A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases

The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.

Start Date15 Jun 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06778395

/ CompletedPhase 4IIT

Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease in Egyptian Patients: A Prospective Comparative Study

Gastroenterologists are often hesitated about whether to use the well known PPI in treatment of GERD or the usage of new H/K ATPase inhibitors so its highly needed to test the benefit of each class in Egyptian population to help doctors in decision making

Start Date01 Oct 2024

Sponsor / Collaborator

Zagazig University

[+1]

CTRI/2024/02/062392

/ Not yet recruitingPhase 2IIT

EFFICACY AND SAFETY OF TWO DIFFERENT DOSES OF DEXLANSOPRAZOLE IN ASSESSING FASTING GASTRIC RESIDUAL VOLUME BY USING ULTRASANOGRPHY IN DIABETIC PATIENTS UNDERGOING ELECTIVE SURGERY - NIL

Start Date15 Feb 2024

Sponsor / Collaborator-

100 Clinical Results associated with Dexlansoprazole

100 Translational Medicine associated with Dexlansoprazole

100 Patents (Medical) associated with Dexlansoprazole

401

Literatures (Medical) associated with Dexlansoprazole

01 Mar 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Engineering of a (R)-selective Baeyer-Villiger monooxygenase to minimize overoxidation activity for asymmetric synthesis of active pharmaceutical prazoles

Article

Author: Su, Bingmei ; Xu, Lian ; Chen, Jingjing ; Wang, Xialian ; Xu, Fahui ; Wang, Shumin ; Xu, Xinqi ; Lin, Juan

Baeyer-Villiger monooxygenases (BVMOs) can catalyze the asymmetric sulfoxidation to form pharmaceutical prazoles in environmentally friendly approach. In this work, the thermostable BVMO named PockeMO had high sulfoxidation activity towards rabeprazole sulfide to form (R)-rabeprazole but demonstrated significant overoxidation activity to form undesired sulfone by-product. To address this issue, the enzyme was engineered based on the computer assisted comparison for the substrate binding conformations. A mutant S482Y/L532Q (MU2) was obtained with much alleviated overoxidation activity and enhanced sulfoxidation activity towards rabeprazole sulfide. The catalytic efficiency for (R)-rabeprazole oxidation decreased 35 folds and increased 40 folds for the sulfoxidation of lansoprazole sulfide. The structural mechanism for the selectivity improvement was illuminated to find a selectivity decision pocket that was conservatively present in BVMOs composed of 4 loops. In upscaled reaction system, the substrate loading for MU2 increased from 40 mM to 100 mM for the synthesis of enantiopure (R)-rabeprazole. The sulfone content decreased from 16.6 % to 1.2 % compared to PockeMO. Lansoprazole sulfide could also be fully converted into enantiopure (R)-lansoprazole at 50 mM in 4 h by MU2 while PockeMO almost did not have activity. This work indicated the synthetic applicability of MU2 for active pharmaceutical (R)-prazoles.

01 Mar 2025·FOOD AND CHEMICAL TOXICOLOGY

Dexlansoprazole is an aryl hydrocarbon receptor agonist

Article

Author: Wei, Kuo-Liang ; Kuo, Wei-Tin ; Chuah, Teik-Wei ; Chou, Yu-Ting ; Lin, Chih-Yi ; Chen, Shan-Chun ; Joseph Su, Jyan-Gwo

Dexlansoprazole, a proton pump inhibitor, is commonly used to treat gastro-esophageal reflux disease and erosive esophagitis. The activated aryl hydrocarbon receptor (AhR) functions as a transcription factor by binding to the aryl hydrocarbon response element (AHRE) of its target genes, with cytochrome P450 (CYP) 1A1 being the most well-known target. In this study, we demonstrated that dexlansoprazole stimulates AhR activity, leading to increased CYP1A1 expression. Our findings indicate that treatment with 2 μM dexlansoprazole is sufficient to induce CYP1A1 mRNA and protein expression, as well as AHRE-mediated transcriptional activity, in both human and mouse cells. Using AhR signal-deficient mutant cells and specific AhR antagonists-SR1, GNF351, and CH-223191-we confirmed that AhR is required for dexlansoprazole-induced CYP1A1 expression. Additionally, we showed that dexlansoprazole promotes AhR nuclear translocation, acting as an AhR agonist. However, due to its lower potency compared to FICZ and ITE in activating AhR, dexlansoprazole suppresses FICZ- and ITE-induced CYP1A1 expression in human liver HepG2 and ovarian granulosa HO23 cell lines, suggesting that it functions as both an AhR agonist and a modulator. This study offers valuable insights into the potential clinical side effects of dexlansoprazole.

