Delving into the Latest Updates on Fexuprazan hydrochloride with Synapse

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 Date24 Oct 2024

Sponsor / Collaborator-

KCT0008892

/ RecruitingNot Applicable

A Multi-center, Investigator Initiated Trial to Evaluate the Efficacy of FEXUCLUE®40mg(Fexuprazan hydrochloride) in Patients with Iatrogenic Gastric Ulcer After Endoscopic Submucosal Dissection

Start Date30 Jul 2024

Sponsor / Collaborator

Presbyterian Medical Center

100 Clinical Results associated with Fexuprazan hydrochloride

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100 Translational Medicine associated with Fexuprazan hydrochloride

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100 Patents (Medical) associated with Fexuprazan hydrochloride

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28

Literatures (Medical) associated with Fexuprazan hydrochloride

01 Dec 2025·LUNG

Efficacy and Safety of Fexuprazan Versus Esomeprazole for Gastroesophageal Reflux Disease-Related Chronic Cough: A Randomized, Double-Blind, Active-Controlled Exploratory Trial

Article

Author: Kang, Sung-Yoon ; Kang, Noeul ; Lee, Byung-Jae ; Kang, Min-Gyu ; Lee, Ji Ho ; Jo, Eun-Jung ; Song, Woo-Jung ; Lee, Seung Eun ; Kim, Sae-Hoon ; Bahn, Joon-Woo

PURPOSE:

Potassium-competitive acid blockers (P-CABs) are a newer class of acid suppressants with convenient dosing and a rapid onset of action, while showing efficacy comparable to proton pump inhibitors (PPIs) in treating peptic symptoms of gastroesophageal reflux disease (GERD). This study aimed to assess the effect of P-CABs on GERD-related chronic cough.

METHODS:

This randomized, double-blind, active-controlled, exploratory trial evaluated adults with chronic cough (≥ 8 weeks) and a recent physician diagnosis of GERD or peptic symptoms (< 1 month). Participants were randomized (1:1) to receive either fexuprazan 40 mg or esomeprazole 40 mg (PPI) once daily for eight weeks, along with matched placebos. The primary endpoint was the change in Leicester Cough Questionnaire (LCQ) score from baseline. Secondary endpoints included changes in the cough severity Numerical Rating Scale (NRS) and Reflux Disease Questionnaire (RDQ) scores. Safety was evaluated through monitoring adverse events.

RESULTS:

Of the 190 subjects recruited, 161 met the selection criteria and were randomized, and 146 completed the trial. The participants were predominantly female (74.3%, mean age 39 ± 12 years). After 8 weeks of treatment, cough-related quality of life improved significantly, with comparable LCQ scores change between the groups (fexuprazan: 4.9 ± 4.0 vs. esomeprazole: 5.3 ± 3.8, p = 0.558). Changes in cough severity NRS and RDQ scores were also similar between the groups. Adverse events were comparable and consisted mostly of mild symptoms.

CONCLUSION:

These findings support the potential of P-CABs as a promising alternative to PPIs for patients with chronic cough requiring acid-suppressive therapy.

01 Jul 2025·BIOMEDICINE & PHARMACOTHERAPY

Restoration of intestinal barrier function by fexuprazan, a potassium-competitive acid blocker, in Caco-2 cells and its higher gastrointestinal distribution in rats

Article

Author: Baek, Yeon-Ju ; Choi, Min-Koo ; Lim, Kwon-Jo ; Song, Im-Sook ; Park, Joon Seok ; Kim, Ji Duck ; Lee, Jihoon ; Jeon, Ji-Hyeon

