Lyvdelzi (Seladelpar)
PPAR Delta Agonist for Primary Biliary Cholangitis (PBC)
Lyvdelzi (seladelpar) is a prescription medication used to treat primary biliary cholangitis (PBC) in adults. It belongs to a class of drugs known as PPAR delta agonists and works by reducing bile acid accumulation and inflammation in the liver. This comprehensive guide covers dosage, side effects, drug interactions, storage, and important safety information based on international medical guidelines.
Quick Facts
Key Takeaways
- Lyvdelzi (seladelpar) is approved for adults with primary biliary cholangitis (PBC), either in combination with UDCA or as monotherapy for those who cannot tolerate UDCA.
- The recommended dose is one 10 mg capsule taken once daily by mouth, with or without food.
- Liver function tests must be monitored before and during treatment; treatment may be paused or stopped if liver function worsens.
- The most common side effect is abdominal pain (very common), followed by headache, nausea, and abdominal distension (common).
- Bile acid sequestrants must be taken at least 4 hours apart from Lyvdelzi to avoid reduced efficacy.
What Is Lyvdelzi and What Is It Used For?
Lyvdelzi contains the active substance seladelpar, which belongs to a class of medications called peroxisome proliferator-activated receptor delta (PPAR delta) agonists. This class of drugs represents an important therapeutic advance in the management of cholestatic liver diseases, addressing a significant unmet medical need for patients who do not respond adequately to existing treatments.
This medication is indicated for use in adults for the treatment of primary biliary cholangitis (PBC), a chronic autoimmune liver disease in which the bile ducts within the liver are gradually destroyed. This progressive destruction impairs the normal flow of bile, a digestive fluid that assists in the breakdown and absorption of fats and fat-soluble vitamins. When bile cannot flow properly into the digestive tract, it accumulates in the liver — a condition known as cholestasis — where it causes damage to liver tissue, inflammation, and progressive fibrosis.
Over time, untreated cholestasis can lead to significant deterioration of liver function, potentially progressing to cirrhosis and liver failure. PBC predominantly affects women, with a female-to-male ratio of approximately 9:1, and is most commonly diagnosed in middle-aged individuals between the ages of 40 and 60. The disease is characterized by elevated levels of alkaline phosphatase (ALP) and the presence of anti-mitochondrial antibodies (AMA) in the blood.
How Lyvdelzi Works
The active substance in Lyvdelzi, seladelpar, exerts its therapeutic effects through the selective activation of the PPAR delta receptor. This nuclear receptor is a protein that plays a central role in regulating several key physiological processes in the liver, including bile acid homeostasis, inflammatory responses, and fibrotic pathways.
When seladelpar binds to and activates the PPAR delta receptor, it triggers a cascade of beneficial effects. First, it downregulates the synthesis of bile acids by modulating the expression of genes involved in bile acid production, thereby reducing the overall bile acid pool. Second, it enhances bile secretion and flow, alleviating the cholestatic burden on the liver. Third, it exerts potent anti-inflammatory effects by suppressing pro-inflammatory cytokines and pathways within the liver parenchyma. Finally, it may help to reduce hepatic fibrosis by inhibiting the activation of hepatic stellate cells, which are primarily responsible for the deposition of extracellular matrix proteins that lead to scar tissue formation.
Lyvdelzi can be used in combination with ursodeoxycholic acid (UDCA), which is the established first-line treatment for PBC, or it can be used alone in patients who are unable to tolerate UDCA. In clinical trials, seladelpar demonstrated significant reductions in alkaline phosphatase (ALP) levels — a key biomarker of cholestatic liver disease — in patients with inadequate response to UDCA, as well as improvements in other liver biochemistry parameters.
Lyvdelzi does not cure PBC but helps manage the disease by reducing bile accumulation and liver inflammation. Continued treatment as directed by your healthcare provider is essential for optimal disease management.
What Should You Know Before Taking Lyvdelzi?
Contraindications
Lyvdelzi is contraindicated in patients with a known hypersensitivity to seladelpar or to any of the excipients listed in the product composition. Hypersensitivity reactions, though uncommon with this medication, can range from mild skin reactions to more serious systemic responses. If you have experienced an allergic reaction to any component of Lyvdelzi in the past, you must not take this medication.
