四烯甲萘醌(Menatetrenone) - 在研适应症：维生素K缺乏性出血，骨质疏松症，出血_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Menaquinone-4、Menatetrenone (JP17/INN)、VITAMIN-MK-4

+ [20]

靶点-

作用机制

骨生成刺激剂

治疗领域

遗传病与畸形内分泌与代谢疾病血液及淋巴系统疾病+ [2]

在研适应症

维生素K缺乏性出血骨质疏松症出血+ [1]

非在研适应症

肝细胞癌绝经期后骨质疏松

原研机构-

在研机构

Sannova KK

Alfresa Pharma Corp.

Eisai Co., Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

日本 (1972-06-29),

出血低凝血酶原血症

最高研发阶段(中国)无进展

特殊审评孤儿药 (美国)

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结构

分子式C31H40O2

InChIKeyDKHGMERMDICWDU-GHDNBGIDSA-N

CAS号863-61-6

关联

46

项与四烯甲萘醌相关的临床试验

DRKS00034742 / SuspendedN/AIIT

Vitamin supplementation in cystic fibrosis in the era of modulators: the impact of vitamin K2 on cardio-metabolic health – a randomised double-blind placebo-controlled trial

开始日期2024-08-05

申办/合作机构-

ChiCTR2400081931 / SuspendedN/AIIT

The effect of vitamin K2 fortified nutritional intervention on muscle condition and clinical outcomes in elderly patients with muscle wasting syndrome

开始日期2024-03-19

申办/合作机构-

ChiCTR2400081953 / Recruiting临床1期IIT

A single-arm clinical trial study of the efficacy and safety of vitamin k2 in combination with a second-line standard regimen for the treatment of advanced hepatocellular carcinoma

开始日期2024-03-18

申办/合作机构

青岛大学附属医院

100 项与四烯甲萘醌相关的临床结果

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100 项与四烯甲萘醌相关的转化医学

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100 项与四烯甲萘醌相关的专利（医药）

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1,397

项与四烯甲萘醌相关的文献（医药）

2024-11-01·Bioresource Technology

Geranylgeraniol: Bio-based platform for teprenone, menaquinone-4, and α-tocotrienol synthesis

Article

By utilizing the conformational selectivity of biosynthesis and the flexibility of chemical synthesis, researchers have formulated metabolic engineering-based semi-synthetic approaches that initiate with the final product's structure and identify key biosynthesis intermediates. Nonetheless, these tailored semi-synthetic routes focused on end-products, neglecting the possibility of biobased intermediates as a platform for derivatization. To address this challenge, this studyproposed a novel strategy resembling chemosynthesis-style divergent exploration to amplify the significance of biobased intermediates, in the case of geranylgeraniol (GGOH). Using the novel bifunctional terpene synthase PTTC066 and systematic metabolic engineering modifications, the engineered yeast straindemonstrated high GGOH production levels (3.32 g/L, 0.039 g/L/h). This platformenabled the semi-synthesis of various pharmaceuticals, including the anti-ulcer drug teprenone, the osteoporosis treatment drug menaquinone-4, and introduced a novel route for synthesizingα-tocotrienol. This study offers a fresh outlook on semi-synthetic approaches, opening avenues for improvements, substitutions, and innovations in industrial production processes.

2024-09-02·Zhonghua er ke za zhi = Chinese journal of pediatrics

[Establishing reference ranges of serum vitamin K in healthy children].

Article

作者: Fan, X ; Huang, Q L ; Chen, Y P ; Li, Y ; Fang, S F ; Wang, F ; Wu, J Z ; Liu, L M ; Bai, D ; Liu, Q Q ; Jin, C H ; Chen, Y J ; Liu, X ; Chen, Y Q

