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

PURPOSELaryngopharyngeal 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.METHODSThis 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.RESULTSA 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.CONCLUSIONFexuprazan 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 REGISTRATIONKCT0007251, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22100 .

01 Nov 2024·Current Gastroenterology Reports

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

Review

Author: Scarpignato, Carmelo ; Hunt, Richard H

AbstractPurpose of the ReviewAcid 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 FindingsOver 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.SummaryFour 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 May 2024·Clinical and Translational Science

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

Article

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

AbstractFexuprazan, 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

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

06 Feb 2024

·www.prnewswire.com

Daewoong Pharmaceutical Announces 2023 Financial Results

Recorded FY'23 unconsolidated revenue of KRW 1.22 trillion and FY'23 operating profit of KRW 133.4 billion SEOUL, South Korea, Feb. 6, 2024 /PRNewswire/ -- Daewoong Pharmaceutical (KRX: 069620.KS), a global pharmaceutical company located in Seoul, announced its marvelous financial results for 2023. Demonstrating a consistent growth trajectory, the company reported stand-alone sales of KRW 1.22 trillion and a commendable operating profit of KRW 133.4 billion. Chang-jae Lee, CEO of Daewoong Pharmaceutical, emphasized the company's global reach and innovative edge, stating, "Our role as a global healthcare solutions provider is mirrored in the impressive global performance of our novel drugs and our strategic expansion initiatives. Our strong financial results, characterized by record revenues and profits, affirm our unwavering commitment to innovation and to expanding our global market presence." Key Highlights (Unconsolidated) (unit: KRW billion) Revenues reached KRW 1,222 billion in 2023, marking a 60.7% increase from the previous year. Operating profit was KRW 134 billion in 2023, reflecting a 25.9% increase from the previous year. The annual net income was KRW 111.5 billion, an increase of 129.6% compared to the previous year. Product Developments: Fexuclue (Fexuprazan): A P-CAB drug for GERD, Fexuclue, has shown strong sales since its launch, amassing KRW 55 billion. It quickly became a blockbuster, accumulating a cumulative revenue of KRW 71.7 billion, attributable to its fast positioning in both local and global markets. Within just 17 months of its release, Fexuclue climbed to the 2nd rank in the domestic GERD treatment market. Additionally, it is gaining international traction, with NDA submissions in 18 countries and approvals from 5, including key Latin American markets such as Ecuador, Chile, and Mexico. Envlo (Enavogliflozin): An SGLT-2 inhibitor, Envlo, has rapidly expanded globally, submitting NDAs in 11 countries, including Indonesia and the Philippines, within just six months of its domestic launch. The global expansion of Envlo is regarded as a meaningful step, considering it is the only SGLT-2 inhibitor originally made by South Korea. NABOTA (Botulinumtoxin Type A): Recognized as Asia's first FDA-approved botulinum toxin, NABOTA has recorded sales of KRW 147 billion. It is expanding its international footprint through Evolus, launching as Nuceiva in several European countries and strengthening its position in North America and Europe. Additionally, Daewoong's US clinical trial partner, AEON Biopharma, secured a U.S. patent for migraine treatment last September. Pipeline Developments: DWP213388, targeting both BTK and ITK for immune cell activation, has received approval for U.S. Phase 1 Clinical Trials. The FDA endorsed its IND application in August 2023, highlighting its potential in treating autoimmune diseases such as RA. Bersiporocin, focusing on the PARS1 enzyme essential for collagen synthesis, is progressing through Phase 2 trials in the US and Korea. With its potential anti-fibrotic benefits, Daewoong remains dedicated to ensuring its safe use. The drug has achieved the FDA's Orphan Drug and Fast Track Designations for IPF. Additionally, it has received Orphan Drug and Fast Track Designations for IPF in Europe. DWRX2008, a novel drug candidate from Daewoong Therapeutics, a subsidiary of Daewoong Pharmaceutical Group, aims to revolutionize the treatment of diabetic retinopathy by transitioning Envlo from oral administration to an innovative ocular pathway. As a first-in-class development, DWRX2008 has secured approval from South Korean's Ministry of Food and Drug Safety (MFDS) to commence Phase 1 clinical trials for its innovative candidate targeting diabetic eye diseases. DWP306001, which incorporates Envlo, is in development as a potential treatment for obesity. The combination of Envlo with an appetite suppressant is set to enter Phase 2 clinical trials later this year. Forward-Looking Statements: This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials. 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. 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. SOURCE Daewoong Pharmaceutical Co., Ltd.

Orphan DrugDrug ApprovalFast TrackPhase 2Phase 1

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
Gastroesophageal Reflux	NDA/BLA	VN	Daewoong Pharmaceutical Co., Ltd.	-
Gastroesophageal Reflux	NDA/BLA	SA	Daewoong Pharmaceutical Co., Ltd.	-
Esophagitis, Peptic	Phase 3	CN	Daewoong Pharmaceutical Co., Ltd.	30 Dec 2021
Peptic Ulcer	Phase 3	KR	Daewoong Pharmaceutical Co., Ltd.	21 May 2021
Non-erosive gastro-esophageal reflux disease	Phase 3	KR	Daewoong Pharmaceutical Co., Ltd.	07 Feb 2019
Gastritis	Phase 1	KR	Daewoong Pharmaceutical Co., Ltd.	02 Jun 2020
Non-erosive reflux disease	Phase 1	KR	Daewoong Pharmaceutical Co., Ltd.	07 Feb 2019
Erosive esophagitis	Phase 1	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	tkmissqojj(aktfftmtxp) = ljjmdzlbxe jucxdjhaqw (taqunovpsa, -2.80 to 9.23) View more	-	13 Oct 2024
				Esomeprazole 40 mg	tkmissqojj(aktfftmtxp) = rnkrrzsewh jucxdjhaqw (taqunovpsa, -2.80 to 9.23) View more
NCT05813561 (Pubmed) Manual	Phase 3	Erosive esophagitis	332	Fexuprazan 40 mg	(yefpmtcbsx) = dbuuigywcl wdjnxxcbkp (fldndkzoaa ) View more	Positive	22 Jan 2024
				Esomeprazole 40 mg	(yefpmtcbsx) = eqatorpmki wdjnxxcbkp (fldndkzoaa ) View more
NCT04341454 (Pubmed)	Phase 3	Acute gastritis \| Chronic gastritis	327	Fexuprazan 20 mg q.d.	khktmjvlxj(fjfhidgtlh) = roskkgivch nvrhoiqxuw (qbveqnnyaz )	-	15 Feb 2023
				Fexuprazan 10 mg b.i.d.	khktmjvlxj(fjfhidgtlh) = jwfjchdjzb nvrhoiqxuw (qbveqnnyaz )
NCT03574415 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 1	-	80	DWP14012	bekuzjgmqj(dmfvmhdqpi) = 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. hvpiuarplh (coxjzevddx )	Positive	01 Dec 2020
				Placebo
NCT03736369 (Biospace) Manual	Phase 3	Gastroesophageal Reflux	263	Fexuprazan	(xifovdayrv) = dggdvkzvhk gdajgopmdy (gvhmbgswxu )	Non-inferior	08 May 2020
				Esomeprazole Magnesium	(xifovdayrv) = zlmvhdwmtl gdajgopmdy (gvhmbgswxu )

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