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.

NCT07344506

/ RecruitingPhase 4IIT

Evaluating the Effectiveness of Anti- Ulcerants (Dexlansoprazole, Lansoprazole, and Vonoprazan) With Levofloxacin-based Triple Therapy for Helicobacter Pylori Eradication - A Three-arm Randomized Controlled Trial

This study, titled CURE-H. Pylori, is a three-arm, parallel-group, open-label, randomized controlled trial designed to evaluate the effectiveness of Dexlansoprazole, Lansoprazole, and Vonoprazan in combination with Levofloxacin and Amoxicillin for Helicobacter pylori eradication. H. pylori infection is a significant health issue worldwide, with an estimated prevalence of 44% globally and around 60% in Pakistan, leading to gastritis, peptic ulcer disease, and increased risks of gastric cancer and mucosa-associated lymphoid tissue lymphoma. Despite the widespread use of PPI-based triple therapies, treatment efficacy has decreased due to increasing antibiotic resistance, especially to Clarithromycin and Metronidazole. This study aims to assess the eradication rate of H. pylori in patients receiving either Dexlansoprazole 60mg, Lansoprazole 30mg, or Vonoprazan 20mg, each combined with Levofloxacin 500mg and Amoxicillin 1g for 14 days. Participants will be randomized into three arms (314 participants per arm) and assessed for H. pylori eradication using a Urea Breath Test (UBT) at follow-up, which will serve as the primary endpoint. Secondary objectives include assessing symptom improvement using the Gastrointestinal Symptom Rating Scale (GSRS), measuring symptoms such as reflux, abdominal pain, indigestion, diarrhea, and constipation. The study will enroll adult patients diagnosed with H. pylori via UBT and who are not currently receiving treatment for the infection. The study will be conducted at healthcare centers in major cities across Pakistan, including Peshawar, Faisalabad, Rawalpindi, Multan, Lahore, Karachi, and Quetta, over a 12-month period. All participants will sign informed consent forms before enrollment, ensuring they understand the study's procedures and risks. Statistical analysis will be performed using SPSS version 26, with categorical variables analyzed using the Chi-square or Fisher's exact test and continuous variables using descriptive statistics. The primary outcome is the H. pylori eradication rate, and secondary outcomes include the improvement in gastrointestinal symptoms. This study is significant because it aims to compare three different PPI-based therapies in the context of H. pylori eradication in a high-resistance population, providing much-needed data for tailoring treatment strategies in regions with high antibiotic resistance like Pakistan. The results could enhance the effectiveness and cost-efficiency of treatment regimens for H. pylori, ultimately improving patient outcomes and reducing the burden of gastric diseases. Ethical approval has been obtained from the Institutional Review Board (IRB) of Dow University of Health Sciences, Karachi, and all procedures will adhere to the principles of human subjects protection. This study will provide valuable insights into the comparative efficacy of different proton pump inhibitors when combined with Levofloxacin-based triple therapy, potentially leading to more effective treatment options for H. pylori infections in Pakistan and similar regions. The total required sample size for this study is 942 participants, with a 20% expected dropout rate. Data collection will be conducted at baseline and six weeks post-treatment, with the aim of addressing the region-specific challenges in H. pylori treatment and contributing to the global knowledge on optimal therapeutic strategies for this infection. Additionally, the trial's findings may contribute to the broader understanding of how regional antibiotic resistance patterns affect treatment outcomes and help shape future guidelines for H. pylori management in endemic areas. This trial will also help assess the safety and tolerability of the different therapies, providing a comprehensive evaluation of both therapeutic efficacy and patient quality of life post-treatment.

Start Date01 May 2025

Sponsor / Collaborator

Dow University of Health Sciences

CTR20250500

/ CompletedPhase 3

注射用右旋兰索拉唑治疗胃和/或十二指肠溃疡引起的上消化道出血的有效性和安全性的随机、双盲、阳性药物平行对照、多中心III期临床试验

[Translation] A randomized, double-blind, positive drug parallel-controlled, multicenter phase III clinical trial of the efficacy and safety of dexlansoprazole for injection in the treatment of upper gastrointestinal bleeding caused by gastric and/or duodenal ulcers

以注射用兰索拉唑为对照，评价注射用右旋兰索拉唑治疗胃和/或十二指肠溃疡引起的上消化道出血的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of dexlansoprazole for injection in the treatment of upper gastrointestinal bleeding caused by gastric and/or duodenal ulcers, using lansoprazole for injection as a control.

