A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.

Start Date16 May 2024

Sponsor / Collaborator

Celgene Corp.

NCT06399315 / RecruitingPhase 1

A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug

Start Date28 Jul 2023

Sponsor / Collaborator

Eilean Therapeutics

NCT05899829 / CompletedPhase 1

A Phase 1, 2-part, Open-label, Fixed-sequence Study Evaluating the Effect of Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a Single Dose of Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants Under Fasting Conditions

This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.

Start Date21 Jun 2023

Sponsor / Collaborator

BELLUS Health, Inc.

100 Clinical Results associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

100 Translational Medicine associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

100 Patents (Medical) associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

1,261

Literatures (Medical) associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

01 Jan 2024·Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

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

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.

31 Dec 2023·Journal of enzyme inhibition and medicinal chemistry

Repurposing of rabeprazole as an anti- Trypanosoma cruzi drug that targets cellular triosephosphate isomerase

Article

Author: Pérez-Montfort, Ruy ; López-Velázquez, Gabriel ; Herrera-López, Juliana ; García-Torres, Itzhel ; Hernández, Roberto ; De la Mora-De la Mora, Ignacio ; Flores-López, Luis Antonio ; Enríquez-Flores, Sergio ; Cabrera, Nallely ; Becker, Ingeborg

Trypanosoma cruzi is the causative agent of American trypanosomiasis, which mainly affects populations in Latin America. Benznidazole is used to control the disease, with severe effects in patients receiving this chemotherapy. Previous studies have demonstrated the inhibition of triosephosphate isomerase from T. cruzi, but cellular enzyme inhibition has yet to be established. This study demonstrates that rabeprazole inhibits both cell viability and triosephosphate isomerase activity in T. cruzi epimastigotes. Our results show that rabeprazole has an IC₅₀ of 0.4 µM, which is 14.5 times more effective than benznidazole. Additionally, we observed increased levels of methyl-glyoxal and advanced glycation end products after the inhibition of cellular triosephosphate isomerase by rabeprazole. Finally, we demonstrate that the inactivation mechanisms of rabeprazole on triosephosphate isomerase of T. cruzi can be achieved through the derivatization of three of its four cysteine residues. These results indicate that rabeprazole is a promising candidate against American trypanosomiasis.

18 Dec 2023·Gut microbes

Metaproteomic assessment of gut microbial and host functional perturbations in Helicobacter pylori -infected patients subjected to an antimicrobial protocol

Article

Author: De Diego, Laura ; Pes, Giovanni Mario ; Abbondio, Marcello ; Sau, Rosangela ; Uzzau, Sergio ; Tanca, Alessandro ; Bibbò, Stefano ; Dore, Maria Pina

The impact of therapeutic interventions on the human gut microbiota (GM) is a clinical issue of paramount interest given the strong interconnection between microbial dynamics and human health. Orally administered antibiotics are known to reduce GM biomass and modify GM taxonomic profile. However, the impact of antimicrobial therapies on GM functions and biochemical pathways has scarcely been studied. Here, we characterized the fecal metaproteome of 10 Helicobacter pylori-infected patients before (T0) and after 10 days (T1) of a successful quadruple therapy (bismuth, tetracycline, metronidazole, and rabeprazole) and 30 days after therapy cessation (T2), to investigate how GM and host functions change during the eradication and healing processes. At T1, the abundance ratio between microbial and host proteins was reversed compared with that at T0 and T2. Several pathobionts (including Klebsiella, Proteus, Enterococcus, Muribaculum, and Enterocloster) were increased at T1. Therapy reshaped the relative contributions of the functions required to produce acetate, propionate, and butyrate. Proteins related to the uptake and processing of complex glycans were increased. Microbial cross-feeding with sialic acid, fucose, and rhamnose was enhanced, whereas hydrogen sulfide production was reduced. Finally, microbial proteins involved in antibiotic resistance and inflammation were more abundant after therapy. Moreover, a reduction in host proteins with known roles in inflammation and H. pylori-mediated carcinogenesis was observed. In conclusion, our results support the use of metaproteomics to monitor drug-induced remodeling of GM and host functions, opening the way for investigating new antimicrobial therapies aimed at preserving gut environmental homeostasis.

