Gilead Sciences reported new long-term Phase 3 ASSURE data showing Livdelzi® (seladelpar) achieved durable alkaline phosphatase (ALP) normalization in primary biliary cholangitis (PBC) patients inadequately controlled on prior therapy, reinforcing efficacy, safety, and global approvals.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Gilead Sciences released new long-term findings from the ongoing Phase 3 ASSURE study (NCT03301506) showing that Livdelzi® (seladelpar) achieved high and sustained rates of alkaline phosphatase (ALP) normalization in patients with primary biliary cholangitis (PBC) inadequately controlled on prior therapy. The post hoc analysis will be presented at the European Association for the Study of the Liver Congress 2026 in Barcelona.
Durable Biochemical Response
The analysis focused on patients with baseline ALP levels between 1.0 and 1.67 times the upper limit of normal (ULN), a subgroup historically underrepresented in randomized PBC trials. Among 50 evaluable participants, 83% achieved composite ALP normalization at 12 months, while 74% sustained the response at 24 months. The composite endpoint was defined as ALP ≤1×ULN with at least a 15% reduction from baseline, supporting durable biochemical disease control.
Clinical Importance of ALP Normalization
The findings are clinically important because persistent ALP elevation strongly correlates with disease progression and poorer long-term outcomes in PBC, a chronic autoimmune liver disease that can progress to cirrhosis, liver failure, and transplantation.
Livdelzi is an oral peroxisome proliferator-activated receptor delta (PPAR-δ) agonist that targets inflammatory and cholestatic pathways involved in PBC. Previous studies also demonstrated antipruritic and antifibrotic activity, supporting both biochemical disease control and symptom improvement.
Investigators also observed sustained reductions in gamma-glutamyl transferase levels, while total bilirubin remained stable throughout follow-up.
Safety and Liver Stiffness Outcomes
Livdelzi remained generally well tolerated, with no treatment discontinuations attributed to adverse events and no new safety signals reported over two years of follow-up.
A separate exploratory analysis across the broader ASSURE population showed that 85% of participants who achieved biochemical response at 12 months maintained or improved liver stiffness measurements through three years. Liver stiffness is widely used as a non-invasive marker associated with long-term hepatic outcomes, supporting Livdelzi’s potential long-term hepatic benefit.
Global Regulatory Position
Livdelzi is approved for adults with PBC who show inadequate response or intolerance to ursodeoxycholic acid (UDCA) in the United States, European Union, United Kingdom, Canada, Australia, Switzerland, and Israel.
These long‑term findings complement pivotal RESPONSE data, which established Livdelzi’s efficacy and safety profile and supported its global approval
The long-term ASSURE findings continue to expand clinical evidence supporting sustained biochemical control and symptom improvement across broader and higher-risk PBC populations.
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About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.