01 Jan 2025·OTOLARYNGOLOGY-HEAD AND NECK SURGERY

Availability and Pricing of Drugs Prescribed by Otolaryngologists Through a Direct‐to‐Consumer Pharmacy: Medicare Savings Implications

Article

Author: Erickson, Taylor S. ; Schlosser, Rodney J. ; Soler, Zachary M. ; Rathi, Vinay K. ; Pletcher, Steven D. ; Workman, Alan D.

Abstract:

High prescription drug prices can financially strain patients and insurers, with substantial clinical repercussions. In recent years, direct‐to‐consumer (DTC) pharmacies have emerged as potentially lower‐cost alternatives for patients to fill prescriptions. We evaluated whether drugs commonly prescribed by otolaryngologists were available at a national DTC pharmacy (Mark Cuban Cost Plus Drug Company [MCCPDC]) and estimated potential Medicare savings from DTC pricing. We identified drugs and prices paid by Medicare Part D plans using the 2021 Drug Spending Dashboard. Our analysis included 16 generic drugs within the MCCPDC formulary, which offered lower prices for 14 (87.5%) drugs. If plans had secured MCCPDC pricing for all 16 drugs, Medicare patients and plans would have saved $2.9 billion (relative reduction: 62.3%) in 2021. Estimated total savings were greatest for budesonide‐formoterol ($1.9 billion), dexlansoprazole ($464.6 million), and levothyroxine ($327.4 million). Otolaryngologists and insurers may consider utilizing DTC pharmacies with lower drug prices, though patients may face challenges projecting out‐of‐pocket costs across pharmacies, medications, benefit phases, and formulary tiers.

