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

Start Date23 Dec 2024

Sponsor / Collaborator-

KCT0009504

/ 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 Date24 Oct 2024

Sponsor / Collaborator-

NCT07326904

/ CompletedPhase 3IIT

A Multi-Center, Randomized, Open-Label Study to Evaluate Symptom Relief and Safety After Using Fexuprazan 40 Mg Compared to Esomeprazole 40 Mg in Patients With Gastroesophageal Reflux Disease (GERD)

The goal of this clinical trial was to evaluate the effectiveness and safety of fexuprazan 40 mg for relieving symptoms of gastroesophageal reflux disease (GERD) in adults. The study also compared fexuprazan with esomeprazole 40 mg, a commonly used treatment for GERD.
The main questions this study aimed to answer were:
* Did fexuprazan reduce GERD symptoms such as heartburn and acid regurgitation?
* Was fexuprazan safe and well tolerated compared with esomeprazole?
Researchers compared fexuprazan with esomeprazole to determine whether fexuprazan provided similar symptom relief and safety.
Participants in the study:
* Were randomly assigned to receive fexuprazan 40 mg or esomeprazole 40 mg once daily
* Took the study medication for 4 weeks, with treatment extended up to 8 weeks if symptoms did not improve
* Attended scheduled clinic visits for evaluations
* Completed symptom questionnaires and a daily symptom diary
* Were monitored for side effects and overall safety throughout the study

Start Date23 Sep 2024

Sponsor / Collaborator

University of Indonesia

[+1]

100 Clinical Results associated with Fexuprazan hydrochloride

100 Translational Medicine associated with Fexuprazan hydrochloride

100 Patents (Medical) associated with Fexuprazan hydrochloride

Literatures (Medical) associated with Fexuprazan hydrochloride

30 Jan 2026·Journal of Neurogastroenterology and Motility

Comparison of Fexuprazan and Esomeprazole for the Control of Nocturnal Gastroesophageal Reflux Symptoms: A Randomized, Crossover Study

Article

Author: Oh, Dong Jun ; Jung, Jiyun ; Park, Dong Hwan ; Lim, Yun Jeong

Background/Aims:

: Nocturnal acid reflux disrupts sleep and impairs quality of life. Proton pump inhibitors provide insufficient suppression of nocturnal acid secretion, whereas fexuprazan offers prolonged acid suppression. We compared the efficacy of fexuprazan and esomeprazole in controlling nocturnal reflux.

Methods:

: In a randomized and crossover study, patients received fexuprazan or esomeprazole daily for 4 weeks, followed by a washout and crossover to the alternate medication for another 4 weeks, with a final washout completing the sequence. Severity (scores 0-10), frequency, sleep disturbance, and medication preferences were evaluated.

Results:

: Thirty-nine patients were enrolled and randomized to receive either fexuprazan (n = 20) or esomeprazole (n = 19) first. After the first treatment, fexuprazan reduced severity from 7.5 ± 1.7 to 1.4 ± 1.7 (81.3% decrease), versus 7.8 ± 1.5 to 2.8 ± 1.9 (64.1% decrease) with esomeprazole (P = 0.012). In patients with severe symptoms (scores ≥ 7), fexuprazan led to significantly greater improvement than esomeprazole (P = 0.008). Following the first washout, the second crossover treatment resulted in greater improvement in symptom severity with fexuprazan (P = 0.001). During the second washout, nocturnal symptoms severity and frequencies were better controlled with fexuprazan than with esomeprazole (P = 0.005 and 0.019). Patients who switched from esomeprazole to fexuprazan preferred fexuprazan (P = 0.018).

Conclusions:

: Fexuprazan was more effective than esomeprazole in controlling nocturnal reflux symptom, particularly in patients with severe symptoms. Fexuprazan may offer a therapeutic advantage for patients with severe and persistent nocturnal reflux despite proton pump inhibitor therapy.

01 Jan 2026·CPT-Pharmacometrics & Systems Pharmacology

A Mechanism‐Based Multi‐Level Population PK/PD Model for Potassium‐Competitive Acid Blockers

Article

Author: Lee, Jaeyeon ; Jung, Woojin ; Yun, Hwi‐yeol ; Chae, Jung‐woo ; Jeon, Hyeseon ; Lee, Soyoung ; Sung, Taewook

ABSTRACT:

Potassium‐competitive acid blockers (PCABs) are emerging alternatives to proton pump inhibitors for the treatment of acid‐related diseases. However, due to the complex, nonlinear interaction between drug exposure, food intake, and physiological rhythms, optimizing dosing strategies remains challenging. A multi‐leveled population analysis was conducted using published pharmacokinetic and pharmacodynamic data on four representative PCABs: tegoprazan, YH4808, fexuprazan, and vonoprazan. A semi‐mechanistic population PK/PD model was developed to account for food effects, circadian pH rhythms, and pH‐dependent drug absorption. A multi‐level nonlinear mixed‐effects modeling framework was implemented to capture both inter‐drug and inter‐study variability. The model successfully described the time course of plasma concentration and intragastric pH for all four PCABs under various conditions. The model identified differences in pharmacokinetics and pharmacodynamic potency between drugs (with the relative in vitro potency ranked as vonoprazan > fexuprazan > YH4808 > tegoprazan), and simulations demonstrated that both pre‐ and post‐meal administration enhanced pH control in early time period via potentially distinct mechanisms: the pre‐meal effect may arise from temporally separated contributions of food‐ and drug‐induced pH elevation, whereas the post‐meal effect is likely driven by temporally overlapping, additive actions, particularly under low‐dose or non‐steady‐state conditions. Predicted pH profiles and holding times above pH 4 closely matched reported clinical outcomes. The study demonstrates the application of a mechanistic, multi‐level population approach for cross‐drug PK/PD evaluation of PCABs. The findings support drug‐specific dose optimization and highlight the clinical relevance of food–drug interactions. The modeling approach provides a model platform for pharmacotherapy or model‐informed drug development (MIDD).

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 ; Kang, Min-Gyu ; Lee, Byung-Jae ; Jo, Eun-Jung ; Lee, Ji Ho ; 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.

News (Medical) associated with Fexuprazan hydrochloride

11 Jun 2025

·pipelinereview.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 I June 11, 2025 I 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. 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.

Orphan DrugFast Track

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

100 Deals associated with Fexuprazan hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16078

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04784910 (Pubmed \| Gut Liver)	Phase 3	-	-	Fexuprazan 20 mg/day	oryswaceqb(kgdkavsswv) = yaqahvcqbb aggsttchlz (degyxbwahl ) View more	Positive	15 Sep 2025
				Lansoprazole 15 mg/day	oryswaceqb(kgdkavsswv) = llsmrtrqxh aggsttchlz (degyxbwahl ) View more
NEWS	-	Esophagitis, Peptic	513	非苏拉生	ffkrmrslyf(knwnjvlafl) = znujqcrsdj qmwsqsrzjg (nqrvwmwdqf ) View more	Non-inferior	17 Oct 2024
				艾司奥美拉唑	ffkrmrslyf(knwnjvlafl) = kncdxchxte qmwsqsrzjg (nqrvwmwdqf ) View more
UEGW2024	Not Applicable	-	-	Fexuprazan 40 mg	tknjfgljfy(ogwdjvcqnp) = ekamhtwtyz apgudflecm (ogvglcjaxr, -2.80 to 9.23) View more	-	13 Oct 2024
				Esomeprazole 40 mg	tknjfgljfy(ogwdjvcqnp) = afzsimbpkz apgudflecm (ogvglcjaxr, -2.80 to 9.23) View more
NCT05813561 (Pubmed) Manual	Phase 3	Erosive esophagitis	332	Fexuprazan 40 mg	kexafeenqa(hqdzxotusc) = giunffazxq ribdktltjp (nolvldfydi ) View more	Positive	22 Jan 2024
				Esomeprazole 40 mg	kexafeenqa(hqdzxotusc) = mkdilsgqtl ribdktltjp (nolvldfydi ) View more
NCT04341454 (Pubmed \| Gut Liver)	Phase 3	Acute gastritis \| Chronic gastritis	327	Fexuprazan 20 mg q.d.	fskzjysfap(gxcfnefwks) = ybtegjjmld odknianaie (rrguyqtmgw )	-	15 Feb 2023
				Fexuprazan 10 mg b.i.d.	fskzjysfap(gxcfnefwks) = hkmeffqaux odknianaie (rrguyqtmgw )
UEGW2022	Not Applicable	Acute gastritis \| Chronic gastritis	-	Fexuprazan 20 mg q.d.	bkkqzbffei(kgepelvbzx) = seppidvgeu pwarbukqak (nlruxjlodk )	-	09 Oct 2022
				Fexuprazan 10 mg b.i.d.	bkkqzbffei(kgepelvbzx) = rjjndgnuyi pwarbukqak (nlruxjlodk )
NCT03574415 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 1	-	80	DWP14012	uwczcipvcn(dwsoorwitx) = 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. cvzthvobwh (pbduisgdvk )	Positive	01 Dec 2020
				Placebo
NCT03736369 (Biospace) Manual	Phase 3	Gastroesophageal Reflux	263	Fexuprazan	rtgryuqmey(khjryyprhh) = ilqcyljzue hyipyxneqp (wtwaezhzih )	Non-inferior	08 May 2020
				Esomeprazole Magnesium	rtgryuqmey(khjryyprhh) = inhmvivecm hyipyxneqp (wtwaezhzih )

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