目的： 建立并验证我国健康儿童血清维生素K参考区间。 方法： 横断面研究，根据我国东部、中部、西部、东北各区域0~14岁儿童人口分布比例，于2020年1月至2023年5月分层随机抽取807名0~14岁健康儿童作为研究对象，由12个省、自治区、直辖市16家医院完成样本收集。通过统一自制调查问卷收集儿童基本信息，采用液相色谱串联质谱法测定样本中血清维生素K₁、维生素K₂［四烯甲萘醌（MK-4）和甲萘醌-7（MK-7）］水平，直接法建立参考区间。按年龄分组，采用非参数检验Kruskal Wallis进行组间比较，采用非参数法确定参考区间（P_2.5~P_97.5）。另选取40名健康儿童（东部25名、中部10名、西部5名）进行小样本验证。 结果： 807名儿童年龄5.00（2.00，9.81）岁，男495名（61.3%）、女312名（38.7%）。纳入795名1月龄至14岁儿童建立参考区间，其中1月龄至3岁（303名）、4~14岁（492名），参考区间血清维生素K₁分别为0.09~4.54、0.10~1.73 μg/L，MK-7分别为0.07~1.42、0.19~2.03 μg/L。1月龄至14岁儿童MK-4参考区间为0~0.42 μg/L。验证样本血清维生素K₁、MK-4和MK-7测定值落在参考限外均未超过2个。 结论： 建立1月龄至14岁健康儿童维生素K₁、MK-4、MK-7参考区间并通过验证，可应用于评估儿童维生素K营养状况。.

2024-07-01·Free Radical Biology and Medicine

Corrigendum to “Menaquinone-4 attenuates ferroptosis by upregulating DHODH through activation of SIRT1 after subarachnoid hemorrhage” [Free Radic. Biol. Med. 210 (2024) 416–429]

作者: Lu, Yue ; Li, Wei ; Zhu, Qi ; Hang, Chun-Hua ; Peng, Zheng ; Sheng, Bin ; Gao, Sen ; Li, Xiao-Jian ; Ding, Peng-Fei ; Zhuang, Zong ; Liu, Yang ; Zhang, Jiatong

11

项与四烯甲萘醌相关的新闻（医药）

2024-01-23

·医药观澜

卫材宣布痛风治疗新药在中国申报上市

▎药明康德内容团队报道1月22日，卫材（Eisai）宣布多替诺雷片新药上市申请已获中国国家药监局药品审评中心（CDE）受理。多替诺雷片（dotinurad）是一款促尿酸排泄药，此前已经于2020年在日本获批用于治疗高尿酸血症和痛风。截图来源：CDE官网痛风是由单钠尿酸盐沉积在关节所致的晶体相关性关节病，目前中国的患病率为1% ~ 3%，并呈逐年上升趋势。痛风除了在急性发作期产生剧烈疼痛，对关节造成损害，还会伴发肾脏病变及其他代谢综合征的表现，如高脂血症、高血压、糖尿病和冠心病等。过高的血尿酸水平（即高尿酸血症）是发生痛风的重要危险因素。据卫材新闻稿介绍，多替诺雷是一种新型痛风治疗药物，通过选择性抑制与肾脏中尿酸重吸收有关的尿酸盐转运蛋白（URAT1），抑制尿酸重吸收并降低血尿酸水平。作为一种URAT1选择性抑制剂，该产品有效抑制肾近端小管URAT1而不影响尿酸排泄因子ABCG2和OAT1/3的功能，相比非选择性URAT1抑制剂降血尿酸的效率更高。公开资料显示，多替诺雷最初由富士药品（FUJI YAKUHIN）研发，卫材于2020年与富士药品达成许可协议，获得该产品在中国的独家开发和销售权。此前在日本开展的一项3期临床研究结果显示，多替诺雷4mg治疗伴或不伴痛风的高尿酸血症患者，58周血尿酸水平≤6mg的患者比例为100%，长期使用对肾功能无明显影响，对肝功能无临床相关影响。在中国，卫材开展了一项旨在评估多替诺雷和非布司他治疗痛风疗效的3期临床研究。该研究纳入451例痛风患者，随机分为多替诺雷4mg组和非布司他40mg组，主要研究终点是治疗24周血尿酸水平≤6.0mg/dL的患者百分比。根据卫材新闻稿，除了治疗痛风的新药多替诺雷，该公司在中国已上市的替普瑞酮胶囊、四烯甲萘醌软胶囊和雷贝拉唑钠肠溶片等药物，在风湿科、肾内科、骨科、内分泌科和心内科等多个领域发挥协同作用。多替诺雷的加入将丰富卫材中国在这些领域的产品管线，惠及广大患者。参考资料：[1]卫材治疗痛风新药「多替诺雷」在中国申报上市. Retrieved Jan 22，2024, From https://mp.weixin.qq.com/s/-X_9_97VxnNsh2xVjsMnlQ[2] 徐东, 等. 中华内科杂志. 2020,59(6):421-426.本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈。转发授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期申请上市临床结果

