[6] Sparsentan was discovered by Pharmacopeia, Inc. and developed as PS433540 as their lead compound in a new class of agents called dual acting receptor antagonists (DARA).
[12] Sparsentan was evaluated in a randomized, double-blind, active-controlled, clinical trial (PROTECT) in participants with IgA nephropathy.
[6] Participants with IgA nephropathy and protein in the urine were randomly assigned to receive either sparsentan or irbesartan once daily.
[6] The US Food and Drug Administration (FDA) granted accelerated approved to sparsentan based on evidence from a clinical trial (PROTECT) of participants with IgA nephropathy.
[6] The efficacy analyses were based on an interim analysis of 281 participants (141 on sparsentan, 140 on irbesartan) who reached week 36 in the trial.
[2][6][13] In September 2024, the US FDA converted the conditional approval in the kidney disease IgA nephropathy (IgAN) into a full approval based on positive long-term confirmatory results from the PROTECT Study demonstrating that sparsentan significantly slowed kidney function decline over two years compared to irbesartan.