic Nephropathy, Glomerulonephritis, Hypertensive Nephropathy, Polycystic Kidney Disease, Other Indications), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies , Online Pharmacies), By Geography (North America, Latin America, Asia Pacific, Europe, Middle East, and Africa)
On August 8, 2024, Novartis announced that the FDA had granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor, for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Fabhalta targets the alternative complement pathway, which is implicated in IgAN when overactivated in the kidneys.
In July 2024, Ardelyx, Inc., in partnership with the American Association of Kidney Patients and the National Minority Quality Forum, had filed a lawsuit against the U.S. Department of Health and Human Services and CMS. The lawsuit challenges CMS’s plan to include XPHOZAH (tenapanor) and other oral phosphate-lowering therapies in the end-stage renal disease prospective payment system, arguing it will adversely affect patient access to these crucial medications.
In July 2024, Renalys Pharma initiated its Phase III clinical trial for sparsentan in Japan, targeting IgA nephropathy. The trial, which is a multicenter, open-label study involving around 30 Japanese patients, aims to confirm the drug's efficacy and safety. Results are anticipated in the second half of 2025, supporting a potential approval submission to the Pharmaceuticals and Medical Devices Agency (PMDA).
In June 2024,FibroGen, Inc. announced that the FDA had cleared its Investigational New Drug (IND) application for FG-3165, a monoclonal antibody targeting galectin-9 (Gal9) for treating solid tumors with high Gal9 expression. CEO Thane Wettig highlighted the milestone as a key step in advancing their oncology pipeline. FG-3165 has shown anti-tumor activity and good safety in preclinical studies.