2024-01-22

·美通社

卫材治疗痛风新药「多替诺雷」在中国申报上市

今日（2024年1月22日），中国国家药品监督管理局药品审评中心（CDE）官网公示，卫材中国以注册分类5.1类申报的多替诺雷片上市申请已获得受理1。多替诺雷片（Dotinurad，商品名：优乐思）是一款促尿酸排泄药，此前已经于2020年在日本上市，用于治疗高尿酸血症和痛风2。痛风是由单钠尿酸盐沉积在关节所致的晶体相关性关节病，目前我国的患病率为1% ~ 3%，并呈逐年上升趋势。痛风除了在急性发作期产生剧烈疼痛，对关节造成损害，还会伴发肾脏病变及其他代谢综合征的表现，如高脂血症、高血压、糖尿病和冠心病等3。过高的血尿酸水平（即高尿酸血症）是发生痛风的最重要的危险因素4。多替诺雷是一种新型痛风治疗药物，通过选择性抑制与肾脏中尿酸重吸收有关的尿酸盐转运蛋白（URAT1），抑制尿酸重吸收并降低血尿酸水平5。作为一种URAT1选择性抑制剂，多替诺雷有效抑制肾近端小管URAT1而不影响尿酸排泄因子ABCG2和OAT1/3的功能，相比非选择性URAT1抑制剂降血尿酸的效率更高2。卫材在中国开展了一项旨在评估多替诺雷和非布司他治疗痛风疗效的3期临床研究（NCT05007392）。该研究纳入451例痛风患者，随机分为多替诺雷 4mg组和非布司他 40mg组，主要研究终点是治疗24周血尿酸水平≤ 6.0 mg/dL的患者百分比6。此前在日本开展的一项3期临床研究结果显示，多替诺雷 4mg治疗伴或不伴痛风的高尿酸血症患者，58周血尿酸水平≤ 6.0 mg/dL的患者达标率100%，长期使用对肾功能无明显影响，对肝功能无临床相关影响7。卫材中国始终将患者利益和公众健康放在首位，满足其多样化需求，为提升其福祉做出贡献。除了治疗痛风的新药多替诺雷，卫材中国已上市的施维舒®（替普瑞酮胶囊）、固力康®（四烯甲萘醌软胶囊）和波利特®（雷贝拉唑钠肠溶片）等多款药物在相关领域发挥协同作用。多替诺雷的加入将丰富卫材中国在这些领域的产品管线，惠及广大患者。参考资料： [1] 中国国家药监局药品审评中心（CDE）官网. [2] Ishikawa T, et al. Expert Opin Pharmacother. 2021,22(11):1397-1406. [3] 徐东, 等. 中华内科杂志. 2020,59(6):421-426. [4] Dalbeth N, et al. Lancet. 2021,397(10287):1843-1855. [5] 卫材中国. 2020-02-25 from https://mp.weixin.qq.com/s/CC5rg1feoMe0WVBR66t-_w [6] 美国临床试验注册库 from https://classic.clinicaltrials.gov/ct2/show/study/NCT05007392?term=dotinurad&cond=gout&draw=2&rank=1 [7] Hosoya T, et al. Clin Exp Nephrol. 2020;24(Suppl 1):80-91. 内容来源于网络，如有侵权，请联系删除。

