April 14, 2026
1 min read
Key takeaways:
- Sparsentan received full approval for both adult and pediatric patients aged at least 8 years.
- Patients treated with sparsentan had a similar safety profile as with those treated with irbesartan.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA granted full approval to sparsentan for proteinuria reduction in adults and pediatric patients aged at least 8 years with focal segmental glomerulosclerosis without nephrotic syndrome, according to a company press release.
With the approval, sparsentan (Filspari, Travere Therapeutics), a dual endothelin-angiotensin II receptor antagonist, becomes the first and only FDA-approved medication for treating focal segmental glomerulosclerosis (FSGS), a rare kidney disorder. Sparsentan previously received FDA approval for immunoglobulin A nephropathy in 2024.
The approval was based on the results of the phase 3 DUPLEX trial, in which patients treated with sparsentan had a significant 46% reduction in proteinuria from baseline to week 108 across eGFR and proteinuria levels, compared with a 30% reduction in those treated with maximum dose irbesartan in the overall study population.
Patients without nephrotic syndrome treated with sparsentan had a significant 48% reduction in proteinuria from baseline to week 108 vs. a 27% reduction in the irbesartan group.
In addition, patients without nephrotic syndrome treated with sparsentan had slower eGFR decline compared with the irbesartan group (–11.3 mL/min/1.73 m² vs. –12.4 mL/min/1.73 m²).
Sparsentan was well tolerated among pediatric and adult patients, with similar safety profiles compared with the irbesartan group, according to the press release. The most common adverse reactions for patients treated with sparsentan include peripheral edema, hypotension (including orthostatic hypotension), hyperkalemia, dizziness and anemia.
“Filspari will be available for nephrologists to immediately prescribe to individuals with FSGS,” Eric Dube, PhD, president and CEO of Travere Therapeutics, said in the press release.
Sources/Disclosures
Source:
Press Release
Disclosures:
Dube is an employee of Travere.
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