Multi-center, double blind randomized acitvecontrolled pilot study to Evaluate the Efficacy of FEXUCLUE® 40mg(Fexuprazan hydrochloride) in the night reflux symptoms

Start Date01 Nov 2024

Sponsor / Collaborator-

NCT06437951 / Not yet recruitingPhase 1

A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants

to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants

Start Date01 Jul 2024

Sponsor / Collaborator

Daewoong Pharmaceutical Co., Ltd.

KCT0009504 / Not yet recruitingPhase 3IIT

Randomized Active-Controlled Trial Evaluating Fexuprazan (Fexuclue tab) for Prevention Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy After Coronary Intervention: Scientific Association of Interventional Cardiology – Fexuprazan for patients with dual antiplatelet therapy (SAINT-FEXUDAPT) trial

Start Date01 Jun 2024

Sponsor / Collaborator-

100 Clinical Results associated with Fexolazan hydrochloride

100 Translational Medicine associated with Fexolazan hydrochloride

100 Patents (Medical) associated with Fexolazan hydrochloride

Literatures (Medical) associated with Fexolazan hydrochloride

01 Nov 2024·Current gastroenterology reports

Potassium-competitive Acid Blockers: Current Clinical Use and Future Developments

Review

Author: Scarpignato, Carmelo ; Hunt, Richard H

Abstract:

Purpose of the Review:

Acid suppression with proton pump inhibitors (PPIs) represents the standard of care in the treatment of acid-related diseases. However, despite their effectiveness, PPIs display some intrinsic limitations, which underlie the unmet clinical needs that have been identified over the past decades. The aims of this review are to summarize the current status and future development of the new class of antisecretory drugs (potassium-competitive acid blockers, P-CABs) that have recently been introduced into medical practice.

Recent Findings:

Over the past decades, clinical needs unmet by the current acid suppressants have been recognized, especially in the management of patients with GERD, Helicobacter pylori infection and NSAID-related peptic ulcer. The failure to address these needs is mainly due to their inability to achieve a consistent acid suppression in all patients and, particularly, to control nighttime acidity. It was then realized that an extended duration of acid suppression would exert additional benefits. The available data with P-CABs show that they are able to address these unmet clinical needs.

Summary:

Four different P-CABs (vonoprazan, tegoprazan, fexuprazan and keverprazan) are currently available. However, only two of them are approved outside Asia. Vonoprazan is available in North, Central and South America while tegoprazan is marketed only in Latin American countries. Two other compounds (namely linazapran glurate and zestaprazan) are presently under clinical development. While clinical trials on GERD have been performed with all P-CABs, only vonoprazan and tegoprazan have been investigated as components of Helicobacter pylori eradication regimens. The available data show that—in the above two clinical indications—P-CABs provide similar or better efficacy in comparison with PPIs. Their safety in the short-term overlaps that of PPIs, but data from long-term treatment are needed.

01 Nov 2024·EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY

Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial

Article

Author: Cha, Wonjae ; Lee, Yoon Se ; Lee, Young Chan ; Eun, Young-Gyu ; Jung, Ah Ra ; Kim, Su Il ; Kwon, Min Su ; Lee, Dong Kun ; Choi, Jeong-Seok ; Lee, Hwan Ho ; Jang, Jeon Yeob

PURPOSE:

Laryngopharyngeal reflux disease (LPRD) is mainly treated with proton pump inhibitors (PPI) such as esomeprazole, which have shortcomings like delayed absorption and increased osteoporosis. Fexuprazan is a novel potent potassium-competitive acid blocker that inhibits gastric acid secretion with rapid onset and long duration of action. To assess the efficacy and safety of fexuprazan compared to esomeprazole in patients with LPRD.

METHODS:

This prospective, randomized, double-blinded, multicenter, active-controlled trial was conducted in nine otolaryngologic clinics. Patients with reflux symptom index (RSI) ≥ 13 and reflux finding score (RFS) ≥ 7 were randomly assigned to the fexuprazan or esomeprazole groups, and received fexuprazan 40-mg or esomeprazole 40-mg once daily for 8 weeks. The outcomes were (1) mean change, change rate, and valid rate in RSI, RFS, and LPR-related questionnaires; and (2) adverse events.

