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

开始日期2024-08-01

申办/合作机构-

NCT06437951 / Not yet recruiting临床1期

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

开始日期2024-07-01

申办/合作机构

Daewoong Pharmaceutical Co., Ltd.

KCT0009504 / Not yet recruiting临床3期IIT

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

开始日期2024-06-01

申办/合作机构-

100 项与盐酸非苏拉赞相关的临床结果

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100 项与盐酸非苏拉赞相关的转化医学

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100 项与盐酸非苏拉赞相关的专利（医药）

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项与盐酸非苏拉赞相关的文献（医药）

2024-11-01·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

作者: 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 .

2024-11-01·Current Gastroenterology Reports

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

Review

作者: 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.

2024-05-01·Clinical and Translational Science

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

Article

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

项与盐酸非苏拉赞相关的新闻（医药）

2024-10-16

·EndPoints

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.”

临床2期临床结果临床3期

2024-10-10

·美通社

Daewoong Pharmaceutical在米兰发布"创新给药技术"

包括全球首款微针疗法以及每月使用一次的肥胖症疗法米兰 2024年10月11日 /美通社/ -- Daewoong Pharmaceutical（大熊制药）（联席首席执行官Seongsoo Park和Chang-jae Lee）于10月9日宣布，他们将在意大利米兰的全球最大制药与生物技术展"2024年世界制药原料展"(CPHI Worldwide 2024)上展示其尖端给药技术，包括全球首款微针疗法药物。此外，Daewoong还将继续扩大其创新新药Fexuprazan（非苏拉赞）和Enavogliflozin（依那格列净）的全球影响力。 Daewoong曾参展了2023年在巴塞罗那举办的CPHI，连续第二年展示了其创新药物开发的成果。在今年的米兰CPHI上，Daewoong的目标是通过扩大全球影响力和发布新的给药技术来实现其"一个产品，一万亿韩元"(One Product, One Trillion Won )的愿景。微针技术是Daewoong创新技术中的佼佼者，有望彻底改变给药系统。虽然传统的注射药物能可靠地将药物输送到体内，但它们往往伴随着疼痛，而且需要到医院就诊。相比之下，由微小针头组成的微针消除了人们对注射的恐惧，减少了去医院就诊的需要，大大改善了病人的依从性。尽管许多公司都在研究微针药物，但至今尚未有成功将其商业化的案例。迄今为止，可用的微针产品仅限于美容贴片。 Daewoong的子公司Daewoong Therapeutics开发了一种名为"CLOPAM ® "的创新微针平台，它通过空气动力学工艺和密封包装提高了药物的均匀性和稳定性。该平台克服了以往微针技术中存在的污染和药物不一致性问题。 CLOPAM ® 微针贴片面积为1平方厘米，内含约100根微针，一经皮肤穿透即溶解释放药物。CLOPAM ® 已获得六项国际专利申请和23项国内专利（其中五项已注册），被视为Daewoong未来的一项关键技术。此外，Daewoong Therapeutics最近还获得了韩国食品药品安全部(Ministry of Food and Drug Safety)的批准，可以进行人体生长激素微针贴片的一期临床试验，这也是韩国首例可溶解微针。该公司还在积极开发使用索马鲁肽(Semaglutide)治疗糖尿病和肥胖症的微针疗法，以及使用肉毒杆菌毒素治疗神经系统疾病的微针疗法。除了微针技术外，Daewoong还将展示用于治疗肥胖症的长效索马鲁肽注射剂。这种每月注射一次的注射剂可缓慢释放索马鲁肽，治疗剂量能维持30天。此方法弥补了当前市场的一大空白，因为现有的肥胖治疗方法往往需要每天或每周注射。Daewoong正在开发的微针贴片和每月一次的注射剂有望超越竞争对手，为患者提供一种痛苦更小、更为便捷的治疗方案。 Daewoong还将推出一款新型的、便于患者使用的结肠镜检查肠道准备药物(DWRX1010)。传统的结肠镜检查准备药物通常味道不佳，需要饮用大量水，或需要吞服大药丸，这不仅给患者带来不适，有时甚至让患者不愿接受检查。大熊制药新研发的小型片剂易于吞服，为准备接受结肠镜检查的患者提供了更为便捷的解决方案。 Daewoong全球业务中心负责人Doyoung Kim表示："这是我们第十年参加CPHI展会，如今市场不仅需要原材料和成品，还需要满足消费者需求的技术。随着每年的发展，Daewoong在全球的地位不断提升，尤其是在新药和技术推出方面。我们致力于通过创新的给药技术，培育畅销产品，在Fexuprazan和Enavogliflozin取得成功的基础上，进一步巩固我们在全球医疗市场的领先地位。"