As with all prescription medications, a thorough medical history and review of your current medication regimen should be conducted by your healthcare provider before initiating treatment with Lyvdelzi. This ensures that the medication is appropriate for your individual clinical situation and that potential risks are carefully weighed against the expected benefits.
Warnings and Precautions
Your doctor will perform blood tests before you start taking Lyvdelzi and at regular intervals during treatment to assess how well your liver is functioning. These liver function tests are critical for monitoring the safety of the medication and detecting any early signs of hepatotoxicity. If these tests show that your liver function is deteriorating, your doctor may temporarily interrupt treatment. If your liver recovers, treatment may be resumed under close medical supervision. However, if liver function worsens again after restarting the medication, your doctor may decide to permanently discontinue Lyvdelzi therapy.
Contact your doctor immediately if you develop any of the following symptoms during treatment, as they may indicate liver dysfunction or complete bile duct obstruction:
- Abdominal pain — persistent or worsening pain in the stomach area
- Jaundice — yellowing of the skin and whites of the eyes
- Dark urine — urine that is darker than usual
- Pale stools — unusually light-colored bowel movements
These symptoms may suggest worsening liver function, hepatitis, or complete biliary obstruction, all of which require urgent medical evaluation and potential treatment modification. It is essential that patients remain vigilant for these warning signs throughout the duration of therapy and report them to their healthcare provider without delay.
Use in Children and Adolescents
Lyvdelzi must not be given to children and adolescents under 18 years of age. The safety and efficacy of seladelpar in the pediatric population have not been established. PBC is exceedingly rare in children, and there are currently no clinical data to support the use of Lyvdelzi in patients under 18 years of age.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, it is essential that you consult your doctor or pharmacist before using Lyvdelzi. The safety profile of seladelpar during pregnancy and lactation has not been fully characterized in humans. Your healthcare provider will carefully assess the potential risks and benefits of continued treatment in the context of your individual clinical situation.
Women of childbearing potential should discuss appropriate contraceptive measures with their healthcare provider while taking Lyvdelzi. If you become pregnant during treatment, inform your doctor immediately so that a clinical decision regarding the continuation of therapy can be made promptly.
Driving and Operating Machinery
Lyvdelzi is not expected to affect your ability to drive, cycle, or operate tools and machinery. No studies assessing the effects of seladelpar on driving or machine operation have identified any concern. However, if you experience any side effects that impair your alertness or coordination, you should avoid driving or operating machinery until the symptoms resolve.
This medicine contains less than 1 mmol (23 mg) sodium per hard capsule, meaning it is essentially sodium-free. This is important for patients on a sodium-restricted diet.
How Does Lyvdelzi Interact with Other Drugs?
Drug interactions can significantly affect the efficacy and safety of medications. It is essential to tell your doctor, pharmacist, or nurse about all medicines you are currently taking, have recently taken, or may be planning to take, including over-the-counter medications and herbal remedies. The following table summarizes the most clinically relevant drug interactions with Lyvdelzi.
Major Interactions
Several medications have been identified as having clinically significant interactions with Lyvdelzi. Understanding these interactions is essential for safe and effective use of the medication. The most important interactions involve drugs that either alter the blood levels of seladelpar or whose own efficacy is affected when taken concurrently with Lyvdelzi.
| Drug | Type | Effect | Recommendation |
|---|---|---|---|
| Bile acid sequestrants (cholestyramine, colestipol, colesevelam) | Reduced absorption | May reduce the effectiveness of Lyvdelzi by binding to it in the gastrointestinal tract | Take Lyvdelzi at least 4 hours before or after bile acid sequestrants |
| Probenecid (gout treatment) | Pharmacokinetic | May alter the metabolism and excretion of Lyvdelzi | Inform your doctor; dose adjustment may be necessary |
| Ciclosporin (immunosuppressant) | Pharmacokinetic | May interfere with the pharmacokinetics of Lyvdelzi | Inform your doctor; monitoring may be required |
| Fluconazole (antifungal) | Increased exposure | May increase the amount of Lyvdelzi in the blood, raising the risk of side effects | Inform your doctor; dose adjustment or closer monitoring may be needed |
| Mifepristone | Increased exposure | May increase the amount of Lyvdelzi in the blood, raising the risk of side effects | Inform your doctor; use with caution |
Bile Acid Sequestrant Timing
If you are taking a bile acid sequestrant such as cholestyramine, colestipol, or colesevelam for cholesterol management, the timing of your Lyvdelzi dose is critical. Bile acid sequestrants are large molecular resins that bind substances in the gastrointestinal tract, and they can significantly reduce the absorption of Lyvdelzi if the two medications are taken too close together.
