From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Seladelpar is recommended as a treatment option for patients with primary biliary cholangitis (PBC) who have had an inadequate response to or cannot tolerate ursodeoxycholic acid (UDCA), with a typical dosage of 10 mg taken orally once daily. The medication works as a selective peroxisome proliferator-activated receptor delta (PPAR-δ) agonist, which helps reduce inflammation and bile acid production in the liver, improving liver function tests, particularly alkaline phosphatase levels 1. Key benefits of seladelpar include:
- Significant improvements in liver biochemistry and pruritus in patients with PBC 1
- Dose-dependent, clinically significant, and durable improvements in biochemical markers of cholestasis and inflammation 2
- Safety and tolerability, with no serious treatment-related adverse events reported in clinical trials 1, 2
- Potential to improve quality of life measurements, with reductions in pruritus and improvements in overall quality of life 3 Common side effects may include headache, abdominal pain, and fatigue, and patients taking seladelpar should have regular liver function monitoring to assess treatment response and detect any potential adverse effects. Overall, seladelpar represents an important advancement in PBC treatment options, particularly for those with difficult-to-treat disease, as supported by the most recent and highest quality study available 4.