Seladelar is a selective peroxisome proliferator activated receptor delta (PPAR delta) agonist primarily used for the treatment of cholestatic liver diseases such as primary biliary cholangitis (PBC). It improves liver function indicators and alleviates itching symptoms by regulating bile acid metabolism and anti-inflammatory effects.

1. Indications

(1) Primary biliary cholangitis: suitable for adult PBC patients with poor response or intolerance to ursodeoxycholic acid, which can significantly reduce alkaline phosphatase (ALP) levels.

(2) Other cholestatic diseases: Clinical trials are currently underway for primary sclerosing cholangitis (PSC) and non-alcoholic steatohepatitis (NASH).

2. Mechanism of action

(1) Targeted regulation: selectively activates PPAR δ receptors, upregulates the expression of bile acid transporters, and promotes bile acid excretion.

(2) Multiple effects: Simultaneously possessing anti fibrotic, anti-inflammatory, and mitochondrial function improving effects, delaying disease progression.

3. Clinical efficacy

(1) Biochemical response: Phase III trials showed that 52% of patients' ALP levels returned to normal at 52 weeks, which was three times higher than the placebo group.

(2) Symptom improvement: significantly reduced itching VAS score, and the therapeutic effect continued until the 104 week follow-up period.

(3) Safety: Common adverse reactions include mild headache and gastrointestinal reactions, and the incidence of severe liver toxicity is less than 1%.