Learn about LIVDELZI

In a clinical study, LIVDELZI improved measures of PBC*

In participants taking LIVDELZI, about 6 out of 10 met the key study goal for PBC treatment by 12 months.† The key study goal was:

  • Alkaline phosphatase (ALP) less than 1.67 x the upper limit of normal (ULN)‡

  • ALP decreased by at least 15% from start of study

  • Maintained normal bilirubin levels

In the clinical study, reduction in ALP was evaluated as a secondary study goal

Provided rapid and sustained reduction in ALP (42% ALP reduction on average by 12 months from start of study, compared to 4% of participants in the placebo group)

LIVDELZI is the only PBC treatment that normalized ALP in 1 out of 4 participants by 12 months

LIVDELZI is the only PBC treatment proven to significantly reduce itch by 6 months

In the clinical study, LIVDELZI:  

  • Showed rapid itch reduction as early as month 1

  • Reduced PBC itch by ~2x more than in the placebo group (a mean change of -3.2 points on the Numerical Rating Scale [NRS]§ by 6 months with LIVDELZI vs -1.7 points in the placebo group)

LIVDELZI has an established safety profile across a broad range of people with PBC

The safety of LIVDELZI was studied in people with PBC in combination with or without UDCA. After the study was over, 96% of participants agreed to enter LIVDELZI’s ongoing safety study.

The most common side effects were:

  • headache

  • stomach pain

  • nausea

  • abdominal swelling

  • dizziness

You should tell your healthcare provider if you have any side effects that bother you or do not go away.

LIVDELZI is taken as a once-daily pill

The recommended dose of LIVDELZI is one 10-mg capsule, taken orally once daily. Take LIVDELZI exactly as your doctor tells you to.

  • Take LIVDELZI with or without food

  • Do not take more LIVDELZI than your healthcare provider tells you to

  • If you take too much LIVDELZI, call your healthcare provider or get emergency medical help right away

If you need more from your PBC treatment, ask your doctor if LIVDELZI could work for you.

In this clinical study of 193 people with PBC, LIVDELZI was given either with urso or alone. The results were compared with the placebo group, which included participants who took placebo (a treatment that does not contain medicine) with or without urso. In this study, 128 participants took LIVDELZI and 65 participants were in the placebo group.

†In the clinical study, 2 out of 10 participants in the placebo group met the key study goal for PBC treatment compared to about 6 out of 10 participants taking LIVDELZI.

‡ULN refers to the high end of the normal range of a lab results value.

§The NRS is a scale of 0-10 that measures itch severity, with 10 being the worst possible itch.

Participants evaluated in the study began the trial with NRS scores of ≥4.