ilaprazole / Generic mfg. - LARVOL DELTA

Pharmacokinetics and Bioequivalence of Ilaprazole Enteric-Coated Tablets in Healthy Chinese Volunteers: A Two-Sequence, Four-Period, Fully Replicated Crossover Study. (PubMed, Clin Pharmacol Drug Dev) - "The geometric means and 90% confidence intervals of AUC0-t, AUC0-∞, and Cmax for both fasting and fed conditions were within the 80%-125% bioequivalence range, and the upper limit of the one-sided 95% confidence interval was ≤0. Both formulations demonstrated bioequivalence under these conditions, with no serious adverse reactions observed."

Journal • PK/PD data • Gastroenterology • Gastroesophageal Reflux Disease • CYP2C19

Different Doses of Ilaprazole for Dual Therapy Versus Bismuth-Quadruple Therapy for Helicobacter pylori Infection: A Three-Arm, Randomized Clinical Trial. (PubMed, Helicobacter) - P4 | "The standard- or high-dose dual therapy with ilaprazole demonstrated superior efficacy, safety, and patient compliance compared to quadruple therapy. No significant differences were observed between these dual therapies, which are expected to become promising alternatives for the primary treatment of H. pylori infection."

Clinical • Journal • Infectious Disease

In vitro anti-Helicobacter pylori activity of ilaprazole used alone and in combination with other components of quadruple therapy. (PubMed, Microbiol Spectr) - "The antibacterial activity of ilaprazole was tested on 25 H. pylori strains, including the clinical isolates resistant to clarithromycin (CLA), amoxicillin (AMX), levofloxacin, and/or metronidazole. Importantly, repeated exposure to ilaprazole did not induce resistance, a critical factor for its long-term use. These results provide compelling evidence for ilaprazole's inclusion in clinical treatment strategies, contributing to improved eradication rates and better patient outcomes in H. pylori management."

Journal • Preclinical • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Infectious Disease • Peptic Ulcer

Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer (clinicaltrials.gov) - P3 | N=416 | Recruiting | Sponsor: Il-Yang Pharm. Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Peptic Ulcer

Comparative in vitro assessment of CYP2C19 inhibition by ilaprazole and conventional proton pump inhibitors using a high throughput fluorometric assay. (PubMed, Sci Rep) - "The current study aimed to predict the CYP2C19 inhibitory potential of Ilaprazole versus conventional PPIs (Omeprazole, Lansoprazole, Pantoprazole, and Rabeprazole) on CYP2C19 activity using a high-throughput fluorometric assay. Omeprazole is the most potent CYP2C19 inhibitor, as it exceeded the regulatory threshold guidelines for in vitro study, while other tested PPIs, including Ilaprazole, did not meet this cutoff, suggesting a lower likelihood of clinically significant inhibition. Although previous in vivo studies suggest variable inhibition with other PPIs, current data support the need for further head-to-head in vivo comparisons, particularly between Pantoprazole, Rabeprazole, and Ilaprazole, to determine the most suitable option in clinical scenarios involving CYP2C19 substrate."

Clinical • Journal • Preclinical • CYP2C19

Comparative Analysis of the Efficacy of Esomeprazole and Ilaprazole in Patients With Neurological Disorders Using the Gastroesophageal Reflux Disease Questionnaire. (PubMed, Clin Neuropharmacol) - "Significant differences existed between esomeprazole and ilaprazole users and among ilaprazole users based on aspirin use. Therefore, careful monitoring of PPI use with antiplatelet agents and antacids is recommended in patients with neurological disorders. However, further research is needed to understand these differences and their clinical impact."