Start Date20 Mar 2025

Sponsor / Collaborator

Nanjing Healthnice Pharmaceutical Technology Co., Ltd.

[+1]

100 Clinical Results associated with Dexlansoprazole

100 Translational Medicine associated with Dexlansoprazole

100 Patents (Medical) associated with Dexlansoprazole

278

Literatures (Medical) associated with Dexlansoprazole

15 May 2026·MEDICINE

Sarcopenia and chronic pain: Identification of shared genetic determinants and therapeutic implication

Article

Author: Han, Jiang ; Huang, Jiaqi ; Li, Juan

Sarcopenia and chronic pain are prevalent age-related conditions with substantial health impacts, yet their causal relationship remains unclear. Our aim is to study the bidirectional causal relationship among these diseases and identify potential therapeutic targets through genetic methods, as well as explore new therapeutic drugs. We performed bidirectional Mendelian randomization and Bayesian colocalization analyses using GWAS data from sarcopenia and chronic pain studies to explore their genetic relationships. Through integrating PheWAS and DrugBank analyses, we identified potential therapeutic candidates. We then evaluated these candidates using FAERS database for safety profiles and explored their pathway-level associations through drug-omics data. Our analyses revealed significant bidirectional genetic associations between sarcopenia and chronic pain, identifying 9 shared genes ( MAPKAPK3 , MYBPC3 , POLR2L , DDAH1 , FAM177B , ABCC8 , RMDN3 , RFTN2 , and SUOX ). Four genes ( MAPKAPK3 , DDAH1 , ABCC8 , and SUOX ) were identified as druggable targets, with 18 compounds (including approved, investigational, and preclinical drugs) identified as potential therapeutic candidates. After FAERS screened and excluded candidate drugs that might aggravate muscle or pain symptoms, dexlansoprazole and glipizide showed relatively favorable safety profiles among compounds targeting these genes. Subsequent drug-omics analysis identified pathway enrichments consistent with muscle and pain-related processes, though clinical efficacy remains unestablished. This study provides genetic evidence for a causal bidirectional relationship between sarcopenia and chronic pain, identifying potential therapeutic targets. However, findings are based on computational analyses of summary-level data without experimental validation. The identified drug candidates warrant further rigorous experimental and clinical investigation for repurposing strategies in managing these conditions.

16 Apr 2026·Cureus Journal of Medical Science

Reduction of Proton Pump Inhibitor Dependence in Gastroesophageal Reflux Disease Following Isometric Diaphragmatic Resistance Training With a Novel Respiratory Muscle Training Device: An Autobiographical Case Report

Article

Author: Park, Gukbin

Gastroesophageal reflux disease (GERD) has been associated with transient lower esophageal sphincter relaxations (TLESRs), which are considered a predominant mechanism of reflux and are modulated in part by the crural diaphragm. Long-term proton pump inhibitor (PPI) therapy remains the standard of care but is associated with drug dependency and systemic adverse effects. Strengthening the crural diaphragm through resistive respiratory training represents a mechanistically plausible non-pharmacological approach. We report a case in which a 14-day isometric diaphragmatic resistance training protocol using a novel prototype device substantially reduced PPI requirement and GERD symptom burden in a patient with over a decade of PPI-dependent GERD. A 38-year-old male physician with a more than 10-year history of GERD, refractory to multiple prior acid-suppressive agents and maintained on dexlansoprazole 60 mg daily, voluntarily discontinued his morning PPI. Immediate and consistent nocturnal symptoms, heartburn, regurgitation, and sleep disturbance, emerged upon discontinuation, necessitating nightly rescue dexlansoprazole use. Following a five-day informal observation period and two days of structured formal baseline recording (evening binary GerdQ score 4/6 on both days), a 14-day diaphragmatic resistance training protocol was initiated using a novel prototype respiratory muscle training device incorporating a safety algorithm to limit inspiratory negative pressure below the reflux induction threshold. The protocol comprised three sets of 10 repetitions daily with 2-second isometric inspiratory and expiratory holds and 3-minute inter-set rest periods. Over 14 days, the mean evening GerdQ score decreased to 1.1/6 (71% reduction from baseline), PRN dexlansoprazole was required on only 3 of 14 days (21%), and sleep disturbance was recorded on a single occasion (Day 3 only). This case demonstrates that isometric diaphragmatic resistance training was associated with marked reduction in PPI requirement and GERD symptom burden in a patient with longstanding PPI-dependent disease. The findings support crural diaphragm strengthening as a viable non-pharmacological target in GERD management, warranting controlled trials with objective esophageal endpoints.