News (Medical) associated with Dexlansoprazole

13 Mar 2025

·www.prnewswire.com

Endo Reports Fourth-Quarter and Full-Year 2024 Financial Results

Endo achieved 2024 revenues and adjusted EBITDA expectations, while progressing the Company's strategic priorities XIAFLEX® hit record revenues of $516 million in 2024, up 9% versus 2023 The Company provides 2025 revenue guidance of $1,775 to $1,860 million and adjusted EBITDA guidance of $620 to $650 million MALVERN, Pa., March 13, 2025 /PRNewswire/ -- Endo, Inc. ("Endo" or the "Company") (OTCQX: NDOI) today reported financial results for the fourth quarter and full-year ended December 31, 2024. "We ended the year strong, with XIAFLEX® annual revenues exceeding $500 million for the first time and the successful launch of ADRENALIN® ready-to-use premixed bags," said Scott Hirsch, Interim Chief Executive Officer. "These milestones, along with the strategic realignment of our sterile product pipeline and the two recently announced transformative transactions, underscore our commitment to deliver growth and shareholder value." Separately, the Company announced that it has entered into a definitive agreement to combine with Mallinckrodt plc in a cash and stock transaction. ENDO FOURTH-QUARTER FINANCIAL PERFORMANCE (in thousands) CONSOLIDATED RESULTS Total revenues in fourth-quarter 2024 were $467 million, a decrease of 6% compared to $498 million in fourth-quarter 2023. This decrease was primarily attributable to competitive pressure across the Generic Pharmaceuticals and Sterile Injectables segments. Net Loss in fourth-quarter 2024 was $349 million, compared to a net loss of $2,441 million in fourth-quarter 2023. This change was driven by fourth-quarter 2023 adjustments to estimated allowed claims, including with respect to certain litigation matters and debt obligations that were reduced to actual payments upon emergence from the Chapter 11 process in second-quarter 2024. This was partially offset by fourth-quarter 2024 asset impairment charges and the application of fresh start accounting. Adjusted Net Income in fourth-quarter 2024 was $70 million, compared to $151 million in fourth-quarter 2023. This change was primarily due to increased interest and income tax expenses in fourth-quarter 2024. Adjusted EBITDA in fourth-quarter 2024 was $164 million, compared to $166 million in fourth-quarter 2023. This change was primarily driven by decreased revenues, partially offset by higher adjusted gross margin due to changes in segment and product mix. SEGMENT RESULTS Branded Pharmaceuticals segment revenues in fourth-quarter 2024 were $247 million, compared to $246 million in fourth-quarter 2023. XIAFLEX® revenues were $148 million in both fourth-quarter 2024 and fourth-quarter 2023. Fourth-quarter 2023 results included the benefit of a one-time reserve reversal of approximately $14 million following application of the final Inflation Reduction Act vial-wastage rebate determination to XIAFLEX®. Fourth-quarter 2024 XIAFLEX® revenues were primarily driven by an 8% increase in volume due to strong underlying demand. Sterile Injectables segment revenues in fourth-quarter 2024 were $92 million, compared to $96 million in fourth-quarter 2023. This change was primarily driven by competitive pressure on VASOSTRICT®, partially offset by the resolution of previously disclosed temporary supply disruptions. During fourth-quarter 2024, the Company launched three sterile injectable products, including ADRENALIN® ready-to-use (RTU) premixed bags, the first and only FDA-approved, manufacturer-prepared epinephrine premixed IV bags. Generic Pharmaceuticals segment revenues in fourth-quarter 2024 were $111 million, compared to $139 million in fourth-quarter 2023. This change was primarily attributable to competitive pressure across a number of products, mainly dexlansoprazole delayed-release capsules, partially offset by increased revenues from lidocaine patch 5%. International Pharmaceuticals segment revenues in fourth-quarter 2024 were $17 million, compared to $17 million in fourth-quarter 2023. BALANCE SHEET AND LIQUIDITY As of December 31, 2024, Endo had $387 million in unrestricted cash and cash equivalents. Net cash provided by operating activities in fourth-quarter 2024 was $30 million, compared to $115 million in fourth-quarter 2023. This change was primarily driven by increased interest and tax payments in fourth-quarter 2024 compared to fourth-quarter 2023. FINANCIAL GUIDANCE Endo is providing the following financial guidance for the full year ending December 31, 2025 based on Endo's current views, beliefs, estimates and assumptions. Guidance for the full year 2025 includes the International Pharmaceuticals business and will be updated following completion of the divestiture. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CONFERENCE CALL INFORMATION Endo and Mallinckrodt will host a joint conference call to discuss the proposed transaction and their respective fourth quarter and full year 2024 results today, March 13, 2025, at 8:00 a.m. ET. The webcast may be accessed through this webcast link or from the Investor Relations section of the Company's website at investor.endo.com/events. To access the call through a conference line, participants may dial 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 (outside the U.S.). Participants are advised to join 10 minutes prior to the scheduled start time. A replay of the webcast will be available following the event. FINANCIAL SCHEDULES The following table presents unaudited Total Revenues, Net (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Operations (dollars in thousands): The following table presents unaudited Total Revenues, Net (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Operations (dollars in thousands): The following table presents the unaudited Condensed Consolidated Balance Sheet (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Cash Flow data (dollars in thousands): SUPPLEMENTAL FINANCIAL INFORMATION Non-GAAP Financial Measures To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain financial information of Endo, Inc. in this release that are not prescribed by or prepared in accordance with GAAP. The Company utilizes these non-GAAP financial measures as supplements to financial measures determined in accordance with GAAP when evaluating operating performance and the Company believes that these measures will be used by certain investors to evaluate operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, as more fully described in the reconciliation tables below. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income (unlike GAAP net income and its components) may differ from, and may not be comparable to, the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. These non-GAAP financial measures should not be viewed in isolation or as substitutes for, or superior to, financial measures calculated in accordance with GAAP. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. The tables below provide reconciliations of certain of the non-GAAP financial measures included in this release to their most directly comparable GAAP metrics. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Reconciliation of Net Loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP) The following table provides a reconciliation of Net Loss (GAAP) to Adjusted EBITDA (non-GAAP) (in thousands): Reconciliation of Net Loss (GAAP) to Adjusted Net Income (non-GAAP) The following table provides a reconciliation of Endo's Net Loss (GAAP) to Adjusted Net Income (non-GAAP) (in thousands): Reconciliation of Select Other Adjusted Income Statement Data (non-GAAP) The following tables provide detailed reconciliations of select other income statement data for Endo, Inc. between the GAAP and non-GAAP measure (in thousands): Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to the statements by Mr. Hirsch and any statements relating to financial guidance, expectations, plans or projections, supply disruptions, pipeline development or realignment, product launches and submissions, strategic priorities, the combination with Mallinckrodt, improving performance, revenue growth, competition, demand and any other statements that refer to expected, estimated, predicted or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are examples of forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: with respect to the announced combination with Mallinckrodt, necessary governmental and regulatory approvals, satisfaction of closing conditions and shareholder approval; changes in competitive, market or regulatory conditions; changes in legislation or regulations; global political changes, including those related to the new U.S. presidential administration; our use of artificial intelligence and data science; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; our ability to develop and expand our product pipeline and to launch new products and to continue to develop the market for XIAFLEX® and other branded, sterile injectable or generic products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of business development opportunities and/or any other strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at [email protected]. ##### SOURCE Endo, Inc. 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Financial Statement