News (Medical) associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

19 Dec 2023

·www.prnewswire.com

Proton Pump Inhibitors (PPIs) Market to grow by USD 807.89 million from 2023-2028 | North America to account for 36% of market growth - Technavio

NEW YORK, Dec. 19, 2023 /PRNewswire/ -- The proton pump inhibitors (PPIs) market size is expected to grow by USD 807.89 million from 2023 to 2028. In addition, the momentum of the market will progress at a CAGR of 4.86% during the forecast period, according to Technavio Research. The market is categorized by Product (OTC PPIs and Prescription PPIs), Route Of Administration (Oral and Injectable), and Geography (North America, Europe, Asia, and Rest of World (ROW)). North America will contribute 36% to the growth of the global market during the forecast period. Factors such as the presence of large pharmaceutical companies that offer both branded and generic PPIs and the presence of a proper regulatory framework for the approval of new drugs in the region drive regional market growth. This report offers an up-to-date analysis of the current market scenario, the latest trends and drivers, and the overall market environment. Read a FREE PDF Sample Report Continue Reading Technavio has announced its latest market research report titled Global Proton Pump Inhibitors (PPIs) Market 2024-2028 Company Profile: Amgen Inc., AstraZeneca Plc, Aurobindo Pharma Ltd., Bausch Health Companies Inc., Bayer AG, Cipla Ltd., Dr Reddys Laboratories Ltd., Eisai Co. Ltd., Eli Lilly and Co., Glenmark Pharmaceuticals Ltd., Johnson and Johnson, Perrigo Co. Plc, Pfizer Inc., RedHill Biopharma Ltd., Sanofi, Sun Pharmaceutical Industries Ltd., Takeda Pharmaceutical Co. Ltd., Teva Pharmaceutical Industries Ltd., The Procter and Gamble Co., Zydus Lifesciences Ltd. Amgen Inc. - The company offers proton pump inhibitors such as LUMAKRAS with gastric acid-reducing agents and decreased sotorasib concentrations. To gain access to more vendor profiles available with Technavio, buy the report! Proton Pump Inhibitors (PPIs) Market: Health Analysis Proton Pump Inhibitors (PPIs) play a significant role in managing various gastrointestinal conditions, including Gastroesophageal Reflux Disease (GERD), Peptic Ulcer Disease, and Gastritis, effectively suppressing acid production. Helicobacter pylori, a common bacterium, often contributes to Peptic Ulcer Disease, for which both prescription and non-prescription PPIs are used as part of the treatment regimen, ensuring comprehensive therapy against this bacterial infection. The Proton Pump Inhibitor Market showcases a diverse range of medications, including FDA-approved and generic PPIs, aiming to alleviate symptoms associated with acid-related disorders like Heartburn, Erosive Esophagitis, and NSAID-Induced Ulcers. Understanding the potential side effects of Proton Pump Inhibitors is crucial, as they are associated with complications such as Duodenal Ulcers, necessitating careful consideration of their usage and monitoring for optimal gastrointestinal health. Heartburn, often associated with Acid-related Disorders, manifests as a burning sensation in the chest due to stomach acid reflux into the esophagus. This common symptom occurs post-meals, triggered by specific foods or lying down, contributing significantly to Acid-related Disorders' discomfort. Managing heartburn involves dietary modifications, maintaining an upright posture after eating, and utilizing medications to mitigate stomach acid production. Chronic heartburn, if left unaddressed, may lead to erosive esophagitis or Barrett's esophagus, highlighting its role within Acid-related Disorders and emphasizing the need for prompt intervention to alleviate symptoms and prevent complications. Proton Pump Inhibitors (PPIs) Market: Segmentation Analysis The OTC PPIs segment will be significant during the forecast period. The products in this segment are defined as medicines that are sold directly to patients or consumers without a prescription from a healthcare professional. Furthermore, the availability of OTC PPIs provides patients with an option for self-medication and reduces the financial burden associated with medication treatment. Learn about the contribution of each segment summarized in concise infographics and thorough descriptions. View a PDF Sample Report These six medications—Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, and Dexlansoprazole—belong to the class of proton pump inhibitors, commonly prescribed to treat various gastrointestinal conditions by reducing stomach acid production. Each drug within this group exhibits distinct pharmacokinetic properties and efficacy profiles, catering to individual patient needs for managing acid-related disorders. "Besides analyzing the current market scenario, our report examines historic data from 2017 to 2021"- Technavio Proton Pump Inhibitors (PPIs) Market: Driver & Trend: Driver Reformulation of drugs Growth in prescription rate Strong prevalence of gastroesophageal reflux disease Reformulation of drugs drives market growth. It provides an opportunity to grab patent term extensions, which can delay the entry of generic versions into the market. The availability of two dosage forms, NEXIUM 10 mg and 20 mg, will increase the consumption of the drug for various indications, particularly acid-related diseases, in both children aged one year and above the older patients with difficulty in swallowing. The rising prevalence of obesity is a leading market trend. Identify key trends, drivers, and challenges in the market. Download a sample report to gain access to this information. Unraveling Therapeutic Efficacy and Potential Complications in Gastrointestinal Health The Proton Pump Inhibitors (PPIs) Market comprises an extensive range of medications tailored to manage diverse acid-related disorders like Gastroesophageal Reflux Disease (GERD), Peptic Ulcer Disease, and Gastritis. FDA-approved prescription PPIs play a significant role in treating conditions such as Zollinger-Ellison Syndrome and NSAID-Induced Ulcers, contributing significantly to gastrointestinal health and acid suppression. It's essential to recognize that both non-prescription and generic PPIs exist within this market, each exhibiting distinct efficacy profiles and potential side effects, including complications associated with prolonged use such as erosive esophagitis. Understanding the complexities of these medications is crucial for addressing various conditions and ensuring patient well-being amid the dynamic landscape of Proton Pump Inhibitors (PPIs) Market. Related Reports: The tyrosine kinase inhibitors market is estimated to grow at a CAGR of 8.93% between 2022 and 2027. The market size is forecasted to increase by USD 24.12 billion. The global PARP (poly ADP-ribose polymerase) inhibitors market size is estimated to grow by USD 5,555.99 million at a CAGR of 13.25% between 2023 and 2028. What are the key data covered in this proton pump inhibitors (PPIs) market report? CAGR of the market during the forecast period Detailed information on factors that will drive the growth of the proton pump inhibitors (PPIs) market between 2023 and 2028. Precise estimation of the proton pump inhibitors (PPIs) market size and its contribution to the market in focus on the parent market Accurate predictions about upcoming trends and changes in consumer behavior Growth of the proton pump inhibitors (PPIs) market across North America, Europe, Asia, and ROW A thorough analysis of the market's competitive landscape and detailed information about vendors Comprehensive analysis of factors that will challenge the growth of proton pump inhibitors (PPIs) market vendors. ToC: Executive Summary Market Landscape Market Sizing Historic Market Sizes Five Forces Analysis Market Segmentation by Product Market Segmentation by Route of Administration Market Segmentation by Geography Customer Landscape Geographic Landscape Drivers, Challenges, & Trends Company Landscape Company Analysis Appendix About Technavio Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contacts Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