RESULTS:

A total of 136 patients (fexuprazan n = 68, esomeprazole n = 68) were followed up for ≥ 1 month. Each parameter significantly improved after 4 and 8 weeks in each group, with no significant differences between the two groups. For those with severe symptoms (RSI ≥ 18), the fexuprazan group (n = 32) showed more improvement in the mean change and change rate in the RSI than esomeprazole group (n = 31) after 4 weeks (p = .036 and .045, respectively). This phenomenon was especially observed in hoarseness and troublesome cough.

CONCLUSION:

Fexuprazan improved symptoms and signs without no serious adverse events in patients with LPRD. In patients with severe symptoms, fexuprazan resulted in a faster symptom improvement than PPI.

TRIAL REGISTRATION:

KCT0007251, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22100 .

01 May 2024·CTS-Clinical and Translational Science

Pharmacokinetic interactions between fexuprazan, a potassium‐competitive acid blocker, and nonsteroidal anti‐inflammatory drugs in healthy males

Article

Author: Kim, Eunwoo ; Chung, Jae-Yong ; Jang, In-Jin ; Cho, Joo-Youn ; Won, Heejae ; Lee, Hyejung ; Lee, SeungHwan ; Chae, Jihye ; Kim, Min-Gul

Abstract:

Fexuprazan, a novel potassium‐competitive acid blocker, is expected to be used for the prevention of nonsteroidal anti‐inflammatory drugs (NSAIDs) induced ulcer. This study aimed to evaluate pharmacokinetic (PK) interactions between fexuprazan and NSAIDs in healthy subjects. A randomized, open‐label, multicenter, six‐sequence, one‐way crossover study was conducted in healthy male subjects. Subjects randomly received one of the study drugs (fexuprazan 40 mg BID, celecoxib 200 mg BID, naproxen 500 mg BID, or meloxicam 15 mg QD) for 5 or 7 days in the first period followed by the combination of fexuprazan and one of NSAIDs for the same days and the perpetrator additionally administered for 1–2 days in the second period. Serial blood samples for PK analysis were collected until 48‐ or 72‐h post‐dose at steady state. PK parameters including maximum plasma concentration at steady state (Cmax,ss) and area under plasma concentration–time curve over dosing interval at steady state (AUCτ,ss) were compared between monotherapy and combination therapy. The PKs of NSAIDs were not significantly altered by fexuprazan. For fexuprazan, differences in PK parameters (22% in Cmax, 19% in AUCτ,ss) were observed when co‐administered with naproxen, but not clinically significant. The geometric mean ratio (90% confidence interval) of combination therapy to monotherapy for Cmax,ss and AUCτ,ss was 1.22 (1.02–1.46) and 1.19 (1.00–1.43), respectively. There were no significant changes in the systemic exposure of fexuprazan by celecoxib and meloxicam. Fexuprazan and NSAIDs did not show clinically meaningful PK interactions.

News (Medical) associated with Fexolazan hydrochloride

25 Nov 2024

·www.prnewswire.com

HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals Announce Successful Completion of a First-in-Human Study for Potential Disease-Modifying Therapy for Parkinson's Disease