This study aimed to investigate the efficacy of fexuprazan in restoring intestinal barrier function in comparison with other potassium-competitive acid blockers (P-CABs) and esomeprazole. The effect of fexuprazan on trans-epithelial electrical resistance (TEER) value, mRNA and protein expression of tight junction genes, and cell morphology was investigated using a dextran sulfate sodium (DSS)-induced ulcerative colitis Caco-2 cell model. Treatment with fexuprazan, esomeprazole, tegoprazan, and vonoprazan significantly increased TEER values in a 3 % DSS-induced ulcerative colitis Caco-2 cells in a concentration-dependent manner. The TEER value-concentration profile showed sigmoidal shape curves and yielded half maximal effective concentration of 0.983 - 1.17 μg/mL for P-CABs and 3.27 μg/mL for esomeprazole. Among these drugs, fexuprazan showed the highest activity in the restoring intestinal barrier function. Fexuprazan also increased the expression of tight junction genes including zonula occludens-1, claudin 1, occludin, and mucin 1, and also thickened the epithelial cell membrane after treatment with 20 μg/mL fexuprazan. Fexuprazan showed a particularly high distribution in the liver and gastrointestinal tract in rats following oral administration of 2 mg/kg fexuprazan, which appears to be a positive characteristic of fexuprazan's effect on ulcerative colitis and gastric acid-related diseases although in vivo therapeutic efficacy of fexuprazan for ulcerative colitis requires further validation in both animal and human. In conclusion, fexuprazan can potentially restore intestinal barrier function by increasing the expression of tight junction genes and by strengthening the cell membrane integrity in DSS-induced colitis model.

01 May 2025·AMERICAN JOURNAL OF GASTROENTEROLOGY

The Role of P-CABs in GERD

Review

Author: Howden, Colin W.

Potassium-competitive acid blockers (P-CABs) constitute a relatively new class of gastric acid-suppressing drugs. Among this class, vonoprazan is the first to have been approved in the United States. However, some P-CABs including vonoprazan, tegoprazan, and fexuprazan have been available in other countries since at least 2014. The first aim of this article is to review pharmacological differences between P-CABs that are currently approved or in development with proton pump inhibitors. The specific focus thereafter is on the likely role of P-CABs in the treatment of different manifestations of gastroesophageal reflux disease. Multiple clinical trials have compared P-CABs with proton pump inhibitors in erosive esophagitis. Additional trials have compared P-CABs with placebo in nonerosive reflux disease. Relevant results are reviewed, and inferences are drawn for their use in the United States. Finally, consideration is given to additional, potential uses of P-CABs in the broader spectrum of gastroesophageal reflux disease, and some suggestions are made for future research initiatives.

27

News (Medical) associated with Fexuprazan hydrochloride

11 Jun 2025

·www.prnewswire.com

Salipro Biotech and Daewoong Pharmaceutical Announce Collaboration Agreement to Advance Development of Novel Therapeutics

- The collaboration combines Salipro Biotech's unique expertise and its Salipro® platform technology to stabilize a challenging drug target and advance Daewoong Pharmaceutical's drug discovery programs for the generation of small molecule drugs. SEOUL, South Korea, June 11, 2025 /PRNewswire/ -- Swedish biotech company Salipro Biotech AB today announced that it has entered into a research collaboration with Daewoong Pharmaceutical Co., Ltd. Daewoong Pharmaceutical gains access to Salipro Biotech's expertise and Salipro® platform for stabilizing challenging membrane proteins (e.g., GPCRs, ion channels, transporters). The collaboration will target a specific membrane protein to aid Daewoong's development of novel small molecule drugs. Continue Reading Salipro Biotech and Daewoong Pharmaceutical Announce Collaboration Agreement to Advance Development of Novel Therapeutics Under the terms of this agreement, the collaboration will enable Daewoong Pharma to leverage Salipro Biotech´s expertise and proprietary platform to advance their drug discovery efforts in the development of novel therapeutic small molecules against a challenging membrane protein drug target. "We are excited to join forces with Daewoong Pharmaceutical and contribute with our proprietary Salipro® platform to accelerate the development of novel therapeutic drugs for Daewoong Pharmaceutical's pipeline", said Jens Frauenfeld, CEO of Salipro Biotech. "This partnership is particularly significant as it marks our first collaboration with a partner in South Korea, underscoring the global application and versatility of our expertise and platform to make the undruggable druggable." Seongsoo Park, CEO at Daewoong Pharmaceutical stated, "Collaborating with Salipro Biotech and accessing their Salipro® platform aligns with our goal to address complex drug targets. Salipro's expertise in membrane protein stabilization will benefit our research for novel small molecule therapeutics, and we look forward to the results of our joint efforts." About Salipro Biotech AB Salipro Biotech AB is a privately held biotech company focused on unlocking challenging drug targets for the development of next-generation therapeutics. The company is headquartered in Stockholm, Sweden with a fully owned IP portfolio that covers the Salipro® platform technology for the stabilization of membrane proteins. The majority of drug targets are so-called membrane proteins; however, these targets are inherently unstable and challenging to investigate. The proprietary Salipro® technology stabilizes membrane proteins in their native forms, enabling them to be employed in drug discovery programs for therapeutic antibodies, small molecule drugs and structure-based drug design. To date, Salipro Biotech has signed multiple research collaborations with top-tier pharma and biotech companies. Through in-house and partnered pipelines, Salipro Biotech AB accelerates the discovery of novel drugs. About Daewoong Pharmaceutical 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. 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

