Itching from PSC and PBC

Learn more about our studies in itch in PSC and PBC

The VISTAS Study is seeking patients ages 12 and older with PSC to learn if the investigational medication, volixibat, might be an effective and safe treatment option for itch due to PSC.

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The VANTAGE Study is seeking patients ages 18 and older with PBC to learn if the investigational medication, volixibat, might be an effective and safe treatment option for itch due to PBC.

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What are some differences and similarities between PSC and PBC?

Primary sclerosing cholangitis (PSC)¹

Damages the bile ducts inside and outside the liver
Frequently associated with inflammatory bowel disease (IBD)
PSC is more common in men, but can also affect women and children
A common symptom from PSC is itching

Primary biliary cholangitis (PBC)²

Damages the bile ducts inside the liver
PBC affects mostly women, but can also affect men
A common symptom from PBC is itching

Pruritus, or itching, is one of the most common symptoms reported by 80-100%
of patients with cholestatic liver disease, which includes PSC and PBC.3

Patients with PSC or PBC who itch don’t have a rash. They often scratch all over their body to relieve their itch. The itch often affects their quality of life, leading to lack of sleep, depression, social isolation, and more.3

Currently, there are no approved or effective medications to treat PSC- or PBC-associated itch.⁴

What is volixibat?⁵

Volixibat is an investigational medicine being studied to help with itching in people with PSC and PBC. It works by blocking a protein in the small intestine that normally returns bile acids to the liver. Instead, the bile acids leave the body through stool. This may lower bile acid levels in the blood, which could help protect the liver from damage. Volixibat mostly stays in the gut and does not enter the bloodstream. It can be taken with most other PSC and PBC medicines.

For illustrative purposes only.

What is a clinical study?⁶

A clinical study, also called a clinical trial, is a research test to see if an investigational medicine is safe and effective in human volunteers. It compares the investigational medicine to a placebo (a treatment with no active ingredients). These medicines have not been approved by the FDA (Food and Drug Administration) or other health organizations. However, they can still be given to people as part of the study. Participants play a vital role in advancing medicine for current and future generations.

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company conducting clinical studies to investigate a potential treatment for itch associated with PSC and PBC in pediatric and adult individuals.

For more information about Mirum, please visit MirumPharma.com.

References

1. Mayo Clinic. Primary sclerosing cholangitis. Updated October 5, 2022. Accessed February 10, 2025. https://www.mayoclinic.org/diseases-conditions/primary-sclerosing-cholangitis/symptoms-causes/syc-20355797. 2. Mayo Clinic. Primary biliary cholangitis. Accessed February 10, 2025. https://www.mayoclinic.org/diseases-conditions/primary-biliary-cholangitis/symptoms-causes/syc-20376874. 3. Patel SP, Vasavda C, Ho B, Meixiong J, Dong X, Kwatra SG. Cholestatic pruritus: Emerging mechanisms and therapeutics. J Am Acad Dermatol. 2019;81(6):1371-1378. doi:10.1016/j.jaad.2019.04.035. 4. Zakharia K, Tabibian A, Lindor KD, Tabibian JH. Complications, symptoms, quality of life and pregnancy in cholestatic liver disease. Liver Int. 2018;38: 399–411. https://doi.org/10.1111/liv.13591. 5. National Center for Biotechnology Information. PubChem Compound Summary for CID 24987688, Volixibat. Accessed Feb. 12, 2025. https://pubchem.ncbi.nlm.nih.gov/compound/Volixibat. 6. World Health Organization. Clinical trials. WHO. Accessed February 12, 2025. https://www.who.int/health-topics/clinical-trials#tab=tab_1.

Learn more about our clinical studies, including  the option to have all study visits completed at home: