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PHILADELPHIA, PA – April 14, 2026 — Yesterday marked a historic milestone for the focal segmental glomerulosclerosis (FSGS) community. The U.S. Food and Drug Administration (FDA) has approved Travere Therapeutics’ drug sparsentan (FILSPARI) for FSGS. This is the first-ever FDA-approved treatment option for people living with FSGS, signaling a major step forward after decades without any approved, disease-specific therapies.
Sparsentan is already approved for the treatment of IgA nephropathy, and the FDA’s approval expands its use to include people living with FSGS, reflecting continued progress in the development of treatments for rare kidney diseases (RKD).
FSGS is a rare and progressive kidney disease. It begins in the filtering units of the kidney, the glomeruli, and causes scarring in the kidney and can ultimately lead to kidney failure. For years, patients and families have faced this disease with limited treatment options, and no therapies specifically approved for FSGS.
The FDA’s approval for sparsentan was based on data from Travere Therapeutics’ Phase 3 DUPLEX study, the largest study of FSGS patients to date. In this randomized, controlled trial of 371 patients—including primary and genetic forms, as well as those considered to have refractory FSGS—sparsentan was evaluated against an active comparator treatment, irbesartan. Results, published in The New England Journal of Medicine, showed that patients treated with sparsentan achieved a statistically significant 46% reduction in proteinuria from baseline to week 108, compared to 30% for those treated with maximum labeled dose irbesartan.
In addition, Travere’s press release shared the following:
- Patients without nephrotic syndrome who were treated with sparsentan experienced a 48% reduction in proteinuria, compared to 27% for those treated with irbesartan
- Sparsentan-treated patients without nephrotic syndrome also demonstrated a clinically meaningful benefit and preservation in eGFR.
“Today is a powerful and long-awaited moment for the FSGS community. After decades without approved treatment options, this decision represents real progress and new hope for patients and families who have carried the weight of this disease for far too long. This progress reflects years of dedication from patients, families, researchers, physicians, regulatory partners, industry and many others across the highly collaborative rare kidney disease community who have worked tirelessly to move the science forward,” said Josh Tarnoff, NephCure chief executive officer.
“This approval marks meaningful momentum for everyone living with FSGS. At NephCure, we are committed to helping patients and families understand what this means for them and to ensuring they have access to the information, support, and expert care needed to navigate drug access.”
Sparsentan has been approved to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
While FSGS and nephrotic syndrome may be diagnosed in conjunction, they are not the same condition. FSGS is a disease that is diagnosed through a kidney biopsy, when a characteristic pattern of scarring is seen in the kidneys. This scarring is permanent and can get worse over time. Nephrotic syndrome is a separate term that describes a patient’s condition and indicates the presence of three symptoms occurring at the same time:
- Proteinuria greater than 3.5 g/24h
- Albuminuria less than 3.0 g/dl
- Edema
Nephrotic syndrome can be a symptom of severe FSGS, but not all patients with FSGS have nephrotic syndrome. Many FSGS patients often transition in and out of nephrotic syndrome episodes, depending on how their kidney disease behaves or responds to treatment.
“There are many patients with FSGS who are at risk of losing their kidneys because our current therapeutic options are not enough. To have a new option is an incredible opportunity. I hope that sparsentan is the first of many new therapies and that someday, far fewer patients with FSGS and other glomerular diseases will go on to have kidney failure,” said Laura Mariani, M.D., M.S., NephCure Specialist, Associate Professor of Nephrology at the University of Michigan, PARASOL Project Co-Chair, and Principal Investigator of CureGN.
“In addition, glomerular disease is having an incredible moment, where improved understanding of disease mechanisms is combined with better clinical trial design. Some of the best elements of the way the DUPLEX study was designed make it easier to apply the results to clinical practice. The work of the PARASOL project also provides confidence that results observed in the short window of a clinical trial can give us meaningful information about future risk of kidney failure,” said Mariani.
This approval represents a significant expansion of treatment options for people living with FSGS and reflects growing recognition of the urgent unmet need within the RKD community. It also is a testament to the strength and persistence of the FSGS community, including the individuals who participated in clinical trials such as DUPLEX and DUET, as well as long standing research studies like NEPTUNE, CureGN, and RADAR. Collaborative efforts such as the PARASOL Project, along with the contributions of researchers, advocacy organizations, and industry partners helped make this milestone possible.
NephCure also recognizes Travere Therapeutics for their persistence and dedication to patients, as well as the Division of Cardiology and Nephrology at the FDA for their innovation and commitment to advancing therapies for the RKD community.
While this approval allows doctors to prescribe sparsentan for FSGS, access is not automatic and may vary based on individual circumstances. Patients may encounter differences in access depending on insurance coverage, prior authorization requirements, physician familiarity with the treatment, and their individual health profile. The medication will be distributed through specialty pharmacy channels and may not be immediately available to all patients.
People living with FSGS are encouraged to speak with their nephrologist to understand whether this treatment may be appropriate for them, what the approved indication includes, and how to navigate access. Now more than ever, it is critical to connect with a NephCure Specialist who understands FSGS and evolving treatment options.
This moment also reflects the power of patient advocacy. The voices of the FSGS community, including those who participated in outreach efforts like NephCure’s FSGS Petition to the FDA, played an important role in advancing progress and bringing urgency to the need for new treatment options.
NephCure remains committed to ensuring that this milestone translates into meaningful impact for patients by advancing access, supporting education, and continuing to drive research forward. While this approval is a major step, the work is not done. NephCure will continue to advocate for innovation and improved outcomes for all individuals affected by FSGS and other rare kidney diseases.
We encourage you to join us on Monday, April 20 at 8pm ET for an informative town hall led by Drs. Kirk Campbell, Laura Mariani, and Howard Trachtman, where they will discuss what this approval means for those impacted by FSGS and answer questions from the community. To submit your questions to the doctors and register for the town hall, click here.
If you or a loved one is living with FSGS, speak with your nephrologist to determine whether sparsentan or another treatment option may be right for you.
To read Travere Therapeutics full press release about the FDA approval of sparsentan for FSGS, click here.
About NephCure:
NephCure’s mission is to ensure that all individuals with rare, protein-spilling kidney disease have equitable access to the care and treatments that offer them the best kidney health outcome possible. Founded in 2000 by a group of committed patient parents, NephCure has invested more than $40 million in kidney disease research and helped create a landscape where there are now new treatments and more than 60 interventional drug trials for rare kidney diseases. NephCure is a U.S. tax exempt 501(c)(3) public charity.
