trimebutine maleate / Generic mfg. - LARVOL DELTA

Steatotic liver disease in patients with irritable bowel syndrome- a new category? Evidence based on response to therapy (EASL 2025) - "Patients received treatment with trimebutine maleate 300mg daily and a probiotic containing Saccharomyces cerevisiae for three months and were re-evaluated... Rapid changes in degrees of steatosis and fibrosis under IBS treatment suggest common pathological pathways between IBS and SLD and potential reversal in the early stages."

Clinical • Constipation • Fibrosis • Gastrointestinal Disorder • Hepatology • Immunology • Solid Tumor

Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Valenta Pharm JSC

New P2 trial • Gastroenterology • Hepatology • Movement Disorders

Probiotics Combined With Trimebutine for the Treatment of Irritable Bowel Syndrome Patients: A Systematic Review and Meta-Analysis. (PubMed, J Gastroenterol Hepatol) - "The combination of trimebutine and probiotics is more effective in the treatment of IBS compared with trimebutine alone."

Journal • Retrospective data • Gastrointestinal Disorder • Xerostomia

PET imaging of the anticancer drug candidate [11C]trimebutine in a rat glioma model. (PubMed, Nucl Med Biol) - "Trimebutine exhibits inhibitory effects on the growth and migration of glioma cells in a dose- and time-dependent manner. [11C]Trimebutine was able to penetrate the blood-brain barrier in rats and tracer uptake could be significantly reduced by administration of a μ-opioid receptor antagonist. However, [11C]trimebutine failed to selectively accumulate in orthotopic C6 glioma, which could be caused by low expression levels of the drug target in these tumors, or by fast metabolism of the tracer."

Journal • Preclinical • Addiction (Opioid and Alcohol) • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Turmeric - not just health benefits. A case report on Turmeric related Drug Induced Liver Injury (DILI) (EUSEM 2024) - "We would like to present a patient with Drug Induced Liver Injury (DILI) after consuming 'health shots' containing ginger and turmeric/curcuma.Case report28-year-old female with PMHx of colon irritable with simethicone and trimebutine if needed treatment, and oral contraception...She had jaundice, her cardiopulmonary examination was normal, the abdomen as soft with normal bowel sounds, she had some URQ tenderness, no guarding or mass was found. Her bloods showed normal NFS, RFT and coagulation with TP 95%, but abnormal LFT with minor cytolysis with ALAT 247 U/l (ref"

Case report • Clinical • Hepatology • Liver Failure

Novel Combination Therapy for Heart Failure: Trimebutine-Methoxsalen Identified through Synergistic Network Virtual Screening and Experimental Validation. (PubMed, J Chem Inf Model) - "Further mechanistic studies have demonstrated that trimebutine and methoxsalen could synergistically inhibit intracellular calcium overload in myocardial cells and reduce the production of ROS, thus exerting cardioprotective effects. Overall, this study introduces an advanced computational strategy that not only identifies a novel combination therapy against HF but also sheds light on its underlying synergistic mechanisms."

Combination therapy • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

FAPD_RCT: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Universidad de Colima | Initiation date: Mar 2024 ➔ Sep 2024

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Musculoskeletal Pain • Pain

Trimebutine prevents corneal inflammation in a rat alkali burn model. (PubMed, Sci Rep) - "It reduced scar formation by decreasing the expression of type III collagen. These findings suggest that trimebutine may represent a novel therapeutic strategy for corneal wounds, not only through its anti-inflammatory effects but also by preventing neovascularization."

Journal • Preclinical • Corneal Abrasion • Inflammation • Keratitis • Ocular Inflammation • Ophthalmology • Thermal Injury • HMGB1 • IL1B

THE MULTIDIMENSIONAL/ANTIBACTERIAL BENEFIT OF TRIMEBUTINE MALEATE ON FUNCTIONAL DYSPEPSIA: A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND CONTROLLED STUDY (DDW 2024) - "TM appears to be effective and safe in treating FD. The potential mechanisms could include TM-related gastrointestinal tract motor bacteriostatic/bactericidal and anti-inflammatory activities."

