更新于：2024-11-15

Dapagliflozin

达格列净

更新于：2024-11-15

概要

概要

基本信息

药物类型

小分子化药

别名

(2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol、Dapagliflozin propandiol monohydrate、Dapagliflozin propanediol (USAN)

+ [20]

靶点

SGLT2

作用机制

SGLT2抑制剂(钠-葡萄糖协同转运蛋白-2抑制剂)

治疗领域

免疫系统疾病心血管疾病内分泌与代谢疾病+ [3]

在研适应症

1型糖尿病慢性心力衰竭慢性肾病+ [9]

非在研适应症

新型冠状病毒感染非胰岛素依赖型糖尿病2射血分数保留型心力衰竭+ [17]

原研机构

Bristol Myers Squibb Co.

在研机构

Bristol Myers Squibb Co.

阿斯利康制药有限公司

AstraZeneca PLC

+ [4]

非在研机构

AstraZeneca Pharmaceuticals LP

最高研发阶段批准上市

首次获批日期

澳大利亚 (2012-10-22),

慢性肾病2型糖尿病心脏衰竭

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (中国)、优先审评 (澳大利亚)

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结构

分子式C24H35ClO9

InChIKeyGOADIQFWSVMMRJ-UPGAGZFNSA-N

CAS号960404-48-2

关联

799

项与达格列净相关的临床试验

NCT06560333 / Not yet recruiting临床3期

Evaluate the Efficacy and Safety of the Combined Use of a Sodium-glucose Cotransporter 2 (iSGLT2) Inhibitor and a Dipeptidyl Peptidase-4 (iDPP -4) Inhibitor in the Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin

The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

开始日期2026-11-30

申办/合作机构

Eurofarma Laboratórios SA

NCT04818034 / Recruiting临床2期IIT

The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study

Cystinuria is an inherited autosomal recessive disorder of the kidney that is the result of an inability to reabsorb cystine from the urine. Supersaturation of cystine in the urine produces crystals that precipitate and form stones in the kidney, which can be a cause of obstruction, infection, and chronic kidney disease. Cystine stones constitute a major health challenge for affected individuals with cystinuria because of the frequent recurrence of painful symptoms and the current absence of effective, patient-accepting treatment.
A mainstay of therapy is breaking or preventing the cystine bond on the molecular level such that cystine (which is formed from the joining of two cysteine amino acids and their corresponding sulfur atoms) cannot precipitate in the urine. It is hypothesized that a glucose molecule may be able to do this if introduced into the urine. SGLT-2 inhibitors are a class of drug that are FDA approved to treat diabetes mellitus (DM) and heart failure by inhibiting an enzyme in the kidney that allows for reabsorption of glucose from the urine. This effectively increases the concentration of glucose in the urine. Our hypothesis suggests that administration of this drug to patients with cystine will introduce sufficient glucose into the urine to prevent the formation of cystine stones. To date, there has been no published data on the effectiveness of this therapy for this indication, although the dosage and administration would be identical to that already approved by the FDA for the treatment of DM and heart failure.

开始日期2025-05-02

申办/合作机构

The University of California, San Francisco

NCT06677060 / Not yet recruiting临床3期

A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.
The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1.
Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation.
Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.
The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD.
In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.

开始日期2025-03-28

申办/合作机构

AstraZeneca PLC

100 项与达格列净相关的临床结果

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100 项与达格列净相关的转化医学

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100 项与达格列净相关的专利（医药）

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2,793

项与达格列净相关的文献（医药）

2024-12-01·PEDIATRIC NEPHROLOGY

Efficacy and safety of dapagliflozin in children with kidney disease: real-world data

Article

作者: Choi, Naye ; Ahn, Yo Han ; Lee, Hyeonju ; Kim, Ji Hyun ; Kang, Hee Gyung ; Park, Hye Won ; Park, Peong Gang ; Min, Jeesu

Abstract:

Background:

Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, has shown results in slowing estimated glomerular filtration rate (eGFR) decline and reducing proteinuria in adult patients with chronic kidney disease. This retrospective study examines dapagliflozin’s effects in 22 children with kidney disease and proteinuria.

Methods:

Children with a median age of 15.6 years were treated with dapagliflozin for > 3 months between July 2022 and December 2023. All children had been treated with either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for at least 1 month before starting dapagliflozin.