28 Jul 2023

·www.jnj.com

Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT ®

TITUSVILLE, N.J., July 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe. These applications reflect Janssen’s longstanding commitment to address the needs of adults, adolescents and children affected by the global HIV epidemic.If the new applications are approved, EDURANT®, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children. “We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”The expanded pediatric applications are supported by data from the Phase 2 PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed that EDURANT®, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.The expansion of the EDURANT® indication would mark the latest step forward in Janssen’s efforts to make its HIV medicines available to young people living with HIV. In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.Johnson & Johnson’s Commitment to HIVIn addition to driving innovation in HIV care, Johnson & Johnson also works with vulnerable communities on the global frontlines of the HIV epidemic, and has supported collaborative initiatives like Positively Fearless, the DREAMS Partnership and the MenStar Coalition. We also support the New Horizons Collaborative, which is working to address the unmet needs of HIV treatment-experienced children, adolescents and young adults in sub-Saharan Africa.To learn more about Johnson & Johnson’s commitment to combating HIV, please visit jnj.com/HIV.About EDURANT®EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. Limitations of Use:EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.Please see full Prescribing Information for important safety information.Important Safety InformationWho should not take EDURANT®?Do not take EDURANT® if you also take:What should I tell my healthcare provider before taking EDURANT®?Before taking EDURANT®, tell your healthcare provider about all your medical conditions, including if you:Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Some medicines interact with EDURANT®. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EDURANT®.Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT® with other medicines.How should I take EDURANT®?What are the possible side effects of EDURANT®?EDURANT® can cause serious side effects including:Stop taking EDURANT® and get medical help right away if you develop a rash with any of the following signs or symptoms:Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with EDURANT®. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.You are encouraged to report side effects of prescription drugs to the FDA. www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).Please read the full Product Information for EDURANT® and discuss any questions you have with your healthcare provider.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Sciences Ireland Unlimited Company and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and other treatments for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland Unlimited Company, Janssen Research & Development, LLC, the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.###© Janssen Therapeutics, Division of Janssen Products, LP

