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For many people with primary biliary cholangitis (PBC), itching can be one of the most frustrating and disruptive symptoms. It can affect sleep, mood, and quality of life. This itching, also called pruritus, can be mild for some people with PBC and severe for others. It may also come and go without obvious reason.
One myPBCteam member described just how unpredictable it can be: “Sometimes the itching is 10/10, sometimes absent when nothing else seems to have changed.” Another member said severe itching once made it take “hours to get to sleep.”
Research suggests that seladelpar, sold under the brand name Livdelzi, can reduce itching in some people with primary biliary cholangitis. Evidence comes from several clinical trials and analyses, rather than just one study.
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Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPAR-delta) agonist. It activates proteins that help control processes involving bile acids and inflammation.
The U.S. Food and Drug Administration (FDA) approved seladelpar in 2024 for adults with PBC who haven’t responded well enough to ursodeoxycholic acid (UDCA) or who can’t tolerate UDCA. UDCA is the standard first-line treatment for PBC.
More specifically, seladelpar can be used with UDCA when it hasn’t worked well enough, or it can be used alone in people who can’t tolerate UDCA.
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. Seladelpar isn’t FDA-approved specifically as an anti-itch medication. However, its effect on PBC-related itching has been an important finding in studies.
Itching in PBC can be difficult to treat. It also isn’t always like the occasional itch caused by dry skin.
People may itch on their hands, feet, scalp, face, back, or other areas. One myPBCteam member described itching on their “arms, head, neck, and face” that felt like “ants crawling over my face.”
Itching can also interfere with sleep. One member described back itching that “was so bad it felt like my skin was crawling. Took me hours to get to sleep.”
Research supports these experiences. Studies have linked more severe pruritus in PBC with poorer quality of life, including problems with sleep and emotional well-being.
If you’ve wondered why liver disease causes itching, the answer isn’t completely understood. PBC interferes with normal bile flow. Researchers believe changes caused by cholestasis can affect substances and nerve pathways that send itch signals to the brain.
This may help explain why liver disease itching doesn’t always match how severe PBC appears based on liver tests.
Seladelpar has been studied in several clinical trials involving people with PBC.
In a recent study, 193 adults received either 10 milligrams of seladelpar daily or a placebo, an inactive compound used for comparison.
The study mainly looked at liver blood tests. At 12 months, about 62 percent of people taking seladelpar reached the study’s main liver-test goal, compared with 20 percent taking placebo.
Researchers also looked at participants with moderate to severe itching. People taking seladelpar had a greater reduction in itching than those taking placebo. Another study confirmed evidence that seladelpar reduced itching in people with moderate to severe pruritus.
Researchers looked at combined results from two large clinical trials. They looked at 126 people living with PBC who had moderate to severe itching at the start of the study. They measured itching on a scale of zero to 10. On this scale, zero means no itching while 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 the average improvement was about 1 point greater with seladelpar.
A separate analysis of the RESPONSE trial found that seladelpar improved both itching and sleep disturbances related to itching.
That can be meaningful for people whose symptoms are worse at night. One myPBCteam member said they used guided meditation “to fall asleep and keep my mind off not feeling well, pain, and itching.” Another said an ice pack moved between itchy areas provides “some comfort.”
The ASSURE study has followed people from earlier seladelpar trials, providing more information about longer-term treatment and safety, showing positive results at up to two years.
Still, studies describe what happens across groups of people. They can’t predict exactly how one person will respond. A treatment that works well for one person may not work the same way for someone else.
If you’re considering treatment, you may have questions about Livdelzi 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:
The prescribing information also includes warnings about bone fractures, changes in liver tests, and bile duct blockage. Seladelpar is not recommended for people who have or develop decompensated cirrhosis, a severe stage of liver disease that can cause problems such as fluid buildup in the abdomen, bleeding from enlarged veins, or confusion.
Your doctor can review your liver health, other medical conditions, and medications to decide whether seladelpar is appropriate for you.
Commonly used medications for PBC itching, such as bile acid-binding resins, rifampin, selective serotonin reuptake inhibitors (SSRIs), and naltrexone, may not work for everyone and can have side effects. Additionally, linerixibat (Lynavoy) is an FDA-approved medication for itching associated with PBC in adults.
Seladelpar is different because it treats PBC itself while also showing an effect on pruritus in clinical trials.
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.
The evidence around seladelpar pruritus relief matters because pruritus in PBC can affect sleep, mood, and everyday life. Still, whether seladelpar is right for you depends on your response to UDCA, liver tests, symptoms, other health conditions, and medications.
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.
Tell your doctor where you itch, how severe it gets, whether it comes and goes, and whether it keeps you awake. Those details can help your healthcare team understand how much itching is affecting you.
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I'm in the same boat. My doc want3d me on this drug right away and I complied. The manufacturer will give u paperwork for types of discounts. I eventually am paying my total deductible by month… read more
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