Ganaton (itopride) / Abbott - LARVOL DELTA

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

Efficacy and safety of itopride SR for upper gastrointestinal symptoms in patients with diabetic gastroparesis: real-world evidence from Pakistan. (PubMed, Drugs Context) - "Both statistical and clinical effectiveness were observed. Moreover, the treatment demonstrated a favourable tolerability profile, with a low incidence of adverse effects."

HEOR • Journal • Real-world • Real-world evidence • Diabetes • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Metabolic Disorders • DRD2

Satellite Symposium TRUVION HEALTHCARE: New Kid on the Block: How to position Itopride? (BWG 2024) - "Sponsored by TRUVION HEALTHCARE"

Statistically Optimized Polymeric Buccal Films of Eletriptan Hydrobromide and Itopride Hydrochloride: An In Vivo Pharmacokinetic Study. (PubMed, Pharmaceuticals (Basel)) - "The drug was found to rapidly permeate across the buccal mucosa, leading to increased bioavailability of the drug: C of 130 and 119 ng/mL of ITHC and EHBR, respectively, as compared to 96 (ITHC) and 90 ng/mL (EHBR) of oral solution. The conclusion can be drawn that possible reasons for the enhanced bioavailability could be the increased surface area in the form of buccal films, its rapid disintegration, and faster dissolution, which led toward the rapid absorption of the drug into the blood stream."

Journal • PK/PD data • Preclinical • CNS Disorders • Migraine • Pain

Prokinetics for the treatment of functional dyspepsia: an updated systematic review and network meta-analysis. (PubMed, BMC Gastroenterol) - "Metoclopramide and cinitapride may have a better efficacy than other prokinetics in the treatment of FD, and cinitapride may have a lower risk of total adverse events. Further studies using uniform definitions or validated tools to measure the total efficacy rate are needed."

Clinical • Journal • Retrospective data • Review • Dyspepsia

Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: October 6 University | Trial completion date: Nov 2024 ➔ Dec 2025 | Initiation date: Aug 2023 ➔ Dec 2023 | Trial primary completion date: Jul 2024 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • Hepatology • Non-alcoholic Fatty Liver Disease • IL6 • TNFA

Prevalence and Choice of Pharmacologic Management of Functional Dyspepsia and Irritable Bowel Syndrome During Pregnancy (ACG 2023) - "Pylori Antibiotics = Metronidazole, Clarithromycin, Levofloxacin, Tetracycline, Doxycycline, Tinidazole, Nitazoxanide, Rifabutin. Anti-Diarrheals = Loperamide, Diphenoxylate, Bismuth Salicylate. Bile Acid Sequestrants = Cholestyramine, Colesevelam, Colestipol. Bowel Stimulants = Bisacodyl, Sennosides. Exposure to IBS or FD medications was significantly elevated in IBSFD compared to NONE. 17,984 of 48,208 IBSFD patients (37%) were exposed to proton pump inhibitors compared to 266,835 of 3,046,065 (9%) of NONE (OR 6.20; 95% CI 6.08 - 6.52). 1.4% of IBSFD were exposed to Rifaximin compared to 0.032% of NONE (OR 44.44; CI 40.19 - 49.14)."

Dyspepsia • Gastrointestinal Disorder

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

Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD) (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: October 6 University

New P2 trial • Hepatology • Non-alcoholic Fatty Liver Disease • IL6 • TNFA

Design and Evaluation of S-Protected Thiolated-Based Itopride Hydrochloride Polymeric Nanocrystals for Functional Dyspepsia: QbD-Driven Optimization, In Situ, In Vitro, and In Vivo Investigation. (PubMed, Pharmaceuticals (Basel)) - "Finally, at the measured concentrations, the ITH/NC showed minimal cytotoxicity against lung cells, indicating that it may have potential for additional in vivo research. The enhanced bioavailability and mean residence time of the designed mucoadhesive NC formulations were confirmed by pharmacokinetic studies."

Journal • Preclinical • Dyspepsia • Gastrointestinal Disorder

The Cost-Effectiveness and Budget Impact of Itopride Hydrochloride for the Treatment of Functional Dyspepsia in Vietnam (ISPOR 2023) - "This study shows that itopride is a cost-effective medication and would likely impose only a small budget impact if the subsidised access was widened in Vietnam."

Cost effectiveness • HEOR • Dyspepsia • Pain

Pharmacoeconomic Analysis of Fixed-Dose Combinations of Proton Pump Inhibitors Available in India. (PubMed, Cureus) - "Results The results show a huge variation (1788.88%) in costs of different brands with the highest being rabeprazole 20 mg and domperidone 10 mg (cost ratio: 18.88, percentage cost variation: 1788.88%) in oral formulation, followed by pantoprazole 40 mg and itopride 150 mg. The minimum cost ratio (1.35) and percentage cost variation (1.35%) is for pantoprazole 40 mg and levosulpiride 75 mg...Conclusion There is a wide variation in the prices of PPIs available in the market, which can inadvertently increase the financial burden of therapy on patients. Physicians need to be made aware of these price differences so that they can choose the best available alternative for patients, which can help in increasing compliance with the prescribed drugs."

HEOR • Journal • Gastroenterology • Gastrointestinal Disorder

Carbopol Based Hydrogels for ITOPRIDE Hydrochloride Delivery; Synthesis, Characterization and Comparative Assessment with Various Monomers. (PubMed, J Funct Biomater) - "An in-vitro release study was performed on pH 1.2 and 6.8. The synthesized hydrogels exhibited excellent mechanical strength, higher drug loading, pH sensitive and time dependent release up to 30 h. The excellent mechanical strength and extended drug release of Carbopol-co-poly-MAA-ITA hydrogels make them a potential candidate for controlled delivery of Itopride hydrochloride."

Journal