[Translation] An open-label, randomized, crossover bioequivalence study of ilaprazole enteric-coated tablets in healthy participants under fasting/fed conditions

主要试验目的研究空腹/餐后状态下单次口服受试制剂艾普拉唑肠溶片（规格：5mg，山东药石药业有限公司生产）与参比制剂艾普拉唑肠溶片（商品名：壹丽安；规格：5mg；丽珠集团丽珠制药厂生产）在健康参与者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要试验目的评估受试制剂艾普拉唑肠溶片（规格：5mg）与参比制剂艾普拉唑肠溶片（商品名：壹丽安，规格：5mg）在健康参与者中的安全性。

[Translation]

Main purpose of the study To study the pharmacokinetics of a single oral dose of the test preparation ilaprazole enteric-coated tablets (specification: 5 mg, produced by Shandong Yaoshi Pharmaceutical Co., Ltd.) and the reference preparation ilaprazole enteric-coated tablets (trade name: Yilian; specification: 5 mg; produced by Livzon Pharmaceutical Factory of Livzon Group) in healthy participants in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study To evaluate the safety of the test preparation ilaprazole enteric-coated tablets (specification: 5 mg) and the reference preparation ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5 mg) in healthy participants.

Start Date11 Apr 2025

Sponsor / Collaborator

Duoduo Pharmaceutical Co. Ltd.

CTR20250352

/ Active, not recruitingNot Applicable

艾普拉唑肠溶片（5mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of ilaprazole enteric-coated tablets (5 mg) in Chinese healthy volunteers under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择丽珠集团丽珠制药厂为持证商的艾普拉唑肠溶片（商品名：壹丽安，规格：5mg）为参比制剂，对四川科伦药业股份有限公司生产并提供的受试制剂艾普拉唑肠溶片（规格：5mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂艾普拉唑肠溶片（规格：5mg）和参比制剂艾普拉唑肠溶片（商品名：壹丽安，规格：5mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5mg) of which Livzon Pharmaceutical Factory of Livzon Group is the licensee was selected as the reference preparation, and the test preparation ilaprazole enteric-coated tablets (specification: 5mg) produced and provided by Sichuan Kelun Pharmaceutical Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation ilaprazole enteric-coated tablets (specification: 5mg) and the reference preparation ilaprazole enteric-coated tablets (trade name: Yilian, specification: 5mg) to healthy subjects.

Start Date26 Feb 2025

Sponsor / Collaborator

Guilin Dahua Pharmaceutical Co. Ltd.

CTR20250156

/ CompletedNot Applicable

评估受试制剂艾普拉唑肠溶片与参比制剂在健康成年参与者空腹和餐后状态下的单中心、开放、随机、单剂量、四周期、两序列、完全重复交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study to evaluate the test formulation of ilaprazole enteric-coated tablets versus the reference formulation in healthy adult participants under fasting and fed conditions

主要研究目的：研究空腹和餐后状态下单次口服受试制剂艾普拉唑肠溶片（规格：5 mg，辰欣药业股份有限公司生产）与参比制剂艾普拉唑肠溶片（壹丽安®，规格：5 mg，丽珠集团丽珠制药厂生产）在健康参与者体内的药代动力学，评价空腹和餐后状态下口服两种制剂的生物等效性。次要研究目的：评估受试制剂艾普拉唑肠溶片（规格：5 mg）和参比制剂艾普拉唑肠溶片（壹丽安®，规格：5 mg）在健康参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation ilaprazole enteric-coated tablets (specification: 5 mg, produced by Chenxin Pharmaceutical Co., Ltd.) and the reference preparation ilaprazole enteric-coated tablets (Yilian®, specification: 5 mg, produced by Livzon Pharmaceutical Factory of Livzon Group) in healthy participants after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary purpose of the study is to evaluate the safety of the test preparation ilaprazole enteric-coated tablets (specification: 5 mg) and the reference preparation ilaprazole enteric-coated tablets (Yilian®, specification: 5 mg) in healthy participants.

