Filspari sparsentan

Drug Class

Dual endothelin and angiotensin II receptor antagonist

Mechanism

Sparsentan blocks both endothelin type A (ETA) and angiotensin II type 1 (AT1) receptors, preventing downstream pathway activation linked to proteinuria and kidney damage.

Approved Indication

Treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression to slow kidney function decline; and to reduce proteinuria in adults and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS).

What This Means For Patients

Filspari (sparsentan) is a novel dual receptor antagonist indicated for adult patients with primary IgA nephropathy and focal segmental glomerulosclerosis (FSGS). It acts by targeting two key pathways responsible for kidney damage and protein loss. Although not officially approved by the NMPA in China, it can be clinically accessed through the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2024) — source

Pivotal Clinical Evidence

• PROTECT — Heerspink et al., Lancet 2023 (NCT03762850) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216403s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/filspari
• https://doi.org/10.1016/S0140-6736(23)02302-4