Ibodutant (MEN 15596) / Menarini - LARVOL DELTA

Drugs of the future for diarrhea-predominant irritable bowel syndrome: an overview of current investigational drugs. (PubMed, Expert Opin Investig Drugs) - "Clinical trial evidence has shown that loperamide, eluxadoline, alosetron, ramosetron, bile acid sequestrants, and rifaximin can modulate GI alterations and benefit patients with IBS-D. Among the potential therapies, ibodutant, ibudilast, blautix, BOS-589, solabegron, vibegron, olorinab, ebastine, and ORP-101 have demonstrated possible effects but remain confirmed...Therefore, we should focus on developing new, efficient, and affordable medications for IBS-D. The government, insurers, and society must recognize this need and collaborate to ensure its fulfillment."

Journal • Review • Gastrointestinal Disorder • Inflammation

Sex-Gender Differences in the Effectiveness of Treatment of Irritable Bowel Syndrome: A Systematic Review. (PubMed, Int J Gen Med) - "Treatment with serotonin antagonist alosetron, treatment with ibodutant and crofelemer and adding cognitive behavioral therapy to medical treatment found significant differences between men and women in favor of effectiveness towards women in either satisfactory relief of overall IBS symptoms or percentage of pain-free days. Due to the limited number of studies per treatment option, no recommendations can be made on the choice of a specific treatment. It is clear, however, that so as not to miss beneficial treatment options for either sex, the inclusion, analysis and description of data on the basis of sex is of the utmost importance."

Journal • Review • Gastrointestinal Disorder • Immunology • Pain

Gender-related differences of tachykinin NK receptor expression and activity in human colonic smooth muscle. (PubMed, J Pharmacol Exp Ther) - "In patients with diarrhoea-predominant irritable bowel syndrome, the NK receptor antagonist ibodutant had a greater therapeutic effect in females than males...These factors may underlie the gender differences in the treatment of diarrhoea-predominant irritable bowel syndrome with NK2 receptor antagonists. Our findings highlight that gender differences should be considered in the therapeutic development of NK2 receptor agents."

Journal • Gastrointestinal Disorder • Immunology

IRIS-05: 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: Menarini Group; N=500 ➔ 0; Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal • Biosimilar • Immunology • Pain

The place of tachykinin NK2 receptor antagonists in the treatment diarrhea-predominant irritable bowel syndrome. (PubMed, J Physiol Pharmacol) - "The promising results were not replicable and confirmed in phase III of clinical trials. Ibodutant is not ready to be introduced in the pharmaceutical market and further studies on alternative NK2 antagonist are needed to make NK2 antagonists useful tools in IBS-D treatment."

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