Ganaton (itopride) / Abbott - LARVOL DELTA

Effect of Itopride on Semaglutide Gastroparesis (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Ain Shams University

New P4 trial • Anesthesia • Gastrointestinal Disorder

Quality by design approach for optimization, in-vitro and in-vivo evaluation of compression-spheronized itopride hydrochloride loaded gastroretentive pellets for the treatment of gastroesophageal reflux disease. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "In vivo gastric residence time was observed to be 6 h, with a bioavailability of 52.87 ± 0.15 µg/mL/h. Based on in vitro and in vivo findings, the developed gastroretentive mucoadhesive pellet formulation presents a promising drug delivery system for the treatment of GERD, potentially enhancing drug efficacy through prolonged gastric retention."

Journal • Preclinical • Gastroenterology • Gastroesophageal Reflux Disease

ITOPRIDE'S ROLE IN FUNCTIONAL DYSPEPSIA: A META-ANALYSIS OF PLACEBO-CONTROLLED AND PROKINETIC-CONTROLLED TRIALS (UEGW 2025) - "Aims & This meta-analysis evaluates the therapeutic efficacy of Itopride compared to placebo and other prokinetic agents in managing FD symptoms.A total of 19 randomized controlled trials were included in the analysis, comprising six placebo-controlled studies (n=1981, 976 on placebo and 1005 on Itopride) and 13 trials comparing Itopride to another prokinetic (n=1077, 515 on Itopride and 562 on control prokinetics including mosapride citrate, levosulpiride, metoclopramide, domperidone, and cisapride). This meta-analysis suggests that Itopride provides significant symptom relief in patients with FD compared to placebo, particularly in overall responder rates. While Itopride's benefits over other prokinetics were modest in general symptom relief, it demonstrated a statistically significant advantage over domperidone for early satiation."

Retrospective data • Dyspepsia • DRD2

Acotiamide vs Itopride in Postprandial Distress Syndrome (clinicaltrials.gov) - P3 | N=152 | Not yet recruiting | Sponsor: Getz Pharma

New P3 trial • Dyspepsia

PASSPORT: Postprandial Distress Itopride Cohort Trial (clinicaltrials.gov) - P=N/A | N=200 | Not yet recruiting | Sponsor: Universitaire Ziekenhuizen KU Leuven

New trial • Dyspepsia • Musculoskeletal Pain • Pain

Therapeutic Efficacy of Flupentixol-Melitracen for Treatment of Aerophagia in Adults: A Single-Center Parallel Randomized Controlled Trial. (PubMed, JGH Open) - P4 | "Groups 1, 2, and 3 were treated with itopride hydrochloride, flupentixol-melitracen, and the combination of two medicines, respectively. The findings suggest that short-term treatment with flupentixol-melitracen, with or without a prokinetic benzamide derivative, is likely to improve symptoms of aerophagia in adults without significant adverse effects. Trial Registration: ClinicalTrials.gov identifier: ChiCTR-IPR-15006869."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Proposed Algorithm for the Diagnosis and Management of Diabetic Gastroparesis in the Indian Clinical Setting. (PubMed, Indian J Endocrinol Metab) - "Additionally, the algorithm underscores the significance of endoscopic evaluation and gastric emptying studies in DGP diagnosis, as well as the use of prokinetics, antiemetics, and neuromodulators in treatment. Notably, the experts favoured itopride as the preferred and relatively safer prokinetic for treating DGP and its varied clinical presentations."

Journal • Review • Anorexia • Diabetes • Gastrointestinal Disorder • Metabolic Disorders

Functional disorders of the upper digestive tract: epidemiological, clinical and therapeutic aspects. (PubMed, Recenti Prog Med) - "First-line drugs for the management of functional dyspepsia include prokinetics, such as domperidone and itopride, and proton pump inhibitors, the latter being indicated mainly in patients with symptoms associated with hyperacidity. However, current guidelines emphasize the need for further clinical evidence to consider such approaches as standard of care. In conclusion, although significant progress has been made in the understanding and treatment of these disorders, there remains much room for development with regard to targeted and personalized therapeutic strategies."

