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    DRUG:

    Aramchol (aramchol meglumine)

    Associations

    News

    Trials
    Company:
    Galmed, Weizmann Institute of Science
    Drug class:
    Cholesterol absorption inhibitor, Stearoyl CoA desaturase inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis (clinicaltrials.gov)
    P2, N=24, Suspended, Galmed Pharmaceuticals Ltd | Trial completion date: Dec 2026 --> Dec 2027 | Not yet recruiting --> Suspended | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial suspension • Trial primary completion date
    |
    Aramchol (aramchol meglumine)
    2ms
    Pipeline of New Drug Treatment for Non-alcoholic Fatty Liver Disease/Metabolic Dysfunction-associated Steatotic Liver Disease. (PubMed, J Clin Transl Hepatol)
    Agents in this group include peroxisome proliferator-activated receptor agonists (e.g., pioglitazone, elafibranor, saroglitazar), bile acid-farnesoid X receptor axis regulators (obeticholic acid), de novo lipogenesis inhibitors (aramchol, NDI-010976), and fibroblast growth factor 21/19 analogs...Agents in this group include antioxidants (vitamin E), tumor necrosis factor α pathway regulators (emricasan, pentoxifylline, ZSP1601), and immune modulators (cenicriviroc, belapectin). The final group targets the gut (IMM-124e, solithromycin). Combination therapies targeting different pathogenetic pathways may provide an alternative to MASLD treatment with higher efficacy and fewer side effects. This review aimed to provide an update on these medications.
    Review • Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • FGF21 (Fibroblast Growth Factor 21)
    |
    Aramchol (aramchol meglumine) • Iqirvo (elafibranor)
    3ms
    Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment (clinicaltrials.gov)
    P1, N=57, Completed, Galmed Research and Development, Ltd. | Enrolling by invitation --> Completed
    Trial completion
    |
    Aramchol (aramchol meglumine)
    4ms
    Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets (clinicaltrials.gov)
    P1, N=16, Not yet recruiting, Galmed Pharmaceuticals Ltd
    New P1 trial
    |
    Aramchol (aramchol meglumine)
    4ms
    A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Galmed Research and Development, Ltd. | Initiation date: Jun 2024 --> Jun 2025
    Trial initiation date
    |
    Aramchol (aramchol meglumine)
    1year
    A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Galmed Research and Development, Ltd.
    New P2 trial
    |
    Aramchol (aramchol meglumine)
    1year
    URI alleviates tyrosine kinase inhibitors-induced ferroptosis by reprogramming lipid metabolism in p53 wild-type liver cancers. (PubMed, Nat Commun)
    The combination of SCD1 inhibitor aramchol and deuterated sorafenib derivative donafenib displays promising anti-tumor effects in p53-wild type HCC patient-derived organoids and xenografted tumors. This combination therapy has potential clinical benefits for the patients with advanced HCC who have wild-type p53 and high levels of URI/SCD1.
    Journal
    |
    SCD (Stearoyl-CoA Desaturase) • TRIM28 (Tripartite Motif Containing 28)
    |
    TP53 wild-type
    |
    sorafenib • Zepsun (donafenib) • Aramchol (aramchol meglumine)
    almost3years
    Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial. (PubMed, Nat Med)
    Early termination due to adverse events (AEs) was <5%, and Aramchol 600 and 400 mg were safe, well tolerated and without imbalance in serious or severe AEs between arms. Although the primary end point of a reduction in liver fat did not meet the prespecified significance level with Aramchol 600 mg, the observed safety and changes in liver histology and enzymes provide a rationale for SCD1 modulation as a promising therapy for NASH and fibrosis and are being evaluated in an ongoing phase 3 program.
    Clinical • P2b data • Journal
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    SCD (Stearoyl-CoA Desaturase)
    |
    Aramchol (aramchol meglumine)