Livdelzi (seladelpar) / Gilead, Kaken Pharma - LARVOL DELTA

Single and Multiple Doses of Seladelpar Decrease Diurnal Markers of Bile Acid Synthesis in Mice. (PubMed, PPAR Res) - "No changes in nuclear receptors, clock genes, and sex-specific genes were observed. Overall, these results are consistent with a model where seladelpar treatment reduces bile acid synthesis by upregulating Fgf21 and modulating other PPAR-responsive genes."

Journal • Preclinical • Cholestasis • FGF21 • PDK4

Seladelpar treatment of patients with primary biliary cholangitis improves the GLOBE score and predicts improved transplant-free survival (EASL 2025) - No abstract available

Clinical • Hepatology • Immunology • Primary Biliary Cholangitis • Transplantation

Safety of seladelpar in primary biliary cholangitis patients with cirrhosis and clinical signs of portal hypertension: data from the ENHANCE and RESPONSE studies (EASL 2025) - No abstract available

Clinical • Cardiovascular • Fibrosis • Hepatology • Immunology • Portal Hypertension • Primary Biliary Cholangitis

Gilead: Creating change today: Lowering risk, lowering burden of PBC in practice (EASL 2025) - "Sponsored by Gilead. This session aims to provide practical guidance and expert insights on the use of seladelpar in the clinical practice."

Primary Biliary Cholangitis

Gilead: Creating change today: Lowering risk, lowering burden of PBC (EASL 2025) - "Sponsored by Gilead. Describe the overall epidemiology and holistic burden of PBC from a biochemical, symptomatic and patient perspectiveExamine the current landscape for the diagnosis and treatment of PBC, including current unmet needs, challenges and future treatment goalsEvaluate evolving options for second line treatment of PBC, including Seladelpar, and opportunities to optimise outcomes for patients"

Primary Biliary Cholangitis

Pharmacokinetics, safety, and tolerability of seladelpar in people with renal impairment (EASL 2025) - No abstract available

Clinical • PK/PD data • Renal Disease

Evaluation of the potential impact of seladelpar on the pharmacokinetics of midazolam, tolbutamide, simvastatin, rosuvastatin, and atorvastatin (EASL 2025) - No abstract available

PK/PD data

Efficacy and safety of seladelpar in patients previously treated with fibrates or OCA (EASL 2025) - No abstract available

Clinical

Seladelpar treatment of patients with primary biliary cholangitis improves the GLOBE score and predicts improved transplant-free survival (EASL 2025) - No abstract available

Clinical • Hepatology • Immunology • Primary Biliary Cholangitis • Transplantation

Safety of seladelpar in primary biliary cholangitis patients with cirrhosis and clinical signs of portal hypertension: data from the ENHANCE and RESPONSE studies (EASL 2025) - No abstract available

Clinical • Cardiovascular • Fibrosis • Hepatology • Immunology • Portal Hypertension • Primary Biliary Cholangitis

The role of Seladelpar in primary biliary cholangitis: a systematic review and meta-analysis. (PubMed, BMC Gastroenterol) - "Seladelpar appears to be an effective treatment for PBC, demonstrating significant improvements in key liver function markers. While it has shown therapeutic benefits, further research is warranted to evaluate its long-term safety, particularly regarding adverse event incidence, and to determine its efficacy across different dosages."

Clinical • Journal • Retrospective data • Review • Cholestasis • Hepatology • Immunology • Liver Failure • Pain • Primary Biliary Cholangitis

AFFIRM: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (clinicaltrials.gov) - P3 | N=318 | Recruiting | Sponsor: Gilead Sciences | N=192 ➔ 318 | Trial completion date: Jul 2029 ➔ Aug 2030 | Trial primary completion date: Jul 2029 ➔ Aug 2030