Journal • Review • Dyspepsia • Gastrointestinal Disorder • Immunology • Musculoskeletal Pain • Pain

GRV: Efficacy of Itopride Versus Metoclopramide in Hospitalized Medicine Patients With High Gastric Residual Volume (clinicaltrials.gov) - P4 | N=86 | Not yet recruiting | Sponsor: Chulalongkorn University

New P4 trial

Advances in Gastroesophageal Reflux Disease Management: Exploring the Role of Potassium-Competitive Acid Blockers and Novel Therapies. (PubMed, Pharmaceuticals (Basel)) - "Emerging treatment options include potassium-competitive acid blockers (PCABs) like vonoprazan, which offer more potent and sustained inhibition of gastric acid secretion compared to traditional PPIs. Additionally, prokinetic agents such as itopride have gained attention due to their potential to improve GERD symptoms by enhancing gastrointestinal motility and accelerating gastric emptying. This article reviews the mechanisms of action, clinical efficacy, and potential of these novel therapeutic approaches in improving patient outcomes in GERD management. With the growing prevalence of PPI resistance and side effects, a personalized, multifaceted approach to treatment is becoming increasingly necessary to optimize care for patients with GERD."

Journal • Review • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Pain

An Extremely Rare Case of Gastroptosis Treated Successfully with Itopride in a Patient with Parkinson's Disease. (PubMed, Niger Postgrad Med J) - "Although the presence of Parkinson's disease casts doubt on the use of dopamine antagonists, itopride has a very low central nervous system (CNS) pass and CNS-related side effects. Moreover, the absence of effective and safe measures other than dopaminergic antagonists and interventional methods renders their use compulsory."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

The Quantitative Analysis of Solid Dosage Forms of Itopride using Raman Spectroscopy. (PubMed, Curr Pharm Des) - "These findings demonstrated that the concentration of itopride in pharmaceutical samples using an established Partial Least Squares Regression calibration model can be determined with reliability."

Journal

Design, statistical optimization, in vitro and biological characterization of Eudragit L100-gelatin based buccoadhesive bilayer patch for managing oral mucositis. (PubMed, Int J Biol Macromol) - "This study deals with the development of a bilayer biodegradable mucoadhesive patch using the solvent casting approach, incorporating a ropivacaine (RC)-loaded gelatin layer and an itopride (IP)-loaded eudragit L100 layer for managing oral mucositis, nausea, vomiting, and gastrointestinal disorders. Tail flick tests in rats confirmed local anesthetic action, and strong mucoadhesive strength was observed in rabbits' buccal mucosa. Cytotoxicity studies exhibited enhanced cell survival, while histopathological analysis demonstrated no inflammatory or harmful effects, confirming the safety of the patch."

Journal • Preclinical • Anesthesia • Gastroenterology • Gastrointestinal Disorder • Mucositis • Stomatitis

Effect of acupuncture in patients with postprandial distress syndrome: study protocol for a randomized controlled trial. (PubMed, Front Med (Lausanne)) - "Two hundred and one eligible participants will be randomly assigned into three groups: a verum acupuncture plus placebo group, an itopride plus sham acupuncture group, and a sham acupuncture plus placebo group...In conclusion, this trial will determine the efficacy and safety of acupuncture for PDS and provide more high-level evidence to support its application in treating FD. Identifier [ITMCTR2024000510]."

Journal • CNS Disorders • Depression • Dyspepsia • Mood Disorders • Psychiatry

Itopride in functional dyspepsia: open-label, 1-year treatment follow-up of two multicenter, randomized, double-blind, placebo-controlled trials. (PubMed, Therap Adv Gastroenterol) - P3 | "In this population, itopride, given for up to 12 months, was safe, and up to two-thirds appeared to maintain symptom benefit. NCT00110968 and NCT00112203."

Clinical • Journal • Dyspepsia • Gastrointestinal Disorder • DRD2

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia (clinicaltrials.gov) - P3 | N=564 | Active, not recruiting | Sponsor: Abbott | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Dyspepsia • Gastrointestinal Disorder

Proposed Algorithm for the Diagnosis and Management of Functional Dyspepsia in India. (PubMed, J Assoc Physicians India) - "The experts also reviewed the use of several prokinetics and provided their views on the choice of drugs for varied clinical presentations of functional dyspepsia. Among prokinetics, the experts believed that itopride was the preferred and relatively safer option for the treatment of functional dyspepsia."