HL192 (ATH-399A) was well tolerated with no major safety issues in any of the 76 participants. No serious treatment related adverse events were reported and such findings were proportional between placebo and dosed groups. PK results support once a day dosing. ROCKVILLE, Md. and SEOUL, South Korea, Nov. 25, 2024 /PRNewswire/ -- HanAll Biopharma, Daewoong Pharmaceutical and NurrOn Pharmaceuticals successfully completed their Phase 1 study of HL192 (ATH-399A), which is being developed as a disease-modifying therapy for Parkinson's disease. The study met its primary endpoints of safety and tolerability in 5 different ascending dose groups, demonstrating significant progress in the treatment of this debilitating neurological disorder. This first-in-human study included single ascending dose (SAD), multiple ascending dose (MAD), and food effect components. "We are extremely pleased to announce the completion of the first-in-human study," said Sean Jeong, MD, MBA, CEO of HanAll Biopharma. "Successfully demonstrating the safety and tolerability in healthy volunteers, including older adults, is a key step in our mission to develop a disease-modifying therapy for Parkinson's disease. These findings bring hope to millions of patients and their families who are affected by this challenging condition." "We are excited to report positive results for our Phase 1 trial, confirming the well-tolerated safety profile of HL192 (ATH-399A) in healthy participants and expect to launch the next clinical trial in people with Parkinson's disease," said Deog Joong Kim, PhD., CEO of NurrOn Pharmaceuticals. NurrOn was awarded a $1.7 million grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) in support of the Phase 1 clinical trial of HL192 (ATH-399A), that initiated in the second half of 2023. "The Michael J. Fox Foundation remains steadfast in our commitment to accelerate the development of better treatments for the more than 6 million people living with Parkinson's disease around the world," said Katharina Klapper, principal of clinical research at MJFF. "The successful completion of the study's Phase 1 HL192 (ATH-399A) trial marks a meaningful step forward in advancing today's therapeutic pipeline." Parkinson's disease is a progressive neurological disorder that affects millions of people worldwide. Current treatments primarily focus on managing symptoms, but there is an urgent need for therapies that can alter the disease's progression. HL192 (ATH-399A) represents a promising approach, targeting the underlying mechanisms of Parkinson's disease to provide a more effective and long-lasting treatment. The study enrolled 76 healthy participants. Participants in the SAD and food effect arms received HL192 (ATH-399A) once, while participants in the MAD arm received a single dose once a day for twelve days, with careful monitoring and assessment of safety and tolerability. The results demonstrated a favorable safety profile. Key findings include equivalent percentages of treatment emergent adverse events (TEAEs) between those who received treatment compared to those who received placebo, with no clear dose dependent trends. Additionally, all tested dose levels were well below the pre-determined NOAEL (no observed adverse effect level) concentrations, further confirming the safety and tolerability of the chosen dose levels. HanAll and Daewoong plan to initiate the next clinical trial in people with Parkinson's disease in collaboration with NurrOn. The study will further evaluate the safety of HL192 (ATH-399A). The companies remain dedicated to developing this important asset with the goal to improve patient lives in an area of great unmet need. About HanAll Biopharma HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with presence in Korea, the USA, Japan, and Indonesia with the mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years. HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. One of its lead pipeline assets, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP). HL161ANS (IMVT-1402), another anti-FcRn antibody from HanAll, is planned to begin registrational studies in GD and Rheumatoid Arthritis (RA). Another lead asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, has commenced a Phase 3 clinical study in the US and is also being evaluated in China for the treatment of dry eye disease. HL192 (ATH-399A), a Nurr1 activator targeting Parkinson's Disease, has completed a Phase 1 study in healthy volunteers. For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR ([email protected], [email protected]). About Daewoong Pharmaceutical. Co., Ltd. Daewoong Pharmaceutical (KRX: 069620.KS), established in 1945, is a global pharmaceutical company based in South Korea. The company is committed to the development, manufacturing, and commercialization of pharmaceutical products, with a mission to provide the most beneficial total solutions, including pharmaceuticals and services, which contribute to improving the quality of life of valued consumers. Operating with a keen focus on both domestic and international markets, Daewoong Pharmaceutical specializes in developing treatments for intractable and rare diseases. The company's diverse portfolio encompasses novel drugs, biologics, new products, and C&D, all supported by in-house research and development, open collaboration, and advanced manufacturing facilities. Marking significant achievements in drug development, Daewoong Pharmaceutical has successfully developed novel drugs for GERD, featuring the active ingredient Fexuprazan, and for Type 2 diabetes, with the active ingredient Enavogliflozin, in two consecutive years. The company is currently advancing in the development of First-in-Class Oral Anti-Fibrotic Agent for Idiopathic Pulmonary Fibrosis, utilizing Bersiporocin as a PRS Inhibitor. Notably, Bersiporocin has been designated by the U.S. FDA as an orphan drug and a Fast Track development product. Daewoong is dedicated to completing the Phase 2 clinical study of this drug by 2025. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. Media inquiries can be directed to Daewoong's PR at [email protected]. About NurrOn Pharmaceuticals NurrOn Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing novel, targeted therapeutics for the treatment of Parkinson's disease (PD) and other Nurr1-related incurable human disorders. Through targeting Nurr1, the master regulator for dopaminergic neuron development and maintenance, we aim to develop a paradigm changing PD treatment to improve patients' quality of life. While currently there are only symptomatic treatment options for patients with PD, there have not been any successful therapies to slow or prevent the progression of the disease. We believe that disease-modifying therapies will be achieved through targeting Nurr1, which has generated supportive data as a new druggable PD target. NurrOn was awarded a substantial grant from Michael J. Fox Foundation in support of the Phase 1 clinical trial of HL192 (ATH-399A), that initiated in the second half of 2023. For further information on NurrOn Pharmaceuticals, please visit our official website or contact [email protected]. Disclaimer Statement The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should," and include statements HANALL (the company, we) makes concerning its 2024 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners', advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. SOURCE HanAll Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical ResultPhase 2Orphan DrugFast Track

