A Phase 1, Open-Label, Crossover Study to Assess the Potential for Gastric pH-Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants

The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) [rabeprazole] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants.

Start Date12 Feb 2024

Sponsor / Collaborator

Biogen, Inc.

CTR20233879 / RecruitingNot Applicable

雷贝拉唑钠肠溶片在健康成年受试者空腹和餐后状态下人体生物等效性研究

[Translation] Study on the human bioequivalence of rabeprazole sodium enteric-coated tablets in healthy adult subjects under fasting and postprandial conditions

主要研究目的：本试验旨在研究单次空腹和餐后口服浙江华海药业股份有限公司研制、生产的雷贝拉唑钠肠溶片（10 mg）的药代动力学特征；以卫材（中国）药业有限公司生产的雷贝拉唑钠肠溶片（波利特，10 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。次要研究目的：评价中国健康受试者单次空腹/餐后口服受试制剂和参比制剂后的安全性。

[Translation]

Main research purpose: This trial aims to study the pharmacokinetic characteristics of rabeprazole sodium enteric-coated tablets (10 mg) developed and produced by Zhejiang Huahai Pharmaceutical Co., Ltd. after a single fasting and postprandial oral administration; based on Eisai ( Rabeprazole sodium enteric-coated tablets (Polite, 10 mg) produced by China) Pharmaceutical Co., Ltd. are used as reference preparations. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations are compared and the pharmacokinetic parameters of the two preparations are evaluated. Human bioequivalence. Secondary study objectives: To evaluate the safety of the test preparation and reference preparation after single fasting/postprandial oral administration to Chinese healthy subjects.

Start Date28 Dec 2023

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

NCT06349486 / RecruitingNot ApplicableIIT

Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment

1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.

Start Date28 Nov 2023

Sponsor / Collaborator

Kaohsiung Medical University

100 Clinical Results associated with Rabeprazole Sodium

100 Translational Medicine associated with Rabeprazole Sodium

100 Patents (Medical) associated with Rabeprazole Sodium

143

Literatures (Medical) associated with Rabeprazole Sodium

09 Feb 2024·Medicine

High frequency electrocoagulation resection effect analysis and prognosis observation in the treatment of patients with gastric polyps under painless gastroscopy

Article

Author: Zhang, Dandan ; Chen, Mei ; Chen, Xiaomei

To explore high frequency electrocoagulation resection effect in treatment of patients with gastric polyps under painless gastroscopy. Sixty-four patients with gastric polyps were randomly divided into experimental group (32 cases) and control group (32 cases). Experimental group received basic treatment drugs for 8 weeks, and then treated with painless gastroscope high-frequency electrocoagulation resection. Control group was also given basic treatment drugs for 8 weeks, and then received high-frequency electrocoagulation resection under ordinary gastroscope. The patients in both groups were given rabeprazole sodium enteric coated capsules for 4 weeks. The improvement of symptom score, postoperative gastric mucosal healing and comprehensive curative effect of the 2 groups were observed after treatment. The patients with polyps cured under gastroscopy were subjected to a 6-month follow-up period during which gastroscopy was performed to assess the recurrence of polyps. Symptom scores comparison after treatment showed that experimental group had obvious advantages in improving epigastric fullness, fatigue and loose stool in patients with gastric polyps (P < .01 or P < .05). Gastric mucosa healing in experimental group was better at 2 weeks after operation (P < .05), showing no difference 4 weeks after operation (P > .05). Comprehensive curative effect comparison showed that the experimental group was better (P < .01), showing no difference in long-term efficacy (P > .05). In treating patients with gastric polyps, painless endoscopic high-frequency electrocoagulation resection effect is better, which not only promotes postoperative rehabilitation in patients but also reduces complications incidence, demonstrating a high level of safety. Therefore, it is highly recommended for widespread adoption and application.

