Top six 2025 nephrology drug approvals

In 2025, the United States Food and Drug Administration (FDA) approved six medications across four indications for renal disorders, including medications for primary immunoglobulin A nephropathy, lupus nephritis, C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis, and chronic kidney disease progression.

“2025 has been a landmark year for kidney disease therapeutics, marked by a comprehensive slate of FDA approvals covering endothelin-receptor blockade, complement inhibition, GLP-1-based metabolic protection, and B-cell-directed therapy,” Prakash Gudsoorkar, MD, associate professor of clinical medicine at the University of Cincinnati College of Medicine and staff nephrologist at UC Health, recently told MedCentral.

Gudsoorkar said these advances highlight three major themes: “First, the expansion of first-in-disease treatments for rare glomerulopathies; rapid growth in precision, mechanism-targeted therapeutics; and an increasing reliance on surrogate outcomes, such as proteinuria and histologic clearance, to support accelerated approvals for high-risk kidney diseases with limited existing options,” he said.

In January 2025, the FDA expanded the indication of Ozempic (semaglutide) for adults with type 2 diabetes and chronic kidney disease (CKD) to reduce the risk of worsening kidney disease and cardiovascular death.

“Semaglutide continues to expand its role beyond glycemic control. Data demonstrating reductions in albuminuria and slowed decline in kidney function have solidified its place in the management of diabetic CKD,” said Gudsoorkar. “Its cardiovascular and metabolic benefits complement foundational therapies, such as RAS inhibition and SGLT2 inhibitors, making it increasingly central to multidisciplinary strategies to mitigate CKD risk.”

A notable approval in October was Gazyva (obinutuzumab), the first anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis.

“Obinutuzumab has gained heightened importance in 2025, as additional Phase 3 evidence supports its use in proliferative lupus nephritis,” said Gudsoorkar. “Improved B-cell depletion relative to rituximab positions it as a promising option for high-risk or treatment-resistant LN. Its emergence reflects the broader movement toward targeted B-cell modulation as part of combination-based strategies to improve long-term renal survival."

Gudsoorkar noted the nephrology pipeline is poised for further expansion in 2026.

Read the full MedCentral article.

Featured image at top: lIlustration that highlights kidneys in the body's midsection. Photo/iStock/peterschreiber.media.