申请上市临床结果

2024-01-04

·GlobeNewswire-Health Care

Healthy Extracts Launches First Anti-Aging Formulation, LONGEVITY

LAS VEGAS, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Healthy Extracts Inc. (OTCQB: HYEX), a platform for acquiring, developing, patenting, marketing, and distributing plant-based nutraceuticals that target select high-growth categories within the multibillion-dollar nutraceuticals market, has launched LONGEVITY Anti-Aging™, a new proprietary formulation designed to support skin vitality, arterial flexibility, and cellular and joint health. LONGEVITY Anti-Aging is available to order today on BergametNA.com. In celebration of the launch, for a limited time you can buy two and get one free. You can also subscribe and save 15% on every order. The formulation is a special blend of the most powerful anti-aging warriors that include trans-resveratrol, quercetin, vitamin D, and vitamin K2. These substances are known to boost blood flow and circulation, reduce the deleterious effects of misplaced calcium in the body, and slow the effects of aging with powerful antioxidants. “LONGEVITY Anti-Aging complements our growing heart health product portfolio which supports a holistic approach to anti-aging like healthy skin,” noted Healthy Extracts president, Duke Pitts. “We anticipate this new product, along with the others we’re planning to launch early this year, will continue drive our growth and market expansion, as they leverage our multiple sales and distribution channels and existing customer base.” LONGEVITY Anti-Aging represents a holistic approach to aging, with a proprietary blend focused on providing the nutrition the body needs for optimal health. It is formulated to help sustain vitality, support heart health, ensure robust bone strength, and contribute to a healthier aging process. The formulation is vegan friendly, non-GMO, gluten-free, and produced and tested by certified U.S. facilities. Key substances and benefits: Trans-resveratrol and quercetin are powerful antioxidants that shield cells from aging and oxidative stress for more youthful function.Vitamin D and K2 are vital for proper calcium absorption and distribution, bolstering bone health and reducing osteoporosis risk.For heart health, ingredients like vitamin K2 and trans-resveratrol are key in maintaining cardiovascular wellness, helping to lower the risk of heart ailments.Vitamin D and quercetin also strengthens immune defense, enhancing protection against infection and disease. LONGEVITY Anti-Aging is your ally for overall longevity, blending ingredients renowned for their anti-aging benefits that support a longer, healthier life. LONGEVITY Anti-Aging introduction follows the recent official launch of BERGAMET SLEEP BREATHING SUPPORT™ , a natural supplement designed to support respiratory function for deeper, more restorative sleep. Given the better than anticipated initial sales of this new product, it is on track to become one of the company’s best sellers in 2024. Healthy Extracts’ full line of natural heart health formulations address the fast-growing, multi-billion dollar heart-health supplement market which is projected to grow at 5.9% CAGR to reach $24.8 billion by 2027, according to ResearchAndMarkets. To learn more about Healthy Extracts’ full line of clinically-backed, natural brain and hearth health products, go to bergametna.com or tryubn.com. About Healthy Extracts “Live Life Young Again” Healthy Extracts Inc. is a platform for acquiring, developing, researching, patenting, marketing, and distributing plant-based nutraceuticals. The company’s subsidiaries, BergametNA™ and Ultimate Brain Nutrients™ (UBN), offer nutraceutical natural heart and brain health supplements. This includes the only heart health supplement distributed in North America containing Citrus Bergamot SuperFruit™. This superfruit has the highest known concentration of polyphenols and flavonoids. UBN’s KETONOMICS® proprietary formulations, which have been designed to enhance brain activity, focus, headache and cognitive behavior, provide many sales and intellectual property licensing opportunities. For more information visit: healthyextractsinc.com, bergametna.com or tryubn.com. Forward-Looking Statements and Safe Harbor Notice All statements other than statements of historical facts included in this press release are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include our expectations and those statements that use forward-looking words such as "projected," "expect," "possibility" and "anticipate." The achievement or success of the matters covered by such forward-looking statements involve significant risks, uncertainties and assumptions. Actual results could differ materially from current projections or implied results. Investors should read the risk factors set forth in the Company's Annual Report on Form 10-K filed with the SEC on March 31, 2023, and future periodic reports filed with the SEC. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The Company cautions that statements and assumptions made in this news release constitute forward-looking statements and make no guarantee of future performance. Forward-looking statements are based on estimates and opinions of management at the time statements are made. The information set forth herein speaks only as of the date hereof. The Company and its management undertake no obligation to revise these statements following the date of this news release. Food & Drug Administration Disclosure The product and formulation featured in this release is not for use by or sale to persons under the age of 12. This product should be used only as directed on the label. Consult with a physician before use if you have a serious medical condition or use prescription medications. A doctor’s advice should be sought before using this and any supplemental dietary product. These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease. BergametNA™, Ultimate Brain Nutrients™, UBN™, Citrus Bergamot SuperFruit™ and F4T® are registered trademarks of Healthy Extracts Inc.™ Company ContactDuke Pitts, PresidentHealthy Extracts Inc.Tel (720) 463-1004Email contact Investor ContactRonald Both CMA Investor RelationsTel (949) 432-7566Email contactMedia Contact:Tim RandallCMA Media RelationsTel (949) 432-7572Email Contact A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/200b922a-c04a-45ab-b819-dba1b9750c42

上市批准

100 项与四烯甲萘醌相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00100	四烯甲萘醌	B02BA	DB12148

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
维生素K缺乏性出血	日本	Sannova KK	2012-05-25
维生素K缺乏性出血	日本	Alfresa Pharma Corp.	2012-05-25
骨质疏松症	日本	Eisai Co., Ltd.	1995-06-30
出血	日本	Eisai Co., Ltd.	1972-06-29
低凝血酶原血症	日本	Eisai Co., Ltd.	1972-06-29