微生物疗法临床1期

2024-10-09

·PRNewswire

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

临床1期上市批准

100 项与盐酸非苏拉赞相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16078

研发状态

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适应症	国家/地区	公司	日期
胃食管反流	韩国	Daewoong Pharmaceutical Co., Ltd.	2022-07-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
胃食管反流	申请上市	越南	Daewoong Pharmaceutical Co., Ltd.	-
胃食管反流	申请上市	沙特阿拉伯	Daewoong Pharmaceutical Co., Ltd.	-
反流性食管炎	临床3期	中国	Daewoong Pharmaceutical Co., Ltd.	2021-12-30
消化性溃疡	临床3期	韩国	Daewoong Pharmaceutical Co., Ltd.	2021-05-21
非糜烂性胃食管反流病	临床3期	韩国	Daewoong Pharmaceutical Co., Ltd.	2019-02-07
幽门螺杆菌感染	临床申请批准	中国	Daewoong Pharmaceutical Co., Ltd.	2024-08-01
胃炎	临床前	韩国	Daewoong Pharmaceutical Co., Ltd.	2020-06-02
非糜烂性反流病	临床前	韩国	Daewoong Pharmaceutical Co., Ltd.	2019-02-07
糜烂性食管炎	临床前	韩国	Daewoong Pharmaceutical Co., Ltd.	2018-12-13

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05813561 (Pubmed) 人工标引	临床3期	糜烂性食管炎	332	Fexuprazan 40 mg	(選築糧鹹繭鹹顧廠願夢) = 鏇壓憲窪繭艱襯製積顧顧襯醖膚蓋憲繭構膚網 (簾範鹽膚糧艱觸築觸蓋 ) 更多	积极	2024-01-22
				Esomeprazole 40 mg	(選築糧鹹繭鹹顧廠願夢) = 網廠膚願蓋膚夢範廠淵顧襯醖膚蓋憲繭構膚網 (簾範鹽膚糧艱觸築觸蓋 ) 更多
NCT04341454 (Pubmed)	临床3期	急性胃炎 \| 慢性胃炎	327	Fexuprazan 20 mg q.d.	積範繭顧餘願膚壓醖築(憲壓繭醖鏇糧蓋簾遞繭) = 願獵積襯選淵蓋選蓋壓鬱網鏇選艱鑰鹽艱製壓 (構鏇鏇餘鬱獵衊築選糧 )	-	2023-02-15
				Fexuprazan 10 mg b.i.d.	積範繭顧餘願膚壓醖築(憲壓繭醖鏇糧蓋簾遞繭) = 積廠鹹艱廠壓餘網糧獵鬱網鏇選艱鑰鹽艱製壓 (構鏇鏇餘鬱獵衊築選糧 )
NCT03574415 (Pubmed \| Aliment Pharmacol Ther) 人工标引	临床1期	-	80	DWP14012	襯遞網鬱繭窪醖鏇淵網(艱鹽觸廠願網糧齋餘鑰) = 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. 築蓋願糧築齋網網積構 (積築鑰鬱衊鬱鏇選襯壓 )	积极	2020-12-01
				Placebo
NCT03736369 (Biospace) 人工标引	临床3期	胃食管反流	263	Fexuprazan	(鏇鹹願鏇鹽繭襯醖蓋繭) = 鹹鑰鹽艱製憲膚膚廠窪鹽鑰積製鹽膚獵襯鹹夢 (窪築憲壓淵觸壓艱膚蓋 )	非劣	2020-05-08
				Esomeprazole Magnesium	(鏇鹹願鏇鹽繭襯醖蓋繭) = 糧廠衊網製窪簾齋鏇壓鹽鑰積製鹽膚獵襯鹹夢 (窪築憲壓淵觸壓艱膚蓋 )