About Seladelpar API
Categoría Terapéutica Hepatology
Número CAS
851528‑79‑5
Tecnología del API
Small‑molecule synthetic API
Forma de Dosificación
Sólido Oral/Cápsulas
Estado de Desarrollo en Dr. Reddy’s
En desarrollo
Mechanism of action
Seladelpar activates PPAR‑δ, a nuclear receptor expressed in the liver and other tissues.
PPAR‑δ activation:
Reduces bile acid synthesis via FGF21‑mediated downregulation of CYP7A1, the rate‑limiting enzyme in bile acid production
Decreases cholesterol synthesis and absorption
Lowers hepatic and circulating bile acid levels
These effects result in:
Reduced cholestatic liver injury
Improvement in biochemical markers (e.g., alkaline phosphatase)
Reduction in pruritus, partly associated with decreased interleukin‑31 levels
Indication
Approved indication (FDA / EMA):
Treatment of primary biliary cholangitis (PBC) in adults:
In combination with ursodeoxycholic acid (UDCA) in patients with inadequate response to UDCA, or
As monotherapy in patients unable to tolerate UDCA
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