To avoid this interaction, you must take Lyvdelzi at least 4 hours before or 4 hours after taking your bile acid sequestrant. This separation allows sufficient time for Lyvdelzi to be absorbed from the gastrointestinal tract before the sequestrant can interfere with its bioavailability. If you are unsure about the timing of your medications, consult your doctor, pharmacist, or nurse for personalized guidance.
Medications That Increase Lyvdelzi Levels
Certain medications can inhibit the metabolic pathways responsible for the clearance of seladelpar from the body, leading to higher blood levels and a potentially increased risk of adverse effects. Fluconazole, an antifungal medication commonly used for yeast infections, and mifepristone have both been identified as drugs that can increase systemic exposure to seladelpar. If you are taking either of these medications, your doctor should be informed so that appropriate monitoring can be implemented and dose adjustments considered if necessary.
What Is the Correct Dosage of Lyvdelzi?
Always take this medicine exactly as your doctor, pharmacist, or nurse has instructed. Do not change your dose or stop taking Lyvdelzi without first consulting your healthcare provider. If you are unsure about any aspect of your dosing regimen, ask your doctor or pharmacist for clarification.
Adults
Standard Adult Dosage
Dose: 10 mg once daily
Form: Hard capsule, swallowed whole with water
Timing: Can be taken with or without food, at the same time each day
Use: In combination with UDCA, or alone if UDCA cannot be tolerated
The recommended dose of Lyvdelzi is one 10 mg capsule taken once daily. The capsule should be swallowed whole with water and must not be opened, crushed, or chewed. Taking the medication at the same time each day helps maintain consistent blood levels and supports adherence to the treatment regimen.
Lyvdelzi can be taken with or without food, providing flexibility in how patients incorporate the medication into their daily routine. The bioavailability of seladelpar is not significantly affected by food intake, so there is no requirement to take it in a fasted or fed state.
Lyvdelzi is typically prescribed as an adjunctive therapy alongside ursodeoxycholic acid (UDCA, also known as ursodiol), the established first-line treatment for PBC. For patients who cannot tolerate UDCA due to side effects or other contraindications, Lyvdelzi may be used as monotherapy. Your doctor will determine the most appropriate treatment approach based on your individual clinical circumstances.
Children and Adolescents
Pediatric Dosage
Not applicable. Lyvdelzi must not be given to children and adolescents under 18 years of age. The safety and efficacy of seladelpar in this population have not been established.
Elderly Patients
Elderly Dosage
Dose: No dose adjustment is required based on age alone
However, elderly patients are more likely to have impaired hepatic or renal function, and your doctor may monitor you more frequently. Individual dose adjustments should be based on clinical response and tolerability.
Missed Dose
If you forget to take your dose of Lyvdelzi, skip the missed dose and take your next dose at the usual scheduled time. Do not take a double dose to make up for the one you forgot. Taking a double dose could increase the risk of side effects without providing additional therapeutic benefit. If you frequently forget doses, consider setting a daily alarm or using a pill organizer to help you remember.
Overdose
If you have taken more than the prescribed dose of Lyvdelzi, contact your doctor, pharmacist, or nurse immediately. Symptoms of overdose may include dark urine or muscle pain. In the event of an overdose, seek medical advice promptly, even if you feel well, as some adverse effects may not manifest immediately. There is no specific antidote for seladelpar, and treatment of overdose is supportive and symptomatic.
Do not stop taking Lyvdelzi without speaking to your doctor, pharmacist, or nurse first. Abrupt discontinuation of treatment may lead to worsening of your underlying condition. Your healthcare provider will advise you on how to manage any changes to your treatment regimen safely.
What Are the Side Effects of Lyvdelzi?
Like all medicines, Lyvdelzi can cause side effects, although not everybody experiences them. The side effects listed below have been reported during clinical trials and post-marketing surveillance. Understanding the frequency and nature of potential side effects helps patients and healthcare providers make informed decisions about treatment and recognize when medical attention may be needed.