Orphan DrugFast Track

07 Apr 2025

·pharma.economictimes.indiatimes.com

Sun Pharma launches its novel licensed brand Fexuclue in India

Mumbai: Indian drug maker, Sun Pharma has launched its its brand Fexuclue tablets version Fexuclue, a novel potassium competitive acid blocker , indicated for the treatment of adults with Erosive Esophagitis of all grades. The drug is marketed by Daewoong Pharmaceutical and Sun Pharma has obtained India rights through a licensing deal under which the Korean-drug maker is entitled to upfront and milestone payments, including royalties. "Erosive Esophagitis is a serious condition that greatly affects patients' quality of life. Despite available treatments, there remains a significant unmet need in its management but Fexuclue, is a best-in-class treatment option with the potential to bridge this gap," said Kirti Ganorkar, CEO, India Business, Sun Pharma. In a stock exchange filing, Sun Pharma shared that, “the drug was evaluated in a double-blind, double-dummy, comparative Phase 3 study in adult Indian population and the primary efficacy measure was healing of Erosive Esophagitis which was confirmed endoscopically and was was found to be well tolerated in Indian patients.” “The study met its primary endpoint, where over 95 per cent of the patients achieved Erosive Esophagitis healing by eight weeks,” it added. By Online Bureau ,

Phase 3Clinical ResultLicense out/inDrug Approval

06 Apr 2025

·www.pharmaindustrial-india.com

Sun Pharma Launches Novel Drug in India for Treatment of Erosive Esophagitis

Sun Pharmaceutical Industries Ltd. has announced that it has launched Fexuprazan tablets 40 mg in India under the brand name ‘FEXUCLUE’. FEXUCLUE, a novel potassium-competitive acid blocker (PCAB), is approved as a new treatment for adults with Erosive Esophagitis of all grades. Sun Pharma has obtained rights from Daewoong Pharmaceutical Co Ltd., Korea, a biopharmaceutical company, to manufacture and commercialise FEXUCLUE (Fexuprazan) in India. As per agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties. Commenting on the development, Kirti Ganorkar, CEO – India Business, Sun Pharma, said, “Erosive Esophagitis is a serious condition that greatly affects patients' quality of life. Despite available treatments, there remains a significant unmet need in its management. FEXUCLUE is a best-in-class treatment option with the potential to bridge this gap. At Sun Pharma, we are committed to introducing innovative medicines that enhance patients' quality of life.” Fexuprazan was evaluated in a double-blind, double-dummy, comparative Phase 3 study in adult Indian population. The primary efficacy measure was healing of Erosive Esophagitis which was confirmed endoscopically. The study met its primary endpoint. Over 95 percent of the patients achieved Erosive Esophagitis healing by 8 weeks. Fexuprazan was found to be well tolerated in Indian patients.