Start Date18 Feb 2025

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

100 Clinical Results associated with Ilaprazole

100 Translational Medicine associated with Ilaprazole

100 Patents (Medical) associated with Ilaprazole

209

Literatures (Medical) associated with Ilaprazole

14 Mar 2025·SCIENCE

Excited-state configuration of nitroarenes enables oxidative cleavage of aromatics over alkenes

Article

Author: Leonori, Daniele ; Hitoshio, Kenshiro ; Ruffoni, Alessandro ; Olivier, Wesley J. ; Marchand, Isabelle ; Arpa, Enrique M. ; Poisson, Thomas ; Błyszczyk, Piotr ; Gomez-Mendoza, Miguel ; de la Peña O’Shea, Víctor

The ozonolytic deconstruction of aromatics remains a challenge in organic chemistry. Ozone preferentially reacts with alkenes over arenes, meaning that once the initial aromatic cleavage occurs, the dearomatized products are inherently more reactive than the starting materials. Consequently, the process cannot be halted, resulting in full oxidation. Addressing this challenge requires subverting intrinsic rules of chemoselectivity to transform a less reactive substrate in the presence of a more reactive one. We demonstrate that this concept can be achieved by using photoexcited nitroarenes. Crucial to the success of this chemoselective process is the use of a nitroarene that is preferentially excitable to a triplet π,π* state over the n,π* state. This switch in excited-state configuration provides an otherwise inaccessible manifold, in which oxidative cleavage is diverted toward aromatics in the presence of alkenes.

01 Mar 2025·CLINICAL NEUROPHARMACOLOGY

Comparative Analysis of the Efficacy of Esomeprazole and Ilaprazole in Patients With Neurological Disorders Using the Gastroesophageal Reflux Disease Questionnaire

Article

Author: Kim, Ye Ryung ; Kang, Hyun Goo ; Kim, Chae Hyun

Objectives:

Proton pump inhibitors (PPIs) are widely used to reduce gastric acid levels and are often prescribed with antiplatelet agents in patients with stroke. However, the interactions and differences among various PPIs remain unclear. Therefore, we aimed to compare the differences between esomeprazole and ilaprazole in patients with and without stroke. We also compared the effects of aspirin use in the ilaprazole group.

Methods:

We retrospectively analyzed 580 patients with neurological disorders who responded to the Gastroesophageal Reflux Disease Questionnaire at a tertiary hospital between October 2020 and December 2023. Comparative and subgroup analyses were performed using the chi-squared test, Fisher's exact test, and t tests.

Results:

In the overall patient cohort, patients using esomeprazole had lower rates of dyslipidemia and lower white blood cell, hemoglobin, triglyceride, and low-density lipoprotein cholesterol levels, compared to ilaprazole users. However, among patients with stroke, esomeprazole users had higher rates of atrial fibrillation and lower triglyceride, hemoglobin, and uric acid levels, compared to ilaprazole users. In the ilaprazole group, nonaspirin users were younger and had fewer stroke episodes and higher total cholesterol levels, compared to aspirin users. Furthermore, patients using antiplatelet and PPI therapies and antacids had lower hemoglobin levels, compared to antacid nonusers.

Conclusions:

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.

01 Mar 2025·Current drug discovery technologies

Delineating CYP2C19-mediated Interactions: Network Pharmacology Investigation of Ilaprazole and Clopidogrel versus Conventional Proton Pump Inhibitors

Article

Author: Narayanasamy, Damodharan ; Ananthathandavan, Priyadharshini

Background::

Clopidogrel, an antiplatelet drug commonly used in cardiovascular disease, is metabolized by the liver mainly through CYP2C19. Concomitant use of Proton pump inhibitors along with clopidogrel may affect the potency of clopidogrel by CYP2C19 inhibition. However, a novel PPI, ilaprazole is known to differ in its pharmacokinetic features, given the potential differences between ilaprazole’s interactions and their metabolism with clopidogrel. Network pharmacology investigation could be a useful tool to evaluate the drug-drug interaction between them.

Methodology::

The molecular structures and targets were retrieved from PubChem and SwissTargetPrediction to establish the information related to the identified drugs. The possible shared targets between the clopidogrel and PPIs were explored by a Venn analysis. Subsequently, Protein-Protein Interaction networks were established using the STRING database. Hub genes were also determined using the Cytoscape cytoHubba plugin.