Journal • Atrial Fibrillation • Cardiovascular • CNS Disorders • Dyslipidemia • Gastroenterology • Gastroesophageal Reflux Disease • Metabolic Disorders

Medication Safety in Intravenous Therapy: Compatibility of Etoposide with Frequently Drugs Used in Tumour Critical Care During Simulated Y-Site Administration. (PubMed, Drug Des Devel Ther) - "Within 1 h, four medications (cefuroxime sodium, ilaprazole sodium, mycophenolate, and xuebijing) were incompatible. Within 4 h, one medications (ceftazidime) were also found to be incompatible with etoposide under observation. Seven of the 45 common medications in tumor critical care tested with etoposide were incompatible within 4 h. If co administration is inevitable and the drug is infused through a port catheter, a larger volume of saline (NS) or dextrose 5% in water (D5W) should be used to flush the port catheter before and after the etoposide infusion to clean the lumen of the port catheter."

Journal • Critical care • Oncology • Pediatrics

Simultaneous Determination of Multiple Acid-Suppressing Drugs by UPLC-MS/MS Method and Application for Pharmacokinetics Study. (PubMed, Drug Des Devel Ther) - "This study aimed to establish a generic and efficient ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) assay for the determination of five PPIs (esomeprazole, rabeprazole, ilaprazole, lansoprazole, and pantoprazole) and the P-CAB (vonoprazan) in human plasma. The UPLC-MS/MS assay provided an efficient and reliable approach for the simultaneous determination of six acid-suppressing medications in a single analytical run. It has been successfully applied to the pharmacokinetic studies of PPIs and P-CABs, offering a valuable tool for clinical research and therapeutic drug monitoring."

Journal • PK/PD data

Efficacy and safety of high-dose ilaprazole dual therapy for Helicobacter pylori eradication: a multicenter, open-label, randomized controlled clinical trial (ChiCTR) - P4 | N=504 | Sponsor: Shenzhen Hospital of Southern Medical Unversity; Shenzhen Hospital of Southern Medical Unversity

New P4 trial • Infectious Disease

Delineating CYP2C19-Mediated Interactions: Network Pharmacology Investigation of Ilaprazole and Clopidogrel versus Conventional Proton Pump Inhibitors. (PubMed, Curr Drug Discov Technol) - "The application of the network pharmacology technique allows us to consider the potential for different effects of PPIs on clopidogrel and its metabolism via CYP2C19. There is a lower chance of experiencing adverse effects from an interaction between ilaprazole and clopidogrel as ilaprazole has not been linked to CYP2C19. More research is necessary to confirm these results and provide clinical guidance for patients undergoing clopidogrel and PPI combination therapy."

Journal • Cardiovascular • CYP2C19

Biophysical interactions between self-sufficient cytochrome P450 from Tepidiphilus thermophilus and ilaprazole. (PubMed, Dalton Trans) - "This study investigated CYP116B46, a self-sufficient monooxygenase with a reductase domain, to elucidate its interaction with ilaprazole, a PPI. Binding assays and docking simulations indicate that CYP116B46 serves as a suitable model for studying PPI metabolism."

Journal

TREATMENT PATTERNS IN CHINESE PATIENTS WITH HELICOBACTER PYLORI: A MULTICENTER, RETROSPECTIVE, REAL-WORLD STUDY (UEGW 2024) - P=N/A | "Distribution of eradication therapy based upon the type and year of treatment initiation TreatmentType of Eradication therapy (N=13, 234)n (%)aYear of treatment initially prescribed , 2019(N=4492)n (%)aYear of treatment initially prescribed, 2020(N=4125)n (%)aYear of treatment initially prescribed, 2021 (N=4616)n (%)aTotalBismuth quadruple therapyAmoxicillin and ClarithromycinAmoxicillin and FurazolidoneAmoxicillin and LevofloxacinAmoxicillin and MetronidazoleAmoxicillin and TetracyclineFurazolidone and TetracyclineOther Bismuth quadrupleTriple therapycDual therapyc13,234b (-)11,301 (85.39)4376 (38.72)2074 (18.35)2007 (17.76)76 (0.67)9 (0.08)12 (0.11)2747 (24.31)999 (7.55)934 (7.06)4492 (-)4368 (97.24)1800 (41.21)689 (15.77)1021 (23.37)27 (0.62)5 (0.11)1 (0.02)825 (18.89)105 (2.34)19 (0.42)4125 (-)3299 (79.98)1324 (40.13)480 (14.55)516 (15.64)10 (0.30)1 (0.03)0 (0.00)968 (29.34)551 (13.36)275 (6.67)4617 (-)3634 (78.71)1252 (34.45)905 (24.90)470 (12.93)39 (1.07))3..."