Drug ApprovalPhase 2

23 Feb 2023

·www.pharmaceutical-technology.com

EC approves AstraZeneca’s Calquence tablet formulation for CLL

The tablet formulation of Calquence received approval to treat chronic lymphocytic leukaemia. Credit: Nephron / Wikimedia. The European Commission (EC) has granted approval for AstraZeneca ’s tablet formulation of Calquence (acalabrutinib) to treat chronic lymphocytic leukaemia (CLL) in adult patients. The selective Bruton’s tyrosine kinase (BTK) inhibitor Calquence binds covalently to BTK, and then inhibit its activity. EC’s approval comes after the Committee for Medicinal Products for Human Use’s positive opinion. It is based on the data obtained from the ELEVATE-PLUS trials, which include three single-dose, open-label, cross-over Phase I trials conducted in 116 healthy participants. The studies established bioequivalence between acalabrutinib 100mg tablets and acalabrutinib 100mg capsules. They assessed the proton pump inhibitors (PPI) effect of acalabrutinib tablets given in the presence against the absence of PPI rabeprazole. Findings demonstrated that the Calquence capsule and tablet formulations are bioequivalent in the trials. AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “The Calquence tablet formulation underscores our commitment to understanding the needs of the chronic lymphocytic leukaemia community and providing patient-oriented treatment solutions. “Today’s approval offers physicians and patients in the EU more flexibility to determine the right treatment plan and enables more patients to potentially benefit from this medicine.” In the US, Calquence received approval as a capsule and tablet formulation to treat CLL, small lymphocytic lymphoma (SLL) and relapsed or refractory mantle cell lymphoma (MCL) patients. In a separate development, AstraZeneca has received EC approval for its Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations to treat advanced liver and lung cancers. The combination of Imfinzi with Imjudo received approval for the first-line treatment of advanced or unresectable hepatocellular carcinoma (HCC) in adult patients. Imfinzi along with Imjudo and platinum-based chemotherapy, received approval to treat metastatic (Stage IV) non-small cell lung cancer (NSCLC) in these patients. The two regulatory approvals are based on the data obtained from the Phase III HIMALAYA and POSEIDON trials.

