Travere Therapeutics, Inc. (TVTX) has received full FDA approval for FILSPARI (sparsentan) to reduce proteinuria in adults and children aged 8 years and older with focal segmental glomerulosclerosis who do not have nephrotic syndrome-making it the first and only FDA- approved medicine for this rare kidney disorder.
Focal segmental glomerulosclerosis (FSGS) is a progressive disease that causes scarring in the kidney's filtering units, leading to protein leakage into the urine and, over time, kidney failure. Until now, patients relied largely on off-label treatments such as steroids, which often come with significant side effects and inconsistent benefit.
FILSPARI, already approved for IgA nephropathy (IgAN), is a once-daily oral dual endothelin and angiotensin receptor antagonist designed to protect the kidney and reduce proteinuria- an important marker of disease progression.
A New Option for a Long-Underserved Patient Population
The FDA's decision expands FILSPARI's reach to an estimated 30,000 patients in the U.S. living with FSGS without nephrotic syndrome, part of a broader population of more than 100,000 individuals across FSGS and IgAN who may now be eligible for treatment.
"Today marks a historic milestone for people living with FSGS, who for the first time have an FDA-approved medicine for this rare and devastating condition," said Eric Dube, Ph.D.,
President and CEO of Travere Therapeutics. "This approval reflects years of perseverance and expands FILSPARI's potential to help more patients who urgently need better options."
Backed by the Largest Interventional Study in FSGS The approval is supported by results from the Phase 3 DUPLEX Study the largest interventional trial conducted in FSGS to date.
Key findings include:
-46% reduction in proteinuria from baseline to Week 108 in the overall population for FILSPARI vs 30% for maximum-dose Irbesartan
-In patients without nephrotic syndrome, FILSPARI achieved a 48% reduction in proteinuria vs 27% for Irbesartan
-A favorable trend in kidney function (eGFR) decline compared to Irbesartan
-A safety profile generally comparable to Irbesartan across adult and pediatric patients.
These results align with KDIGO clinical practice guidelines, which emphasize reducing proteinuria as a key strategy to slow FSGS progression.
Commercial Momentum Already Building
FILSPARI has been a major growth driver for Travere. According to the company's 2025 financial results U.S. net product sales of FILSPARI reached $322 million in 2025, up 144% from $132.2 year-over-year. For the fourth quarter of 2025, sales totaled $103.3 million, marking a 108% increase from the $49.6 million reported in the same period in 2024.
Travere ended 2025 with $322.8 million in cash, cash equivalents, and marketable securities, and expects to receive an additional $25 million milestone payment from Mirum Pharmaceuticals in the first half of 2026, supporting readiness for a potential commercial launch in FSGS. Ligand Pharmaceuticals Inc. (LGND) maintains a licensing agreement with Travere for FILSPARI and receives a 9% royalty on global net product sales.
Patient Access and SupportFILSPARI will be available immediately for nephrologists to prescribe. Travere continues to offer Travere TotalCare, a support program that assists with insurance navigation, financial support, REMS liver-monitoring requirements, and educational resources for patients and caregivers.
TVTX has traded between $13.88 and $42.13 over the past year. The stock closed Monday's trading at $30.70, up 6.01%. During afterhours trading the stock is at $30.96, up 0.85%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.