Enrollment change • Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis

Breaking Grounds: A Comprehensive Analysis of Cutting-Edge Treatments for Primary Biliary Cirrhosis/Primary Biliary Cholangitis With Futuristic Treatments. (PubMed, Cureus) - P2, P3 | "Treatment options have progressed from ursodeoxycholic acid (UDCA) and obeticholic acid (OCA) to liver and stem cell transplant...Elafibranor, a recently FDA-approved agent based on its efficacy, was shown in the ELATIVE trial. Seladelpar, currently under FDA review in the ENHANCE III trial, is also used in PBC...The question of whether we use immunotherapy has been answered in the NCT02376335 and NCT00746486 trials, stating that rituximab and budesonide cannot be used as no clinical significance is observed. The emergence of new therapies and the potential of combination treatments offer hope for improving outcomes for all patients with PBC. Personalized treatment strategies, continuous monitoring, and a comprehensive approach to symptom management are key to optimizing care and enhancing the quality of life for individuals affected by this chronic liver disease."

IO biomarker • Journal • Review • Bone Marrow Transplantation • Cholestasis • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Primary Biliary Cholangitis • Transplantation

The Efficacy and Safety of Seladelpar in the Asian Subpopulation of Patients With Primary Biliary Cholangitis: Results From the RESPONSE and ASSURE Studies (APASL 2025) - P1, P2, P3 | " Patients with PBC and inadequate response or intolerance to ursodeoxycholic acid received daily oral seladelpar 10 mg or placebo (PBO; 2:1 randomization) for 12 months (M) in RESPONSE. Seladelpar reduced biomarkers of cholestasis among Asian and non-Asian patients in the RESPONSE and ASSURE trials. Seladelpar was overall safe and well tolerated in Asian patients. Table and Figure:Figure 1.Figure 1."

Clinical • Late-breaking abstract • Cholestasis • Hepatology • Immunology • Primary Biliary Cholangitis

Long-Term Efficacy and Safety of Open-Label Seladelpar Treatment in Patients With Primary Biliary Cholangitis: Pooled Interim Results for up to 3 Years From the ASSURE (APASL 2025) - P1, P2, P3 | "The parent studies required an inadequate response or intolerance to first-line ursodeoxycholic acid. By M30 of the long-term ASSURE study, seladelpar resulted in a durable and sustained biochemical response in 81% of pts, with an ALP normalization rate of 41%, and robust improvement in pruritus. Seladelpar continues to appear safe and well tolerated, with no new safety signals or change in frequency of AEs with up to 3 years of exposure. Table and Figure:Figure 1.(A) Composite Biochemical Response Rate Through Month 30, (B) ALP Normalization Through Month 30, (C) ALP Percentage Change From BL Through Month 30, and (D) Pruritus NRS Change From BL Through Month 6"

Clinical • Dermatology • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Attenuation, Near Resolution, and Prevention of Pruritus in Patients With Primary Biliary Cholangitis Treated With Seladelpar: A Secondary Analysis of Patterns of Pruritus Change in the RESPONSE Trial (APASL 2025) - P3 | " Patients with PBC who received ursodeoxycholic acid (UDCA) for ≥12 months or were UDCA intolerant and had alkaline phosphatase ≥1.67 × upper limit of normal (ULN) and total bilirubin ≤2 × ULN were randomized 2:1 to receive daily oral seladelpar 10 mg or placebo for 12 months. Seladelpar reduced pruritus severity in patients with PBC with a durable effect over time and even led to near resolution of itch in some patients, an effect not observed with placebo. Seladelpar mitigated new onset of itch in patients without pruritus and was overall safe and well tolerated regardless of baseline itch. Table and Figure:Figure 1.Mean Pruritus NRS Over Time and Declines in NRS in Patients With PBC With Moderate to Severe Pruritus (NRS ≥4) in the RESPONSE Trial"

