6 Nephrology Headlines You Missed in September 2025

September 2025 delivered several notable updates in nephrology, spanning US Food and Drug Administration (FDA) news, new clinical guidelines for immunoglobulin A nephropathy (IgAN) and immunoglobulin A vasculitis (IgAV) management, and research on hypertensive kidney disease trends over the past 25 years.

In the past month, the FDA removed an advisory committee requirement for the supplemental New Drug Application (sNDA) for sparsentan (Filspari) in focal segmental glomerulosclerosis (FSGS), approved Corstasis Therapeutics’ bumetanide nasal spray (Enbumyst) for the treatment of edema, and cleared an Investigational New Drug (IND) application from eGenesis to initiate a clinical trial evaluating EGEN-2784 in patients with end stage kidney disease (ESKD).

Paired with new Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and the release of the latest episode of Kidney Compass on trial design in cardio-kidney-metabolic (CKM) syndrome, September was a busy month in the realm of kidney health.

Check out this September 2025 nephrology month in review for a recap of HCPLive’s coverage of the top renal news and research from the past few weeks:

FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA

On September 10, 2025, the FDA informed Travere Therapeutics that following further review of the sNDA for sparsentan (Filspari) in FSGS, an advisory committee is no longer needed.

The sNDA remains under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If approved, sparsentan would be the first medication indicated for FSGS.

FDA Approves Bumetanide Nasal Spray for Edema with Congestive Heart Failure

On September 15, 2025, the FDA approved Corstasis Therapeutics’ bumetanide nasal spray (Enbumyst) for the treatment of edema associated with congestive heart failure, liver disease, and chronic kidney disease. It is expected to launch in the US in the fourth quarter of 2025.

FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD

On September 8, 2025, the FDA cleared an IND application from eGenesis to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with ESKD. The IND supports a phase 1/2/3 study designed to assess the safety, tolerability, and efficacy of EGEN-2784 at 24 weeks post-transplant in patients with ESKD who are ≥ 50 years of age, dialysis-dependent, and on the kidney transplant waitlist.

Related: Xenotransplantation: A New Frontier in Kidney Transplantation, With Pranav Garimella, MBBS, MPH

KDIGO Releases Updated IgA Nephropathy, IgA Vasculitis Clinical Practice Guideline

On September 18, 2025, KDIGO released its 2025 Clinical Practice Guideline for the Management of IgAN and IgAV, providing comprehensive, evidence-based recommendations for clinicians managing these kidney diseases and building upon the last update to the IgAN and IgAV management guideline published as part of the KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases.

Hypertensive Kidney Disease Death Rate Up 48% in Past 25 Years

Findings from a recent analysis of US Centers for Disease Control and Prevention - Wide-Ranging Online Data for Epidemiology Research (CDC WONDER) data show the death rate from hypertensive kidney disease in the US has increased by 48% since 1999. In addition to the stark increase in high blood pressure-related renal disease mortality over the past 25 years, study findings highlight disproportionate impacts on African American and Hispanic males.

Kidney Compass: The Future of Cardiovascular-Kidney-Metabolic Trial Design

In the latest episode of Kidney Compass, host Brendon Neuen, MBBS, PhD, is joined by Richard Pratley, MD, medical director at the Advent Health Diabetes Institute, and Muthiah Vaduganathan, MD, MPH, codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women’s Hospital, to discuss the evolving landscape of clinical trials in CKM.