Drug ApprovalImmunotherapyPhase 3Phase 1Clinical Result

100 Deals associated with Rabeprazole Sodium/Metronidazole/Amoxicillin

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J01CR02	DB01129

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Duodenal Ulcer	JP	Eisai Co., Ltd.	15 Aug 2013
Gastritis	JP	Eisai Co., Ltd.	15 Aug 2013
Helicobacter pylori infection	JP	Eisai Co., Ltd.	15 Aug 2013
Purpura, Thrombocytopenic, Idiopathic	JP	Eisai Co., Ltd.	15 Aug 2013
Stomach Ulcer	JP	Eisai Co., Ltd.	15 Aug 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal Reflux	Phase 3	US	Eisai, Inc.	01 Aug 2008
Dyspepsia	Phase 2	JP	Eisai Co., Ltd.	01 Apr 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02423187 (Pubmed) Manual	Not Applicable	Ulcer	1,513	Aspirin+Rabeprazole	lfvmybzqkp(zrdqnviwsq) = rsudtzqryf stbhsnuqou (cqrylktqzu ) View more	Positive	29 Jul 2022
NCT02135107 (CTgov)	Phase 3	Gastroesophageal Reflux	517	Rabeprazole (Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily)	nnedljmaum(dbawyiofta): P-Value = <0.001 View more	-	19 Nov 2018
				Rabeprazole (Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily)
ChiCTR1800014832 (Pubmed \| Antimicrob Agents Chemother)	Phase 4	Helicobacter pylori infection First line	431	Low-dose rabeprazole + bismuth + amoxicillin + clarithromycin	mhdcqusfwo(fdjibllsdb) = hyoeqeqnpa ddiuwaglbc (twxshhhqys )	-	01 Sep 2018
				Low-dose rabeprazole + bismuth + amoxicillin + tetracycline	mhdcqusfwo(fdjibllsdb) = wdkvjeqxcv ddiuwaglbc (twxshhhqys )
NCT02135107 (EXTEND, Pubmed)	Phase 3	Esophagitis, Peptic Maintenance	517	Rabeprazole 10 mg q.d.	nszqctbpnc(wbzuomkjxg) = fzcgcshwjy hmpkngdlhw (jgxstomudt )	-	01 Jul 2018
				Rabeprazole 10 mg b.i.d.	nszqctbpnc(wbzuomkjxg) = horsxpoxlx hmpkngdlhw (jgxstomudt )
NCT01398410 (CTgov)	Phase 2/3	Stomach Ulcer	405	Rabeprazole (Rabeprazole 5 mg)	xtrofelzcl(iafrrfkphd) = fpmsohpbyo zmarfnzkhe (pdyxvojnft, jqnphqixfz - knaszmvdyj) View more	-	16 Nov 2015
				Rabeprazole (Rabeprazole 10 mg)	xtrofelzcl(iafrrfkphd) = btmpuwwmux zmarfnzkhe (pdyxvojnft, ihpuqbunol - cqmcuizovw) View more
NCT00539240 (CTgov)	Phase 2/3	Pain \| Gastroesophageal Reflux	236	placebo+Rabeprazole+AciPhex (Arm 1)	tyemuryazc(inxqzdxkcq) = lqtdclfeey ctlzvbirlk (gqusmxdklg, edwoplhian - xfwrhyjwkt) View more	-	18 Aug 2014
				placebo+Rabeprazole+AcipHex (Arm 2)	tyemuryazc(inxqzdxkcq) = lcyhxpcpkz ctlzvbirlk (gqusmxdklg, dhlekftbib - dcvqgacmor) View more
NCT01136317 (Pubmed \| BMC Gastroenterol)	Phase 2	Obesity	-	Rabeprazole 20 mg	aizkquixeh(vkwuthrdck) = vdkzcqrjug tyakdfpsti (lfblmemobn )	-	15 Jul 2014
				Omeprazole 20 mg	aizkquixeh(vkwuthrdck) = xvfoqtsgdf tyakdfpsti (lfblmemobn )
NCT01089543 (E3810-J081-204, CTgov)	Phase 2	Dyspepsia	338	Rabeprazole (Rabeprazole 10 mg)	hwdmmlzbkz(jemvhvftlc) = muwdlxtgdr swnfxtchdz (cjqzxmqolh, rhxztytmgt - xsgeamffbl) View more	-	19 Nov 2013
				Rabeprazole (Rabeprazole 20 mg)	hwdmmlzbkz(jemvhvftlc) = ungnxeqjln swnfxtchdz (cjqzxmqolh, ydjfoyemoj - soavfbjttx) View more
NCT01089543 (SAMURAI, Pubmed \| Aliment Pharmacol Ther)	Phase 2	Dyspepsia	392	Rabeprazole 20 mg	hqigzzkpxo(lczldxovoq) = hcpzpbreuc pyxjxelndk (hwyeiqxkxx )	Positive	01 Oct 2013
				Placebo	hqigzzkpxo(lczldxovoq) = aspwdrpplb pyxjxelndk (hwyeiqxkxx )
NCT01008696 (CTgov)	Phase 4	Esophagitis, Peptic	217	Rabeprazole (Rabeprazole)	ebpblidoxl(uprdmejlrs): P-Value = 0.8849; P-Value = 0.8650; P-Value = 0.2660 View more	-	13 Aug 2013
				Lansoprazole (Lansoprazole)

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