01 Feb 2024·The Lancet Infectious Diseases

Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials

Article

Author: Lou, Jinfeng ; Wang, Jing ; Ma, Zhenkun ; Wang, Meng ; Geng, Guozhu ; Liu, Yusi ; Chen, Hong ; Gao, Lei ; Li, Xiaojiao ; Chen, Jing ; Zhang, Hong ; Wu, Min ; Ding, Yanhua ; Liu, Jingrui

BACKGROUNDDue to the rapid development of antimicrobial resistance, the efficacy of most Helicobacter pylori eradication therapies have progressively decreased to an unacceptable level. Rifasutenizol (TNP-2198) is a new molecular entity with a synergistic dual mechanism of action currently under clinical development for the treatment of microaerophilic and anaerobic bacterial infections. We aimed to evaluate the safety, pharmacokinetics, and efficacy of rifasutenizol in healthy Chinese participants and patients with H pylori.METHODSWe conducted four clinical trials of rifasutenizol capsules in healthy participants (aged 18-55 years) and patients with asymptomatic H pylori infection (aged 18-65 years) in a clinical trial centre in Jilin province, China. Trial 1 was a phase 1, double-blind, randomised, placebo-controlled, single ascending dose study, in which participants were enrolled into one of seven rifasutenizol dose groups (50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, or 1000 mg) and were randomly assigned in a 4:1 ratio to study drug or placebo. Trial 2 was a phase 1, double-blind, randomised, placebo-controlled, multiple ascending dose study, in which patients were enrolled into one of three rifasutenizol dose groups (200 mg, 400 mg, or 600 mg) and were randomly assigned in a 3:1 ratio to study drug or placebo. Trial 3 was a phase 2a, open-label, randomised, multiple-dose, dose-finding study in which patients enrolled into one of four cohorts were randomly assigned in a 1:1:1:1 ratio to a rifasutenizol dual or triple regimen. Trial 4 was a phase 2b, open-label, randomised, multiple-dose, regimen exploration study, in which patients enrolled into one of five cohorts were randomly assigned in a 2:2:1:1:2 ratio to a rifasutenizol dual therapy, triple therapy, or a control cohort. Block randomisation (block size 4 or 8) was used in all four trials. The key primary endpoints for trials 1, 2, and 3 were the tolerability, safety, and pharmacokinetics of rifasutenizol. For trial 4, the primary endpoint was the eradication rate of H pylori. These four trials were registered at ClinicalTrials.gov (NCT06081699, NCT06081712, NCT06076681, and NCT06076694) and chinadrugtrials.org.cn (CTR20190734, CTR20192553, CTR20212050, and CTR20220625) and are completed.FINDINGSBetween May 9, 2019, and Sept 14, 2022, 78 healthy participants (trial 1: n=10 per cohort in a 4:1 rifasutenizol:placebo ratio; and an additional eight for the food-effect cohort) and 168 patients with asymptomatic H pylori infection (trial 2: n=16 per cohort in a 3:1 rifasutenizol:placebo ratio; trial 3: n=10 per cohort; trial 4: n=10 or n=20 per cohort) were enrolled in the four clinical trials. Single doses of rifasutenizol (50-1000 mg) and multiple doses of rifasutenizol (200 mg to 600 mg, twice a day), either as monotherapy or co-administered with rabeprazole and amoxicillin, showed favourable safety and tolerability profiles. Most adverse events were mild, and no serious adverse events were reported. Rifasutenizol demonstrated a linear pharmacokinetic profile over the dose range of 50-800 mg, and there were no apparent pharmacokinetic interactions between rifasutenizol and the co-administrated drugs. Food intake slightly elevated the area under the plasma concentration-time curve (AUC) of rifasutenizol, and the geometric mean of AUC from time 0 to the last timepoint with a quantifiable concentration (AUC_0-t) and AUC from time 0 to infinity (AUC_0-∞) in the fed state were 1·334 and 1·396 times of those in the fasted state, respectively. There was mild accumulation after continuous administration of rifasutenizol, and the R_ac(AUC) of rifasutenizol 400 mg in the dual and triple regiments in trial 3 were 1·37 and 1·49, respectively. In trial 3, the eradication rates of H pylori with 200 mg, 400 mg, or 600 mg of rifasutenizol in combination with rabeprazole, twice a day for 14 days, were 0% (95% CI 0-31), 30% (7-65), and 40% (12-74), respectively, identifying rifasutenizol 400 mg as the effective dose. In trial 4, H pylori eradication rates with the triple regimen in cohort A (400 mg rifasutenizol, 20 mg rabeprazole sodium, and 1 g amoxicillin) twice a day for 14 days was 95% (95% CI 74-100), and triple therapy (600 mg rifasutenizol, 20 mg rabeprazole sodium, and 1 g amoxicillin) three times a day for 7 days was 100% (69-100).INTERPRETATIONRifasutenizol monotherapy and combination therapy was generally safe and well tolerated in healthy participants and patients with H pylori infection. A triple regimen of 400 mg rifasutenizol capsules, 20 mg rabeprazole sodium enteric-coated tablets, and 1 g amoxicillin capsules twice a day for 14 days showed promising efficacy as a new treatment regimen for H pylori infection.FUNDINGTenNor Therapeutics and National Natural Science Foundation of China.TRANSLATIONFor the Chinese translation of the abstract see Supplementary Materials section.

