FDA Approves Sparsentan for Focal Segmental Glomerulosclerosis

The US Food and Drug Administration (FDA) has granted full approval to sparsentan (Filspari) for the treatment of focal segmental glomerulosclerosis (FSGS), according to a release from Travere Therapeutics.1

Announced on April 13, 2026, the approval is supported by data from 2 of the largest head-to-head interventional studies in adult and pediatric patients with FSGS, the phase 3 DUPLEX study and the phase 2 DUET study.1,2

“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.1 “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.”

Sparsentan is the only non-immunosuppressive, oral medication designed to directly target podocyte injury by optimally blocking the endothelin A receptor and the angiotensin II subtype 1 receptor. In May 2025, Travere Therapeutics’ supplemental New Drug Application was accepted by the FDA for FSGS.

Prior to this submission, the agency previously approved sparsentan for slowing kidney function decline in adults with IgA nephropathy (IgAN) in September 2024, based on 2-year confirmatory results from the phase 3 PROTECT study.2

In January 2026, the FDA extended the review timeline for sparsentan’s sNDA after requesting further characterization of the clinical benefit of sparsentan and subsequently determined the response constituted a Major Amendment to the sNDA.

The sNDA for the use of sparsentan in FSGS was supported by findings from the phase 3 DUPLEX Study and the phase 2 DUET Study.

The phase 3 DUPEX study was the largest interventional study in FSGS, as well as the only one against a maximally dosed active comparator. At 36 weeks, study investigators reported achievement of the prespecified interim FSGS partial remission of proteinuria endpoint and statistical significance at 36 weeks. However, it did not achieve the primary efficacy estimated glomerular filtration rate slope endpoint in 108 weeks of treatment.2

In concurrence, the phase 2 DUET study met the primary efficacy endpoint for the combined treatment group, demonstrating a > two-fold reduction in proteinuria compared to irbesartan. Its safety profile was consistent across all clinical trials and comparable to the maximally dosed active control. Both DUPLEX and DUET participants were eligible to continue into the open-label extension of the trials.2

“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, PhD, president and chief executive officer of Travere Therapeutics.1 “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.”

References

1. Travere Therapeutics. Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the First and Only Approved Medicine for FSGS. Travere.com. Published April 13, 2026. Accessed April 13, 2026. https://ir.travere.com/press-releases/news-details/2026/Travere-Therapeutics-Announces-Full-FDA-Approval-of-FILSPARI-sparsentan-the-First-and-Only-Approved-Medicine-for-FSGS/default.aspx

2. Travere Therapeutics Announces FDA Acceptance of sNDA for FILSPARI® (sparsentan) in FSGS. Travere.com. Published 2025. Accessed January 5, 2026. https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Announces-FDA-Acceptance-of-sNDA-for-FILSPARI-sparsentan-in-FSGS/default.aspx

3. Hillenbrand A. FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis. HCPLive. Published January 13, 2026. Accessed April 13, 2026. https://www.hcplive.com/view/fda-extends-sparsentan-filspari-focal-segmental-glomerulosclerosis-snda-review