Evaluating the safety and efficacy of seladelpar for adults with primary biliary cholangitis
Abstract
Introduction Seladelpar (MBX-8025) is a once-daily administered highly specific PPAR-δ agonist in Phase 3 and extension trials for use in patients with primary biliary cholangitis (PBC).Areas covered This review provides background on current treatment options for PBC, and summarizes clinical trial data regarding the safety and effectiveness of seladelpar within the context of these treatments.Expert opinion Clinical trials results demonstrate the safety and tolerability of seladelpar use for PBC, including in patients with cirrhosis. The primary composite endpoint (ALP <1.67 times ULN, decrease ≥ 15% from baseline, and TB ≤ULN) was met in 61.7% of the patients treated with seladelpar and in 20% receiving placebo (p < 0.001). Moreover, pruritus – a cardinal and often intractable symptom of PBC – was improved with seladelpar treatment, as were overall quality of life measurements. Improvements in markers of inflammation were likewise observed. These biochemical and clinical findings therefore represent landmark developments in PBC treatment and offer a therapeutic option for PBC.
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Seladelpar has anti-inflammatory effects on hepatic macrophages and stellate cells, reducing pro-inflammatory cytokines and fibrogenic activity.
“Additionally, it has anti-inflammatory effects on hepatic macrophages and stellate cells, which in turn reduces pro-inflammatory cytokines and fibrogenic activity [44,45,46].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [46]
In patients with cirrhosis, close monitoring is recommended throughout seladelpar treatment.
“In patients with cirrhosis, close monitoring is recommended throughout treatment [46].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [46]
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- Authors
- Caines, A., Trudeau, S., & Gordon, S. C.
- Affiliations
- Henry Ford Health (US)
- Corresponding author
- Gordon, Stuart C.
- Venue
- Expert Opinion on Pharmacotherapy
- Publisher
- Informa UK Limited
- Published
- 2024-07-23
- Volume
- 25
- Issue
- 11
- Pages
- 1517-1523
- ISSN
- 1465-6566 (ISSN-L)
- 1744-7666
- OpenAlex
- W4401403357
- Cited by
- 7
- References
- 49
- Citations by year
- 2026: 3 · 2025: 4
- FWCI
- 0.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Expert Opinion on Pharmacotherapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Keywords
- seladelpar, primary biliary cirrhosis, PPARδ agonist, drug safety, drug efficacy, pruritus, quality of life, liver cirrhosis, alanine aminotransferase, treatment options
- MeSH terms
- Adult, Humans, Liver Cirrhosis, Biliary, Propionates, Pruritus, Quality of Life, Chalcones, PPAR delta
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