Focal Segmental Glomerulosclerosis

Rapid advances in glomerular disease, from single-cell tech to biomarkers and phase 3 trials, are reshaping diagnosis and treatment.

In a 31-center phase 2 trial in 10 countries, apecotrep BI 764198 reduced proteinuria in patients with primary focal segmental glomerulosclerosis.

An audio recap of the top 5 stories in healthcare news from the week of 01/04-01/10.

The FDA has extended its review of the sNDA, delaying the previous January 13, 2026, PDUFA date, to April 13, 2026.

An age-based observational study in glomerular disease suggests different rates of disease progression and remission in young adults compared to adult and pediatric patients.

A review of 32 years of global data on FSGS highlights increased prevalence, with a limitation of biopsy variation and regional practices.

A curated recap of 8 impactful trial updates from the American Society of Nephrology Kidney Week 2025.

Sparsentan shows superior proteinuria reduction in pediatric FSGS patients, setting the stage for potential FDA approval.

New findings reveal sparsentan significantly reduces proteinuria in FSGS patients, offering hope for improved kidney health and lower failure risk.

Kidney Week 2025 showcases groundbreaking clinical trials and FDA approvals, marking a transformative era in nephrology and kidney disease treatment.

The Q3 recap for nephrology spotlights key FDA decisions, new KDIGO IgA nephropathy guidelines, and other top renal news and research.

An audio recap of the top 5 stories in healthcare news from the week of 9/5-9/13.

Upon further review of the sNDA, the Agency indicated an advisory committee for sparsentan in FSGS is no longer needed.

The Q2 recap for nephrology spotlights key FDA decisions and top coverage from the 62nd European Renal Association Congress.

A study presented at ERA 2025 validates the use of proteinuria as a surrogate endpoint for FSGS clinical trials.

With the sNDA acceptance, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.

Norouzi discusses recent advancements in IgAN therapeutics and looks ahead to a potential first FDA-approved FSGS treatment.

Tumlin reviews findings from a posthoc analysis of DUPLEX demonstrating sparsentan’s impact on partial remission, complete remission, and kidney failure.

The submission is supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study in adult and pediatric patients with FSGS.

An approval for sparsentan in focal segmental glomerulosclerosis would mark the second rare kidney disease approval for the agent.

Despite having a lower risk of hospitalization, cardiovascular events, and mortality, patients with IgAN and FSGS had a higher risk of CKD progression.

Yee discussed research she is conducting into gFSGS and nephrotic syndrome, presented at ASN Kidney Week.

Zand discussed the unmet need for refractory primary FSGS and the importance of investigations specifically in this population.

Yee discussed how the data show a benefit in this hard-to-treat population, similarly to the heterogeneous FSGS group.

Zand discussed interim 12-month findings from an open-label, phase 2 trial currently ongoing for patients with refractory primary focal segmental glomerulosclerosis.