Phase 3Clinical ResultLicense out/inDrug Approval

100 Deals associated with Fexuprazan hydrochloride

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peptic Ulcer	South Korea	Daewoong Pharmaceutical Co., Ltd.	12 May 2025
Gastroesophageal Reflux	South Korea	Daewoong Pharmaceutical Co., Ltd.	30 Dec 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Helicobacter pylori infection	Phase 3	United States	Daewoong Pharmaceutical Co., Ltd.	06 Feb 2024
Esophagitis, Peptic	Phase 3	China	Daewoong Pharmaceutical Co., Ltd.	30 Dec 2021
Gastritis	Phase 3	United States	Daewoong Pharmaceutical Co., Ltd.	02 Jun 2020
Non-erosive gastro-esophageal reflux disease	Phase 3	United States	Daewoong Pharmaceutical Co., Ltd.	07 Feb 2019
Non-erosive reflux disease	Phase 3	United States	Daewoong Pharmaceutical Co., Ltd.	07 Feb 2019
Erosive esophagitis	Phase 3	United States	Daewoong Pharmaceutical Co., Ltd.	13 Dec 2018
Erosive gastro-esophageal reflux disease	Phase 3	United States	Daewoong Pharmaceutical Co., Ltd.	13 Dec 2018
Stomach Ulcer	Phase 1	South Korea	Daewoong Pharmaceutical Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	-	-	Fexuprazan 40 mg	eklbidozkv(lrcyrbglzi) = falzvblrvh baqbyeubwj (roaovuqnlg, -2.80 to 9.23) View more	-	13 Oct 2024
				Esomeprazole 40 mg	eklbidozkv(lrcyrbglzi) = yzgbwjzpdg baqbyeubwj (roaovuqnlg, -2.80 to 9.23) View more
NCT05813561 (Pubmed) Manual	Phase 3	Erosive esophagitis	332	Fexuprazan 40 mg	ikhnvpptwx(trdfbhdxls) = rxvhafwjom ujbppzphqm (udbvhhxhos ) View more	Positive	22 Jan 2024
				Esomeprazole 40 mg	ikhnvpptwx(trdfbhdxls) = jbxgtaimpy ujbppzphqm (udbvhhxhos ) View more
NCT04341454 (Pubmed \| Gut Liver)	Phase 3	Acute gastritis \| Chronic gastritis	327	Fexuprazan 20 mg q.d.	nwgkswlewg(ynnyjsfdlf) = jgdqwfmmbh wzgnzjpgah (yqezujelcg )	-	15 Feb 2023
				Fexuprazan 10 mg b.i.d.	nwgkswlewg(ynnyjsfdlf) = vxdliegrjp wzgnzjpgah (yqezujelcg )
UEGW2022	Not Applicable	Acute gastritis \| Chronic gastritis	-	Fexuprazan 20 mg q.d.	dbyjltvtjd(momosguhzh) = leifcpkvsv vkzkvxfrra (abgufeurhn )	-	09 Oct 2022
				Fexuprazan 10 mg b.i.d.	dbyjltvtjd(momosguhzh) = ikneyvysed vkzkvxfrra (abgufeurhn )
NCT03574415 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 1	-	80	DWP14012	gcnduvnand(riwhaafiak) = 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. vdifwvqibl (edymwgfork )	Positive	01 Dec 2020
				Placebo
NCT03736369 (Biospace) Manual	Phase 3	Gastroesophageal Reflux	263	Fexuprazan	qolmyjtfiq(nosgtsewwg) = eqsoeqedfh yxjjzahchp (xhmdyogxbf )	Non-inferior	08 May 2020
				Esomeprazole Magnesium	qolmyjtfiq(nosgtsewwg) = zcdjiftkii yxjjzahchp (xhmdyogxbf )