Two phase 3 clinical trials have found that seladelpar significantly reduced pruritus (itching) in people living with primary biliary cholangitis (PBC) who had moderate to severe symptoms. Improvements were seen as early as one month after starting treatment and continued through six months.

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For many people with PBC, itching can be one of the most frustrating and disruptive symptoms. It can affect sleep, mood, and quality of life. By some estimates, around 81 percent of people with PBC experience itchy skin. There are currently no U.S. Food and Drug Administration (FDA)-approved treatments specifically for PBC-related itch. These findings may offer hope for people whose symptoms are not well controlled.

What Is Seladelpar?

Seladelpar, sold as Livdelzi, is a selective peroxisome proliferator-activated receptor delta (PPAR-delta) agonist. The FDA approved the drug in 2024 for the treatment of PBC in adults who haven’t found relief from ursodeoxycholic acid (UDCA) or who can’t tolerate UDCA. UDCA is the standard first-line therapy for PBC.

PBC is a chronic autoimmune liver disease in which the body’s immune system slowly damages the bile ducts in the liver. This damage can lead to cholestasis (impaired bile flow that leads to bile buildup). High bile acid levels are believed to play a role in itching.

Seladelpar works by activating PPAR-delta receptors. These are proteins in the body that help control how the liver processes bile acids and manages inflammation. By helping the liver handle bile acids more effectively and reducing inflammation, seladelpar may improve cholestasis. In turn, this may help slow liver damage and reduce itching symptoms.

What the Studies Found

Researchers combined results from two large phase 3 clinical trials. They looked at 126 people living with PBC who had moderate to severe itching at the start of the study.

• 76 people took a daily dose of seladelpar.
• 50 people took a placebo (an inactive pill).

Participants were followed for up to six months.

Study Found 50% Improvement in Itching

Researchers measured itching on a scale of 0 to 10. On this scale, a 0 means no itching while a 10 means the worst itching imaginable.

After six months, people taking seladelpar improved by a little more than 3 points on average. Those taking placebo improved by about 2 points on average. That means seladelpar reduced itching about 1 point more than placebo on a 10-point scale, roughly a 50 percent greater improvement.

Other Itch Measures Showed Similar Results

Researchers also used two other questionnaires that measure how itching affects daily life, sleep, and how much of the body is involved.

Across these tools:

• On the itchiness scale from 0 to 10, people taking seladelpar improved by about 1 point more than those taking placebo.
• On a more detailed itch questionnaire called the 5-D scale, the seladelpar group improved by about twice as much as the placebo group.

Improvements Started Early

Some people noticed improvement as early as the first month, and the benefits continued through the sixth month.

The greatest improvements were in sleep quality and a reduction in the body areas affected by itching.

Safety and Side Effects

In the clinical trials, side effects were reported at similar rates in both groups:

• About 76 percent of people taking seladelpar reported at least one side effect.
• About 80 percent of people taking placebo reported side effects.

This means overall side effects were not more common with seladelpar than with placebo in the studies.

Most Common Side Effects

According to the prescribing label, the most common side effects (reported in at least 5 percent of people and more often than with placebo) include:

• Headache
• Abdominal (stomach) pain
• Nausea
• Abdominal distension (bloating)
• Dizziness

These were generally mild to moderate in severity.

Less Common but Serious Risks

The prescribing information also lists important warnings:

• Bone fractures
• Changes in liver test results
• Biliary obstruction (when the bile duct becomes blocked)

As with any medication, side effects and risks vary from person to person. A treatment that works well for one person may not work the same way for someone else.

Why These Findings Matter for People With PBC

Itching in PBC can be difficult to treat. Commonly used medications — such as antihistamines, bile acid-binding resins, rifampin, selective serotonin reuptake inhibitors (SSRIs), and naltrexone — may not work for everyone and can have side effects.

Seladelpar is already used to treat the underlying liver disease in people who do not respond adequately to UDCA. A medication that could improve liver markers and reduce itching may change how providers approach PBC care.

Still, this analysis looked at results over six months, and longer-term outcomes will continue to be studied. Decisions about adding or changing treatment depend on many factors, including liver test results, symptom severity, and other health conditions.

If you’re living with PBC and itching is affecting your sleep or daily life, consider talking with your healthcare provider. They can help review your current treatment plan and discuss whether changes might be appropriate for you.

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