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肝细胞癌	临床3期	日本	Eisai Co., Ltd.	2004-03-01
绝经期后骨质疏松	临床前	中国	Eisai Co., Ltd.	2005-05-01

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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


MO789 (ERA2022)	N/A	matrix Gla protein (MGP)	120	Vitamin K1	鹹窪觸膚憲壓選觸憲觸(構憲齋襯構襯糧簾選鑰) = 壓築範鑰艱製衊淵鑰鹹餘餘築製遞鬱鑰淵簾醖 (憲鏇餘醖範淵醖膚顧淵 )	积极	2022-05-03
				Vitamin K2	鹹窪觸膚憲壓選觸憲觸(構憲齋襯構襯糧簾選鑰) = 夢繭願積築壓鏇鏇繭鏇餘餘築製遞鬱鑰淵簾醖 (憲鏇餘醖範淵醖膚顧淵 )
FP608 (ERA2019)	N/A	血管钙化 uncarboxylated-MGP	102	Vitamin K2 supplementation (200μg/day)	壓糧獵簾鬱構艱膚積壓(糧鹹獵製糧餘鏇網顧蓋) = 鏇夢壓範鏇壓憲遞衊衊遞膚艱獵齋鹹膚鑰壓遞 (夢願蓋築艱觸簾製選鹹 ) 更多	不佳	2019-06-13
				Vitamin K2	壓糧獵簾鬱構艱膚積壓(糧鹹獵製糧餘鏇網顧蓋) = 壓襯膚遞顧遞積壓鹽醖遞膚艱獵齋鹹膚鑰壓遞 (夢願蓋築艱觸簾製選鹹 ) 更多
NCT01101698 \| NCT04247087 (Pubmed)	临床4期	慢性肾病	42	Vitamin K2 + cholecalciferol (K+D)	鑰窪齋鬱鹽淵艱鹹窪顧(網襯糧鏇艱選繭構憲簾) = 壓範餘願選鏇蓋鹽構醖鑰廠襯鑰選餘顧願廠窪 (範鬱遞艱衊廠鬱鑰糧構 )	-	2015-01-01
				Cholecalciferol (D)	鑰窪齋鬱鹽淵艱鹹窪顧(網襯糧鏇艱選繭構憲簾) = 觸夢襯遞廠蓋餘鏇餘選鑰廠襯鑰選餘顧願廠窪 (範鬱遞艱衊廠鬱鑰糧構 )
ASN2013	N/A	慢性肾小球肾炎 \| 糖皮质激素诱导的骨质疏松症 N-terminal telopeptide of type I collagen (NTx) \| uncarboxylated osteocalcin (ucOC)	43	Etidronate	壓艱築衊鹽淵衊鏇願鏇(壓積壓範遞鑰廠窪齋餘) = There were no significant differences in BMD between these groups during the study 廠衊構簾獵餘壓夢餘網 (憲襯艱選壓構鹹製夢繭 )	积极	2013-11-05
				Etidronate+Menatetrenone
ASN2012	N/A	dp-uc-MGP	200	Vitamin K2 360 µg	鹽顧網積襯窪鏇鹹鬱遞(築廠糧選積願鑰觸簾顧) = 13% of patients suffered from gastro-intestinal side effects, unrelated to the dose. Nausea caused by the unpleasant smell of the uncoated tablets was reported most frequent. 齋鹽糧積蓋糧膚夢衊獵 (鏇獵觸淵膚壓繭遞觸顧 )	积极	2012-10-30
				Vitamin K2 720 µg
NCT00165698 (CTgov)	临床3期	绝经期后骨质疏松	240	Menatetrenone (Menatetrenone)	醖夢襯築餘壓遞窪窪製(淵鹽夢鑰製遞餘選觸淵) = 遞遞築觸鏇夢網鏇醖餘齋網築製獵範餘築鹹鏇 (選鹹鬱夢鏇夢範餘齋積, 顧醖製築壓膚構製膚鏇 ~ 構鹹積網鏇構廠構鹽壓) 更多	-	2011-08-11
				Alfacalcidol (Alfacalcidol)	醖夢襯築餘壓遞窪窪製(淵鹽夢鑰製遞餘選觸淵) = 鹹顧構築遞鬱壓鑰艱遞齋網築製獵範餘築鹹鏇 (選鹹鬱夢鏇夢範餘齋積, 鑰壓襯膚網齋窪膚繭鹹 ~ 簾獵獵積齋夢廠簾醖築) 更多