07 Feb 2025

·www.businesswire.com

Devonian Reports Distribution Agreement Termination

QUEBEC CITY--( BUSINESS WIRE )--Devonian Health Group Inc. (“ Devonian ” or the “ Corporation ”) ( TSXV: GSD; OTCQB: DVHGF ), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, today announced that its pharmaceutical distribution division, Altius Healthcare Group L.P. (" Altius "), has been informed that one of its licensor does not intend to exercise its contractual license renewal option for the distribution of Dexlansoprazole for an additional term. Revenue for Dexlansoprazole represented 86% and 92% of Devonian’s total reported revenues for the fiscal year ended July 31, 2024, and the quarter ended October 31,2024, respectively. The Corporation will continue selling Dexlansoprazole until April 17, 2025, when the licence agreement will terminate, and will continue to sell Pantoprazole Magnesium and Cleo-35® thereafter. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Montmagny, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “Exchange”) (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF). About Altius Altius is a generic pharmaceutical distribution division of Devonian with a primary focus of acquiring and in-licensing safe and innovative medicines and healthcare products designed to help people of all ages live healthier lives. Altius then leverages its expertise in the commercialization activities required to successfully launch and distribute these medicines in Canada. For more information, visit www.altiushealthcare.ca Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including but, not limited to those relating to the economic impact of the termination of the distribution of the Dexlansoprazole and, generally, the above “About Devonian” and “About Altius” paragraphs, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

License out/in

23 Dec 2024

·www.businesswire.com

Devonian Health Group Reports First Quarter 2025 Financial Results and Grants Stock Options

