Lynavoy (linerixibat) / Alfasigma 
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  • ||||||||||  Iqirvo (elafibranor) / Ipsen, Lynavoy (linerixibat) / Alfasigma
    Real-world efficacy and safety of fibrates in patients with primary biliary cholangitis (Poster Area - Hall 7) -  Mar 18, 2026 - Abstract #EASL2026EASL_2589;    
    Fibrates provide significant biochemical improvement in vast majority of these patients; however, adverse events occur in a substantial proportion, leading to the discontinuation of therapy. This finding highlights the need for novel therapeutic alternatives with better tolerability, reinforcing the importance of expanding the treatment landscape in PBC.
  • ||||||||||  Lynavoy (linerixibat) / Alfasigma
    Trial completion date, Trial primary completion date:  LLSAT: Linerixibat Long-term Safety, and Tolerability Study (clinicaltrials.gov) -  Feb 20, 2026   
    P3,  N=242, Active, not recruiting, 
    This finding highlights the need for novel therapeutic alternatives with better tolerability, reinforcing the importance of expanding the treatment landscape in PBC. Trial completion date: Aug 2027 --> Sep 2026 | Trial primary completion date: Aug 2027 --> Sep 2026
  • ||||||||||  linerixibat (GSK2330672) / GSK
    Treating itch in primary biliary cholangitis  (Convention Center: Hall DE 4392-4545 Posters) -  Oct 7, 2025 - Abstract #AASLD2025AASLD_3454;    
    P3
    Although a preliminary MCT of 2.8 for SI-NRS was identified, further validation is warranted using concept-specific anchors. MCTs are critical for interpretation of PRO measures and help facilitate responder endpoint analyses.
  • ||||||||||  linerixibat (GSK2330672) / GSK, Livmarli (maralixibat) / Mirum Pharma
    EFFICACY AND SAFETY OF ILEAL BILE ACID TRANSPORTER INHIBITORS IN AUTOIMMUNE CHOLESTATIC LIVER DISEASES: A META-ANALYSIS (Poster Stage 6) -  Jul 8, 2025 - Abstract #UEGW2025UEGW_878;    
    Although adverse events are common, serious events are infrequent, supporting a favorable safety profile. These findings highlight the promise of IBAT inhibitors as an emerging therapeutic option for cholestatic pruritus, though further high-quality studies are needed to confirm long-term benefits and safety across diverse patient populations.
  • ||||||||||  linerixibat (GSK2330672) / GSK
    Trial completion:  Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) (clinicaltrials.gov) -  Feb 26, 2025   
    P3,  N=238, Completed, 
    Linerixibat, an investigational targeted ileal bile acid transporter inhibitor, is a twice-daily oral tablet for the treatment of cholestatic pruritus in PBC...Participants were either treatment-na Active, not recruiting --> Completed
  • ||||||||||  Lynavoy (linerixibat) / Alfasigma
    Enrollment closed, Trial completion date, Trial primary completion date:  LLSAT: Linerixibat Long-term Safety, and Tolerability Study (clinicaltrials.gov) -  Jan 24, 2025   
    P3,  N=251, Active, not recruiting, 
    For each 1-point improvement in NRS HRQoL improved, clinicians should offer appropriate and timely intervention. Recruiting --> Active, not recruiting | Trial completion date: Feb 2027 --> Aug 2027 | Trial primary completion date: Feb 2027 --> Aug 2027
  • ||||||||||  linerixibat (GSK2330672) / GSK
    Enrollment closed:  Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) (clinicaltrials.gov) -  Jun 3, 2024   
    P3,  N=241, Active, not recruiting, 
    Reductions in these biomarkers are associated with clinical response in patients with PBC and pruritus.Funding: GSK (201000).Encore statement: This abstract was originally presented as poster 4574-C at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting on November 13, 2023; this encore is presented on behalf of the original authors with their permission. Recruiting --> Active, not recruiting
  • ||||||||||  Lynavoy (linerixibat) / Alfasigma
    Trial completion date, Trial primary completion date:  LLSAT: Linerixibat Long-term Safety, and Tolerability Study (clinicaltrials.gov) -  Nov 7, 2023   
    P3,  N=305, Recruiting, 
    This quantitative framework highlights the trade-off between benefit and tolerability and supported the selection of 40 mg BID in the Phase 3 GLISTEN trial (NCT04950127). Trial completion date: Dec 2025 --> Feb 2027 | Trial primary completion date: Dec 2025 --> Feb 2027
  • ||||||||||  linerixibat (GSK2330672) / GSK
    Trial completion date, Trial primary completion date:  Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) (clinicaltrials.gov) -  Aug 14, 2023   
    P3,  N=230, Recruiting, 
    Trial completion date: Dec 2025 --> Feb 2027 | Trial primary completion date: Dec 2025 --> Feb 2027 Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Sep 2024
  • ||||||||||  linerixibat (GSK2330672) / GSK
    The devastating impact of severe pruritus in primary biliary cholangitis (Poster Area) -  Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_540;    
    P2
    Severe sleep disturbance and moderate and severe depression were far more common in patients with severe pruritus. In patients suffering with both severe pruritus and moderate to severe depression, health utility was severely impaired.
