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Background: <p>Primary Biliary Cholangitis (PBC) is a cholestatic autoimmune liver disease of small bile ducts. Ursodeoxycholic acid (UDCA) was approved as a first line therapeutic option for PBC in 1997. It was later noted that 40% of patients with PBC are either non-responders or intolerant to UDCA. In 2016, obeticholic acid (OCA) was approved as a second-line therapy for PBC. However, due to the side effects associated with OCA and the FDA restricting its use in patients with cirrhosis, there was a need for additional therapies.</p> Aims: <p>This review summarizes the current literature regarding the new and emerging therapies for patients with PBC.</p> Key Findings: <p>In 2024, two new therapies, elafibranor and seladelpar were approved as a second-line treatment for PBC. In 2025 OCA was withdrawn from the market. Multiple additional therapies targeting biochemical remission are under investigation. Furthermore, a new class of medication, ileal bile acid transporter inhibitors (IBAT inhibitors), is being studied for pruritus among these patients.</p> Conclusion: <p>The therapeutic landscape for PBC has been rapidly evolving with the discovery of second-line agents. Ongoing trials studying biochemical response, symptom control and long-term clinical outcomes among patients with PBC will be beneficial.</p>

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New therapies for primary biliary cholangitis

  • 期刊论文

  • 发表日期：

    2026年5月8日

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  • Aalam Sohal,
  • Mariam Alamgir,
  • Kris V. Kowdley

摘要

Background:

Primary Biliary Cholangitis (PBC) is a cholestatic autoimmune liver disease of small bile ducts. Ursodeoxycholic acid (UDCA) was approved as a first line therapeutic option for PBC in 1997. It was later noted that 40% of patients with PBC are either non-responders or intolerant to UDCA. In 2016, obeticholic acid (OCA) was approved as a second-line therapy for PBC. However, due to the side effects associated with OCA and the FDA restricting its use in patients with cirrhosis, there was a need for additional therapies.

Aims:

This review summarizes the current literature regarding the new and emerging therapies for patients with PBC.

Key Findings:

In 2024, two new therapies, elafibranor and seladelpar were approved as a second-line treatment for PBC. In 2025 OCA was withdrawn from the market. Multiple additional therapies targeting biochemical remission are under investigation. Furthermore, a new class of medication, ileal bile acid transporter inhibitors (IBAT inhibitors), is being studied for pruritus among these patients.

Conclusion:

The therapeutic landscape for PBC has been rapidly evolving with the discovery of second-line agents. Ongoing trials studying biochemical response, symptom control and long-term clinical outcomes among patients with PBC will be beneficial.