TVTX

Sparsentan

Focal segmental glomerulosclerosis (FSGS)

Stage (next event)

Expected Date

Phase 3 (Top-line Data)

Q3 2021

Catalyst Info & Data Links

Mechanism of Action

MECHANISM OF ACTION

  • Sparsentan is an investigational product candidate in Phase 3 clinical development that has a dual mechanism of action combining endothelin receptor type A blockade with angiotensin receptor blockade. Retrophin is developing sparsentan for the treatment of FSGS, as well as for IgA nephropathy (IgAN), rare kidney disorders that often lead to ESRD. In several forms of chronic kidney disease, such as FSGS and IgAN, endothelin receptor blockade has been shown to have an additive beneficial effect on proteinuria in combination with renin-angiotensin blockade via angiotensin receptor blockade or angiotensin converting enzyme inhibitors. Sparsentan has been granted orphan drug designation for the treatment of FSGS by the FDA and European Commission.

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  • The incidence of FSGS in the US has risen over the last 3 decades in children and adults.

  • Race, ethnicity, and gender all have a significant effect on the incidence of FSGS.8-10 FSGS is more common in people of African ancestry.

  • In the US, incidence of FSGS is thought to be 2.7 new cases in 100,000 people per year. Data from the US Renal Data System shows the incidence rate of end-stage kidney disease caused by FSGS increased by 11 times between 1980 to 2000.

Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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