Livdelzi (seladelpar) / Gilead 
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 8 Diseases   4 Trials   4 Trials   310 News 


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  • ||||||||||  Livdelzi (seladelpar) / Gilead
    Review, Journal:  Seladelpar for the Treatment of Primary Biliary Cholangitis. (Pubmed Central) -  Mar 12, 2025   
    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.
  • ||||||||||  Livdelzi (seladelpar) / Gilead
    Enrollment closed:  Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) (clinicaltrials.gov) -  Feb 4, 2025   
    P3,  N=500, Active, not recruiting, 
    Seladelpar's clinical benefit predicted by improvement in surrogate endpoints may need confirmation for traditional FDA approval. Recruiting --> Active, not recruiting
  • ||||||||||  Livdelzi (seladelpar) / Gilead
    Review, Journal:  Peroxisome proliferator-activated receptor delta and liver diseases. (Pubmed Central) -  Feb 3, 2025   
    Promising results have been reported in clinical trials for PPAR-delta agonists in liver disease, and the selective agonist seladelpar was recently conditionally approved in the United States as a new treatment option for primary biliary cholangitis. This review provides an overview of PPAR-delta's function and biology in the liver, examines its kinetics and therapeutic potential across different liver diseases, and discusses the current status of clinical trials involving its agonists.
  • ||||||||||  Iqirvo (elafibranor) / Ipsen, Ocaliva (obeticholic acid) / Intercept, Livdelzi (seladelpar) / Gilead
    Review, Journal:  Up-to-Date Snapshot of Current and Emerging Medical Therapies in Primary Biliary Cholangitis. (Pubmed Central) -  Dec 27, 2024   
    UDCA should remain the treatment of choice for PBC, though perhaps not as monotherapy. With further investigation, BF shows promise as a new second-line therapy alongside OCA, which it may outperform.
  • ||||||||||  Iqirvo (elafibranor) / Ipsen, Ocaliva (obeticholic acid) / Intercept, Livdelzi (seladelpar) / Gilead
    Journal:  Primary Biliary Cholangitis: personalizing second-line therapies. (Pubmed Central) -  Dec 21, 2024   
    They also have shown biochemical improvements among patients with an inadequate response to ursodeoxycholic acid but may improve symptoms of pruritus. Herein, we review the patient features to consider when deciding whether a second-line agent is indicated and which agent to consider for a truly personalized approach to PBC patient care.
  • ||||||||||  Iqirvo (elafibranor) / Ipsen, Lipaglyn (saroglitazar) / Zydus Lifesci, Livdelzi (seladelpar) / Gilead
    Review, Journal:  PPAR agonists for the treatment of cholestatic liver diseases: Over a decade of clinical progress. (Pubmed Central) -  Dec 19, 2024   
    Several PPAR agonists have been investigated as second-line therapy for people living with PBC, including the recent accelerated United States Food and Drug Administration approval of elafibranor and seladelpar. This review evaluates available data on the efficacy and safety of the five PPAR agonists investigated for the treatment of cholestasis and associated pruritus in PBC and PSC, namely fenofibrate, bezafibrate, saroglitazar, elafibranor, and seladelpar.
  • ||||||||||  Livdelzi (seladelpar) / Gilead
    Review, Journal:  Seladelpar: First Approval. (Pubmed Central) -  Nov 28, 2024   
    Effective second-line therapies area available and continue to receive long-term evaluation in patients with PBC. On 14
  • ||||||||||  Iqirvo (elafibranor) / Ipsen, Livdelzi (seladelpar) / Gilead
    Review, Journal:  Hard-to-treat autoimmune hepatitis and primary biliary cholangitis: The dawn of a new era of pharmacological treatment. (Pubmed Central) -  Nov 16, 2024   
    In future pharmacological treatment of AIH and PBC, the primary objective for AIH is likely to focus on lowering the number of hard-to-treat patients with personalized steroid sparing treatment regimens. A challenging goal in PBC treatment is the further optimization of treatment surrogate endpoints, even to the stricter ALP normalization, with which an indication of second- or later-line drugs might be expanded, but could ultimately lengthen patients' long-term survival.