Clinical • Dyspepsia

Fentanyl Analogs Exert Antinociceptive Effects via Sodium Channel Blockade in Mice. (PubMed, Biol Pharm Bull) - "The administration of morphine (3 mg/kg), hydromorphone (0.4 mg/kg), or fentanyl (0.03 mg/kg) suppressed glutamate-induced nociceptive response, but not veratrine-induced nociceptive response at the same doses...In contrast, trimebutine (100 mg/kg) and fentanyl analog isobutyrylfentanyl (iBF; 0.1 mg/kg) suppressed both glutamate- and veratrine-induced nociceptive response...Cancer pain is a complex condition driven by inflammatory, neuropathic, and cancer-specific mechanisms. Thus, iBF may have the potential to be a superior analgesic than fentanyl."

Journal • Preclinical • Addiction (Opioid and Alcohol) • Gastrointestinal Cancer • Gastrointestinal Disorder • Neuralgia • Oncology • Pain

In vitro and in silico investigation of FDA-approved drugs to be repurposed against Alzheimer's disease. (PubMed, Drug Dev Res) - "The results showed that trimebutine, theophylline, and levamisole had the highest acetylcholinesterase inhibitory actions among the tested drugs, and these drugs inhibited by 68.70 ± 0.46, 53.25 ± 3.40, and 44.03 ± 1.20%, respectively at 1000 µM. Molecular modeling predicted good fitness in acetylcholinesterase active site for these drugs and possible central nervous system action for trimebutine. All of these results demonstrated that trimebutine was determined to be the drug with the highest potential for use in AD."

FDA event • Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Dementia

Effect of Trimebutine and Rifaximin on Breath Hydrogen and Methane by Glucose Breath Test in Patients With Functional Bloating: A Randomized Double-blind Clinical Trial. (PubMed, J Neurogastroenterol Motil) - "The adverse events were similar in the 2 groups. While the combination therapy was not superior over rifaximin alone for SIBO eradication, it improves the symptom of bloating with numerically reducing the concentration of breath H2/CH4."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Valenta Pharm JSC

New P1 trial • Gastroenterology • Hepatology

FAPD_RCT: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: Universidad de Colima

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Musculoskeletal Pain • Pain

Clinical Characteristics and Treatment of Irritable Bowel Syndrome in a Colombian Population: A Cross-Sectional Study. (PubMed, Drugs Real World Outcomes) - "The patients were diagnosed without clearly established criteria, and they were treated symptomatically with little follow-up."

Journal • Observational data • Gastrointestinal Disorder • Pain

Pharmacotherapy for gastric and intestinal cramping pain: Current and emerging therapies. (PubMed, Expert Opin Pharmacother) - "Consensus dictates that antispasmodics such as hyoscine-N-butyl bromide and mebeverine should be the primary treatment for GICP...Currently, several antispasmodics are undergoing clinical trials, including drotaverine, alverine, pinaverium bromide, fenoverine, tiropramide, otilinium bromide, trimebutine, and peppermint oil...Recent studies have shown that fixed-dose combinations of antispasmodics + NSAIDs or two different antispasmodics can improve patient compliance and synergistically reduce GICP. Therefore, it is recommended that the global availability and accessibility of these products be enhanced."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Pain

Effect of Rebamipide on the Intestinal Barrier, Gut Microbiota Structure and Function, and Symptom Severity Associated with Irritable Bowel Syndrome and Functional Dyspepsia Overlap: A Randomized Controlled Trial. (PubMed, J Clin Med) - "In conclusion, rebamipide improves the intestinal barrier condition and symptoms in D-IBSoFD. The rebamipide effects are not inferior to those of trimebutine."

Journal • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Inflammation • Inflammatory Bowel Disease

EAST-EUROPEAN CONSENSUS ON MANAGEMENT OF FD (UEGW 2023) - "There was no support for trimebutine(29%), prucalopride(38%), herbal agents(38%), rifaximin(33%), probiotics(25%), neuromodulators(17-58%) or for behavioral treatments such as hypnotherapy(29%), cognitive behavioral therapy(50%), acupuncture(8%), mindfulness(25%). In contrast to the European consensus, the East-European consensus on FD insists on early diagnostic endoscopy, regardless of alarm features. There is lack of consensus regarding treatment modalities for this highly prevalent condition, but there was a tendency to support PPI as first-line treatment and itopride as effective therapy."

Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Mood Disorders • Musculoskeletal Pain • Pain • Psychiatry

Efficacy of probiotics and trimebutine maleate for abemaciclib-induced diarrhea: A randomized, open-label phase II trial (MERMAID, WJOG11318B). (PubMed, Breast) - "Probiotic Bifidobacterium or the combination of probiotic Bifidobacterium with TM did not decrease the incidence of grade 2 or greater diarrhea compared with historical control, although the grade 3 or greater diarrhea was reduced."

Journal • P2 data • Breast Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Effectiveness of Saccharomyces Boulardii CNCM I-745 probiotic in acute inflammatory viral diarrhoea in adults: results from a single-centre randomized trial. (PubMed, BMC Gastroenterol) - P=N/A | "Treatment with Sb on acute inflammatory diarrhoea of viral aetiology shows no changes regarding the severity of the symptoms; nevertheless, it seems to impact improvement positively."

Journal • Gastroenterology • Gastrointestinal Disorder • Pain

Repurposing of US-FDA approved drugs against SARS-CoV-2 main protease (M) by using STD-NMR spectroscopy, in silico studies and antiviral assays. (PubMed, Int J Biol Macromol) - "In this study, 156 drugs and natural compounds were evaluated against M. Among them, 10 drugs were found to be interacting with M, including diltiazem HCl (1), mefenamic acid (2), losartan potassium (3), mexiletine HCl (4), glaucine HBr (5), trimebutine maleate (6), flurbiprofen (7), amantadine HCl (8), dextromethorphan (9), and lobeline HCl (10) in STD-NMR spectroscopy. Their interactions were compared with three standards (Repurposed anti-viral drugs), dexamethasone, chloroquine phosphate, and remdesivir...This study demonstrates the importance of drug repurposing against emerging and neglected diseases. This study also exhibits successful application of STD-NMR spectroscopy and plaque reduction assay in rapid identification of potential anti-viral agents."

FDA event • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Trimebutine Maleate Combined With Rabeprazole in Patients With Grade A or B Reflux Esophagitis Whose Symptoms Refractory to Rabeprazole (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Xijing Hospital of Digestive Diseases | N=500 ➔ 0 | Unknown status ➔ Withdrawn

Enrollment change • Trial withdrawal • Gastrointestinal Disorder

Effects of L1 adhesion molecule agonistic mimetics on signal transduction in neuronal functions. (PubMed, Biochem Biophys Res Commun) - "Our findings indicates that L1 agonistic mimetics trigger the same cell signaling pathways underlying neurite outgrowth, but only the L1 mimetics tacrine, polydatin, trimebutine and honokiol trigger neuronal migration. In contrast, the mimetics crotamiton and duloxetine did not affect neuronal migration, thus limiting their use in increasing neuronal migration, leaving open the question of whether this is a desired or not desired feature in the adult."

Journal • CNS Disorders • Developmental Disorders • Psychiatry • L1CAM

Visceral sensitivity in diagnostics and treatment of severe irritated bowel syndrome (PubMed, Ter Arkh) - "The insufficient effect of the trimebutine therapy can be explained by the somatoform disorders persistence in patients from group 1. Meanwhile SNRI-duloxetine therapy in group 2 showed a clinical remission of IBS: such as a reliable relief from pain and diarrheal syndrome, as well as an increase in the HF threshold. Thus, Duloxetine is a promising treatment for severe IBS with somatoform disorders. BDT can be used as an objective criterion to diagnose and evaluate the effectiveness of therapy in patients with IBS."

Journal • CNS Disorders • Depression • Gastrointestinal Disorder • Immunology • Mood Disorders • Musculoskeletal Pain • Pain • Psychiatry • Psychosomatic Disorders

Utility of Cilefa Pink B, a food dye in a facile decoration of the first green molecular-size-based fluorescence probe (MSBFP) for determining trimebutine; application to bulk, dosage forms, and real plasma. (PubMed, Spectrochim Acta A Mol Biomol Spectrosc) - "A significant achievement was using the developed fluorimetric method to monitor the drug of interest in human biofluids. The environmental friendliness of the planned procedure was then evaluated."

Journal