05 Dec 2025·MEDICINE

Analysis of infection-related adverse events induced by proton pump inhibitors based on the FAERS and JADER databases

Article

Author: Hu, Shanshan ; Yu, Hongxiu ; Liu, Zhi

Background::

This study aims to analyze infection-related adverse events related to different proton pump inhibitors (PPIs) and explore the characteristics of Infection-related adverse events and the intensity of drug association based on the U.S. Food and Drug Administration adverse event reporting system (FAERS) database and Japan Adverse Drug Event Report Database (JADER), so as to promote the rational application of PPIs.

Methods::

The adverse event reports of omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, dexlansoprazole and vonoprazan in 78 quarters from the first quarter of 2004 to the fourth quarter of 2023 were searched and extracted by FAERS and JADER, and the adverse events were systematically classified by the Medical Dictionary for Regulatory Activities term set. Then, data processing and analysis of the 7 drug-related reports were carried out by reporting odds ratio method.

Results::

Inclusion of infection-related adverse event report statistics: in the FAERS database, 2 806 reports of omeprazole, 1 652 reports of lansoprazole, 2 922 reports of pantoprazole, 265 reports of rabeprazole, 6 004 reports of esomeprazole, and 297 reports of dexlansoprazole; and in the JADER database, 79 reports of omeprazole, 137 reports of esomeprazole, 414 reports of lansoprazole, 117 reports of rabeprazole, and 204 reports of vonoprazan; 3 185 adverse drug reactions (ADRs) signals were obtained in the FAERS database with signals involving 27 system organ class, whereas 478 ADRs signals were obtained in the JADER database with ADRs signals involving 25 system organ class, and infectious pneumonias were the most common in both databases.

Conclusions::

In the use of PPIs, we should pay attention to the occurrence of related adverse reactions, especially the damage to the infection-related adverse effects, monitor the relevant indicators, and take timely intervention measures to ensure the safety of medication.

News (Medical) associated with Dexlansoprazole

30 Jun 2026

·www.prnewswire.com

Devonian Health Group Reports Financial and Operating Results of its Three and Nine Months Ended April 30, 2026