01 Jan 2024·Journal of Chromatography B

Improved quantitative determination of (R)- and (S)‐rabeprazole sodium and its metabolites in rat plasma by LC-MS/MS and its application to a toxicokinetic study

Article

Author: Zhang, Rui ; Bu, Fanlong ; Guo, Jianman ; Ma, Xiaoyuan ; Sun, Jie ; Wang, Jian

There exist two enantiomers: (R)- and (S)-rabeprazole. (R)-rabeprazole offers specific pharmacokinetic advantages and enhanced therapeutic efficacy, warranting further investigation and development. Here, we developed a simple and rapid chiral liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to simultaneously quantify rabeprazole enantiomers and their metabolites (rabeprazole sulfoxide and desmethyl rabeprazole enantiomers) and a LC-MS to quantify rabeprazole thioether. As for the chiral LC-MS/MS method, Chiral-AGP column (150 × 4 mm, 5 μm) was used and its mobile phase was acetonitrile (mobile phase A) and 10 mmol/L ammonium acetate (mobile phase B) (linear gradient profile: 0 min, 10 % B; 5 min, 15 % B; 9 min, 15 % B; 9.01 min, 10 % B; 13 min, 10 % B). The multiple reactions monitoring transitions of m/z 360.3 → 242.1, 376.2 → 240.1, 346.2 → 228.2 and 368.2 → 190.2 were opted for quantifying rabeprazole enantiomers, rabeprazole sulfoxide, desmethyl rabeprazole enantiomers and internal standard omeprazole. The analyte samples were prepared by a simple liquid-liquid extraction method. As for the LC-MS method, analytes were separated on a Inertsil® ODS-3 column (4.6 × 150 mm, 5 μm). The mobile phase was acetonitrile-5 mmol/L ammonium acetate water solution (65:35, v/v). ESI+ was used and ion peaks with m/z 344.2 (rabeprazole thioether) and 285.1 (internal standard diazepam) were monitored. Both these 2 methods were validated for specificity, linearity, precision, accuracy, matrix effect and extraction recovery, and, particularly, the stability of analytes under various conditions. We successfully applied these methods to a 13-week toxicokinetic study of rabeprazole in rats after intravenous administration of (R)- (80, 20, 5 mg/kg/d) and racemic (80 mg/kg/d) rabeprazole sodium. The results showed that rabeprazole and its metabolites did not accumulate in rats. However, desmethyl rabeprazole and rabeprazole thioether showed higher exposure and lower clearance rate in the last administration than in the first one. (R)-rabeprazole showed a higher exposure and a slower elimination rate than (S)-rabeprazole in rats. These findings offer experimental evidence and a theoretical foundation for further preclinical investigations and clinical applications of (R)-rabeprazole.