Results:

The most common kidney disease diagnoses in this study included Alport syndrome (n = 7) and medication-resistant nephrotic syndrome or focal segmental glomerulosclerosis (n = 7). After 6.1 months of treatment, dapagliflozin treatment did not result in significant changes in eGFR or proteinuria. However, at the latest follow-up, a statistically significant decrease in eGFR was noted (65.5 compared to the baseline 71.1 mL/min/1.73 m2, P = 0.003). Proteinuria remained stable between baseline and the last follow-up (final spot urine protein/creatinine ratio (uPCR) 0.7 vs. baseline uPCR 0.6 mg/mg, P = 0.489). In the subgroup analysis of children treated for > 8 months, the eGFR decline post-treatment changed from − 0.5 to − 0.2 ml/min/1.73 m2 per month (P = 0.634). Only two children discontinued dapagliflozin due to suspected adverse events.

Conclusions:

Dapagliflozin has not been associated with serious side effects. Further prospective clinical trials are needed to confirm the efficacy and safety of dapagliflozin in children with kidney disease.

Graphical abstract:

2024-12-01·MOLECULAR BIOLOGY REPORTS

Potential ameliorative effect of Dapagliflozin on systemic inflammation-induced cardiovascular injury via endoplasmic reticulum stress and autophagy pathway

Article

作者: Tepebasi, Muhammet Yusuf ; Aydın, Bunyamin ; Gunes, Ali Baran ; Sarisahin, Berkehan ; Taner, Rumeysa ; Asci, Halil ; Selcuk, Esma ; Tasan, Serife

BACKGROUND:

Dapagliflozin (DPG) is a sodium-glucose cotransporter-2 inhibitor and is used in the treatment of diabetes. In this study, we aimed to investigate the effect of DPG on cardiotoxicity caused by systemic inflammation via endoplasmic reticulum (ER) stress and autophagy.

METHODS AND RESULTS:

Four groups of thirty-two Wistar Albino rats were created: Control (1 ml oral physiological saline for five days and intraperitoneal saline on the 5th day), LPS (1 ml oral physiological saline for five days and intraperitoneal 5 mg/kg of LPS on the 5th day), LPS + DPG (10 mg/kg of DPG orally for five days and 5 mg/kg of LPS intraperitoneally on the 5th day), and DPG (10 mg/kg of DPG orally for five days and 5 mg/kg of SF intraperitoneally on the 5th day). Histopathological and immunohistochemical analyses were performed on heart and aorta tissues. ER stress and autophagy gene markers in heart tissues were evaluated by RT-qPCR. Oxidative stress in heart tissues and serum cardiac enzymes were analyzed by spectrophotometric method. The heart and aortic tissues of the LPS group showed increased expressions of Tumor Necrosis Factor-α (TNF-α) and Caspase-3 (Cas-3), along with mild hyperemia, slight inflammatory cell infiltrations, and myocardial cell damage. The heart tissues also showed genetically increased expressions of include binding immunoglobulin protein (BiP/ GRP78), protein kinase RNA-like ER Kinase (PERK), inositol-requiring enzyme 1 (IRE-1), activating transcription factors 4 (ATF-4), activating transcription factors 4 (ATF6), C/EBP homologous protein (CHOP), and BECLIN 1. Furthermore, Creatine kinase-MB (CK-MB) and Lactate dehydrogenase (LDH) levels in blood tissue significantly increased, according to biochemical analysis. With DPG therapy, all of these findings were reversed.

CONCLUSION:

In conclusion, DPG protects against the cardiotoxic effect of systemic inflammation with its antioxidant and anti-inflammatory properties by regulating ER stress and autophagy pathways.

2024-12-01·Molecular biology reports

Dapagliflozin promotes browning of white adipose tissue through the FGFR1-LKB1-AMPK signaling pathway

Article

作者: Li, Weiping ; Zhao, Chengrui ; Rong, Yilin ; Ma, Mingfeng ; Liang, Lili ; Jiang, Qiuyan ; Wu, Huiwen ; Xu, Ning ; Lv, Yue ; Zhang, Jiuxuan

Abstract:

Background:

Obesity is associated with a wide variety of metabolic disorders that impose significant burdens on patients and society. The “browning” phenomenon in white adipose tissue (WAT) has emerged as a promising therapeutic strategy to combat metabolic disturbances. However, though the anti-diabetic drug dapagliflozin (DAPA) is thought to promote “browning,” the specific mechanism of this was previously unclear.

