anaprazole / Sihuan Pharmaceutical - LARVOL DELTA

Absorption, Metabolism, and Excretion of [14C]-Labeled Anaprazole: A New Proton Pump Inhibitor, After a Single Oral Administration in Healthy Chinese Male Subjects. (PubMed, Clin Pharmacol Drug Dev) - "Blood/plasma ratios of the radioactivity (approximately 0.60) remained consistent over time. Anaprazole showed good absorption and was extensively metabolized majorly to thioether M8-1 via nonenzymatic metabolism, and cytochrome P450 3A4 also contributed to its metabolism in healthy individuals."

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

Integrated Models of Population Pharmacokinetics and Exposure Response to Optimize Dosage Regimen for Anaprazole Sodium in Duodenal Ulcer. (PubMed, Eur J Pharm Sci) - "Meanwhile, Anaprazole had a good healing rate (94.0%) in duodenal ulcer patients and the exposure-response analysis indicated that the cured results were not influenced by the exposure parameters of parent drug or metabolite. In conclusion, the drug is safe when dosing between 20 and 100 mg once a day."

Journal • PK/PD data • Gastrointestinal Disorder • Peptic Ulcer

Safety, Tolerability, and Pharmacokinetics of Anaprazole, a Novel Proton Pump Inhibitor, in Healthy Chinese Subjects. (PubMed, Clin Pharmacol Drug Dev) - "In conclusion, anaprazole sodium enteric-coated tablets were found to be safe and well tolerated in healthy Chinese individuals. Anaprazole is absorbed and metabolized consistently in the human body without any accumulation."

Journal • PK/PD data

Budget Impact Analysis of Anaprazole for the Treatment of Duodenal Ulcer in China (ISPOR 2024) - "When Anaprazole is included in the NRDL, it has less impact on the total expenditure of health insurance, and the impact on the health insurance fund can be reduced by negotiating price reductions of health insurance drugs in exchange for volume."

HEOR • Gastroenterology • Peptic Ulcer

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

Physiologically Based Pharmacokinetic Modeling to Assess the Drug-Drug Interactions of Anaprazole with Clarithromycin and Amoxicillin in patients undergoing eradication therapy of H. pylori infection. (PubMed, Eur J Pharm Sci) - "The whole-body PBPK models of anaprazole, clarithromycin, and amoxicillin were built and qualified, which can predict DDIs that are mediated by gastric pH change and inhibition of metabolic enzymes, providing a mechanistic understanding of the DDIs observed in the clinic of clarithromycin, amoxicillin with anaprazole."

Journal • PK/PD data • Infectious Disease

Combined contributions of cytochrome P450s (CYPs) and non-enzymatic metabolism in the in vitro biotransformation of anaprazole, a novel proton pump inhibitor. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Both enzymatic and non-enzymatic metabolisms contribute to the clearance of anaprazole in human. Anaprazole is less likely to develop drug-drug interactions in clinical use compared to other PPIs."

Journal • Preclinical • Gastroenterology • Gastroesophageal Reflux Disease • Peptic Ulcer • CYP2C9 • CYP3A4

Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study. (PubMed, Chin Med J (Engl)) - P3 | "The efficacy of anaprazole is non-inferior to that of rabeprazole in Chinese patients with duodenal ulcers."

Clinical • Head-to-Head • Journal • P3 data • Gastroenterology • Infectious Disease • Peptic Ulcer • CYP2C19

Pharmacokinetic Interaction of Anaprazole, Amoxicillin and Clarithromycin after Single-Dose Simultaneous Administration and the Effect of Adding Bismuth on Their Pharmacokinetics in Healthy Male Chinese Subjects. (PubMed, Eur J Drug Metab Pharmacokinet) - "Dose adjustments for individual drugs are not necessary with combined dosing of anaprazole, amoxicillin, clarithromycin and bismuth."

Journal • PK/PD data • Infectious Disease

A Study of Anaprazole Sodium Enteric-coated Tablets in the Treatment of Reflux Esophagitis (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P2 trial • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Otorhinolaryngology