QUEBEC CITY--( BUSINESS WIRE )--Devonian Health Group Inc. (“ Devonian ” or the “ Company ”) ( TSXV: GSD; OTCQB: DVHGF ), today announced financial results for its first quarter ended on October 31, 2024. Management Comments “ Devonian continued to improve its financial position in the first fiscal quarter ended October 31, 2024, ” said Luc Gregoire, President and CEO of Devonian. “ While continuing our scientific activities for the continued development of Thykamine for atopic dermatitis (eczema), our quarter was highlighted by a 360% revenue growth at Altius, providing significant financial support to our ongoing operations .” Business Highlights Altius Healthcare Inc. (“ Altius ”), the Company’s wholly owned subsidiary, continued to see a strong uptake with DEXLANSOPRAZOLE, the only authorized generic formulation of that pharmaceutical drug in the Canadian market for the treatment of gastroesophageal reflux disease (GERD). The Company continued to progress its preparation for its planned phase II/III clinical study for Thykamine TM in the treatment of mild to moderate atopic dermatitis (eczema) in pediatric patients, including preparatory work in the batch qualifications of the product to be used in our clinical studies. Financial Highlights Distribution revenue for the first quarter was $5.85 million, up 360% year over year, driven by DEXLANSOPRAZOLE which launched earlier in 2024. Net loss for the quarter was $0.362 million, or $0.002 per share, against the year-ago quarterly loss of $0.721 million, or $0.005 per share. Cash and cash equivalents on October 31, 2024, was $12.5 million, with debt of $2.1 million, as compared to cash of $9.9 million and debt of $2.1 million at the beginning of the fiscal year. To consult the Interim Consolidated Financial Statements for the three month period ended October 31, 2024 and 2023, please click on the following link: https://groupedevonian.com/investor-center/financial-reports/ or see the Company profile on SEDAR+. Grant of stock options The Corporation also announced the granting of stock options to the independent directors of its board to purchase 1,535,715 common shares in the capital of the Corporation (the “ Options ”) at an exercise price of $0.19 for a period of ten (10) years from the date of grant. These Options are exercisable on the grant date. About Devonian Devonian Health Group is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a US FDA set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Devonian is traded publicly on the TSX Venture Exchange (the “ Exchange ”) ( TSXV: GSD ) and on OTCQB exchange ( OTCQB: DVHGF ). For more information, visit www.groupedevonian.com About Altius Altius is a generic pharmaceutical distribution company with a primary focus of acquiring and in-licensing safe and innovative medicines and healthcare products designed to help people of all ages live healthier lives. Altius then leverages its expertise in the commercialization activities required to successfully launch and distribute these medicines in Canada. Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including, but not limited to those relating, the impact of proposed optimizations at the Corporations’ projects, global liquidity and credit availability on the timing of cash flows and the values of assets and liabilities based on projected future conditions, changes in accounting policies, the impact of inflation, the PCT patents for Thykamine TM might not be granted, and, generally, the above “About Devonian” and “About Altius” paragraphs, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.

