Seladelpar, sold under the brand name Livdelzi, is a medication used for the treatment of primary biliary cholangitis. It is used as the lysine dihydrate salt and is formulated as an oral small molecule that acts as a selective peroxisome proliferator activated receptor delta agonist to modulate bile acid homeostasis and inflammatory pathways in the liver; the active pharmaceutical ingredient is a chlorinated heteroaryl piperidine derivative provided as a crystalline lysine dihydrate API, controlled in immediate release tablet forms and characterized by validated physicochemical and stability profiles with predominant hepatic metabolism and renal and fecal excretion pathways.
The seladelpar lysine dihydrate API is controlled by validated chromatographic methods for related substances and degradation products; typical identified related compounds include process-related precursors, positional isomers, oxidative byproducts and ring-modified species, and analytical acceptance criteria are established in accordance with ICH guidance: reporting threshold approximately 0.05 percent, identification threshold approximately 0.10 to 0.15 percent, individual unspecified impurity limits commonly set at 0.10 to 0.15 percent and total impurities typically limited to 0.5 percent by area percent, with genotoxic impurities controlled to permitted daily exposure levels per ICH M7 and residual solvents limited per ICH Q3C.
Seladelpar is indicated for the treatment of primary biliary cholangitis to reduce cholestatic liver biochemistry and improve markers such as alkaline phosphatase in adults, including patients with inadequate response to or intolerance of ursodeoxycholic acid, according to its clinical labeling.
Yes, seladelpar is approved in the United States and is marketed under the brand name Livdelzi for the treatment of primary biliary cholangitis.
Regulatory status in Europe is determined by the European Medicines Agency and national authorities; as regulatory reviews and national decisions may change over time, consult EMA public records or national competent authorities for the current approval status in the European Union.
