A multicenter, randomized, double-blind, double-dummy phase II clinical trial to evaluate the efficacy and safety of injectable LX22001 versus esoprazole sodium for injection in reducing the risk of rebleeding after endoscopic treatment for peptic ulcer bleeding

Start Date15 Jan 2025

Sponsor / Collaborator

Ruijin Hospital

ChiCTR2200063082

/ Not yet recruitingPhase 1IIT

Phase Ia of a randomized, double-blind, active drug/placebo-controlled evaluation of the safety, tolerability and pharmacokinetics/pharmacodynamics (PK/PD) of a single administration of H008 injection in healthy adult subjects clinical research

Start Date31 Aug 2022

Sponsor / Collaborator

Jiangsu Carephar Pharmaceutical Co., Ltd.

[+1]

ChiCTR2100053078

/ RecruitingPhase 4IIT

The efficacy of sucralfate suspension gel in the treatment of artificial ulcer after gastric ESD, a multicenter randomized, controlled, non-inferiority study

Start Date01 Dec 2021

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

100 Clinical Results associated with Esomeprazole Sodium

100 Translational Medicine associated with Esomeprazole Sodium

100 Patents (Medical) associated with Esomeprazole Sodium

1,707

Literatures (Medical) associated with Esomeprazole Sodium

01 Feb 2026·Expert Opinion On Drug Safety

Exploration of the clinical characteristics and potential mechanisms of liver injury induced by proton pump inhibitors

Article

Author: Wang, Shijian ; Chen, Xi ; Wang, Jiabing ; Wang, Libo ; Wei, Jing

BACKGROUND AND AIMS:

Data related to clinical characteristics and potential mechanisms of proton pump inhibitors (PPIs)-related liver injury are sparse, thus the purpose of this study is to summarize the clinical features and molecular mechanisms of PPIs-induced liver injury.

METHODS:

We collected case report on liver injury induced by PPIs in English and Chinese for retrospective analysis. Clinical and pathological data and outcomes were obtained and analyzed. Network pharmacology and molecular docking techniques were employed to examine the mechanism.

RESULT:

Twenty-three patients with PPIs-induced liver injury were enrolled. PPIs-induced liver injury is a rare adverse reaction, ranging from asymptomatic elevated transaminases to fulminant liver failure. Omeprazole was the drug with the highest number of associated reports. The most common symptom was fatigue. The most common liver injury pattern was hepatocellular injury. A total of 13 intersection targets of PPIs and liver injury were screened, and the top 10 targets were included, and the PI3K-Akt signaling pathway was significantly enriched. The results of molecular docking implied that the PPIs could combine well with key targets.

CONCLUSION:

Patients receiving long-term treatment with PPIs should consider monitoring liver function. PPIs exhibit considerable capacity in liver injury via especially the PI3K-Akt signaling pathway.

02 Jan 2026·Expert Opinion On Drug Safety

Gastrointestinal adverse events associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the EudraVigilance and VigiAccess databases

Article

Author: El-Tanani, Mohamed ; Sharma, Shrestha ; Rabbani, Syed Arman ; Dubey, Harikesh ; Khurana, Atul ; Sridhar, Sathvik B. ; Arora, Mandeep Kumar

BACKGROUND:

This study aimed to provide an overview of gastrointestinal (GI) adverse events associated with immune checkpoint inhibitors (ICIs) using two pharmacovigilance databases, EudraVigilance and VigiAccess.

RESEARCH DESIGN AND METHODS:

Data was collected from the date of ICI's marketing authorization until 30 November 2023. Reporting odds ratio (ROR) was used as a measure of ADR reporting disproportionality for signal detection.