Results & Discussion::

Ilaprazole (13.6%) and pantoprazole (13.6%) were characterized by fewer targets being shared with clopidogrel compared to conventional PPIs (14.9%). Moreover, CYP2C19 was not a hub gene in ilaprazole and pantoprazole interactions, which indicated no significant CYP2C19 involvement. On the other hand, CYP2C19 functioned as a hub gene in the interactions with rabeprazole, lansoprazole, dexlansoprazole, omeprazole, and esomeprazole. As a result, patients receiving pantoprazole and ilaprazole would be at a lower risk for developing adverse cardiovascular events by maintaining the clopidogrel therapeutic effect.

Conclusion::

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.

News (Medical) associated with Ilaprazole

06 Feb 2025

·www.echemi.com

Pfizer Reports 2024 Earnings with $63.6 Billion Revenue and Concerns Over Innovation

On February 4, Pfizer announced its financial results for the fourth quarter and the entire year of 2024, revealing a total revenue of $63.6 billion, a 7% increase year-on-year. The fourth quarter alone saw revenues of $17.8 billion, reflecting a substantial 22% growth compared to the same period last year. However, the net profit for the year was $8.031 billion, with only $410 million generated in the fourth quarter, raising concerns among investors. Pfizer operates through three main business segments: Generic Medicines, Specialty Medicines, and Oncology. The Generic Medicines division reported annual revenues of $30.135 billion, a 2% decline from the previous year. In contrast, the Specialty Medicines segment achieved $16.652 billion in revenue, marking an 11% increase, while the Oncology division saw a 25% rise in revenue, totaling $15.612 billion. In the Generic Medicines segment, sales of the COVID-19 vaccine reached $5.353 billion, down 52% year-on-year. Despite this significant drop, there is no indication that the vaccine has fallen out of favor. Sales of apixaban totaled $7.366 billion, up 9%, although this product is nearing the end of its lifecycle. The pneumonia vaccine family generated $6.411 billion, a slight 1% decline. Notably, sales of Rimegepant, an oral CGRP inhibitor, surged to $1.263 billion, a 36% increase from 2022. The RSV bivalent vaccine Abrysvo brought in $755 million, down approximately $150 million from the previous year. Other pipeline products primarily consist of Pfizer's mature offerings, which generally experienced declines. In the Specialty Medicines sector, the drug Vyndaqel for transthyretin amyloidosis proved to be a significant revenue generator, contributing $5.411 billion in sales, a remarkable 64% increase. However, sales of tofacitinib fell 31% to $1.168 billion due to patent cliffs affecting the immediate-release formulation. The older drug ilaprazole saw sales of $690 million, down 17% year-on-year. Surprisingly, the antibiotic sufentanil still managed to generate $637 million in sales, despite a 4% decline, with a significant portion likely coming from China. The injectable ceftazidime-avibactam (Sivextro) achieved $586 million in sales, a 16% decline, marking it as the first cephalosporin antibiotic to surpass $500 million in sales since 2010. In the Oncology division, palbociclib generated $4.367 billion, down 8% year-on-year. Enzalutamide saw revenues of $2.039 billion, a 23% increase. The new drug padcev (enfortumab vedotin) performed exceptionally well, achieving $1.588 billion in sales during its first full fiscal year. Adcetris (brentuximab vedotin) also showed strong performance, with sales soaring to $1.089 billion. Axitinib generated $978 million, down 6%, while bosutinib remained stable at $645 million. Despite maintaining its position as the world's largest pharmaceutical company, Pfizer faces significant challenges regarding innovation and pipeline development. As of December 2024, the company's market capitalization stood at $150 billion, significantly lower than competitors such as Eli Lilly ($750 billion), Johnson & Johnson ($350 billion), AbbVie ($320 billion), Novo Nordisk ($300 billion), Merck ($250 billion), Roche ($220 billion), Novartis ($210 billion), and AstraZeneca ($200 billion). The pressure to innovate and expand its product pipeline remains a critical concern for Pfizer moving forward.

