Where primary biliary cholangitis treatment is heading

Primary biliary cholangitis (PBC) is an autoimmune liver disease that slowly destroys the small bile ducts, mostly in women over 40; several thousand Americans are diagnosed each year. Untreated it can lead to cirrhosis, and many people have severe itch and fatigue. Ursodiol works for most, but about 1 in 3 need more. Since 2024, two PPAR pills (seladelpar, elafibranor) and a drug for itch (linerixibat) have been approved, and trials now test whether they prevent cirrhosis.

• 48studies open or running
• 18phase 3 trials
• 459papers published this year
• 20NIH-funded projects

1. Now

   Nov 2026

   Two new second-line pillsHappened 61.7% biochemical response

   Seladelpar (61.7% vs 20.0% response) and elafibranor (51% vs 4%) were approved in 2024.

   61.7%: biochemical response at 12 months, vs 20.0% with placebo.

   • RESPONSE trial (seladelpar)
   • ELATIVE trial (elafibranor)

   A drug for PBC itchHappened -2.86 itch score change

   Linerixibat eased itch more than placebo (-2.86 vs -2.15); diarrhea was common.

   -2.86: point change in itch score, vs -2.15 with placebo.

   • GLISTEN trial (linerixibat)

   Updated US guidelinesHappened

   The 2026 AGA/AASLD guideline incorporates the new drugs, including linerixibat for itch.

   • 2026 AGA/AASLD guideline

2. 6 months

   by May 2027

   A third PPAR drugPossible

   Zydus' saroglitazar is under FDA review, with more trials under way.

   • EPICS-IV

3. 12 months

   by Nov 2027

   Another itch drugPossible

   Mirum's volixibat VANTAGE (333 people) is due January 2027.

   • VANTAGE

   Fibrates as a cheaper optionPossible

   BEZURSO 2 tests bezafibrate doses added to ursodiol; due December 2027.

   • BEZURSO 2

4. 3 years

   by late 2029

   Do the new drugs prevent liver failure?Possible 51% response (ELATIVE)

   Ipsen's ELFIDENCE (276 people) tracks long-term outcomes with elafibranor; due May 2029.

   51%: biochemical response at 52 weeks, vs 4% with placebo.

   • ELATIVE trial (elafibranor)
   • ELFIDENCE

   Combining drug typesLong shot

   Gilead tests seladelpar with cilofexor, an FXR agonist; due December 2028.

   • Seladelpar-cilofexor trial

5. 5 years

   by late 2031

   Seladelpar in cirrhosisPossible 61.7% response (RESPONSE)

   Gilead's AFFIRM (402 people) tests whether seladelpar prevents complications in people with cirrhosis; due August 2030.

   61.7%: biochemical response at 12 months, vs 20.0% with placebo.

   • RESPONSE trial (seladelpar)
   • AFFIRM

The research paths

Borrowed from other conditions

Open to join now

• PBC with compensated cirrhosis

  Seladelpar

  Phase 3 · 218 sites

  Locations and eligibility →

• PBC

  Elafibranor

  Phase 3 · 198 sites

  Locations and eligibility →

• PBC not responding to ursodiol

  CS0159

  Phase 3 · 41 sites

  Locations and eligibility →

• PBC

  Seladelpar plus cilofexor

  Phase 2 · 4 sites

  Locations and eligibility →

See every recruiting PBC trial →

When the trials finish

Completion dates the trials registered. Results usually follow 3 to 12 months later.

What just happened

Standard treatment today

• First treatmentUrsodiol (UDCA), lifelong.
• Not responding to ursodiolAdd seladelpar or elafibranor; fibrates off-label.
• Severe itchLinerixibat, cholestyramine, rifampicin or sertraline; seladelpar may help.
• Cirrhosis or liver failureSpecialist care; liver transplant, with excellent results.

See PBC trials recruiting now →