RESULTS:

Overall, across both databases, EudraVigilance and VigiAccess, a total of 76,606 ADR reports were analyzed. In EudraVigilance, colitis (12,581) and diarrhea (12,108) were the most reported GI adverse events, with similar findings in VigiAccess. Furthermore, in both databases, the most ADR reports were associated with nivolumab and pembrolizumab. Durvalumab (ROR: 3.96, 95%CI :3.65-4.28), ipilimumab (ROR: 1.95, 95%CI: 1.89-2.01), nivolumab (ROR: 1.05, 95%CI: 1.02-1.07), and atezolizumab (ROR: 1.04, 95%CI: 1.01-1.07) demonstrated higher risks of GI events compared to other ICIs. EudraVigilance analysis identified dysphagia, ascites, hematochezia, and gastroesophageal reflux disease as potential signals associated with ICI therapy. Majority of ADR reports (87.2%) comprised serious GI adverse events, a portion of which was associated with fatal outcomes (14.5%). Atezolizumab (14.9%) and pembrolizumab (11.9%) were linked to a higher incidence of fatal outcomes compared to other ICIs.

CONCLUSION:

The differential risk profiles of ICIs-associated-GI adverse events underscore the importance of personalized therapy in oncology.

02 Nov 2025·Expert Opinion On Drug Safety

Drug-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database

Article

Author: Zhang, Rui ; Li, Dongxuan ; Du, Qian ; Zhu, Jun ; Wang, Yalan ; Dai, Liyang ; Liu, Songqing ; Zhang, Tongyan ; Wu, Fan

BACKGROUND:

The comprehensive quantitative and comparative risk data of drug-induced erectile dysfunction (ED) are still lacking, and this study aims to supplement this information.

RESEARCH DESIGN AND METHODS:

We reviewed all the ED reports in the FDA Adverse Event Reporting System (FAERS) database from 2004 to 2023 and summarized a potential ED culprit-drug list and its corresponding reporting frequency. The reporting odds ratio (ROR) method was used to conduct disproportionality analysis.

RESULTS:

A total of 20,098 ED reports were retrieved from the FAERS database, which recorded 734 different ED culprit-drugs, involving 74 drug classes. Finasteride was the drug with the highest reporting frequency, and urologicals was the drug class with the highest reporting frequency. In disproportionality analysis, 209 drugs with positive signals showed a close relationship with ED occurrence, among which finasteride was the drug with the highest signal strength. Among 209 drugs with positive signals, 27 were compound preparations, and the risk level of compound preparations was usually higher than their single active ingredient.

CONCLUSIONS:

Our study integrated quantitative and comparative ED risk data of 734 drugs by using the FAERS database, which can provide reference information for regulators, medical personnel, and others involved in drug management and use.

News (Medical) associated with Esomeprazole Sodium

20 Sep 2021

·www.biospace.com

Human Microbiome Market: Escalating Diabetes Cases to Accelerate the Demand for Microbiome-Based Therapies