Side effects are classified according to the standard medical frequency categories established by the Council for International Organizations of Medical Sciences (CIOMS). These categories provide a standardized way to communicate how often side effects occur in the treated population.
Very Common
May affect more than 1 in 10 patients
- Abdominal pain — pain or discomfort in the stomach area. This is the most frequently reported side effect. It is usually mild to moderate in severity and may diminish over time as the body adjusts to the medication. If abdominal pain is severe, persistent, or accompanied by jaundice or dark urine, contact your doctor immediately as this may indicate a more serious condition.
Common
May affect up to 1 in 10 patients
- Headache — mild to moderate headaches that typically do not require discontinuation of therapy. Over-the-counter analgesics such as paracetamol (acetaminophen) may be used if necessary, but consult your doctor before taking any additional medications.
- Nausea — a feeling of sickness or the urge to vomit. This is usually transient and tends to improve with continued use. Taking Lyvdelzi with food may help reduce nausea in some patients.
- Abdominal distension — a sensation of bloating or fullness in the abdomen. This effect is generally mild and self-limiting.
The overall safety profile of Lyvdelzi observed in clinical trials was favorable, with most adverse events being mild to moderate in severity. Serious adverse events were uncommon. It is important to note that clinical trials are conducted under carefully controlled conditions, and the actual incidence of side effects in everyday clinical practice may vary.
If you experience any side effects not listed above, or if any of the described side effects become severe or persistent, inform your healthcare provider. Reporting suspected adverse reactions after authorization of the medicine is important, as it enables continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report suspected adverse reactions to their national pharmacovigilance authority.
Managing Common Side Effects
Many of the common side effects associated with Lyvdelzi can be managed with simple strategies. For abdominal pain, eating smaller, more frequent meals and avoiding fatty or spicy foods may help alleviate symptoms. Staying well hydrated and getting adequate rest can help manage headaches. If nausea is troublesome, taking Lyvdelzi with a light meal or snack may reduce its severity. However, if any side effect becomes severe, persistent, or troublesome, always consult your healthcare provider for personalized advice.
How Should You Store Lyvdelzi?
Proper storage of medications is essential to maintaining their efficacy and safety throughout their shelf life. Lyvdelzi should be stored under specific conditions to ensure that the active substance, seladelpar, remains stable and effective.
- Temperature: Store at temperatures not exceeding 30°C (86°F). Do not refrigerate or freeze.
- Access: Keep out of the sight and reach of children. The product comes in a child-resistant container for additional safety.
- Expiry date: Do not use this medicine after the expiry date printed on the container after "EXP." The expiry date refers to the last day of that month.
- Packaging: Lyvdelzi capsules are packaged in bottles with child-resistant closures. Each bottle contains 30 capsules. Keep the bottle tightly closed when not in use to protect the capsules from moisture.
- Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment.
If you notice any changes in the appearance of the capsules, such as discoloration, unusual odor, or physical damage, do not take the medication and consult your pharmacist for a replacement. Always check the expiry date before taking your medicine, particularly if the bottle has been open for an extended period.
What Does Lyvdelzi Contain?
Understanding the full composition of a medication is important, particularly for patients with known allergies or intolerances to specific excipients. Below is a complete list of the active and inactive ingredients contained in each Lyvdelzi 10 mg hard capsule.
Active Ingredient
Each hard capsule contains 10 mg of seladelpar.
Inactive Ingredients (Excipients)
Capsule contents: microcrystalline cellulose, mannitol, croscarmellose sodium, butylhydroxytoluene, magnesium stearate, colloidal silicon dioxide.
Capsule shell: gelatin, titanium dioxide, black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), indigotine (E132).
Black printing ink (marking "10" on capsule body): shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172).
White printing ink (marking "CBAY" on capsule cap): shellac (E904), propylene glycol (E1520), sodium hydroxide (E524), povidone (E1201), titanium dioxide.
Appearance and Pack Sizes
Lyvdelzi is a hard capsule with a dark blue opaque cap and a light grey opaque body. The cap is printed with "CBAY" in white ink and the body is printed with "10" in black ink. The capsules are packaged in bottles with child-resistant closures.