Real-world • Real-world evidence • Retrospective data • Gastric Cancer • Gastrointestinal Cancer • Infectious Disease • Oncology • Solid Tumor

Clinical efficacy of ilaprazole combined with somatostatin on severe acute pancreatitis and the effects on oxidative stress and inflammatory response. (PubMed, Pak J Pharm Sci) - "In treatment of SAP, ilaprazole combined with somatostatin can enhance the curative efficacy and decrease the oxidative stress and the inflammatory response in patients. In addition, it cannot increase the adverse reactions, with good safety."

Clinical • Journal • Inflammation • Oncology • Pain • Pancreatitis • CRP • IL6 • TNFA

Efficacy and safety of vonoprazan versus proton pump inhibitors in the treatment of peptic ulcer disease: a systematic review and network meta-analysis for randomized controlled trails. (PubMed, Front Nutr) - "In terms of the healing rate at 2 weeks, lansoprazole 30 mg ranked first, followed by vonoprazan 20 mg and ilaprazole 10 mg. In terms of the healing rate at 4 weeks, pantoprazole 40 mg ranked first, with rabeprazole 10 mg and lansoprazole 30 mg ranking second and third, respectively...Furthermore, lansoprazole 30 mg has shown to be superior in terms of safety outcomes. These findings, derived from a network meta-analysis, necessitate further research for validation."

Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Peptic Ulcer

Comparison of the Efficacy and Safety of Dual and Quadruple Therapy with Ilaprazole in the Eradication of Helicobacter pylori (ChiCTR) - P4 | N=480 | Completed | Sponsor: Beijing Huaxin Hospital (The First Affiliated Hospital of Tsinghua University); China Health Medical Development Foundation

New P4 trial • Infectious Disease

The Impact of a Twice-daily vs Once-daily Proton Pump Inhibitor Dosing Regimen on Laryngopharyngeal Reflux Symptoms: A Prospective Randomized Controlled Trial. (PubMed, J Neurogastroenterol Motil) - "These patients were randomly assigned to receive either a 10 mg twice daily (BID) or a 20 mg once daily (QD) dose of ilaprazole for 12 weeks...Both BID and QD PPI dosing regimens improved subjective symptom scores and objective laryngoscopic findings. There was no significant difference in RSI improvement between the 2 dosing regimens, indicating that either dosing regimen could be considered a viable treatment option."

Journal

Cost-effectiveness analysis of Anaprazole versus Ilaprazole for the treatment of duodenal ulcers in China. (PubMed, Front Pharmacol) - P2/3, P3 | "Compared with Ilaprazole, Anaprazole has similar efficacy, safety, and high cost-effectiveness, while also impacting the total expenditure of the healthcare system. ClinicalTrials.gov, identifier NCT04215653 and NCT02847455."

Cost effectiveness • HEOR • Journal • Peptic Ulcer

Potassium-competitive acid blockers and proton-pump inhibitors for healing of erosive esophagitis: a systematic review and network meta-analysis. (PubMed, Therap Adv Gastroenterol) - "The main analysis only included studies conducted for both patients with and without severe EE at baseline, and the proportion of severe EE included in the study was >10%, Keverprazan 20 mg qd ranked best with a surface under the cumulative ranking curve (SUCRA) value of 84.7, followed by Ilaprazole 10 mg qd with a SUCRA value of 82.0, for the healing rate at 8 weeks...The healing effect of Keverprazan (20 mg qd) ranked best in 8-week treatment, for both severe and non-severe EE patients. The study protocol was registered with INPLASY (registration number INPLASY2023120053)."

