No immunotoxicity in repeat-dose studies; negative mouse local lymph node assay
“Seladelpar did not show potential for immunotoxicity in the repeat-dose toxicity studies and no sensitisation potential was recorded in the local lymph node assay in mouse.”
Wide distribution in rats (QWBA), highest in liver, kidney and bladder
“Seladelpar was widely distributed in rats, as demonstrated by quantitative whole-body autoradiography (QWBA) data in both non-pigmented and pigmented rats with the highest radioactivity detected in the liver, kidney, and bladder.”
Rodent liver effects and tumors; PPARα-dependent (rodent-specific) mode of action investigated
“The 14-day study in the PPARα null mice showed that wild-type mice are more sensitive to liver effects that PPARα null mice, suggesting that PPARα plays a role in the observed liver effects in mice.”