Clinical • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis and Compensated Cirrhosis in the Phase 3 Placebo-Controlled RESPONSE Trial (APASL 2025) - P3 | " Patients with PBC with an inadequate response or intolerance to ursodeoxycholic acid, ALP ≥1.67 × ULN, and total bilirubin ≤2 × ULN received daily oral seladelpar 10 mg or placebo (2:1 randomization) for 12 months. Seladelpar reduced biomarkers of cholestasis and liver injury in patients with PBC with compensated cirrhosis and in patients without cirrhosis. Seladelpar was overall safe and well tolerated in patients with and without cirrhosis. Table and Figure:Figure 1.Changes in ALP in Patients With PBC With or Without Cirrhosis at Baseline Treated With Seladelpar or Placebo in the RESPONSE Trial"

Clinical • P3 data • Cholestasis • Fibrosis • Hepatology • Immunology • Liver Failure • Primary Biliary Cholangitis

Alkaline Phosphatase Changes With Seladelpar Across Subgroups of Primary Biliary Cholangitis Patients in the RESPONSE Trial (APASL 2025) - P3 | " Patients with PBC who received ursodeoxycholic acid (UDCA) for ≥12 months or were UDCA intolerant and had ALP ≥1.67 × ULN and TB ≤2 × ULN were randomized 2:1 to daily seladelpar 10 mg or placebo. Seladelpar led to robust and consistent ALP decreases across all subgroups studied. Substantial ALP decreases were also observed in patients who did not meet the composite endpoint criteria at month 12. Seladelpar was overall safe and well tolerated, regardless of baseline ALP level."

Clinical • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis

Long-Term Safety of Seladelpar 10 mg With Up to 5 Years of Treatment in Patients With Primary Biliary Cholangitis (APASL 2025) - P3 | "The Phase 3, placebo-controlled RESPONSE study (NCT04620733) in patients with PBC with an inadequate response or intolerance to ursodeoxycholic acid demonstrated significant improvements in cholestatic markers and pruritus with seladelpar over 1 year. Analysis of a large safety database for seladelpar in PBC patients with exposure through 5 years indicated that seladelpar was well tolerated with a safety profile similar to that of placebo. Table and Figure:Figure 1."

Clinical • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study (APASL 2025) - P3 | " Eligible patients had ursodeoxycholic acid (UDCA) treatment for ≥12 months or were intolerant and had alkaline phosphatase (ALP) ≥1.67 × upper-limit-of-normal (ULN) and total bilirubin (TB) ≤2 × ULN. In this placebo-controlled pivotal trial of patients with PBC and incomplete response or intolerance to UDCA, seladelpar 10 mg for 12 months resulted in rapid, statistically significant, and durable improvements in markers of cholestasis and liver injury, and improved pruritus. Seladelpar appeared overall safe and well tolerated through Month 12. The long-term safety and tolerability are being evaluated in an open-label trial (NCT03301506)."

Clinical • P3 data • Cholestasis • Dermatology • Hepatology • Immunology • Liver Failure • Primary Biliary Cholangitis • Pruritus

IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) (clinicaltrials.gov) - P3 | N=90 | Recruiting | Sponsor: Gilead Sciences | N=150 ➔ 90 | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Hepatology • Immunology • Primary Biliary Cholangitis

An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Gilead Sciences | Recruiting ➔ Completed

Trial completion • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Primary Biliary Cholangitis

Seladelpar for the Treatment of Primary Biliary Cholangitis. (PubMed, Ann Pharmacother) - "Seladelpar is a safe and effective treatment for PBC and fills a significant unmet need. Seladelpar's clinical benefit predicted by improvement in surrogate endpoints may need confirmation for traditional FDA approval."

Journal • Review • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENTS IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: POOLED INTERIM RESULTS FOR UP TO 3 YEARS FROM THE ASSURE STUDY (DDW 2025) - No abstract available

Clinical • Hepatology • Immunology • Primary Biliary Cholangitis

EFFICACY AND SAFETY OF SELADELPAR AS MONOTHERAPY IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS AND INTOLERANCE TO URSODEOXYCHOLIC ACID (DDW 2025) - No abstract available

Clinical • Monotherapy • Hepatology • Immunology • Primary Biliary Cholangitis