Iqirvo (elafibranor) / Genfit, Ipsen - LARVOL DELTA

Exploratory Changes in FibroScan Liver Stiffness After Elafibranor or Seladelpar Therapy in Primary Biliary Cholangitis (ACG 2026) - "Thirteen patients had baseline FibroScan data, including 7 with paired 6-month LSM and 7 with paired 12-month LSM. Median LSM decreased from 8.7 kPa [IQR, 7.95-9.35] to 6.1 [5.25-10.3] at 6 months, with median change -2.2 kPa [-2.55 to -0.7] and percent change -21.8% [-33.9 to -7.3] (p=0.1508). At 12 months, median LSM decreased from 8.6 [8.0-8.65] to 6.6 [5.6-7.75], with median change -1.6 kPa [-3.0 to -0.7] and percent change -23.3% [-31.6 to -8.6] (p=0.0754)."

Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis

Characteristics of Clinical Studies on Primary Biliary Cholangitis Registered in ClinicalTrials.gov: A Cross-Sectional Analysis (ACG 2026) - "Ursodeoxycholic acid (UDCA) remains first-line therapy, with obeticholic acid used for inadequate responders. Recent approvals of PPAR agonists seladelpar and elafibranor reflect a rapidly evolving therapeutic landscape... A total of 219 PBC studies were identified, representing 0.037% of 587,109 total CTG studies, with 63 (28.7%) ongoing. Of all PBC studies, 166 (75.8%) were interventional and 146 (66.7%) were pharmacological. Industry funding was significantly higher in PBC compared to all CTG (40.2% vs 28.1%; OR 1.73, 95% CI 1.32â2.26, p< 0.001), while NIH funding was significantly lower (3.7% vs 7.4%; OR 0.21, 95% CI 0.11â0.44, p< 0.001)."

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

Comparative Real-World Likelihood of Complete Alkaline Phosphatase Normalization With Obeticholic Acid Versus Elafibranor in Primary Biliary Cholangitis (ACG 2026) - "Introduction: In patients with Primary Biliary Cholangitis (PBC) who respond inadequately to first-line Ursodeoxycholic Acid (UDCA), reducing Alkaline Phosphatase (ALP) is essential to slowing disease progression. Propensity matching generated two balanced cohorts of 444 patients each (N=888 total). The post-match cohorts were identical in age (mean 61.3 vs. 61.2 years) and female sex (92.8% vs."

Clinical • Real-world • Real-world evidence • Hepatology • Immunology • Primary Biliary Cholangitis

Real-World Biochemical and Symptomatic Outcomes of PPAR Agonists in Primary Biliary Cholangitis (ACG 2026) - "We evaluated biochemical and symptomatic outcomes following Seladelpar and Elafibranor therapy. Twenty-six patients were included in the study (96% female,77% white, mean age 61yrs). Five patients (19%) were not on therapeutic dose of Ursodiol at the time of initiation of second-line agents. Nine patients had evidence of cirrhosis of whom 6 had evidence of portal hypertension."

Clinical • Real-world • Real-world evidence • Cardiovascular • Cholestasis • Fibrosis • Hepatology • Immunology • Liver Failure • Portal Hypertension • Primary Biliary Cholangitis • Pruritus

Elafibranor Is Effective in Real-World Settings in Patients With Primary Biliary Cholangitis Who Switched Treatment From Obeticholic Acid (ACG 2026) - P3 | "In total, 59 pts switched from OCA to ELA vs 305 ELA only; of these, 14 (Cohort 1) vs 108 (Cohort 2) met the full inclusion criteria. Median (IQR) ELA treatment duration was 171.5 (123.3, 298.3) vs 160.5 (90.0, 253.5) days. For Cohort 1, observed OCA treatment duration during the study period was 242.0 (205.3, 331.5) days and duration between OCA to ELA switch was 26.0 (17.8, 33.8) days."