An increase in the prevalence of lifestyle diseases around the world and the rising geriatric population will serve as prominent reason for the growth of the human microbiome market during the forecast period of 2018-2026. The emergence of lifestyle-based metabolic diseases is also at an all-time high. These factors will have a great impact on the growth of the human microbiome market across the assessment period of 2018-2026. The human microbiome, also referred to as the microbiota, contains microbes such as bacteria, viruses, and fungi. The microbes stay in saliva, oral mucosa, conjunctiva, gastrointestinal tracts, or on the surface or deep layers of the skin. The bacteria in the microbiome have a massive number of benefits. They help in regulating our immune systems, produce vitamins such as riboflavin, thiamine, vitamin B, vitamin K, and vitamin B12. These vitamins are important for blood coagulation. Such benefits bode well for the growth of the human microbiome market. Request Brochure of Report - An increase in the incidence of obesity, cancer, diarrhea, central nervous system disorders, and others will bring profitable growth for the human microbiome market. Furthermore, the growing efforts of pharmaceutical companies to develop novel drugs based on microbiome science will bring expansive growth prospects for the human microbiome market during the tenure of 2018-2026. The emergence of omics technologies and an increased focus on improving the affordability aspect across the healthcare sector will serve as major growth-generating factors for the human microbiome market. Transparency Market Research’s (TMR’s) research report on the human microbiome market has every component that will assist the stakeholder in understanding the current scenario. Prominent trends in the human microbiome market are included in the report that enables stakeholders and CXOs to take calculated risks. Top key players in human microbiome market are also compiled in the research report. The overall market survey on human microbiome by TMR suggests a promising growth period. According to the TMR experts, the market for human microbiome is prognosticated to expand at a healthy CAGR of 9.8 percent during the assessment period of 2018-2026. Request for Analysis of COVID-19 Impact on Human Microbiome Market – Growing Funding Initiatives from the Government Bodies of Numerous Countries to Add Extra Stars of Growth to the Human Microbiome Market Whether it is monitoring drugs or other innovations, the life sciences sector has always been at the forefront in terms of advancements. The government bodies of numerous countries have understood the importance of the life sciences sector contribution. They are taking many initiatives to improve the research and development activities in the sector. Hence, the government bodies of numerous countries are focusing on funding initiatives in the life science sector. The rising prominence of life sciences and their use in treating a massive number of diseases and disorders will bring exponential growth for the human microbiome market during the assessment period of 2018-2026. In addition, the market data on human microbiome generated by TMR suggests the prominence of private investors in the growth structure. The raising of US$ 68 mn by microbiome startup, Vedanta Biosciences for propelling its bacteria-based drug candidates into the later stage clinical trials is a classic instance. Buy Human Microbiome Market Report at Escalating Diabetes Cases to Accelerate the Demand for Microbiome-Based Therapies Diabetes cases are at an all-time high. The prevalence of diabetes has increased exponentially over the years. The World Health Organization (WHO) estimates that the number of people with diabetes rose from 108 mn in 1980 to 422 mn in 2014. These statistics explain the problem of diabetes in a wider aspect. Microbiomes help in decreasing the effect of diabetes exponentially as it is associated with the pathophysiology of most chronic diseases. Thus, the market analysis of human microbiome suggests that these factors have a major impact on the growth of the human microbiome market. Top of Form Browse More Market Reports: Global Esomeprazole Sodium Market: Esomeprazole sodium is a proton pump inhibitor that decreases the amount of acid produced in the stomach. It is used to relieve symptoms related to gastro oesophageal reflux disease (GERD) and other conditions involving excessive stomach acid.GERD usually occurs when stomach acid frequently flows back into the tube connecting the mouth and stomach (oesophagus). In majority of cases related to GERD, people experience acid reflux frequently. GERD is a mild acid reflux that occurs at least twice a week, while moderate to severe acid reflux occurs at least once a week. The discomfort caused due to GERD can be easily managed by lifestyle changes and over-the-counter medication. Vascular Grafts Market: Vascular diseases have high worldwide mortality, propelling advances in endovascular surgeries. Developing effective and long-term revascularization solutions has gathered immense attention among healthcare providers. Autologous arteries or veins as well as synthetic grafts have gained acceptance in the vascular grafts market. A key aim is to improve patency rates in such procedures. In this light, tissue-engineered vascular grafts are attracting attention and research interest among industry players. Though synthetic vascular prostheses have gained significant acceptance among the patient populations, some glaring limitations have hindered the commercialization scope of respective implant developers. Particularly, the marketplace hasn’t been so promising in regard to developing grafts for small-diameter vessels, which is less than 6 mm. About Us Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals. Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories. TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision. Contact Mr. Rohit Bhisey Transparency Market Research State Tower, 90 State Street, Suite 700, Albany NY - 12207 United States USA - Canada Toll Free: 866-552-3453 Email: sales@transparencymarketresearch.com Website:

30 Oct 2018

·www.biospace.com

AstraZeneca Divests Two Drugs to Grünenthal in $90 Million Deal

Warren Price Photography / Shutterstock Privately-held Grunenthal GmbH will pay AstraZeneca $700 million for the prescription medicine rights to acid-reflux medicine Nexium. The deal with AstraZeneca represents the largest investment in Grünenthal company history. Warren Price Photography / Shutterstock Privately-held Grunenthal GmbH will pay AstraZeneca $700 million for the prescription medicine rights to acid-reflux medicine Nexium. The German company also agreed to pay future milestones and sales-related payments of up to $90 million for the medication, AstraZeneca announced this morning. U.K. pharma giant AstraZeneca announced the deal with privately-held Grunenthal today. Nexium, a proton pump inhibitor, is a well-known treatment to help reduce the amount of acid in the stomach from gastrointestinal reflux conditions and ulcers. Nexium has been approved for a number of indications, including the prevention and treatment of gastric ulcers induced by pain-relieving non-steroidal anti-inflammatory drugs (NSAIDs). Nexium has lost patent protection in a number of markets. Pfizer produces an over-the-counter Nexium in the United States. AstraZeneca will continue to commercialize Nexium in all markets outside Europe, where the company retains the rights. AstraZeneca will continue to manufacture and supply Nexium under a long-term supply agreement. Nexium generated $121 million in Europe during the first half of 2018, AstraZeneca said. In addition to Nexium, AstraZeneca divested some rights to Vimovo (naproxen/esomeprazole) to Grünenthal an upfront payment of $115 million, Vimovo is a fixed-dose combination tablet of naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and esomeprazole. The medication is used for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing NSAID-associated gastric and/or duodenal ulcers. AstraZeneca kept the Vimovo rights for the United States and Japan, the company said. Vimovo garnered $37 million in revenue during the first half of the year in global sales. That figure excludes the United States and Japan. Grünenthal Chief Executive Officer Gabriel Baertschi said the acquisition of the two AstraZeneca drugs is the largest single investment in the history of the company . He also noted that the deal is “an important step” in pursuing the company’s vision of a “world free of pain for patients.” Baertschi said there is a high unmet need for patients who are on long-term high-dose NSAIDs. “Despite all guidelines recommending gastrointestinal protection for these patients, evidence suggests that one out of four may develop stomach ulcer with its serious health complications. Therefore, combining Grünenthal’s extensive pain expertise with the well-established products Nexium and Vimovo is a perfect strategic fit,” Baertschi said in a statement. With this acquisition of the two drugs, Grünenthal expects to significantly enhance its business across multiple pain-related therapeutic categories and geographies, the company said. AstraZeneca said it divested itself of the rights to those medications because they are outside of the company’s three main therapy areas of oncology, cardiovascular, renal and metabolism, and respiratory. Nexium has lost compound patent protection in the majority of global markets. Vimovo is patent protected in most European markets until 2025, AstraZeneca said. Mark Mallon, AstraZeneca’s head of global product and portfolio strategy, said the divestment of the two medications to Grünenthal allows the company to “realize value” from its successful medicines, while “redeploying our resources on developing innovative medicines for patients across our three main therapy areas.” “Grünenthal is a science-based pharmaceutical company specialized in innovative pain management and related therapies. Its expertise and distribution networks will help expand the commercial potential of both Nexium and Vimovo, helping to reach many patients who could benefit,” Mallon said.

Drug ApprovalAcquisitionLicense out/in

24 Nov 2016

·www.bioportfolio.com

Hybio Pharmaceutical Co., Ltd. 300199 Financial and Strategic SWOT Analysis Review Prices from USD $300

