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Primary biliary cholangitis (PBC) is an acquired, immune-mediated cholestatic liver disease. The condition is classified as multifactorial autoimmune rather than Mendelian, with no causative genes or Mendelian inheritance patterns documented in this packet. Five disease subtypes are listed in this packet — designated PBC 1 through PBC 5 — representing genetic susceptibility loci identified through genomic association studies rather than distinct clinical phenotypic variants.
Phenotypic data, characteristic clinical findings, and diagnostic methods are not established in this packet's structured fields.
PBC is an acquired autoimmune condition. No causative genes, molecular mechanism data, or Mendelian inheritance patterns are documented in this packet, consistent with its multifactorial immunological etiology.
Specific diagnostic criteria and structured diagnostic methods are not established in this packet's fields.
Three FDA-approved therapies for PBC carry active market status in this packet. Ursodiol (URSO 250) received NDA approval on December 10, 1997, and is currently marketed with active status. Elafibranor (IQIRVO) received NDA approval on June 10, 2024, and is currently marketed with active status. Seladelpar lysine (LIVDELZI) received NDA approval on August 14, 2024, and is currently marketed with active status.
59 trials found
Prognostic information is not established in this packet's structured fields.
Three clinical trials are documented in this packet. NCT04526665 is a Phase 3 study of elafibranor in patients with PBC, sponsored by Ipsen, currently active but not recruiting, with planned completion December 2028. NCT06016842 is a Phase 3 long-term study of elafibranor also sponsored by Ipsen, currently recruiting, with planned completion May 2029. NCT07795151 is a Phase 1 to Phase 2 trial investigating human umbilical cord mesenchymal stromal cells for UDCA-refractory PBC, sponsored by Beijing 302 Hospital, not yet recruiting as of this packet, with planned initiation August 2026 and planned completion August 2030.
Data assembled from 5 of 12 sources · Last updated Sep 18, 2026, 6:00 AM UTC
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AI-curated news mentioning primary biliary cholangitis
Updated Sep 11, 2026
A recent study explores cognitive and affective predictors of exertion-related fatigue in patients with primary biliary cholangitis. This research contributes to understanding the psychosocial factors influencing fatigue in this patient population.
The Scottish Medicines Consortium has accepted Livdelzi for the treatment of primary biliary cholangitis, enhancing treatment options for patients suffering from chronic itch associated with the disease. This decision marks a significant step in addressing the unmet needs of this patient population.
A recent study establishes meaningful improvement thresholds for pruritus and sleep disturbance in primary biliary cholangitis (PBC) using the Worst Itch and Sleep Interference Numerical Rating Scales. This research provides valuable insights for assessing treatment efficacy in PBC patients.
A recent study published in PubMed examines real-world treatment patterns and clinical outcomes for patients with primary biliary cholangitis in the United States. The findings provide insights into the effectiveness of current therapies and patient management strategies.
The CHMP has recommended Lynavoy for EU approval as the first IBAT inhibitor targeting cholestatic pruritus in primary biliary cholangitis (PBC). This marks a significant advancement in treatment options for patients suffering from this rare condition.