VaccineFinancial StatementDrug ApprovalClinical ResultBiosimilar

04 Sep 2023

·synapse.patsnap.com

Comprehensive understanding of Proton Pump Inhibitors

Proton pumps are enzymes found in the stomach lining that play a crucial role in the production of gastric acid. These pumps are responsible for the secretion of hydrogen ions into the stomach, which helps in the digestion of food. By regulating the acidity levels in the stomach, proton pumps aid in the breakdown of proteins and the absorption of essential nutrients. However, excessive acid production can lead to conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Therefore, pharmaceutical companies have developed proton pump inhibitors (PPIs) to selectively inhibit these pumps, reducing acid secretion and providing relief from acid-related disorders. PPIs act on H+-K+-ATPase, effectively inhibiting both basal and various stimuli-induced gastric acid secretion. These medicines have fast onset, powerful and lasting acid-suppressing effects, and offer good safety and tolerance. They are the first choice of drugs for the clinical treatment and prevention of acid-related diseases. PPIs are widely used in the treatment of acute and chronic digestive system acid-related diseases, including gastroesophageal reflux disease, peptic ulcer, upper gastrointestinal bleeding, and other related diseases. They are also applied in eradicating Helicobacter pylori (H. pylori) infection, and in the prevention and treatment of stress-related gastromucosal lesions. With the long-term and extensive use of PPIs, combined with an ever-expanding user population, the issue of PPI overuse (super-indication, overdose, and over-treatment duration) has become increasingly prominent. Among the global patients receiving PPI treatment, 25% to 70% of prescriptions are improperly managed, leading to an unnecessary annual cost of up to 2 billion pounds due to PPI overuse. This significantly increases the economic burden of patients and health insurance departments. Proton pump Competitive LandscapeAccording to the data provided by Patsnap Synapse-Global Drug Intelligence Database: the following figure shows that as of 3 Sep 2023, there are a total of 82 Proton pump drugs worldwide, from 120 organizations, covering 65 indications, and conducting 2109 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, organizations, clinical trials, clinical results, and drug patents related to this target. The analysis of the current competitive landscape of the target Proton pump reveals that Takeda Pharmaceutical Co., Ltd., AstraZeneca PLC, and Eisai Co., Ltd. are the companies growing fastest in this field. These companies have made significant progress in the research and development of drugs targeting the Proton pump. The indications with the highest number of approved drugs include Duodenal Ulcer, Stomach Ulcer, and Gastroesophageal Reflux. The presence of a large number of small molecule drugs indicates intense competition around the innovative drug. China, Japan, and the United States are the countries/locations that are developing fastest under the current target Proton pump, with China showing significant progress in drug development. The future development of the target Proton pump is expected to be driven by the continued research and development efforts of these companies and the exploration of new indications and drug types. Classification of Proton Pump InhibitorsAfter the market introduction of Omeprazole in 1988, a series of proton pump inhibitors have sequentially appeared. Based on whether they can reversibly inhibit H+-K+-ATPase (proton pump), they are divided into irreversible proton pump inhibitors and reversible proton pump inhibitors. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Irreversible proton pump inhibitors, mainly metabolized by isoenzymes CYP2C19 and CYP3A4 in the liver CYP450 enzyme system, can irreversibly inactivate H+-K+-ATPase. Due to the different genotypes and activity levels between individuals, there is a significant individual variation in the therapeutic effects of some irreversible proton pump inhibitors. They can further be classified into CYP2C19-dependent proton pump inhibitors and CYP2C19-independent proton pump inhibitors. CYP2C19-dependent proton pump inhibitors include drug representatives such as Omeprazole, Lansoprazole, etc., which belong to the first generation of proton pump inhibitor drugs. These drugs suffer from issues such as low bioavailability, short half-life, large individual differences, drug interactions, unstable acid suppression, slow onset, nocturnal acid breakthrough, rebound of gastric acid secretion, etc. It is suggested that medical institutions with the necessary resources should carry out gene typing tests, monitor blood drug concentrations, make reasonable drug selections to improve efficacy and reduce adverse reactions. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The CYP2C19-independent proton pump inhibitors include Rabeprazole Sodium and Ilaprazole, which are part of the second-generation proton pump inhibitors. Compared to the first-generation proton pump inhibitors, they have faster onset, better acid suppression, longer acid suppression time (24-hour acid suppression), no obvious breakthrough at night, less individual variation, high safety, and fewer drug interactions. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Reversible Proton Pump Inhibitors belong to the Potassium-Competitive Acid Blocker (P-CAB) class, which competitively antagonizes the K+ binding sites on the proton pumps of gastric wall cells, inhibiting the exchange of cytoplasmic K+ and intracellular H+, thus achieving the purpose of acid suppression. They have a fast onset of action, strong acid suppression effect, higher selectivity and adverse reactions.