Methods:

In this study, C57BL/6 J male mice were used to establish an obesity model by high-fat diet feeding, and 3T3-L1 cells were used to induce mature adipocytes and to explore the role and mechanism of DAPA in “browning” through a combination of in vitro and in vivo experiments.

Results:

The results show that DAPA promotes WAT "browning" and improves metabolic disorders. Furthermore, we discovered that DAPA activated "browning" through the fibroblast growth factor receptors 1-liver kinase B1-adenosine monophosphate-activated protein kinase signaling pathway.

Conclusion:

These findings provide a rational basis for the use of DAPA in treating obesity by promoting the browning of white adipose tissue.

741

项与达格列净相关的新闻（医药）

2024-11-15

·士研生命科学

【产业周报】步长制药：子公司复方硫酸钠片药品临床试验申请获受理；中国医药：车凌云先生申请辞去公司董事及董事会专门委员会相关职务

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引进/卖出高管变更财报申请上市

2024-11-15

·生物制药小编

【专家洞见】张琳博士邀您共襄盛举，深入了解全球GLP-1类药物临床研究的最新进展！

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上市批准生物类似药

2024-11-14

·医药健闻

阿斯利康前高管王雅丽加入亿腾集团；冯煌接任天津医药集团董事长；药明生物将扩大德国勒沃库森基地产能 | 日报

全球医疗行业每日重点资讯文 | 卓悦企业动态阿斯利康泰州供应基地可持续发展战略项目在中国医药城正式启动。据悉，2024-2025年期间阿斯利康泰州供应基地计划投资3000万元人民币打造零碳绿色示范企业目标在2026年减少98%的碳排放和40%水资源消耗并将能耗强度降低20%。2012年阿斯利康泰州供应基地落户中国医药城，2014年泰州基地正式投入使用，总投资3亿美金，是迄今阿斯利康在江苏单体投资最大的项目。主要产品有倍他乐克、波依定、帮备安达唐，向中国及世界供应高品质固体口服制剂。药明生物将扩大德国勒沃库森基地产能，新建一条隔离器灌装预充针生产线。此次扩建将优化基地生产布局，为多产品的CRDMO服务提供更高效的解决方案。该新增产线可以为多种规格的预充针进行灌装(1毫升、2.25毫升和3毫升)，灌装速度最快可达400支/分钟，年产能超过1700万支。目前德国勒沃库森基地已有一条无菌灌装和冻干制剂生产线，年产能达1000万瓶。该新增产线预计将在近期启动建设，2026年达到GMP生产标准。王雅丽自加入亿腾集团，担任肿瘤事业部北中国销售总监职务，负责肿瘤事业部北中国的销售管理，兼管肿瘤事业部南中国销售和市场医学管理工作。王雅丽拥有25年医药行业销售与市场经验，曾就职于阿斯利康、GSK 等跨国药企，加入亿腾医药之前，是阿斯利康区域销售总监。天津医药：冯煌任董事长，张旺任副董事长。天津市医药集团有限公司公告，拟选举冯煌、王东、张旺、徐阳雪、王光华为公司董事，陈津竹不再担任公司董事长、董事职务，滕飞不再担任公司副董事长、董事职务，张铭芮、孙利军、于克祥不再担任公司董事职务；选举冯煌担任公司董事长，张旺担任公司副董事长，赵忱担任公司监事会主席。大冢制药和ICU医疗打造共建联盟供应美国。大冢制药厂将向医疗设备公司ICU medical支付2亿美元，以建立向美国供应静脉注射产品的联盟。该合资企业将拥有17个全球生产基地，每年向美国市场提供约14亿单位的静脉注射药物。根据周二发布的消息，预计将从2025年第二季度开始实施。这两家公司还将开发新的静脉注射药物，ICU称这些产品历来难以获得融资。ICU将推广合资企业开发的任何新药。全球领先的生命科学投资集团Novo Holdings宣布，其共同牵头了Alentis Therapeutics的1.814亿美元D轮融资。Alentis是一家临床阶段的生物技术公司，总部位于瑞士巴塞尔，正在开发以Claudin-1（CLDN1）为靶点的药物管线。这笔融资将使Alentis能够启动两种首创ADC药物的1/2期临床试验。爱尔康(Alcon)公布2024年第三季度业绩。季度净销售额和其他营收24.54亿美元，上年同期为23.29亿美元。季度营业利润3.32亿美元，上年同期为2.93亿美元。季度净利润2.63亿美元，上年同期为2.04亿美元。产业动态礼来阿尔茨海默病新药Donanemab日本定价获批。日本厚生劳动相的咨询机构“中央社会保险医疗协议会”批准了阿尔茨海默病新药“多奈单抗”的官方定价，一名患者一年的治疗费用约为308万日元。20日起将适用公共保险。该药由美国制药巨头礼来公司研发。雅培不断引入全球前沿的技术解决方案，助力中国检验医学加速发展；通过持续深入本土化战略，深耕中国满足更广阔的医疗发展需求。旗下两款重磅智能化解决方案——免疫模块 Alinity i 和自动化流水线 GLP，宣布实现中国本地化生产之后，在 11 月 6 日迎来首条国产化流水线 GLP 的正式交付。自动化流水线 GLP 从提升样本周转时间、确保准确临床决策、降低人员工作强度以及充分利用场地空间等多个维度满足实验室日益增长的需求。参天制药与极目生物就眼科疗法ARVN001开展商业化合作。参天制药与极目生物宣布，极目生物将其正在研发中的ARVN001在中国内地的独家商业化权益授权于参天制药。ARVN001采用脉络膜上腔微注射专利技术，将用于治疗葡萄膜炎性黄斑水肿和其他一些正在开发中的潜在眼科适应症。联系美通社 +86-10-5953 9500 info@prnasia.com