16 Oct 2024

·endpts.com

Seeking to treat obesity drug side effect, Neurogastrx releases data on drug for GLP-1-associated nausea, vomiting

Neurogastrx believes its drug could treat one of the most troublesome side effects of one of the industry’s biggest blockbusters. On Wednesday, the Boston-area biotech said that its experimental drug, NG101, reduced the incidence of nausea by 40% and cut vomiting by 56% in adults taking Novo Nordisk’s semaglutide, which is marketed as Wegovy for obesity and Ozempic for type 2 diabetes. In the Phase 2 trial, about 90 adults received a single subcutaneous dose of semaglutide, at 0.5 mg, and then for five days, they took two capsules of NG101 or placebo each day. The results were statistically significant. Neurogastrx sees a market opportunity worth “billions of dollars,” CEO James O’Mara told Endpoints News. “The GLP-1s are miracle drugs,” O’Mara said. But many patients stop taking the medicines within a year, and a lot of them cite the gastrointestinal side effects as a key reason, he said. The news is Neurogastrx’s first major step since 2021, when it outlined a $60 million Series B and unveiled a partnership with Daewoong Pharmaceutical, which it then terminated in mid-2023. NG101 is a dopamine D2 antagonist, and it affects the area postrema, or the “nausea center of the brain,” O’Mara said. That region is outside the blood-brain barrier, meaning it might allow the medicine to avoid CNS side effects that come with some other dopamine modulators, the CEO said. Neurogastrx will have to test NG101 in larger studies and for a longer duration before seeking regulatory approval, and the company aims to start either a Phase 2 or a Phase 2/3 trial next year, the CEO said. “Whether it’s registrational, we’ll have to see,” O’Mara said. A Phase 3 would likely involve both semaglutide and Eli Lilly’s related drug tirzepatide. “I think you would have to include both eventually in order to get them in the label,” O’Mara said. The company thinks it can raise the money it needs to get into later-stage testing, O’Mara said, noting Neurogastrx is starting discussions with potential partners and funding sources. In February 2023, Neurogastrx completed a Phase 2 of NG101 in patients with gastroparesis, in which the body struggles to empty food, but the company has yet to announce the results. O’Mara said the results have been submitted for publication and described the data as “interesting.” “We had endpoints which looked good and others which we were disappointed in,” he said. In May, another biotech in the space, CinDome Pharma, announced a $40 million funding extension to finish its Phase 2 in diabetic gastroparesis. It anticipates results next year and will likely seek a pharma partner or acquirer to bring it into Phase 3, CinDome creator CinRx CEO Jon Isaacsohn told Endpoints in May . O’Mara also gave more details of the company’s terminated pact with South Korea’s Daewoong. Under the deal, Neurogastrx was to have developed Daewoong’s investigational acid blocker fexuprazan for GERD and other acid-related conditions. The US and Canada-focused agreement was terminated last year. “We did a deal for fexuprazan when there was a lot of money flowing into biotech, and very shortly, frankly, after we closed that deal, it was just harder to raise capital,” O’Mara said. “We wanted to be fair with our collaborator and give them the opportunity to find another company that could better escort the drug forward.”