Clinical • Real-world • Real-world evidence • Hepatology • Immunology • Primary Biliary Cholangitis

Comparative Post-Marketing Safety Signals of Elafibranor Versus Seladelpar: A Head-to-Head Disproportionality Analysis of the FDA Adverse Event Reporting System (FAERS) (ACG 2026) - "Both represent second-line options for patients with inadequate response to ursodeoxycholic acid (UDCA). After exclusion of PBC-activity and procedural PTs, 14 signals showed disproportionately higher reporting with elafibranor, while 2 signals were disproportionately higher with seladelpar. Key elafibranor PTs included: muscle spasms (ROR 23.21, 95% CI 3.14â171.62), constipation (22.20, 5.37â91.80), myalgia (13.78, 4.26â44.60), arthralgia (13.45, 4.15â43.57), increased weight (8.83, 3.49â22.35), nausea (3.60, 1.98â6.54), and fatigue (2.59, 1.63â4.12). Seladelpar showed disproportionately higher reporting for pneumonia (0.14, 0.03â0.63) and fall (0.11, 0.03â0.36)."

Adverse events • Clinical • Head-to-Head • P4 data • Cholestasis • Constipation • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Infectious Disease • Musculoskeletal Pain • Pneumonia • Primary Biliary Cholangitis • Pruritus • Respiratory Diseases • PPARA

Comparative Efficacy and Safety of Emerging Second-Line Therapies for Primary Biliary Cholangitis: A Systematic Review and Network Meta-Analysis of Seladelpar, Elafibranor, and Obeticholic Acid (ACG 2026) - "A total of 9 randomized controlled trials comprising 2,184 patients with Primary Biliary Cholangitis were included. Overall, 1,962 (89.8%) were female, with a mean age ranging from 52â61 years and baseline alkaline phosphatase levels between 2.1â3.4 times the upper limit of normal. Seladelpar was evaluated in 812 patients, elafibranor in 604, obeticholic acid in 568, and placebo/standard therapy in 200 patients."

Retrospective data • Review • Cholestasis • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Efficacy, symptoms, and safety of second-line PBC therapies: a network meta-analysis. (PubMed, Front Pharmacol) - "The therapeutic landscape for primary biliary cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA) is rapidly evolving...We included randomized controlled trials (RCTs) with durations of 12-52 weeks evaluating PPAR agonists (bezafibrate, seladelpar, elafibranor, saroglitazar), farnesoid X receptor (FXR) agonists (obeticholic acid [OCA]), and IBAT inhibitors (linerixibat) against placebo/UDCA...While bezafibrate offers unparalleled potency for POISE criteria, seladelpar 10 mg provides the most advantageous clinical balance, achieving deep biochemical remission (ALP normalization) alongside profound pruritus relief and a favorable safety profile. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=261351, identifier 420261351426."

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

Austrian Society of Gastroenterology and Hepatology (ÖGGH) consensus on primary biliary cholangitis. (PubMed, Wien Klin Wochenschr) - "Approximately 60-70% of patients achieve clinical and biochemical remission with first-line treatment, i.e., ursodeoxycholic acid (UDCA). For patients who do not sufficiently respond to UDCA, the newly approved peroxisome proliferator-activated receptor (PPAR) agonists elafibranor and seladelpar, as well as bezafibrate (off-label use), should be used as a combination treatment with UDCA. In patients with decompensated cirrhosis, liver transplantation has been associated with good long-term outcomes, albeit disease recurrence occurs in up to 50% by 15 years."

Journal • Autoimmune Hepatitis • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Primary Biliary Cholangitis • Transplantation

Elafibranor in primary biliary cholangitis: two-year placebo-controlled outcomes and long-term open-label data from the ELATIVE® phase III trial. (PubMed, J Hepatol) - P3 | "Through three years of treatment, elafibranor led to sustained biochemical improvements and was generally well tolerated, with numerical improvements in fatigue and pruritus."