News (Medical) associated with Rabeprazole Sodium

13 Feb 2024

·www.globenewswire.com

Cingulate Appoints Jay Roberts, Bryan Lawrence, and Jeff Ervin to its Board of Directors

Announcement Follows Recent Public Offering and Successful Capital Raising ActivityKANSAS CITY, Kan., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has appointed three new directors to its board: Jay Roberts, Bryan Lawrence, and Jeff Ervin. The appointment of the new directors follows the completion of the Company’s recent follow-on offering of $7.5 million in February 2024, sales under the Company’s at-the-market offering (ATM) facility in January 2024 of $3.2 million, as well as the conversion of $3.3 million of outstanding debt into equity at a 10 percent premium to market. “We always look forward to adding directors who complement our management team, mission and overall vision, and we are pleased to welcome Jay, Bryan and Jeff to our board,” said Cingulate Chairman and CEO Shane J. Schaffer. “We believe their collective experience in business, public markets, finance, healthcare and pharmaceuticals will be instrumental to the Company as we move forward with our clinical trials and business opportunities.” About the Directors Jay RobertsJay Roberts has been a senior strategic executive in the healthcare industry for over 30 years. He is serving as a Venture Partner for DigiLife Fund II, leading fundraising, due diligence, and investment decisions along with members of the DigiLife team and syndicate investment funds. He currently serves as a member of the Board of Directors for Caidya, Inc.; Veriskin, Inc.; NaviPoint Health, Inc.; Vyant Bio, Inc. and is a member of the Fellows of DIA. Jay has held CEO, COO, and CFO positions for publicly traded and venture and private equity backed healthcare technology, diagnostics, software solutions and manufacturing companies throughout a successful industry career. Bryan LawrenceBryan Lawrence has nearly 25 years of experience in the pharmaceutical and healthcare industries, serving in a variety of research-based capacities in Pharmacoeconomics and Managed Care Outcomes Research departments at Novartis (formerly Sandoz) and Janssen Pharmaceutica (J&J), as well as some diverse commercial roles. Bryan served as Director, Managed Care Marketing, and was a member of the Aciphex® Launch Team at Janssen. He was also responsible for contracting efforts with United Healthcare for nine Johnson & Johnson operating companies as a Corporate Account Director at Johnson & Johnson Health Care Systems. Dr. Lawrence has significant experience in healthcare consulting and has held roles at Navigant Consulting and Applied Health Outcomes, and was one of four owners/partners who rebranded Applied Health Outcomes as Xcenda, a diverse consulting company that worked with pharmaceutical industry clients. Dr. Lawrence was serving as Xcenda’s Vice President, Marketing and Business Development, when Xcenda was acquired by AmerisourceBergen Corporation. Bryan holds a Doctor of Pharmacy degree from the University of Kansas, a two-year Pharmacoeconomics Fellowship from Glaxo Inc. and the University of South Carolina, and an MBA from the Wharton School at the University of Pennsylvania. He is also a member of the University of Kansas School of Pharmacy Advisory Council. Jeff ErvinJeff Ervin has more than 20 years of experience as an executive and investor in high growth businesses. Mr. Ervin has held the position of Chairman and CEO of IMAC Holdings (NASDAQ: BACK) since 2015. Prior to IMAC, Mr. Ervin served as senior financial officer for Medicare.com and its parent company Medx Publishing. He launched his post-MBA career as Senior Financial Analyst for the Baptist Hospital System of Nashville where he was responsible for evaluating direct equity placement and managing portfolio investments in healthcare. Mr. Ervin holds an MBA from the Owen School of Management at Vanderbilt University and a Bachelor of Science in Finance from Miami University. About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80 percent receive treatment, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), almost double the size of the child and adolescent segment combined, however, only an estimated 20 percent receive treatment. About CTx-1301Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off. About Precision Timed Release™ (PTR™) Platform TechnologyCingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform click here. About Cingulate Inc.Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 10, 2023. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. Investor Relations:Thomas DaltonVice President, Investor & Public Relations, Cingulatetdalton@cingulate.com(913) 942-2301 Matt KrepsDarrow Associatesmkreps@darrowir.com(214) 597-8200