Phase 2Clinical ResultPhase 3

09 Oct 2024

·www.prnewswire.com

Daewoong Pharmaceutical Unveils 'Innovative Drug Delivery Technologies' in Milan--From World's First Microneedle Therapy to Once-a-Month Obesity Treatment

MILAN, Oct. 9, 2024 /PRNewswire/ -- Daewoong Pharmaceutical (Co-CEOs Seongsoo Park and Chang-jae Lee) announced on the 9th that they will present their cutting-edge drug delivery technologies, including the world's first microneedle-based drugs, at 'CPHI Worldwide 2024'—the world's largest pharmaceutical and biotech exhibition—held in Milan, Italy. In addition, Daewoong will continue to expand the global reach of its innovative new drugs, Fexuprazan and Enavogliflozin. Daewoong participated in CPHI in 2023, held in Barcelona, where it showcased its success in developing innovative drugs for the second consecutive year. At this year's CPHI in Milan, Daewoong aims to achieve its 'One Product, One Trillion Won' vision by expanding its global footprint and unveiling new drug delivery technologies. At the forefront of Daewoong's innovations is the microneedle technology, which is poised to revolutionize drug delivery systems. While traditional injectable drugs reliably deliver medication into the body, they often come with pain and require clinical visits. In contrast, microneedles—composed of tiny needles—eliminate the fear of injections and reduce the need for hospital visits, significantly improving patient-compliance. Though many companies have pursued microneedle-based drugs, none have successfully commercialized them. To date, available microneedle products are limited to cosmetic patches. Daewoong's subsidiary, Daewoong Therapeutics, has developed an innovative microneedle platform called 'CLOPAM ® ,' which enhances drug uniformity and stability through Aerodynamic crafting and Hermetic packaging. This platform overcomes the issues of contamination and drug inconsistency that have plagued previous microneedle technologies. The CLOPAM ® microneedle patch, measuring1 cm² and contains approximately 100 microneedles, dissolves upon skin penetration to release the medication. With recognition as a key future technology for Daewoong, CLOPAM ® has garnered six international patent applications (PCT) and 23 domestic patents (five registered). Additionally, Daewoong Therapeutics recently received approval from Korea's Ministry of Food and Drug Safety to conduct a Phase 1 clinical trial for a human growth hormone microneedle patch—the first case of a dissolvable microneedle in Korea. The company is also actively developing microneedle-based treatments for diabetes and obesity using Semaglutide, as well as a neurological treatment using its botulinum toxin. In addition to its microneedle technology, Daewoong will showcase its long-acting Semaglutide injection for obesity treatment. This once-monthly injectable slowly releases Semaglutide, maintaining therapeutic levels for 30 days. This approach addresses a significant gap in the market, where current obesity treatments often necessitate daily or weekly injections. Daewoong's microneedle patch and once-monthly injection, both under development, are poised to outpace competitors, offering patients a less painful and more convenient solution. Daewoong will also introduce a new patient-friendly colonoscopy bowel preparation (DWRX1010). Traditional preparations for colonoscopy often involve unpleasant tastes, large water intake, or swallowing large pills, causing discomfort for patients and sometimes deterring them from undergoing the procedure. Daewoong's newly developed mini tablet is easy to swallow, offering a more convenient solution for patients preparing for a colonoscopy. Doyoung Kim, head of Daewoong's global business center, commented, "This marks our 10th year participating in CPHI, and the market now demands not just raw materials and finished products but also technologies that meet consumer needs. With each year, Daewoong's global standing rises, especially with the launch of new drugs and technologies. We are committed to fostering blockbuster products through innovative drug delivery technologies, further solidifying our leadership in the global healthcare market alongside the success of Fexuprazan and Enavogliflozin." SOURCE Daewoong Pharmaceutical Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Drug Approval