  • ||||||||||  linerixibat (GSK2330672) / GSK
    Preclinical, Journal:  Combining ASBT inhibitor and FGF15 treatments enhances therapeutic efficacy against cholangiopathy in female but not male Cyp2c70 knockout mice. (Pubmed Central) -  Mar 29, 2023   
    This study investigates if combining an apical sodium-dependent bile acid transporter inhibitor GSK2330672 (GSK) and fibroblast growth factor-15 (FGF15) overexpression, via simultaneous inhibition of bile acid synthesis and gut bile acid uptake, achieves enhanced therapeutic efficacy in alleviating hepatobiliary injury in Cyp2c70 KO mice...The combined treatment reduced bile acid pool by ?80% compared to ?50% reduction by GSK or AAV-FGF15, and enriched tauro-conjugated ursodeoxycholic acid in the bile...AAV-FGF15 and the combined treatment, but not GSK, reduced gut exposure to lithocholic acid and improved gut barrier function. In conclusion, the combined treatment improved therapeutic efficacy against cholangiopathy than either single treatment in the female but not male Cyp2c70 KO mice by reducing bile acid pool size and hydrophobicity.
  • ||||||||||  Update on clinical management of Primary Biliary Cirrhosis (3F Plenary Hall) -  Dec 18, 2022 - Abstract #APASL2023APASL_237;    
    Novel PPAR agonists for PBC including elafibranor (PPAR-ad), saroglitazar (PPARa/g), and seladelpar(PPARd) showed a favorable biochemical response in phase 2 clinical trials. Lastly, RCT of linerixibat (an ileal bile acid transporter inhibitor) in PBC patients showed improvement in pruritus severity.
  • ||||||||||  linerixibat (GSK2330672) / GSK
    Trial completion, Enrollment change:  Food Effect Study of Linerixibat Tablets in Healthy Adult Participants (clinicaltrials.gov) -  Nov 29, 2022   
    P1,  N=23, Completed, 
    Lastly, RCT of linerixibat (an ileal bile acid transporter inhibitor) in PBC patients showed improvement in pruritus severity. Not yet recruiting --> Completed | N=14 --> 23
  • ||||||||||  linerixibat (GSK2330672) / GSK, seladelpar (MBX-8025) / CymaBay, aldafermin (NGM282) / NGM Biopharma
    Retrospective data, Review:  Efficacy and safety of pharmacological interventions for pruritus in primary biliary cholangitis: A systematic review and meta-analysis. (Pubmed Central) -  Nov 8, 2022   
    UDCA, bezafibrate, OCA, rifampicin, NGM282 and others may improve blood γ-glutamyl transpeptidase (γ-GGT) (p < 0.05), but due to the high heterogeneity and the limitation of research samples, a clear conclusion cannot be drawn...Due to the heterogeneity in the published studies, based on the present review, we cannot explicitly recommend any specific drug for the treatment of PBC-related pruritus. Systematic Review Registration: link-https://osf.io/2g8ya, identifier 10.17605/OSF.IO/2G8YA.
  • ||||||||||  linerixibat (GSK2330672) / GSK
    Trial completion, Trial completion date, Trial primary completion date:  Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants (clinicaltrials.gov) -  Nov 8, 2022   
    P1,  N=52, Completed, 
    Systematic Review Registration: link-https://osf.io/2g8ya, identifier 10.17605/OSF.IO/2G8YA. Recruiting --> Completed | Trial completion date: Nov 2022 --> May 2022 | Trial primary completion date: Nov 2022 --> May 2022
  • ||||||||||  linerixibat (GSK2330672) / GSK
    COMBINED ASBT INHIBITOR AND AAV-FGF15 TREATMENT PREVENTS BILE ACID HEPATOTOXICITY IN FEMALE BUT NOT MALE Cyp2c70 KNOCKOUT MICE WITH HUMAN-LIKE BILE ACID COMPOSITION () -  Oct 23, 2022 - Abstract #AASLD2022AASLD_1644;    
    The effects of an intestine-restricted ASBT inhibitor GSK2330672 (GSK) or AAV-TBG-FGF15 treatment alone or in combination for 4 weeks on bile acid pool and composition, hepatic inflammation, ductular reaction, and portal fibrosis were investigated in Cyp2c70 KO mice...In addition to markedly reduced bile acid pool, the combined treatment also increased the hydrophilic bile acid tauro-ursodeoxycholic acid (TUDCA) in the bile acid pool to ~30%, while the bile acid pool in the untreated Cyp2c70 KO mice consisted predominantly of hydrophobic tauro-cholic acid (T-CA) and tauro-chenodeoxycholic acid (T-CDCA)... Combined ASBT inhibitor and AAV-FGF15 treatment significantly attenuated bile acid hepatotoxicity in female but not male Cyp2c70 KO mice by reducing bile acid pool size and hydrophobicity.