Journal • P3 data • Dermatology • Fatigue • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

ELAFIBRANOR TREATMENT RESULTS IN RAPID REDUCTIONS IN BIOCHEMICAL MARKERS AND SYMPTOM BURDEN IN REAL-WORLD PRACTICE: INTERIM RESULTS FROM THE PROSPECTIVE, NON-INTERVENTIONAL ELFINITY PHASE IV GLOBAL STUDY IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (UEGW 2026) - No abstract available

Clinical • P4 data • Real-world • Real-world evidence • Hepatology • Immunology • Primary Biliary Cholangitis

Targeting PPAR-Regulated Pathways to Treat Cholestatic Liver Diseases: Novel Applications of Liquid Biopsies. (PubMed, Cells) - "First-line therapy for PBC is ursodeoxycholic acid, although up to 40% of patients respond incompletely, and there is no effective therapy for PSC. Newer peroxisome proliferator-activated receptor (PPAR) agonists, e.g., seladelpar and elafibranor, received accelerated FDA approval as second-line treatments for PBC, and additional studies of PPAR agonists for PSC are underway...The transcriptomic profiling of EVs uniquely allows for the quantification of coding and non-coding RNA transcripts, which may be used to study pathways relevant to PPAR expression and regulation and to identify biomarkers of treatment response to PPAR agonists in cholestasis. This review explores the application(s) of liquid biopsy-derived EVs for the identification of PPAR regulated pathways and its potential role in the treatment of PBC and PSC."

Journal • Liquid biopsy • Review • Cholestasis • Hepatology • Immunology • Primary Biliary Cholangitis • PPARA

Elafibranor for primary biliary cholangitis. (PubMed, Aust Prescr) - No abstract available

Journal • Review • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis

Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy (clinicaltrials.gov) - P=N/A | N=3 | Recruiting | Sponsor: Ipsen | Not yet recruiting ➔ Recruiting

Enrollment open

Ipsen announced positive topline results from the Phase IIIb ELSPIRE study of Iqirvo in primary biliary cholangitis (PBC) in July. (GlobeNewswire) - "The study met its primary endpoint, with 85% of patients receiving Iqirvo achieving alkaline phosphatase (ALP) normalization at Week 52 versus 23% on placebo (p=<0.0001), while maintaining a safety profile consistent with previous studies and identifying no new safety signals....Ipsen plans to submit the data to regulatory authorities and present these data at an upcoming scientific congress."

P3 data • Immunology • Primary Biliary Cholangitis

AISF practice guidance on the treatment of primary biliary cholangitis: A 2026 update. (PubMed, Dig Liver Dis) - "Although ursodeoxycholic acid (UDCA) remains the cornerstone of first-line therapy and improves transplant-free survival, an important proportion of patients show an inadequate biochemical response, and many continue to experience substantial symptoms, particularly pruritus and fatigue, with a major impact on quality of life. In recent years, the therapeutic landscape of PBC has evolved following the withdrawal of obeticholic acid and the availability of selective PPAR agonists, including elafibranor and seladelpar...Therapeutic targets should be individualized according to age, disease stage, symptom burden, and risk of progression, distinguishing between "adequate" and "complete" biochemical response and supporting earlier treatment escalation in high-risk and symptomatic patients. This updated AISF guidance provides an evidence-based framework for PBC management in 2026 and beyond, reviewing therapeutic goals, response criteria, second-line..."

Journal • Review • Cholestasis • Dermatology • Fatigue • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Primary Biliary Cholangitis • Pruritus • Transplantation

Primary Biliary Cholangitis. (PubMed, Clin Liver Dis) - "Ursodeoxycholic acid (UDCA) remains first-line, with on treatment biochemical response predicting long-term prognosis...Long-term care includes surveillance for treatment response, development of fibrosis, portal hypertension, bone disease, and hepatocellular carcinoma. Liver transplantation (LT) remains definitive for end-stage or refractory disease, with post-LT UDCA recommended to reduce its recurrence."

Journal • Review • Cardiovascular • Cholestasis • Dermatology • Fatigue • Fibrosis • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Oncology • Portal Hypertension • Primary Biliary Cholangitis • Pruritus • Solid Tumor • Transplantation

ELSPIRE: A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. (clinicaltrials.gov) - P3 | N=92 | Completed | Sponsor: Ipsen | N=69 ➔ 92 | Active, not recruiting ➔ Completed

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

Real-world experience of seladelpar among patients with primary biliary cholangitis including patients switched from obeticholic acid (BSG 2026) - "Seladelpar (SEL), approved in 2024 in the US for patients with PBC and an inadequate response or intolerance to ursodeoxycholic acid (UDCA), offers a new treatment option...SEL treatment duration was determined in patients who switched from OCA within 3 months of SEL (OCA-switch) or patients who started SEL as add on to UDCA or as monotherapy without use of UDCA, OCA, fenofibrate, or elafibranor for >3 months prior to SEL (SEL-2L), using all available data as of 13 Jun 2025...Conclusions These real-world experiences suggest SEL may be an effective and safe alternative for patients switching from OCA and as a second-line therapy. Given the relatively short SEL observation period, further evaluation with extended follow-up is warranted."