Executive ChangeAcquisition

26 Apr 2021

·www.biospace.com

Kinarus Further Strengthens Its Leadership with Two Reputed Industry Experts

Hari Kumar, former CEO of Adheron Therapeutics, Inc. appointed Chairman of the Board of Directors Thierry Fumeaux, MD, former member of Swiss National Covid Taskforce, joined Kinarus as new Chief Medical Officer BASEL, SWITZERLAND / ACCESSWIRE / April 26, 2021 / Kinarus AG, a Swiss clinical-stage biopharmaceutical company and owner of KIN001, a differentiated therapeutic candidate for the treatment of multiple diseases with high unmet need, announced today the appointment of Hari Kumar as Chairman of the Board of Directors and Thierry Fumeaux as Chief Medical Officer. Dr. Hari Kumar's long career took him from Roche to Eisai Ltd where he served as European Marketing Director. He returned to Roche as Global Head of Transplant Immunosuppressives. He subsequently moved to Amira Pharmaceuticals Inc. in 2007 as Chief Business Officer before becoming Chief Executive Officer of Adheron Therapeutics Inc. In his career, Dr. Kumar oversaw the launch of the immunosuppressive, CellCept®, the Alzheimer's drug, Aricept® and the gastric ulcer drug, Aciphex®. At Amira, Dr. Kumar led the process that resulted in its acquisition by Bristol Myers Squibb in 2011. He also navigated the acquisition of Adheron Therapeutics by Roche, in his role as CEO/ Board member. These transactions have delivered over a billion dollars in returns to investors. Dr. Thierry Fumeaux, MD, MBA joined Kinarus as its Chief Medical Officer. In his new role, he will lead the Kinarus clinical development programs and the direction of the clinical strategy of the company. Dr. Fumeaux is a specialist in internal and intensive care medicine, with extensive clinical experience as Head of the Intensive Care Unit and the Internal Medicine Department of the hospital of Nyon. He was a member of the Swiss National Covid Scientific Task Force as president of its Clinical Care Expert group. He was also president of the Swiss Society of Intensive Care Medicine, from 2018 to 2020. The successful addition of these two experienced industry executives to the Kinarus team marks a further key step in the build-out of Kinarus. Just two weeks ago, Kinarus announced enrolment of the first patient in its recently launched Phase 2 clinical trial of KIN001 in COVID-19 hospitalized patients. The Swiss biopharmaceutical company plans additional clinical programs to evaluate KIN001 for treatment of patients with age-related macular degeneration (wet-AMD) as well as Idiopathic Pulmonary Fibrosis (IPF). Incoming Chairman Hari Kumar remarked that "Kinarus has made an exceptionally good start into the new year. I am very honored to join this exciting Swiss biopharmaceutical company and look forward to leading and supporting Kinarus and its team into a promising future." About Kinarus Kinarus AG is a Swiss clinical-stage biopharmaceutical company focused on bringing differentiated treatments to patients suffering from viral, respiratory, or ophthalmic diseases. Kinarus' differentiated therapeutic candidate KIN001 has broad potential to transform numerous therapeutic areas. The company has patent protected and is preparing the application of KIN001 in multiple indications with important unmet medical needs. In March 2021, the company has received a CHF 3 million financial facility after independent scientific assessment for KIN001 development in COVID-19 and ongoing operations. In April 2021, Kinarus enrolled and dosed the first patient in a Phase 2 study for KIN001 in COVID-19 in hospitalized patients. Swiss-based Kinarus is privately owned. The Board of Directors of the company is currently evaluating different financing options. For more information, please visit the company's website at . Contact information: Alexander Bausch CEO Kinarus AG Tel: +41 61 633 2971 alexander.bausch@kinarus.com Disclaimer This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Kinarus AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions. SOURCE: Kinarus AG View source version on accesswire.com:

Acquisition

17 Jun 2017

·www.bioportfolio.com

AcipHex Drug Insights, 2017 [Updated: 30052017] Prices from USD $850

DelveInsight Drug Report, AcipHex Drug Insights, 2017 highlights the AcipHex marketed details, pipeline status and the Global API Manufacturers along with the location. The DelveInsight's report covers the Global Market Assessment of the AcipHex covering the total sales estimation and also provides the AcipHex sales performance during the historical period and forecast period to 2018. DelveInsight's Report also covers the detailed clinical assessment of AcipHex, patents information and exclusivity data, route of synthesis, competitive landscape, and generic players. In addition to this, DelveInsight's Report provides the SWOT analysis for the AcipHex. Please note:This report requires certain updates. We have all the information available but require 3 business days to complete the process and ensure it is as uptodate as possible. Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated drug. Scope A review of the AcipHex based on information derived from company and industryspecific sources Coverage of the Marketed data of the AcipHex on the basis of MOA, target, dosage, route of administration, molecule type, strength, Chemical type and ATC Classification Coverage of the United States Drug Master File US DMF, Active Substance Master File/EU DMF and API Manufactures in China India for AcipHex with location details Patent Expiry Timeline and Exclusivity Details Route of Synthesis of the API Global Forecasted Sales Figure to 2018 Qualitative and quantitative assessment of market space SWOT Analysis Reasons to buy Evaluate the marketing status and exclusivity details of AcipHex to exploit opportunities for generic drug development opportunities. Design effective counterstrategies to gain competitive advantage by identifying the key patent expiry details and exclusivity with respect to AcipHex. API intelligence over AcipHex and gaining primary intelligence over Active Ingredients manufacturers across the globe. Understanding the chemical route of synthesis of AcipHex. Uncovering opportunities in the rapidly growing the US market Stay ahead of competition by understanding the changing competitive landscape Effectively plan your MA and partnership strategies by identifying drugs with the most promising sales potential Make more informed business decisions from insightful and indepth analysis of the drug's performance Obtain sales forecast for currently marketed drug for to 2018

Generic Drug

100 Deals associated with Rabeprazole Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00724	Rabeprazole Sodium	A02BC04	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Erosive gastro-esophageal reflux disease	US	CHARTWELL RX SCIENCES LLC	08 Nov 2013
Helicobacter pylori infection	US	CHARTWELL RX SCIENCES LLC	08 Nov 2013
Peptic Ulcer	SE	EA Pharma Co., Ltd.	07 Apr 1999
Duodenal Ulcer	JP	Eisai Co., Ltd.	14 Oct 1997
Esophagitis, Peptic	JP	Eisai Co., Ltd.	14 Oct 1997
Gastroesophageal Reflux	JP	Eisai Co., Ltd.	14 Oct 1997
Helicobacter Infections	JP	Eisai Co., Ltd.	14 Oct 1997
Stomach Ulcer	JP	Eisai Co., Ltd.	14 Oct 1997
Zollinger-Ellison Syndrome	JP	Eisai Co., Ltd.	14 Oct 1997