Journal • CNS Disorders • Constipation • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Inflammatory Bowel Disease

Clinical Trial: Treatment of Functional Dyspepsia According to Subtype Compared With Empirical Proton Pump Inhibitor. (PubMed, Aliment Pharmacol Ther) - P4 | "Initial treatment of FD according to subtype was not more effective than empirical PPI alone for up to 8 weeks. Further multicentre studies, with a larger sample size, are recommended to validate these findings."

Journal • CNS Disorders • Dyspepsia • Gastrointestinal Disorder • Musculoskeletal Pain • Pain

Prokinetic effect of erythromycin in the management of gastroparesis in critically ill patients-our experience and literature review. (PubMed, Front Med (Lausanne)) - "This contributes to stimulating gastric emptying in critically ill patients with gastroparesis who are hospitalized in an intensive care unit. The use of erythromycin in combination with metoclopramide and/or itopride hydrochloride allows for a synergistic effect, leading to the quickest possible return to enteral feeding."

Journal • Review • Critical care • Gastrointestinal Disorder • Infectious Disease

Gastroesophageal reflux disease in chronic obstructive pulmonary disease. (PubMed, Respir Investig) - "Acid inhibitory agents, such as proton pump inhibitors and histamine H2 receptor antagonists, and prokinetic agents, including mosapride and itopride, are clinically used to treat GERD...There is still insufficient evidence, but an increasing number of studies have suggested the clinical efficacy of treatment in patients with COPD and GERD. As GERD is an evaluative and treatable common disease, and access to evaluation and treatment is relatively easy, clinicians should provide adequate care for GERD in the management of COPD."

Journal • Review • Chronic Obstructive Pulmonary Disease • Esophageal Cancer • Gastric Cancer • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HRH2

EFFECT OF APREPITANT ON ALLYL ISHOTHIOCYANATE-INDUCED MUCOSAL INFLAMMATION AND GASTRIC MOTILITY IMPAIRMENT IN THE RODENT STOMACH (DDW 2024) - "Previously we have shown that the oral administration of allyl isothiocyanate (AITC) produced gastric motility impairment without the hemorrhagic gastric lesions in rodents and that the model was easily accessible to evaluation of the prokinetic agents such as an itopride and a mosapride (JPS 0 1)...And A-967079 (10 mM) a TRPA1 channel blocker was given into gastric mucosa 30 min before AITC application...The mucosal vascular permeability induced by AITC was significantly attenuated by the pretreatment of an indomethacin or an aprepitant but not a BIBN 4096... These results suggest that AITC-induced mucosal inflammation with no mucosal damage is dependent on substance P and endogenous prostaglandin in rodent stomachs. Those inflammation may lead to the impaired motility in rodents."

Preclinical • Anesthesia • Dyspepsia • Hematological Disorders • Inflammation • Mucositis • TRPA1

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia (clinicaltrials.gov) - P3 | N=564 | Recruiting | Sponsor: Abbott | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Dyspepsia • Gastrointestinal Disorder

The efficacy and safety of itopride as an add-on therapy to a proton pump inhibitor in the treatment of gastroesophageal reflux disease. (PubMed, Prz Gastroenterol) - "No adverse effects were noted. The presented study clearly demonstrates that in patients ineffectively treated with PPIs, the addition of itopride to the therapy for 8 weeks without changing the PPI dose, significantly improves the efficacy of treatment of reflux disease and thus shortens the need for medication usage and reduces the costs of therapy, potential side effects of PPI, improves the patient's quality of life and decreases the frequency of medical appointments."

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Otorhinolaryngology

Efficacy and safety of pantoprazole and itopride in patients with overlap of gastroesophageal reflux disease and dyspepsia: A prospective, open-label, single-arm pilot study. (PubMed, JGH Open) - "The FDC of pantoprazole and itopride showed favorable efficacy and safety in patients with GERD and overlapping dyspepsia refractory to pantoprazole monotherapy. Nevertheless, further studies are warranted."

Journal • Dyspepsia • Gastroenterology • Gastroesophageal Reflux Disease

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia (clinicaltrials.gov) - P3 | N=564 | Not yet recruiting | Sponsor: Abbott

Head-to-Head • New P3 trial • Dyspepsia • Gastrointestinal Disorder