(all amounts are in Canadian dollars) Quarter ended April 30, 2026, net loss of $1.9 million dollars, ($0.70) per share Nine months ended April 30, 2026, net loss of $5.7 million dollars, ($2.07) per share Cash as of April 30, 2026, $0.7 million Company remains debt-free QUÉBEC, June 29, 2026 /PRNewswire/ - Devonian Health Group Inc. (" Devonian" or the " Company") (TSXV: GSD) (OTCQB: DVHGF), a clinical-stage biopharmaceutical company focused on developing innovative therapies targeting fibro-inflammatory diseases, today highlighted its financial and operating results for the three and nine months ended April 30, 2026. ''We are pleased with the continued momentum to execute on our priorities and readiness to advance our pipeline'', said Dr. André P. Boulet, PhD, Chief Executive Officer and president of Devonian. Corporate Highlights Strategic Update Company expects to remain highly focused on the development of Thykamine™ in prevention of Radiodermatitis associated to radiotherapy and in the treatment of Atopic Dermatitis in children. Furthermore, the Company will continue to investigate the mechanisms of action of Thykamine™ while advancing the evaluation of its potential as a novel therapeutic candidate for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and fibrotic diseases. Financial Highlights Net Loss and Comprehensive Loss For the three months ended April 30, 2026, the net loss and comprehensive loss was $1.9 million, $0.70 per share, compared to a net loss and comprehensive loss of $4.8 million, $1.94 per share, for the same period in 2025. This decrease of $2.9 million in net loss and comprehensive loss is mainly related to the $4.8 million impairment loss of intangible assets and Goodwill related to the generic business (Altius) recorded in the prior fiscal year, following the expiry of the distribution agreement related to Dexlansoprazole which is partly offset by higher losses from operations for an amount of $1.9 million. For the nine-month period ended April 30, 2026, the net loss and comprehensive loss was $5.7 million, $2.07 per share, compared to a net loss and comprehensive loss of $5.6 million, $2.28 per share, for the same period in 2025. This increase of $0.1 million in net loss and comprehensive loss is primarily due to a higher loss from operations of $5.2 million mainly related to $6.5 million decrease in gross margin, related to the prior period sales only of Dexlansoprazole, partly offset by a decrease of $0.6 million in research and development, $0.5 million in selling and administrative and $0.2 million in financial expenses. The increase in net loss and comprehensive loss was also due to a decrease of $0.1 million in interest income and was partly compensated by $4.8 million lower other expenses related to the impairment of intangible assets and Goodwill related to the generic business (Altius) and $0.4 million lower income tax expenses. Liquidity and Cash Flows As of April 30, 2026, the Company had cash and cash equivalents totaling $0.7 million compared to $7 million as of July 31, 2025. For the nine months ended April 30, 2026, the Company used $8.4 million of cash flows for its operating activities (composed of $4.3 million net loss after items not affecting cash and $4.1 million net change in non-cash working capital items), which were partially offset by the cash inflows of $2 million from two private placements completed as well as warrants exercised of $0.2 million during the same period. The Company is debt-free. To consult the Interim Consolidated Financial Statements and the Management's Discussion and Analysis of Financial Condition and Results of Operations for the three and the nine months ended April 30, 2026 and 2025, please click on the following link : or see the Company profile on SEDAR+. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are covered by patents issued in several North American, European, and Asian countries. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune fibroinflammatory disease with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of fibroinflammatory autoimmune diseases including but not limited to atopic dermatitis, radiodermatitis and ulcerative colitis. Devonian is involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian owns a commercialization unit, Altius Healthcare LP, focused on selling prescription pharmaceutical products in Canada, under licenses from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Quebec, Canada where it owns a state-of-the-art extraction facility. Devonian is traded publicly on the TSX Venture Exchange (the " Exchange") ( TSXV: GSD) and currently quoted on the OTCQB Venture Market ( OTCQB: DVHGF). For more information, visit . 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 Company transitioning toward a focused biopharmaceutical development strategy centered on Thykamine™, its radiodermatitis prevention Prospective Performance clinical study, its Atopic Dermatitis study in Children and pre-clinical studies, potential hepatoprotective effect preventing the progression of liver disease in MASH model, anti-inflammatory and anti-fibrotic effects with the potential to target the underlying pathology of the disease and thus halt the progression of the disease; and generally, the above "About Devonian" paragraph, all of which essentially describes the Company's outlook, constitute "forward-looking information" or "forward-looking statements" within the meaning of certain securities laws (collectively, "forward-looking statements"), and are based on expectations, estimates and projections as of the time of this press release. Such forward-looking statements may be identified by the use of words such as "intends", "believes", "expects", or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", or "will" be taken, occur or be achieved. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company 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 Company 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. SOURCE Devonian Health Group Inc. 21% more press release views with Request a Demo

Phase 2Financial Statement

25 Mar 2026

·www.prnewswire.com

Devonian Health Group Inc. Reports Financial and Operating Results of its Three and Six Months Ended January 31, 2026