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heartburn	Phase 2	US	Teva Pharmaceuticals USA, Inc.	08 Nov 2013
Duodenal Ulcer	Phase 2	US	Aytu Biopharma, Inc.	26 Mar 2013
Gastroesophageal Reflux	Phase 2	US	Aytu Biopharma, Inc.	26 Mar 2013
Zollinger-Ellison Syndrome	Phase 2	US	Aytu Biopharma, Inc.	26 Mar 2013
Non-erosive reflux disease	Phase 1	JP	Eisai Co., Ltd.	01 Sep 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00165672 (CTgov)	Phase 3	Non-erosive gastro-esophageal reflux disease \| Non-erosive reflux disease	26	Pariet (Rabeprazole Sodium) (E3810 Pariet (Rabeprazole Sodium) 5 mg)	fdhklcjihi(enbcspqcnc) = imrfazghgs oinodrklgi (shsbghrycj, wqvqpwvwiu - gdumiithpm) View more	-	05 Oct 2011
				Pariet (Rabeprazole Sodium) (E3810 Pariet (Rabeprazole Sodium) 10 mg)	fdhklcjihi(enbcspqcnc) = pqafpyoscx oinodrklgi (shsbghrycj, ugufrwsiiz - jcxdncnxas) View more
IAS2008	Not Applicable	-	93	Ritonavir 100 mg film-coated tablet	zcaawautoi(czixbvhftd) = qxzwnuvqkx mpwzsyeaxn (zytdecinxj ) View more	-	01 Jan 2008
				Ritonavir 100 mg soft gelatin capsule	zcaawautoi(czixbvhftd) = vehhaoosum mpwzsyeaxn (zytdecinxj ) View more
NCT02037477 (CTgov)	Phase 3	-	20	Vonoprazan (Cohort 1 - Vonoprazan 20 mg)	asnefnraxp(wgyrmixdiq) = ktwfcqzvdw htbibbazdu (wqdmnqebst, gjcqwwrseq - vecunctmmq) View more	-	17 Oct 2016
				Esomeprazole (Cohort 1 - Esomeprazole 20 mg)	asnefnraxp(wgyrmixdiq) = ggsegcjuie htbibbazdu (wqdmnqebst, gsphxunwmk - nyfhtlgylj) View more
NCT01202071 (CTgov)	Phase 2	-	24	Rabeprazole Sodium (Rabeprazole Sodium 5 mg Tablet)	rbztajbheb(wkcdbkexfv) = zmimuzunbi xdygdcccwa (cxkzhlwxgx, lciiareies - fsvatgkooy) View more	-	27 Nov 2012
				Rabeprazole Sodium (Rabeprazole Sodium 10 mg Tablet)	rbztajbheb(wkcdbkexfv) = fyzpxkjseu xdygdcccwa (cxkzhlwxgx, adlnwadhip - ehibvfebqs) View more
IAS2003	Not Applicable	HIV Infections	-	Reverset 0 mg	(jzjflvjotr) = jaoqbxdjyg ycqwilfxcf (dzwxtzcrcz, 0.2) View more	-	01 Jan 2003
				Reverset 50 mg (enteric-coated tablets)	(jzjflvjotr) = zgovykgoju ycqwilfxcf (dzwxtzcrcz, 1.6)
NCT06076681 (CTgov)	Phase 1/2	Helicobacter pylori infection	40	TNP-2198+Rabeprazole Sodium (Group A)	inuzsfihrp(jblusuhqef) = yssutxoalb binzhncuql (rpuqquwrof, imtcxovvwn - rimrycwmci) View more	-	22 Nov 2023
				TNP-2198+Rabeprazole Sodium (Group B)	inuzsfihrp(jblusuhqef) = dzxfmyxzgn binzhncuql (rpuqquwrof, tifzuqlumz - mipcqkmwmr) View more
NCT02605395 (CTgov)	Phase 4	Gastrointestinal Diseases	70	Idiazole (Idiazole 20 mg)	(psuqevendd) = cgtcmffisl babuaxbisw (pjswpkvqpd, ggesipuzxv - abtunrculy) View more	-	01 Oct 2018
				Pariet (Pariet 20 mg)	(psuqevendd) = eireuzpyxo babuaxbisw (pjswpkvqpd, qaswebkhnh - ekqrfgesps) View more
NCT06076694 (CTgov)	Phase 2	Helicobacter pylori infection	80	TNP-2198+Amoxicillin+Rabeprazole Sodium (Group A)	pnkphnxftb(vkntfddemh) = uwlxkvjqlk yyrcqixezk (ayjikcperb, tizvtpfihf - odftrfosth) View more	-	12 Dec 2023
				TNP-2198+Amoxicillin+Rabeprazole Sodium (Group B)	pnkphnxftb(vkntfddemh) = wmtnnmujsq yyrcqixezk (ayjikcperb, hswbnismtd - umuxfplxsq) View more
NCT00770913 (CTgov)	Phase 2/3	Esophagitis, Peptic	337	E3810 (E3810 20 mg Once Daily)	mqlnyxwzhm(issljylogd) = qgipqgeztm oegyqbiuzx (vvpmvykadb, pggxtegbwv - jlnmgkhhjs) View more	-	13 Apr 2012
				E3810 (E3810 10 mg Twice Daily)	mqlnyxwzhm(issljylogd) = qbhjzqwrkx oegyqbiuzx (vvpmvykadb, rotnlfdcwl - qgobfechgm) View more

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