- Single pack: 1 bottle containing 30 capsules
- Multi-pack: 3 bottles containing a total of 90 capsules (3 bottles of 30 capsules each)
Not all pack sizes may be marketed in all countries. Your pharmacist can advise on the pack sizes available in your region.
Do not take Lyvdelzi if you are allergic to seladelpar or any of the other ingredients listed above. If you are unsure whether any ingredient may cause a reaction, consult your doctor or pharmacist before taking this medicine.
Frequently Asked Questions About Lyvdelzi
Lyvdelzi (seladelpar) is used to treat primary biliary cholangitis (PBC) in adults. PBC is a chronic liver disease in which bile ducts are gradually destroyed, leading to bile accumulation in the liver. Lyvdelzi can be used together with ursodeoxycholic acid (UDCA) or alone in patients who cannot tolerate UDCA. It works by activating the PPAR delta receptor, which helps regulate bile acid levels and reduce inflammation in the liver.
Lyvdelzi contains seladelpar, a selective PPAR delta agonist. When it binds to the PPAR delta receptor in liver cells, it triggers multiple beneficial effects: it reduces bile acid production, enhances bile flow, suppresses liver inflammation, and may help slow the progression of liver fibrosis (scarring). These combined actions address the core pathological processes underlying primary biliary cholangitis.
The most common side effect is abdominal pain, which affects more than 1 in 10 patients. Other common side effects include headache, nausea, and abdominal distension (bloating), each affecting up to 1 in 10 patients. Most side effects are mild to moderate and may improve over time. If you experience any side effects that are severe or persistent, inform your doctor.
Lyvdelzi can interact with several medications. If you take bile acid sequestrants (such as cholestyramine, colestipol, or colesevelam), you must take them at least 4 hours apart from Lyvdelzi. Probenecid and ciclosporin may affect how Lyvdelzi works, and fluconazole and mifepristone can increase the amount of Lyvdelzi in your blood. Always tell your doctor about all medications you are taking.
The safety of Lyvdelzi during pregnancy and breastfeeding has not been fully established. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before taking this medicine. Your healthcare provider will weigh the potential benefits against possible risks to determine the best course of action for your situation.
Store Lyvdelzi at temperatures not exceeding 30°C (86°F). Keep it out of the sight and reach of children in the original child-resistant container. Do not use the medicine after the expiry date printed on the bottle. Do not dispose of unused medicine in wastewater or household waste — ask your pharmacist about proper disposal.
References
This article is based on the following peer-reviewed sources and regulatory documents:
- European Medicines Agency (EMA). Lyvdelzi (seladelpar) — Summary of Product Characteristics (SmPC). Last updated 2025. Available at: www.ema.europa.eu
- Hirschfield GM, et al. Seladelpar efficacy and safety at 3 months in patients with primary biliary cholangitis: ENHANCE, a phase 3, randomized, double-blind, placebo-controlled study. Hepatology. 2024;79(2):397-410.
- Bowlus CL, et al. Long-term seladelpar treatment for primary biliary cholangitis: results from an international phase 3 trial. Journal of Hepatology. 2024;80(4):580-591.
- European Association for the Study of the Liver (EASL). EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. Journal of Hepatology. 2017;67(1):145-172.
- Lindor KD, et al. Primary Biliary Cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases (AASLD). Hepatology. 2019;69(1):394-419.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: WHO; 2023.
- Jones D, et al. Seladelpar (MBX-8025), a selective PPAR-delta agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2 trial. The Lancet Gastroenterology & Hepatology. 2017;2(10):716-726.
- Kremer AE, et al. Seladelpar improved measures of pruritus, sleep, and fatigue and decreased bile acids in patients with primary biliary cholangitis. Liver International. 2022;42(1):112-123.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians and pharmacologists specializing in hepatology, gastroenterology, and clinical pharmacology.
iMedic Medical Editorial Team — specialists in hepatology and gastroenterology with documented academic and clinical experience.
iMedic Medical Review Board — independent panel of medical experts reviewing all content according to EMA, FDA, EASL, and AASLD guidelines.
Level 1A — based on systematic reviews, randomized controlled trials, and regulatory agency assessments (GRADE framework).
No commercial funding. No pharmaceutical sponsorship. Independent medical editorial content with full transparency.