(all amounts are in Canadian dollars) Quarter ended January 31, 2026, net loss of $2.2 million dollars, ($0.81) per share Six months ended January 31, 2026, net loss of $3.8 million dollars, ($1.37) per share Cash as of January 31, 2026, $1.3 million; Company remains debt-free Reverse split of our common shares at ratio of sixty to one effected on January 22, 2026 Thykamine™ radiodermatitis prevention pivotal clinical study as a first priority for the Company Company continues preclinical studies for Thykamine™ in MASH and Fibrosis, furthering the understanding of Thykamine™'s mechanism of action Thykamine™: A New Player in the Field of Anti-Inflammatory Drugs published in the peer reviewed journal, Biomedicines. QUÉBEC, March 25, 2026 /PRNewswire/ - Devonian Health Group Inc. (" Devonian" or the " Company") (TSXV: GSD) (OTCQB: DVHGF), a clinical-stage biopharmaceutical company focused on developing innovative therapies targeting fibro-inflammatory diseases, today highlighted its financial and operating results for the three and six months ended January 31, 2026. ''We are pleased with the continued momentum to execute on our priorities and readiness to advance our pipeline'', said Dr. André P. Boulet, PhD, Chief Executive Officer and president of Devonian. Corporate Highlights Board Appointment and CFO On November 26, 2025, the Company announced the appointment of Mr. Pierre Labbé, CPA as Board Director. Mr. Labbé was appointed Chair of the Audit Committee effective February 2, 2026. On February 2, 2026, the Company announced the appointment of Mr. Dennis Turpin, CPA as Chief Financial Officer. Mr. Turpin remains on the Board of directors. He succeeded Ms. Viktoria Krasteva. Strategic Update Following the expiry of the Altius Healthcare LP ("Altius") distribution agreements, the Company is transitioning toward a focused biopharmaceutical development strategy centered on Thykamine™. The Company is actively evaluating strategic alternatives for the Altius business while pursuing financing options to support its pipeline. Steatohepatitis Associated with Metabolic Dysfunction Metabolic dysfunction–associated steatotic liver disease progresses to metabolic dysfunction-associated steatohepatitis ("MASH"), which features inflammation, hepatocellular bloating, and subsequent worsening of fibrosis. If left untreated, MASH can progress to cirrhosis of the liver and hepatocellular carcinoma, liver failure, and death. Devonian recently completed a study investigating the effects of Thykamine™ on liver disease progression in the widely used STAM™ mouse model of MASH/fibrosis at SMC Laboratories in Japan1. In this model, diabetic mice were fed into a high-fat diet and rapidly developed fatty liver disease caused by inflammation and fat accumulation in the organ. Resmetirom, a drug approved by the U.S. FDA for the management of MASH, was used as a positive control at an oral dose of 3.0 mg/kg once daily for 3 weeks. Thykamine™ administered orally, at doses of 0.5 mg/kg, 5.0 mg/kg and 50.0 mg/kg, once daily for 3 weeks, suggest potential hepatoprotective effect preventing the progression of liver disease compared to the control (vehicle) group. The MASH study demonstrates that Thykamine™ has anti-inflammatory and anti-fibrotic effects with the potential to target the underlying pathology of the disease and thus halt the progression of the disease. Further studies are ongoing to highlight the potential of Thykamine™ to be used in the treatment of MASH. Reference: 1 In Vivo Efficacy Study of ThykamineTM in STAMTM Model of Metabolic dysfunction-associated steatohepatitis. SMC Laboratories Inc. Jan 2025. Financial Highlights Net Loss and Comprehensive Loss For the three months ended January 31, 2026, the net loss and comprehensive loss was $2.2 million, $0.81 per share, compared to a net loss of $0.2 million, $0.09 per share, for the same period in 2025. This increase of $2 million in net loss and comprehensive loss is primarily due to lower distribution revenues resulting from the previously announced Dexlansoprazole expiry of its distribution agreement in April 2025. The lower distribution revenues reduced the comparative gross margin by $2.6 million partly offset by lower operating expenses of $0.2 million and lower income tax expenses of $0.4 million. For the