  • ||||||||||  Livdelzi (seladelpar) / Gilead
    Journal:  Seladelpar Lysine. (Pubmed Central) -  Oct 23, 2024   
    This NMA may inform healthcare resource allocation and treatment decisions. No abstract available
  • ||||||||||  Livdelzi (seladelpar) / Gilead
    Trial completion date, Trial primary completion date:  Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) (clinicaltrials.gov) -  Oct 16, 2024   
    P3,  N=500, Recruiting, 
    No abstract available Trial completion date: Dec 2025 --> Nov 2028 | Trial primary completion date: Dec 2024 --> Nov 2028
  • ||||||||||  Livdelzi (seladelpar) / Gilead
    LONG-TERM SAFETY OF SELADELPAR 10 MG WITH UP TO 5 YEARS OF TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS () -  Oct 15, 2024 - Abstract #AASLD2024AASLD_3098;    
    P3
    The phase 3, placebo-controlled RESPONSE study (NCT04620733) in PBC patients with an inadequate response or intolerance to ursodeoxycholic acid demonstrated significant improvements in cholestatic markers and pruritus with seladelpar over one 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 placebo.
  • ||||||||||  Review, Journal:  Bile Acids-Based Therapies for Primary Sclerosing Cholangitis: Current Landscape and Future Developments. (Pubmed Central) -  Oct 15, 2024   
    The ursodeoxycholic acid (UDCA) has been widely used, although there is no evidence that the use of UDCA delays the time to liver transplant or increases survival...The largest group of these new agents is represented by FXR agonists, including obeticholic acid, cilofexor, and tropifexor...Additional agents under evaluation are PPARs (elafibranor and seladelpar), anti-itching agents such as MAS-related G-protein-coupled receptors antagonists, and anti-fibrotic and immunosuppressive agents. Drugs targeting gut bacteria and bile acid pathways are also under investigation, given the strong link between PSC and gut microbiota.
  • ||||||||||  Iqirvo (elafibranor) / Ipsen, Ocaliva (obeticholic acid) / Intercept, Livdelzi (seladelpar) / Gilead
    Review, Journal:  Current Landscape and Evolving Therapies for Primary Biliary Cholangitis. (Pubmed Central) -  Sep 27, 2024   
    In this review, we will examine published and ongoing clinical trials in PBC, including the recently approved peroxisome-proliferator-activated receptor (PPAR) agonist, elafibranor and seladelpar. These novel second-line therapies are expected to improve therapy in PBC and the development of personalized approaches.
  • ||||||||||  Livdelzi (seladelpar) / Gilead
    Cholangiocyte Response to Seladelpar Treatment (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_5148;    
    Introduction : Cholangiocytes are epithelial cells that line bile ducts and play a central role as the site of injury in primary biliary cholangitis (PBC). The Phase 3 RESPONSE trial in patients with PBC demonstrated that seladelpar, a selective peroxisome proliferator
  • ||||||||||  seladelpar (MBX-8025) / Gilead
    Assessment of PPARdelta target engagement in mouse liver assessed by single nuclei sequencing following a single oral dose of seladelpar. (Poster Area) -  Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1954;    
    Identification of changes in gene expression six hours following a single dose of seladelpar, indicate that there are PPARdelta mediated changes in all identified cell types in the mouse liver. Single-cell analyses, such as this, can provide a framework in which to understand the primary PPARdelta responsive genes following seladelpar treatment and can be used to deconvolute the gene expression patterns leading to the beneficial pharmacodynamic effects reported in either humans or mice.
  • ||||||||||  seladelpar (MBX-8025) / Gilead
    PPAR-delta activation with seladelpar regulates cholangiocyte inflammation (Poster Area) -  Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1934;    
    This is the first evidence on the impact of selective PPAR-delta activation in a human cholangiocyte cell line. These findings indicate that seladelpar modulates multiple inflammatory mediators and this warrants further in-depth investigation.
  • ||||||||||  seladelpar (MBX-8025) / CymaBay
    P3 data, Journal:  A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis. (Pubmed Central) -  Feb 29, 2024   
    P3
    The incidence and severity of adverse events were similar in the two groups. (Funded by CymaBay Therapeutics; RESPONSE ClinicalTrials.gov number, NCT04620733; EudraCT number, 2020-004348-27.).