Drug updated on 3/28/2025
| Dosage Form | Capsule (oral; 10 mg) |
| Drug Class | Peroxisome proliferator-activated receptor (PPAR)-delta agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- In patients with Primary Biliary Cholangitis (PBC) refractory to Ursodeoxycholic Acid (UDCA), combination treatments improved Alkaline Phosphatase (ALP) levels. Elafibranor + UDCA showed the greatest improvement (Mean Difference [MD] = 140.73, 95% Confidence Interval [CI]: 74.34 to 209.98), followed by Saroglitazar + UDCA (MD = 132.09, 95% CI: 13.99 to 247.04), Seladelpar + UDCA (MD = 117.39, 95% CI: 19.97 to 213.95), Bezafibrate + UDCA (MD = 104.49, 95% CI: 60.41 to 161.92), Fenofibrate + UDCA (MD = 87.81, 95% CI: 52.34 to 129.79), and Obeticholic Acid (OCA) + UDCA (MD = 65.21, 95% CI: 8.99 to 121.80).
- Elafibranor + UDCA demonstrated the greatest improvement in ALP levels among all combination therapies, while OCA + UDCA showed the smallest improvement.
- There is no safety information available in the reviewed studies.
- There is no information available on population types or subgroups in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Livdelzi (seladelpar) Prescribing Information. | 2024 | Gilead Sciences, Inc., Foster City, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Optimal drug regimens for improving ALP biochemical levels in patients with primary biliary cholangitis refractory to UDCA: a systematic review and Bayesian network meta-analysis | 2024 | Systematic Reviews |