six-month periods ended January 31, 2026, the net loss and comprehensive loss was $3.8 million, $1.37 per share, compared to a net loss and comprehensive loss of $0.8 million, $0.36 per share, for the same period in 2025. This increase of $3 million in net loss and comprehensive loss is primarily due to lower distribution revenues resulting from the previously announced Dexlansoprazole expiry of its distribution agreement in April 2025. The lower distribution revenues reduced the comparative gross margin by $4.0 million, partially offset by lower operating expenses of $0.7 million and lower income tax expenses of $0.4 million net of lower interest income of $0.1 million. In August 2025, Altius, which is ultimately owned by Devonian, was informed that the distribution agreement for Pantoprazole Magnesium would not be renewed after its expiry date of April 23, 2026. Altius continues to sell Cleo-35® while Pantoprazole magnesium will end generating revenue post April 23, 2026. Distribution revenues will be driven by Cleo-35®, a product to treat hormonal acne in women. Liquidity and Cash Flows As of January 31, 2026, the Company had cash and cash equivalents totaling $1.3 million compared to $7 million as of July 31, 2025. For the six months ended January 31, 2026, the Company used $7.7 million of cash flows for its operating activities (composed of $3.2 million net loss after items not affecting cash and $4.5 million net change in non-cash working capital items), which were partially offset by the cash inflows of $2 million from two private placements completed during the same period. The Company is debt- free. To consult the Interim Consolidated Financial Statements and the Management's Discussion and Analysis of Financial Condition and Results of Operations for the three and the six months ended January 31, 2026 and 2025, please visit the following link : or see the Company profile on SEDAR+. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are covered by patents issued in several North American, European, and Asian countries. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune fibroinflammatory disease with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of fibroinflammatory autoimmune diseases including but not limited to atopic dermatitis, radiodermatitis and ulcerative colitis. Devonian is involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian owns a commercialization unit, Altius, focused on selling prescription pharmaceutical products in Canada, under licenses from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Quebec, Canada where it owns a state-of-the art extraction facility. Devonian is traded publicly on the TSX Venture Exchange (the " Exchange") ( TSXV: GSD) and currently quoted on the OTCQB Venture Market ( OTCQB: DVHGF). For more information, visit . 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 Company transitioning toward a focused biopharmaceutical development strategy centered on Thykamine™, the strategic alternatives for the Altius business, the financing options to support the Company's pipeline, the revenues driven by Cleo-35®,the completion of radiodermatitis prevention pivotal clinical study and pre-clinical studies, the potential hepatoprotective effect preventing the progression of liver disease in MASH model, anti-inflammatory and anti-fibrotic effects with the potential to target the underlying pathology of the disease and thus halt the progression of the disease; and generally, the above "About Devonian" paragraph, all of which essentially describes the Company's outlook, constitute "forward-looking information" or "forward-looking statements" within the meaning of certain securities laws (collectively, "forward-looking statements"), and are based on expectations, estimates and projections as of the time of this press release. Such forward-looking statements may be identified by the use of words such as "intends", "believes", "expects", or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", or "will" be taken, occur or be achieved. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company 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 Company 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. SOURCE Devonian Health Group Inc. 21% more press release views with Request a Demo

