Sparsentan
- Generic Name
- Sparsentan
- Brand Names
- Filspari
- Drug Type
- Small Molecule
- Chemical Formula
- C32H40N4O5S
- CAS Number
- 254740-64-2
- Unique Ingredient Identifier
- 9242RO5URM
- Background
Sparsentan is a dual antagonist of the endothelin type A receptor (ETR) and the angiotensin II (Ang II) type 1 receptor (ATR) with a similar affinity for both (9.3 nM for ETR and 0.8 nM for ATR). Sparsentan is first in its class and orally active, and was created by merging the structural elements of irbesartan, an ATR antagonist, and biphenylsulfonamide, an...
- Indication
Sparsentan is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
- Associated Conditions
- Proteinuria
- Associated Therapies
- -
Filspari Approved to Slow Kidney Function Decline in IgA Nephropathy
FDA grants full approval to Filspari® (sparsentan) for slowing kidney function decline in adults with IgA nephropathy at risk of progression. The approval is based on the PROTECT trial's final analysis, showing sparsentan reduced the rate of kidney function decline compared to irbesartan, with a treatment effect of 1.2 mL/min/1.73m² per year.
Related Clinical Trials:
Travere Stock Pops After Snagging Full Approval For Calliditas Rival In Kidney Disease
Travere Therapeutics' stock surged after FDA full approval for kidney disease treatment Filspari, expanding market potential to over 70,000 IgA patients in the U.S. and raising peak sales estimates to $661 million. The approval aligns with Calliditas Therapeutics' similar FDA approval for Tarpeyo in December 2023.
FDA grants full approval to Travere's Filspari for primary IgA nephropathy
Travere Therapeutics receives FDA full approval for Filspari (sparsentan) to slow kidney function decline in IgAN patients. Filspari is an oral, once-daily, non-immunosuppressive medication targeting two key pathways in IgAN progression. The approval is based on the Phase 2 PROTECT Study results showing significant kidney function preservation compared to irbesartan.
Travere Wins Full FDA Approval for IgAN Treatment Filspari
FDA grants full approval to Travere Therapeutics' Filspari (sparsentan) for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, once-daily, non-immunosuppressive treatment for IgAN, targeting glomerular injury. The approval aligns with KDIGO's new guidelines, positioning Filspari as foundational care for IgAN.
Jonathan Barratt, PhD, FRCP: Sparsentan Full FDA Approval, Future IgAN Developments
Recent advancements in IgA nephropathy (IgAN) treatment include FDA approval of sparsentan (Filspari) and budesonide (Tarpeyo), with more drugs like iptacopan (Fabhalta) in development, marking significant progress in managing kidney function loss.
Full FDA Approval of Travere's Kidney Drug Stiffens Competition With Novartis, Calliditas
Travere Therapeutics' drug Filspari, for IgAN, received full FDA approval based on long-term data showing significant kidney function decline slowing. This expands the eligible patient population beyond initial proteinuria thresholds, potentially increasing market opportunity. Filspari competes with Novartis' Fabhalta and Calliditas' Tarpeyo, both also approved for IgAN. Filspari carries a black box warning for liver toxicity and is under a REMS program. Travere reported $46.9 million in Filspari revenue for H1 2024, with growth expected as approvals expand globally.
Drug Development Updates
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