Journal • Retrospective data • Review • Gastrointestinal Disorder

Study to Evaluate the Safety and the Pharmacokinetics of IY-NT-T (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Il-Yang Pharm. Co., Ltd. | Recruiting ➔ Completed

Trial completion

Computational drug-drug interaction prediction mediated by CYP450 isoforms of Ilaprazole coadministered with clopidogrel. (PubMed, Future Sci OA) - " Positive ΔP-values for CYP2C19 (0.955) indicate that it is involved in the drug interaction of Ilaprazole and Clopidogrel. Pantoprazole and Ilaprazole were found to have a low probability of CYP2C19 inhibition Compared with other PPIs, Pantoprazole and Ilaprazole were found to have a low probability of CYP2C19 inhibition; Since Ilaprazole has pharmacokinetic variability, further in vivo and in vitro studies are required on the ilaprazole and clopidogrel combination to assess the effect of drug-drug interaction."

Journal • CYP2C19

COMPARISON OF THE EFFICACY AND SAFETY OF DUAL AND QUADRUPLE THERAPY WITH ILAPRAZOLE IN THE ERADICATION OF H.PYLORI (DDW 2024) - "They were randomly assigned to group A (ilaprazole 5mg + amoxicillin 1g + clarithromycin 500mg + bismuth potassium citrate 0mg Bid) group B (ilaprazole 5mg Bid + amoxicillin 1g Tid) or group C (ilaprazole 10 mg Bid + amoxicillin 1g Tid) for 14 days. The standard- or high-dose were superior to quadruple therapy in terms of efficacy safety and patient compliance; There was no significant difference between these dual therapies with ilaprazole which is expected to become a promising option for H. pylori primary treatment and merits clinical validation and dissemination."

Clinical • Infectious Disease

COMPARATIVE EFFICACY OF VONOPRAZAN WITH PROTON PUMP INHIBITORS AND OTHER POTASSIUM-COMPETITIVE ACID BLOCKERS FOR REFLUX ESOPHAGITIS: A NETWORK META-ANALYSIS (DDW 2024) - "Randomized controlled trials of (1) endoscopy-confirmed RE patients ≥18 years ( ) receiving at least of these intervention arms: vonoprazan tegoprazan kenoprazan fexuprazan linaprazan glurate and/or any oral PPIs (3) reporting at least 1 clinical outcomes of healing rate at 4 weeks for vonoprazan and 8 weeks for PPIs and other P-CABs and (4) those including > 0 patients per group were considered...1) esomeprazole 40mg:1...4) ilaprazole 10mg:...8) lansoprazole 30mg:1...4) omeprazole 40mg:1...1) pantoprazole 40mg:1...8) and rabeprazole 0mg:1...ConclusionThis is the first study showing similar efficacy of 4-week vonoprazan course to 8-week PPI course and other P-CABs in healing RE. These results may be helpful to inform clinical practice."

Retrospective data • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

Fabrication and evaluation of stable amorphous polymer-drug composite particles via a nozzle-free ultrasonic nebulizer. (PubMed, Int J Pharm) - "Model crystalline phase drugs-Empagliflozin, Furosemide, and Ilaprazole-are selected. It provides a straightforward, flexible process adaptable to various drug-polymer combinations and consistently yields spherical amorphous solid dispersion (ASD) particles with a narrow size distribution. These attributes make our method a valuable advancement in pharmaceutical drug formulation and delivery."

Journal

Comparison of vonoprazan dual therapy, quadruple therapy and standard quadruple therapy for Helicobacter pylori infection in Hainan: a single-center, open-label, non-inferiority, randomized controlled trial. (PubMed, BMC Gastroenterol) - "VPZ dual therapy and quadruple therapy shows promise of not being worse than the standard quadruple therapy by a clinically relevant margin. More studies might be needed to definitively determine if the new therapy is equally effective or even superior."

Head-to-Head • Journal • Gastroenterology • Infectious Disease

The Cost-Effectiveness Analysis of Anaprazole Versus Ilaprazole for Treating Duodenal Ulcers in China (ISPOR 2024) - "Compared with Ilaprazole, Anaprazole have similar efficacy and safety when used for the treatment of DU. The ICUR value is lower than WTP, indicating good economic benefits and robust sensitivity analysis results."

Cost effectiveness • HEOR • Peptic Ulcer