Phase 2Executive ChangeDrug ApprovalFinancial Statement

26 Nov 2025

·www.prnewswire.com

Devonian Health Group Reports its Fourth Quarter and Annual 2025 Financial Results and Appointment of a New Board Member

Fourth quarter distribution revenues of $1.3 million Fourth quarter net loss of $0.4 million, $0.003 per share Annual distribution revenues of $23.6 million Annual net loss of $6 million, $0.041 per share Devonian is debt free with $7 million in cash as of July 31, 2025 Pierre Labbé appointed as a new board member QUÉBEC, Nov. 26, 2025 /PRNewswire/ - Devonian Health Group Inc. (" Devonian" or the " Corporation") (TSXV: GSD) (OTCQB: DVHGF), a biopharmaceutical corporation specializing in the development of prescription drugs targeting inflammatory diseases today announced financial results for its fourth quarter and fiscal year ended July 31, 2025. Management Comments "Our year-end results reflect a company that is financially disciplined, debt-free, and strategically positioned for the next phase of value creation. With this strong foundation, we are intensifying our efforts to advance Thykamine™'s added-value programs in the fibro-inflammatory space—an area where unmet medical needs remain significant. Our team is committed to executing with excellence as we continue building momentum and delivering on our long-term vision for Devonian." said Dr. Andre Boulet, Chairman and Chief Executive Officer of Devonian. Business Highlights Completed preclinical studies aimed at demonstrating new potential applications of Thykamine™ across additional inflammatory diseases, including MASH and fibrosis. Focusing on the Thykamine™ phase 2/3 study in pediatric mild-to-moderate atopic dermatitis (eczema) Securing additional patent protection related to mechanisms of action and other therapeutic applications Appointment of Mr. Pierre Labbé, CPA as member of the Board of Directors. Mr. Jean Forcione has resigned. We thank him for his collaboration Continuing the distribution of two (2) products through Altius, namely the Pantoprazole Magnesium, until April 2026 and Cléo-35 Financial Highlights (all amounts are in Canadian dollars) Distribution revenues for the fourth quarter were $1.3 million, down 87% year over year. This decrease is mainly related to the previously announced expiration of the distribution agreement for Dexlansoprazole in April 2025 which related to the subsidiary Altius Healthcare Group LP (" Altius") distribution business. For the fiscal year ended July 31, 2025, distribution revenues were $23.6 million, up 22% year over year. Dexlansoprazole represented 93% of the distribution revenues. For the fiscal year ended July 31, 2025, research and development expenses were $2 million, up 55.8% year over year. This increase is mainly driven by the preparation of the Thykamine™ pediatric Atopic Dermatitis phase 2/3 clinical study as well as the preclinical studies to support new applications. Net loss for the fourth quarter was $0.375 million, or $0.003 loss per share, as compared to a year-ago quarterly net income of $0.75 million, or $0.003 earnings per share. The decrease in net income is mainly related to the lower gross margin net of income taxes from the Altius products distribution business partly compensated by lower Selling and Administrative expenses. For the fiscal year ended July 31, 2025, net loss was $6 million or $0.041 per share, as compared to a $1.83 million net loss or $0.012 per share for the same period last year. The year over year increase in net loss is mainly related to a non-cash, one-time, goodwill impairment loss of $4.6 million and an impairment of intellectual property of $0.2 million both directly related to the Altius products distribution business. The Corporation is debt free after the repayment of its long-term debt of $2.2 million during the fiscal year ended July 31,2025. Cash and cash equivalents as of July 31, 2025, was $7 million, with no debt, as compared to cash and cash equivalents of $9.9 million and debt of $2.08 million at the beginning of the fiscal year. The consolidated financial statements for the fiscal years ended July 31, 2025 and 2024, as well as the management & discussion analysis, are available under the Corporation's profile on SEDAR+ at and on the Corporation's website at: . Appointment of Pierre Labbé as New Board Member "The Devonian's Board of Directors is extremely pleased to be welcoming Mr. Pierre Labbé as director of the Corporation. Pierre brings a wealth of financial experience that enhances the bench strength of the Board of Directors" said Dr. André P. Boulet, President and Chief Executive Officer of the Corporation. Mr. Pierre Labbé has over 30 years of progressive financial leadership experience across various industries. He is currently the Executive Vice-President, Finance at Fonds QScale S.E.C., an organization building and operating high-density AI colocation facilities designed for large-scale training and inference. In this role, he oversees financial strategy, investor relations, financial reporting, tax, treasury, and risk management. Prior to joining Fonds QScale S.E.C., Mr. Labbé served for five years as Chief Financial Officer (" CFO") of IMV Inc. He also previously held the positions of CFO and Corporate Secretary at LeddarTech Inc. and Medicago Inc. (" TSX"). In addition, Mr. Labbé has been a Director of Osisko Gold Royalties Ltd., a TSX- and NYSE-listed precious metal royalty company, since 2015. He currently serves as Chair of the Human Resources Committee and as a member of the Audit and Risk Committee. As a senior financial executive, Mr. Labbé has played a key role in financing, mergers, and acquisitions, overseeing transactions totaling over $1 billion. Mr. Labbé holds a Bachelor's Degree in Business Administration and a license in accounting from Université Laval in Quebec City. He is a member of the Chartered Professional Accountants of Canada, the Québec Chartered Professional Accountants Order, and the Institute of Corporate Directors, where he also earned the ICD.D designation. In addition, Mr. Jean Forcione tendered his resignation from the Board of Directors and its committees, effective as of September 30, 2025. "The Board of Devonian Health Group would like to take this opportunity to express its sincere gratitude and appreciation to Mr. Forcione for his valuable contribution to the company during his tenure of service," said Dr. Andre Boulet, Chairman of Devonian Health Group Inc. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large Phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are covered by patents issued in several North American, European and Asian countries. 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, focused on selling prescription pharmaceutical products in Canada, under a license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec (Quebec) 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 Venture Market ( OTCQB: DVHGF). For more information, visit . 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™ might not be granted, and, generally, the above "About Devonian" 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 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 refuses 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. SOURCE Devonian Health Group Inc. 21% more press release views with Request a Demo

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KEGG	Wiki	ATC	Drug Bank
D08903	Dexlansoprazole	A02BC06	DB05351

R&D Status

Approved

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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.