100 Deals associated with Ilaprazole

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ilaprazole	A02BC	DB11964

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Esophagitis, Peptic	Indonesia	Livzon Pharmaceutical Group, Inc.	27 Sep 2022
Gastroesophageal Reflux	China	Livzon Pharmaceutical Group, Inc.	16 Apr 2015
Erosive esophagitis	South Korea	IlYang Pharmaceutical Co., Ltd.	28 Oct 2008
Stomach Ulcer	South Korea	IlYang Pharmaceutical Co., Ltd.	28 Oct 2008
Duodenal Ulcer	China	Livzon Group Livzon Pharmaceutical Factory	11 Dec 2007

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-erosive gastro-esophageal reflux disease	Phase 3	United States	IlYang Pharmaceutical Co., Ltd.	31 Oct 2018
Non-erosive reflux disease	Phase 3	United States	IlYang Pharmaceutical Co., Ltd.	31 Oct 2018
Duodenal ulcer caused by Helicobacter pylori	Phase 3	United States	IlYang Pharmaceutical Co., Ltd.	01 Dec 2012
Peptic Ulcer	Phase 3	United States	IlYang Pharmaceutical Co., Ltd.	01 Dec 2012
Peptic Ulcer Hemorrhage	Phase 2	-	Livzon Pharmaceutical Group, Inc.	01 Feb 2014
Helicobacter pylori infection	IND Approval	China	Livzon Group Livzon Pharmaceutical Factory	01 Nov 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2020	Not Applicable	IL-13 \| eotaxin-3 \| CCL26	-	Ilaprazole	hidudbqzpy(yaozevawjh) = yedacpeaut mcsfccakgj (efhtfwcrkl )	Positive	01 Feb 2020
				Vonoprazan	hidudbqzpy(yaozevawjh) = qlefdvnpvh mcsfccakgj (efhtfwcrkl )
NCT02638584 (Pubmed \| Surg Endosc) Manual	Phase 4	Stomach Ulcer	176	ilaprazole	mjkdjutdll(uketrttgqi) = eeblxuskks tfuolrbvqc (utoozjwrxa ) View more	Positive	01 May 2019
				rabeprazole	mjkdjutdll(uketrttgqi) = rxmgpeasmz tfuolrbvqc (utoozjwrxa ) View more
NCT02860624 (Pubmed) Manual	Phase 3	Esophagitis, Peptic	537	Ilaparazole	ppqbyewvtz(vubfghznyh) = ilketnfrrp vanzehnyhn (nrehexvzjm ) View more	Similar	01 May 2018
				esomeprazole	ppqbyewvtz(vubfghznyh) = inlxezpncj vanzehnyhn (nrehexvzjm ) View more
UEGW2017	Not Applicable	Stomach Ulcer	88	Ilaprazole 20 mg	ciquweysws(tlfkwfkvku) = pitmlfnzgi jnmeqpcecy (iemicorout )	Negative	01 Oct 2017
				Rabeprazole 20 mg	ciquweysws(tlfkwfkvku) = rxtzdufigh jnmeqpcecy (iemicorout )
NCT01107938 (Pubmed \| Clin Drug Investig)	Phase 2	Esophagitis, Peptic	-	Ilaprazole 10 mg/day	zaoyfqzmak(tibiauqsyy) = ojsyqnydri clswcdvqnl (kejoorhncv, (86.73%)) View more	-	01 Dec 2016
				Ilaprazole 15 mg/day	zaoyfqzmak(tibiauqsyy) = kkfgdwdcbu clswcdvqnl (kejoorhncv, (81.40%)) View more
NCT00952978 (Pubmed \| Curr Med Res Opin)	Phase 3	Duodenal Ulcer	494	Ilaprazole 10mg/d	xpjgyldzct(flffkvnjcp) = jjcyegscza renlihfpwn (vpedslrzef )	Positive	01 Jan 2012
				Omeprazole 20mg/d	xpjgyldzct(flffkvnjcp) = zjvitkmrfl renlihfpwn (vpedslrzef )
NCT00953381 (Pubmed \| J Clin Gastroenterol)	Phase 2	Duodenal Ulcer	235	Ilaprazole 5 mg	itoqcibiuw(ojcrmjfvqv) = itnjlptnyn mmtibrvamn (tkcefeqpso )	-	01 Apr 2011
				Ilaprazole 10 mg	itoqcibiuw(ojcrmjfvqv) = esdsdfqqkm mmtibrvamn (tkcefeqpso )

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