高管变更

100 项与达格列净相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09763	达格列净	A10BK01	DB06292

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
1型糖尿病	日本	阿斯利康制药有限公司	2019-03-26
慢性心力衰竭	欧盟	AstraZeneca AB	2012-11-11
慢性心力衰竭	冰岛	AstraZeneca AB	2012-11-11
慢性心力衰竭	列支敦士登	AstraZeneca AB	2012-11-11
慢性心力衰竭	挪威	AstraZeneca AB	2012-11-11
慢性肾病	澳大利亚	AstraZeneca Pty Ltd.	2012-10-22
2型糖尿病	澳大利亚	AstraZeneca Pty Ltd.	2012-10-22
心脏衰竭	澳大利亚	AstraZeneca Pty Ltd.	2012-10-22

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
急性心肌梗塞	临床3期	瑞典	AstraZeneca PLC	2020-12-22
急性心肌梗塞	临床3期	英国	AstraZeneca PLC	2020-12-22
新型冠状病毒感染	临床3期	美国	AstraZeneca PLC	2020-04-22
新型冠状病毒感染	临床3期	阿根廷	AstraZeneca PLC	2020-04-22
新型冠状病毒感染	临床3期	巴西	AstraZeneca PLC	2020-04-22
新型冠状病毒感染	临床3期	加拿大	AstraZeneca PLC	2020-04-22
新型冠状病毒感染	临床3期	印度	AstraZeneca PLC	2020-04-22
新型冠状病毒感染	临床3期	墨西哥	AstraZeneca PLC	2020-04-22
新型冠状病毒感染	临床3期	英国	AstraZeneca PLC	2020-04-22
呼吸衰竭	临床3期	美国	AstraZeneca PLC	2020-04-22

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临床结果

适应症

分期

评价

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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