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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))	hgqjzpemeq = cwsajkrvuu hemcgguzyq (uzgpnnizjv, tutrajoigu - hlgyrxqumi) View more	-	24 Nov 2020
				amoxicillin+dexlansoprazole+metronidazole+clarithromycin (Dexlan+Clarith+Amox+Metro)	hgqjzpemeq = brrdynwfeq hemcgguzyq (uzgpnnizjv, ojbmkvhter - mftwmwjssa) View more
NCT03801148 (CTgov)	Phase 1	-	122	Dexlansoprazole (Part 1: Dexlansoprazole 30 mg TOB)	kcegfsyotr(pbvorwtbab) = vuxwrjlprt xjkqlgzkme (cngwjgonuy, 52.0) View more	-	19 Mar 2020
				Dexlansoprazole (Part 1: Dexlansoprazole 30 mg TPC)	kcegfsyotr(pbvorwtbab) = btuabunuhw xjkqlgzkme (cngwjgonuy, 49.9) View more
NCT01317472 (CTgov)	Not Applicable	Laryngopharyngeal Reflux	11	dexlansoprazole (Dexlansoprazole)	xrfdkfmvqg(gcjcuwewit) = apeueyfbvj hxrivqawrd (ufkjmqwqys, 3.95) View more	-	01 Oct 2019
				Placebo (Sugar Pill)	xrfdkfmvqg(gcjcuwewit) = dhkzutnisj hxrivqawrd (ufkjmqwqys, 4.54) View more
NCT02873689 (CTgov)	Phase 3	Gastroesophageal Reflux \| Heartburn	217	Placebo (Placebo)	byuuipglib(dzvwoxqsog) = klfavfonbh zfcefxmlul (xvhobmkmhy, hqqwyffrdv - lbxajasmiq) View more	-	05 Jul 2019
				Dexlansoprazole (Dexlansoprazole 30 mg)	byuuipglib(dzvwoxqsog) = ijtwzomnfm zfcefxmlul (xvhobmkmhy, qdjfpzeqjy - zqsocfkblg) View more
NCT03131895 (CTgov)	Phase 1	-	116	Dexlansoprazole (Dexlansoprazole 30 mg TOB)	riliuakgqt(qvzrlgoduf) = uqwmluiuwe ythswiipdg (yzcybzworw, 257.60) View more	-	14 Jun 2019
				Dexlansoprazole (Dexlansoprazole 30 mg TPC)	riliuakgqt(qvzrlgoduf) = aqhtsapqih ythswiipdg (yzcybzworw, 305.66) View more
NCT03316976 (CTgov)	Phase 1	-	40	Dexlansoprazole (Group 1: Dexlansoprazole 30 mg)	sqiejjqpvw(zfgdzezbux) = ejkdsiochi jobclqraki (tuadnmhekd, 43.73) View more	-	10 May 2019
				Dexlansoprazole (Group 2: Dexlansoprazole 60 mg)	sqiejjqpvw(zfgdzezbux) = cbxcfnogfj jobclqraki (tuadnmhekd, 45.83) View more
NCT01216293 (Pubmed \| Gastroenterology)	Phase 1	-	115	Dexlansoprazole 60 mg	xjmwwpgzqq(okatunmqey) = ropsfjpbmm miqzoklktv (wvjonxbkox )	-	01 Mar 2019
				Esomeprazole 40 mg	xjmwwpgzqq(okatunmqey) = wiebrrngna miqzoklktv (wvjonxbkox )
NCT02873702 (CTgov)	Phase 3	Erosive esophagitis	37	Lansoprazole (Healing Period: Lansoprazole 30 mg)	ncmqwfuusy = rfubgevlbk woyhzvnvkj (ndzzjdpbhq, dkgkxidpdg - ldqwwwvtko) View more	-	22 Feb 2019
				Dexlansoprazole (Healing Period: Dexlansoprazole 60 mg)	ncmqwfuusy = uuxrneafbe woyhzvnvkj (ndzzjdpbhq, htcjybiznn - dladeeaokt) View more
NCT03829150 (Pubmed \| Infect Drug Resist)	Not Applicable	Helicobacter pylori infection First line	202	Dexlansoprazole MR-based concomitant therapy	lxyhhtsxwv(dudvioyeht) = qzjcdibptk hxileilfzz (cvojxuirce, 77.8% - 92.2%)	Positive	01 Jan 2019
				Lansoprazole-based concomitant therapy	lxyhhtsxwv(dudvioyeht) = yrujxubfss hxileilfzz (cvojxuirce, 82.6% - 95.2%)
NCT03079050 (Pubmed \| Dig Dis)	Phase 4	Heartburn	32	Dexlansoprazole 60 mg	kzbtppupza(umvydbernc) = nyrqhabqmy etnkshtrxw (pfxxmienxy ) View more	-	01 Jan 2019

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