Financial Statement

100 Deals associated with Dexlansoprazole

External Link

KEGG	Wiki	ATC	Drug Bank
D08903	Dexlansoprazole	A02BC06	DB05351

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Upper gastrointestinal hemorrhage	China	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	09 Jan 2024
Gastroesophageal Reflux	United States	Takeda Pharmaceuticals U.S.A., Inc.	26 Jan 2016
Heartburn	United States	Takeda Pharmaceuticals U.S.A., Inc.	26 Jan 2016
Erosive esophagitis	United States	Takeda Pharmaceuticals U.S.A., Inc.	30 Jan 2009
Esophagitis	United States	Takeda Pharmaceuticals U.S.A., Inc.	30 Jan 2009
Non-erosive gastro-esophageal reflux disease	United States	Takeda Pharmaceuticals U.S.A., Inc.	30 Jan 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Duodenal Ulcer	Phase 3	China	Hunan Province Sailong Pharmaceutical Co. Ltd.	30 Aug 2023
Esophagitis, Peptic	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	Australia	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	Bulgaria	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	Canada	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	Colombia	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	Czechia	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	Germany	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	Hungary	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005
Esophagitis, Peptic	Phase 3	India	Takeda Pharmaceutical Co., Ltd.	01 Dec 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02646332 (CTgov)	Not Applicable	Helicobacter pylori infection	248	amoxicillin+dexlansoprazole MR+metronidazole+clarithromycin ((Dexlan+Amox+Clar+Metr)+(Dexlan+Amox))	xxtqafxupo = tghofqhgrq iehbniwhtx (mfseaaqgij, cgxzsbszld - urfewhktux) View more	-	24 Nov 2020
				amoxicillin+dexlansoprazole+metronidazole+clarithromycin (Dexlan+Clarith+Amox+Metro)	xxtqafxupo = zmmanmaybl iehbniwhtx (mfseaaqgij, aitfpcaqcy - ftsfczxjhs) View more
NCT03120273 (Pubmed \| Clin Drug Investig)	Phase 1	-	70	Dexlansoprazole 15 mg q12h	xrvtollrhr(jnbohnchca) = eqptpnxvxf hqygiqpoiv (ogizywkrft ) View more	-	01 Oct 2019
				Lansoprazole 30 mg q12h	xrvtollrhr(jnbohnchca) = imkkqgsdmc hqygiqpoiv (ogizywkrft ) View more
NCT01317472 (CTgov)	Not Applicable	Laryngopharyngeal Reflux	11	dexlansoprazole (Dexlansoprazole)	nqnnedzque(trytoouttr) = otszpcwtrd qmlhewvbsw (cmgbxhuwdi, 3.95) View more	-	01 Oct 2019
				Placebo (Sugar Pill)	nqnnedzque(trytoouttr) = kqowdjtkfs qmlhewvbsw (cmgbxhuwdi, 4.54) View more
NCT02873689 (CTgov)	Phase 3	Gastroesophageal Reflux \| Heartburn	217	Placebo (Placebo)	sumzjqslqw(yhdbxmbvwr) = syuxysouar jwrbqwejid (ppnjnxnunq, bispyapnur - usaqsqcnbs) View more	-	05 Jul 2019
				Dexlansoprazole (Dexlansoprazole 30 mg)	sumzjqslqw(yhdbxmbvwr) = vflifjrpyb jwrbqwejid (ppnjnxnunq, rbkbozjuih - wyontghejl) View more
NCT03316976 (CTgov)	Phase 1	-	40	Dexlansoprazole (Group 1: Dexlansoprazole 30 mg)	zwgniiwfmj(httapjprwu) = deladdzlmr vtvdlubgec (zkcafarjxn, 43.73) View more	-	10 May 2019
				Dexlansoprazole (Group 2: Dexlansoprazole 60 mg)	zwgniiwfmj(httapjprwu) = wjptginfnj vtvdlubgec (zkcafarjxn, 45.83) View more
NCT01216293 (Pubmed \| Gastroenterology)	Phase 1	-	115	Dexlansoprazole 60 mg	polrfzecrw(yanwffxjnp) = gufbethejv etgkbmezfy (dipmkckvgl )	-	01 Mar 2019
				Esomeprazole 40 mg	polrfzecrw(yanwffxjnp) = qhomoysflc etgkbmezfy (dipmkckvgl )
NCT02873702 (CTgov)	Phase 3	Erosive esophagitis	37	Lansoprazole (Healing Period: Lansoprazole 30 mg)	lhdzfnhfqk = ufvkuhazoq fhdunndwbv (toebxcgngr, wkvtljxyjz - exwpdejmuy) View more	-	22 Feb 2019
				Dexlansoprazole (Healing Period: Dexlansoprazole 60 mg)	lhdzfnhfqk = wjdtjfcrti fhdunndwbv (toebxcgngr, kvborkmejt - aqlkntuvyo) View more
NCT03829150 (Pubmed \| Infect Drug Resist)	Not Applicable	Helicobacter pylori infection First line	202	Dexlansoprazole MR-based concomitant therapy	yoyjmrtumm(sqmzryaose) = rirvijzopw wndjruspvk (ktsqetkwio, 77.8% - 92.2%)	Positive	01 Jan 2019
				Lansoprazole-based concomitant therapy	yoyjmrtumm(sqmzryaose) = uceheiwxsp wndjruspvk (ktsqetkwio, 82.6% - 95.2%)
NCT03079050 (Pubmed \| Dig Dis)	Phase 4	Heartburn	32	Dexlansoprazole 60 mg	dgyqsfrddp(iepwnofhdc) = gwrjsdwmll zapdvxnwek (tcgmoozbzb ) View more	-	01 Jan 2019
NCT01642602 (Pubmed \| Dig Dis Sci) Manual	Phase 2	Erosive gastro-esophageal reflux disease \| Heartburn	104	Dexlansoprazole	kkgbgwynmz(aqurysapxt) = diarrhea and headache（≥5% of patients） dhmogcsqeg (vokplgqote )	Positive	01 Nov 2017

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