Last reviewed 2026-04-20 · How we verify

Livdelzi (SELADELPAR)

Livdelzi works by inhibiting the activity of a specific enzyme involved in the progression of liver disease.

Livdelzi, developed by Gilead Sciences Inc, is a marketed drug for Primary Biliary Cholangitis (PBC) that inhibits a specific enzyme involved in liver disease progression. Its key strength lies in its unique mechanism of action and the protection afforded by its key composition patent, which expires in 2028. The primary risk is the lack of significant revenue data, which may impact its market positioning and investor confidence.

At a glance

Mechanism of action

Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta (δ) agonist. However, the mechanism by which seladelpar exerts its therapeutic effects in patients with PBC is not well understood. Pharmacological activity that is potentially relevant to therapeutic effects includes inhibition of bile acid synthesis through activation of PPARδ, which is a nuclear receptor expressed in most tissues, including the liver. Published studies show that PPARδ activation by seladelpar reduces bile acid synthesis through Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol.

Approved indications

• Primary Biliary Cholangitis (PBC)

Common side effects

• Headache
• Abdominal pain
• Nausea
• Abdominal distension
• Dizziness
• Fractures
• Decreased estimated glomerular filtration rate (eGFR)
• Dyspepsia
• Rash
• Alopecia
• Anemia
• Cough

Drug interactions

• Probenecid
• Strong CYP2C9 Inhibitors
• Dual Moderate CYP2C9 and Moderate or Strong CYP3A4 Inhibitors
• CYP2C9 Poor Metabolizers using Moderate or Strong CYP3A4 Inhibitors
• Dual or Multiple Clinical Inhibitors of Drug Transporters OATP1B1, OATP1B3, and BCRP
• Rifampin
• Bile Acid Sequestrants

Key clinical trials

• Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (PHASE3)
• A Prospective, Open-label, Single-arm, Investigator-initiated Study (SELIC) to Evaluate the Efficacy and Safety of Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (IC).
• Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC) (PHASE3)
• Monitoring the Response of Combination Ursodiol and Seladelpar Treatment
• Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) (PHASE3)
• An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) (PHASE1)
• Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC) (PHASE2)
• A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC (PHASE2)

Patents

Primary sources

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