The US FDA has approved seladelpar capsules in combination with ursodeoxycholic acid (UDCA) to treat adults with primary biliary cholangitis (PBC). Seladelpar is a peroxisome proliferator-activated receptor-delta agonist. While combination therapy is indicated for PBC patients with inadequate response to UDCA, seladelpar monotherapy is recommended for patients unable to tolerate UDCA. Clinical evidence In phase 3 clinical trial conducted on 193 adult PBC patients, seladelpar significantly reduced biomarkers of PBC, including alkaline phosphatase (84% vs.
32%) and total bilirubin (81% vs. 77%), and pruritus score (-3.2 vs. -1.7 [reduction from baseline score]) in patients compared to the placebo group. Administration – 10 mg; orally once daily with or without food Warnings – Fractures, liver test abnormalities, and biliary obstruction Adverse reactions – Headache, nausea, dizziness,…
