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

3 months ago

Trial completion date • Trial suspension • Trial primary completion date

Aramchol (aramchol meglumine)

3ms

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.

3 months ago

Review • Journal

TNFA (Tumor Necrosis Factor-Alpha) • FGF21 (Fibroblast Growth Factor 21)

Aramchol (aramchol meglumine) • Iqirvo (elafibranor)

4ms

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

4 months ago

Trial completion

Aramchol (aramchol meglumine)

5ms

Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets (clinicaltrials.gov)

P1, N=16, Not yet recruiting, Galmed Pharmaceuticals Ltd

5 months ago

New P1 trial

Aramchol (aramchol meglumine)

5ms

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

5 months ago

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.

1 year ago

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.

1 year ago

Journal

SCD (Stearoyl-CoA Desaturase) • TRIM28 (Tripartite Motif Containing 28)

TP53 wild-type

sorafenib • Zepsun (donafenib) • Aramchol (aramchol meglumine)

3years

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.

3 years ago

Clinical • P2b data • Journal

SCD (Stearoyl-CoA Desaturase)

Aramchol (aramchol meglumine)