100 Deals associated with Fexolazan hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16078

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastroesophageal Reflux	KR	Daewoong Pharmaceutical Co., Ltd.	28 Jul 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Esophagitis, Peptic	Phase 3	CN	Daewoong Pharmaceutical Co., Ltd.	30 Dec 2021
Peptic Ulcer	Phase 3	KR	Daewoong Pharmaceutical Co., Ltd.	21 May 2021
Gastritis	Phase 3	KR	Daewoong Pharmaceutical Co., Ltd.	02 Jun 2020
Non-erosive gastro-esophageal reflux disease	Phase 3	KR	Daewoong Pharmaceutical Co., Ltd.	07 Feb 2019
Non-erosive reflux disease	Phase 3	KR	Daewoong Pharmaceutical Co., Ltd.	07 Feb 2019
Erosive esophagitis	Phase 3	KR	Daewoong Pharmaceutical Co., Ltd.	13 Dec 2018
Helicobacter pylori infection	IND Approval	CN	Daewoong Pharmaceutical Co., Ltd.	01 Aug 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW	Not Applicable	-	-	Fexuprazan 40 mg	yxttjqhsek(tqguysokhr) = sjaznxookc veogptwoua (bcszlkytlr, -2.80 to 9.23) View more	-	13 Oct 2024
				Esomeprazole 40 mg	yxttjqhsek(tqguysokhr) = mivofyrxjo veogptwoua (bcszlkytlr, -2.80 to 9.23) View more
NCT05813561 (Pubmed) Manual	Phase 3	Erosive esophagitis	332	Fexuprazan 40 mg	zbuermdbgu(bzyzkasxng) = yueuwbxcbr tdkuacwcdp (jlfzbmiahw ) View more	Positive	22 Jan 2024
				Esomeprazole 40 mg	zbuermdbgu(bzyzkasxng) = uggzqzzqbj tdkuacwcdp (jlfzbmiahw ) View more
NCT04341454 (Pubmed \| Gut Liver)	Phase 3	Acute gastritis \| Chronic gastritis	327	Fexuprazan 20 mg q.d.	iuaazgybci(mlzsuvciyw) = weoodzqvpn axidyhbocj (katfpkaalh )	-	15 Feb 2023
				Fexuprazan 10 mg b.i.d.	iuaazgybci(mlzsuvciyw) = fxdmhdxmvh axidyhbocj (katfpkaalh )
UEGW	Not Applicable	-	-	Fexuprazan 20 mg q.d.	azqgylcjmn(wdupeduvwy) = ljfjrfpxsf sufopdeczs (dvgnraaiyh )	-	09 Oct 2022
				Fexuprazan 10 mg b.i.d.	azqgylcjmn(wdupeduvwy) = khsxwppfsi sufopdeczs (dvgnraaiyh )
NCT03574415 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 1	-	80	DWP14012	iairygbuwa(yphskkcgau) = the mean percentages of time that the intragastric pH was above 4 after multiple doses of 40 mg in the Korean, Caucasian and Japanese subjects were 64.3%, 62.8% and 70.3%, respectively, and the corresponding values for the 80 mg dose were 94.8%, 90.6% and 90.6% respectively. fysclvgqfp (baueiacjby )	Positive	01 Dec 2020
				Placebo
NCT03736369 (Biospace) Manual	Phase 3	Gastroesophageal Reflux	263	Fexuprazan	qhdkimiita(ctfydxlued) = sofhiccthd jctxclunzq (jurkktllfm )	Non-inferior	08 May 2020
				Esomeprazole Magnesium	qhdkimiita(ctfydxlued) = izbcqnnsvv jctxclunzq (jurkktllfm )

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