NCT03036150 (DAPA-CKD, Pubmed \| Clin J Am Soc Nephrol)	临床3期	慢性肾病 type 2 diabetes	4,304	Dapagliflozin 10mg	積糧鬱鹹製淵壓鑰鏇簾(鬱艱醖餘獵艱範製鹹襯) = 鑰積顧齋鑰餘窪遞積艱齋糧憲膚鹹膚膚衊顧艱 (選鑰觸餘築鏇鏇願淵築, 30.2% ~ 42.5%)	积极	2024-10-17
				Placebo	積糧鬱鹹製淵壓鑰鏇簾(鬱艱醖餘獵艱範製鹹襯) = 齋艱構襯壓簾選膚選鬱齋糧憲膚鹹膚膚衊顧艱 (選鑰觸餘築鏇鏇願淵築, 12 ~ 30%)
NCT05014594 (Pubmed \| Dig Dis Sci) 人工标引	临床2期	腹水	40	Dapagliflozin 10 mg/day + standard medical therapy	鑰醖廠齋鏇鹹襯選衊觸(積構衊鬱廠構糧選淵範): P-Value = 0.04 更多	不佳	2024-10-09
				Placebo + standard medical therapy
NCT04730947 (Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction Trial, Pubmed)	临床2期	射血分数保留型心力衰竭	37	Dapagliflozin	壓範淵襯廠廠築構範製(鏇範襯衊觸觸選醖蓋築) = 齋鬱鏇構選顧鏇獵鹽積簾構廠選鬱衊鬱蓋簾構 (齋顧願齋餘淵觸鑰遞選, -33.9 ~ -3.7) 更多	积极	2024-08-05
NCT04724837 (ZENITH-CKD, CTgov)	临床2期	慢性肾病	542	Placebo+Dapagliflozin	範鹽顧構壓憲積構衊構(憲築鹹鹽憲窪廠糧糧獵) = 廠積憲餘積顧醖淵夢範衊鹹獵艱遞膚遞願鹹壓 (願衊糧鏇積願選廠壓齋, 鑰遞衊壓鬱構製鏇衊鹹 ~ 廠獵構範夢顧簾齋構簾) 更多	-	2024-07-30
NCT04730947 (CAMEO-DAPA, Pubmed)	临床2期	射血分数保留型心力衰竭 SGLT2	37	Dapagliflozin	製鏇積膚壓蓋衊選壓範(願蓋襯膚餘艱衊淵獵壓) = 蓋簾積鏇淵壓範選網窪繭願鹽築艱糧觸觸齋鏇 (窪鬱鹹糧糧壓願鏇積網, 0.11 ~ 1.03) 更多	积极	2024-07-24
				Placebo	觸顧鹹鑰蓋醖簾觸醖窪(夢觸淵餘願衊餘窪糧顧) = 壓壓衊製觸艱齋觸膚遞餘蓋鹽範獵製鏇淵鏇糧 (鹽構製鏇觸蓋築艱齋齋, -0.02 ~ 0.05)
930-P (ADA2024)	N/A	1型糖尿病	20	Dapagliflozin	衊觸艱廠鹹願壓獵築艱(憲廠鏇遞網遞獵鹹窪窪) = During usual care, there were 3 ketosis events (cBOHB > 1.5 mmol/L) versus 10 during SGLT-2 treatment (P=0.11). Most ketosis events occurred in one individual over a 24hr period. No DKA occurred. 構蓋鹽壓憲鏇繭簾憲憲 (鏇製蓋構鹹蓋鏇膚築襯 )	积极	2024-06-14
				Dapagliflozin (Usual care)
ADA2024	N/A	糖尿病酮症酸中毒 \| 2型糖尿病 C-peptide \| HbA1c	17,160	Dapagliflozin	觸淵網窪鏇繭壓鏇醖觸(願衊遞繭廠顧淵淵構繭) = 鹽餘蓋觸艱鑰淵鏇淵網範鹽遞積觸願製鹹鹽壓 (簾簾鑰餘顧選壓醖鹹鏇 ) 更多	积极	2024-06-14
				Placebo	觸淵網窪鏇繭壓鏇醖觸(願衊遞繭廠顧淵淵構繭) = 憲糧簾遞餘鏇糧醖憲獵範鹽遞積觸願製鹹鹽壓 (簾簾鑰餘顧選壓醖鹹鏇 ) 更多
ADA2024	N/A	2型糖尿病	-	Dapagliflozin 10 mg	獵憲蓋膚鬱齋鬱繭鹽願(鹽膚鏇觸餘鬱夢醖膚構) = 觸觸醖製廠蓋鹽壓齋繭鹽構艱艱憲顧壓願觸製 (築範餘膚淵簾餘範夢齋 )	-	2024-06-14
				Placebo	獵憲蓋膚鬱齋鬱繭鹽願(鹽膚鏇觸餘鬱夢醖膚構) = 膚夢範蓋積鏇顧積餘廠鹽構艱艱憲顧壓願觸製 (築範餘膚淵簾餘範夢齋 )
301-OR (ADA2024)	N/A	-	40	Placebo	夢築顧簾鏇遞選製積壓(壓製繭觸簾鹹夢選蓋膚) = 顧繭齋蓋憲選壓獵憲窪鹽遞選窪艱選觸範醖製 (鹽鑰餘顧淵製製憲窪簾, 26.2)	积极	2024-06-14
				Tirzepatide 100 nmole/kg	夢築顧簾鏇遞選製積壓(壓製繭觸簾鹹夢選蓋膚) = 淵繭膚艱廠餘艱鑰觸糧鹽遞選窪艱選觸範醖製 (鹽鑰餘顧淵製製憲窪簾, 23.0)