Clinical • Real-world • Real-world evidence • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis

Treatment with elafibranor leads to stabilisation of PRO-C3, a marker of fibrosis, in patients with primary biliary cholangitis (PBC) (BSG 2026) - P3 | "Hepatology . 2025; 81 :60."

Clinical • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Primary Biliary Cholangitis • TIMP1

Early real-world experiences of elafibranor in primary biliary cholangitis (PBC) (BSG 2026) - "Methods The effectiveness, safety and tolerability of Ela was evaluated in patients (pts) initiating therapy in combination with ursodeoxycholic acid (UDCA), obeticholic acid (OCA), and amongst those switching from bezafibrate (BZF). 24 pts who switched from BZF reported pruritus at baseline, and 12 reported improvement on Ela. Conclusions Treatment with Ela in real-world PBC settings is associated with early biochemical and symptomatic improvement, including in pts previously treated with BZF, and in combination with OCA."

Clinical • Real-world • Real-world evidence • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

The efficacy of elafibranor is not affected by body mass index in patients with primary biliary cholangitis (PBC) (BSG 2026) - "In ELATIVE, patients with PBC and an inadequate response to or intolerable side effects with ursodeoxycholic acid were randomized 2:1 to receive elafibranor 80mg daily or placebo for 52 weeks. Conclusion(s) The pharmacokinetics of elafibranor are not clinically meaningfully affected by BMI in patients with PBC. The efficacy of the clinical dose of elafibranor is stable in patients with PBC, regardless of baseline BMI or weight changes during the course of treatment."

Clinical • Hepatology • Immunology • Obesity • Primary Biliary Cholangitis

Long-term elafibranor leads to biochemical and symptomatic improvements for at least 3 years in patients with primary biliary cholangitis (PBC) (BSG 2026) - P3 | "Conclusion(s) In the ongoing ELATIVE ® OLE, ELA has led to rapid, sustained, and reproducible responses in clinically relevant biomarkers of cholestasis and fibrosis, suggesting potential for slowing disease progression. Positive effects on cholestasis, sustained improvement in pruritus and fatigue, stabilization of markers of fibrosis, and a consistent safety profile confirm ELA’s suitability for long-term PBC treatment."

Clinical • Cholestasis • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Musculoskeletal Pain • Primary Biliary Cholangitis • Pruritus

Long-term elafibranor in primary sclerosing cholangitis (PSC): interim safety and efficacy data from the ELMWOOD open-label extension (OLE) trial (BSG 2026) - P2 | "J Hepatol. 2026; 84 :74–85."

Clinical • Cholestasis • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Novel Coronavirus Disease • Pruritus • Solid Tumor

A Review of Therapies for Primary Biliary Cholangitis. (PubMed, Gastroenterol Hepatol (N Y)) - "Ursodeoxycholic acid remains the standard first-line therapy; however, approximately 40% of patients exhibit an inadequate or partial biochemical response, and approximately 5% to 10% of patients are intolerant to the drug...Until recently, obeticholic acid (OCA) and fibrates were the only available second-line therapies. However, the therapeutic landscape for PBC has evolved significantly with the US Food and Drug Administration conditional approval of elafibranor and seladelpar as second-line therapies for patients without cirrhosis. Notably, OCA has been withdrawn as an available treatment option, further shifting the current treatment paradigm. This article aims to examine the current pharmacologic landscape of first-line and second-line PBC treatments, with an emphasis on clinical considerations and strategies for individualized treatment selection to optimize patient outcomes."

Journal • Cholestasis • Fibrosis • Hepatology • Immunology • Primary Biliary Cholangitis