Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the First and Only Approved Medicine for FSGS
Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved FILSPARI® (sparsentan) to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome. FILSPARI is the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease. FILSPARI is currently the most commonly prescribed FDA-approved medicine for IgAN.
People with FSGS who do not have nephrotic syndrome span across types of FSGS and represent a population aligned with the KDIGO guidelines for treating glomerular diseases. Nephrotic syndrome is commonly defined as the presence of three concurrent criteria: proteinuria greater than 3.5 g/24h, edema, and albumin less than 3.0 g/dL. The company estimates that the addressable population in the U.S. is more than 30,000 individuals with FSGS who do not have nephrotic syndrome.
“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 chief executive officer of Travere Therapeutics. “This approval reflects years of perseverance and our belief that those living with FSGS deserve better.
It also builds on our leadership and progress in rare kidney diseases, expanding FILSPARI’s potential reach to more than 100,000 people in the U.S. with FSGS and IgAN who need better treatment options. FILSPARI will be available for nephrologists to immediately prescribe to individuals with FSGS. We are profoundly grateful to the patients, caregivers, investigators, healthcare providers, regulators and advocates who made this moment possible.”
In the Phase 3 DUPLEX Study, the largest head-to-head interventional study in FSGS to date, patients treated with FILSPARI in the overall study population experienced a statistically significant 46% reduction in proteinuria from baseline to Week 108 compared to 30% for those treated with maximum labeled dose irbesartan (nominal p-value, 0.0299). In patients without nephrotic syndrome, FILSPARI demonstrated even greater improvements compared to maximum labeled dose irbesartan across proteinuria and eGFR.
Those without nephrotic syndrome who were treated with FILSPARI experienced a 48% reduction in proteinuria from baseline to Week 108 compared to 27% for those treated with irbesartan, which was statistically significant (nominal p-value, 0.0075). FILSPARI-treated patients without nephrotic syndrome also demonstrated a benefit in eGFR with a treatment difference of 1.1 mL/min/1.73 m2 based on mean change from baseline to Week 108 (-11.3 mL/min/1.73 m2 for FILSPARI compared to -12.4 mL/min/1.73 m2 for maximum labeled dose irbesartan). Across both adult and pediatric patients, FILSPARI was generally well tolerated, with a safety profile comparable to irbesartan and consistent across clinical programs.
In patients without nephrotic syndrome, FSGS is largely driven by stress on the kidney’s glomeruli and the activation of the pathways that cause inflammation and scarring. FILSPARI’s dual mechanism of action addresses these processes by targeting endothelin A and angiotensin II receptors, which are believed to help protect the kidney and reduce damage.
“Today’s approval of FILSPARI provides nephrologists with a new FDA-approved option for patients living with FSGS,” said Kirk Campbell, M.D., president of the National Kidney Foundation and the C. Mahlon Kline Professor and chief of the Division of Renal-Electrolyte and Hypertension in the Perelman School of Medicine at the University of Pennsylvania. “For decades, treatment options have been limited, often relying on off-label therapies such as long-term steroids that can carry a significant burden for patients.
In the DUPLEX Study, FILSPARI delivered rapid and sustained reductions in proteinuria compared to irbesartan, with particularly meaningful effects in patients without nephrotic syndrome. This is consistent with KDIGO guidance, which emphasize reducing proteinuria as a key strategy to slow disease progression in FSGS. For patients without active nephrotic syndrome, where optimizing foundational therapy is critical, FILSPARI represents an important new option.”
“The approval of FILSPARI as the first medication for people with FSGS is a life-changing moment for patients and families who have waited far too long,” said Josh Tarnoff, chief executive officer of NephCure. “This milestone reflects the strength and perseverance of an extraordinary collective and broad stakeholder community who participated in research, raised awareness and never gave up hope.
The pioneering work of the PARASOL project and the countless patients and caregivers who have shared their journeys along the way have helped make this progress possible. It stands as proof that when science and community unite with purpose, we can redefine what’s possible in rare disease care and bring light to those who have long lived in uncertainty.”
The company offers Travere TotalCare®, a comprehensive patient support program designed for patients, their caregivers, and healthcare providers. Travere TotalCare® provides support and resources that can help patients understand FSGS, fill and refill prescriptions, assist with the insurance process, connect patients with financial support and advocacy organizations, and assist with liver-monitoring REMS testing. For more information, patients and providers can call 833-FILSPARI (833-345-7727) or visit TravereTotalCare.com.
Conference Call information
Travere Therapeutics will host a conference call and webcast today, Monday, April 13, 2026, at 6:45 p.m. ET. To participate in the conference call, dial +1 (800) 549-8228 (U.S.) or +1 (646) 564-2877 (International), conference ID 96400 shortly before 6:45 p.m. ET. The webcast can be accessed on the Investor page of Travere’s website at ir.travere.com/events-and-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.
About the DUPLEX Study
The Phase 3 DUPLEX Study is the largest interventional study to date in FSGS. It was a global, randomized, multicenter, double-blind, parallel-arm, active-controlled Phase 3 clinical trial that assessed the efficacy and safety of FILSPARI in 371 patients ages 8 to 75 years with biopsy-proven or genetic FSGS. After a two-week washout period, patients were randomized 1:1 to receive either FILSPARI or irbesartan, the active control, and subsequently dose titrated to the maximum dose of 800 mg of sparsentan or 300 mg of irbesartan, as tolerated.
In the study, nephrotic syndrome was defined as (a) documentation of nephrotic syndrome in the medical history, or (b) the concurrent presence of proteinuria >3.5 g/24 hours (adults) or UPCR >2.0 g/g (pediatric patients <18 years of age), serum albumin <3.0 g/dL, and edema at baseline. The primary efficacy endpoint at the final analysis was the rate of change in eGFR from baseline to Week 108. The two-year results from the study were published in the New England Journal of Medicine. Patients who completed the DUPLEX double-blind portion of the study on treatment were eligible to participate in the open-label extension of the trial.
About Focal Segmental Glomerulosclerosis
Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder in both children and adults defined by progressive scarring of the kidney and often leads to kidney failure. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression. FSGS without nephrotic syndrome spans all categories of the disorder.
About Travere Therapeutics
At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow.
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