Summary Hybio Pharmaceutical Co., Ltd. Hybio is a biopharmaceutical company that develops polypeptide drugs. The company manufactures and develops peptide finished dosage products and peptide active pharmaceutical ingredients. Its finished dosage products include desmopressin for injection, terlipressin for injection, sodium ozagrel for injection, oxytocin for injection, omeprazole sodium for injection,and others. Hybio provides active pharmaceutical ingredients such as abarelix, calcitonin, copaxone, antide, desmopression, alarelin, bivalirudin, desirudin, elecatonin, fertirelin, ganadorelin, histrelin, leuprorelin, vapreotide and haxapeptide. The company conducts research and development to advance its products. Hybio is headquartered in Shenzhen, China. This comprehensive SWOT profile of Hybio Pharmaceutical Co., Ltd. provides you an indepth strategic analysis of the company's businesses and operations. The profile has been compiled by GlobalData to bring to you a clear and an unbiased view of the company's key strengths and weaknesses and the potential opportunities and threats. The profile helps you formulate strategies that augment your business by enabling you to understand your partners, customers and competitors better. This company report forms part of GlobalData's Profile on Demand' service, covering over 50,000 of the world's leading companies. Once purchased, GlobalData's highly qualified team of company analysts will comprehensively research and author a full financial and strategic analysis of Hybio Pharmaceutical Co., Ltd. including a detailed SWOT analysis, and deliver this direct to you in pdf format within two business days. excluding weekends. The profile contains critical company information including*, x000D x000D Business description A detailed description of the company's operations and business divisions.x000D Corporate strategy Analyst's summarization of the company's business strategy.x000D SWOT Analysis A detailed analysis of the company's strengths, weakness, opportunities and threats.x000D Company history Progression of key events associated with the company.x000D Major products and services A list of major products, services and brands of the company.x000D Key competitors A list of key competitors to the company.x000D Key employees A list of the key executives of the company.x000D Executive biographies A brief summary of the executives' employment history.x000D Key operational heads A list of personnel heading key departments/functions.x000D Important locations and subsidiaries A list and contact details of key locations and subsidiaries of the company.x000D Key manufacturing facilities A list of key manufacturing facilities of the company.x000D Detailed financial ratios for the past five years The latest financial ratios derived from the annual financial statements published by the company with 5 years history.x000D Interim ratios for the last five interim periods The latest financial ratios derived from the quarterly/semiannual financial statements published by the company for 5 interims history.x000D x000D Note*: Some sections may be missing if data is unavailable for the company. Key benefits of buying this profile include,x000D x000D You get detailed information about the company and its operations to identify potential customers and suppliers.x000D The profile analyzes the company's business structure, operations, major products and services, prospects, locations and subsidiaries, key executives and their biographies and key competitors.x000D x000D Understand and respond to your competitors' business structure and strategies, and capitalize on their weaknesses. Stay up to date on the major developments affecting the company.x000D The company's core strengths and weaknesses and areas of development or decline are analyzed and presented in the profile objectively. Recent developments in the company covered in the profile help you track important events. x000D x000D Equip yourself with information that enables you to sharpen your strategies and transform your operations profitably.x000D Opportunities that the company can explore and exploit are sized up and its growth potential assessed in the profile. Competitive and/or technological threats are highlighted.x000D x000D Scout for potential investments and acquisition targets, with detailed insight into the companies' strategic, financial and operational performance.x000D Financial ratio presented for major public companies in the profile include the revenue trends, profitability, growth, margins and returns, liquidity and leverage, financial position and efficiency ratios.x000D x000D Gain key insights into the company for academic or business research.x000D Key elements such as SWOT analysis, corporate strategy and financial ratios and charts are incorporated in the profile to assist your academic or business research needs.

Financial StatementAcquisition

100 Deals associated with Esomeprazole Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D04056	Esomeprazole Sodium	A02BC05	DB00736

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophagitis	China	AstraZeneca Pharmaceuticals Co. Ltd.	01 Jan 2009
Duodenal Ulcer	Australia	AstraZeneca Pty Ltd.	27 Jul 2004
Gastroesophageal Reflux	Australia	AstraZeneca Pty Ltd.	27 Jul 2004
Stomach Ulcer	Australia	AstraZeneca Pty Ltd.	27 Jul 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Upper gastrointestinal hemorrhage	Phase 3	China	AstraZeneca Pharmaceuticals Co. Ltd.	15 Jul 2014
Peptic Ulcer Hemorrhage	Phase 3	China	AstraZeneca PLC	01 Feb 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01757275 (CTgov)	Phase 3	Peptic Ulcer Hemorrhage	239	Esomeprazole Na+Esomeprazole Mg (Esomeprazole)	nrcjgxcviy = dgxeagcrwp witsfbdwyq (afubwhiomh, crgmdqhysb - oozuloqkoz) View more	-	08 Mar 2016
				Cimetidine (Cimetidine)	nrcjgxcviy = sjjxejbusn witsfbdwyq (afubwhiomh, cwlbzkiofp - wbvvdklaiz) View more

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