本试验旨在研究单次空腹口服华润赛科药业有限责任公司研制、生产的艾托格列净片（5 mg）的药代动力学特征；以Pfizer Manufacturing Deutschland GmbH生产的艾托格列净片（捷诺妥®，5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

开始日期2025-05-19

申办/合作机构

华润赛科药业有限责任公司

ChiCTR2500107368

N/AIIT

A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Fecal Microbiota Capsule Transplantation Combined with Henagliflozin in Patients with Type 2 Diabetic Kidney Disease

开始日期2024-11-01

申办/合作机构

西南医科大学附属医院

[+1]

CTR20243375

/ CompletedN/A

艾托格列净片在健康受试者中空腹/餐后单次口服给药、随机、开放交叉生物等效性试验

主要目的：以山东朗诺制药有限公司生产的艾托格列净片为受试制剂（T），以Pfizer Manufacturing Deutschland GmbH生产的艾托格列净片（商品名：Steglatro®/捷诺妥®）为参比制剂（R），评估健康受试者在空腹及餐后状态下单次口服受试制剂和参比制剂的人体生物利用度，评价两种制剂的生物等效性。次要目的：评估受试制剂和参比制剂在健康受试者中的安全性。

开始日期2024-08-29

申办/合作机构

山东朗诺制药有限公司

100 项与艾托格列净相关的临床结果

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100 项与艾托格列净相关的转化医学

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100 项与艾托格列净相关的专利（医药）

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项与艾托格列净相关的文献（医药）

2025-12-01·Current Neurology and Neuroscience Reports

The Role of Diabetes and SGLT2 Inhibitors in Cerebrovascular Diseases

Review

作者: Moustafa, Bayan ; Trifan, Gabriela

PURPOSE OF REVIEW:

Diabetes is a well-established risk factor for stroke. Understanding the pathophysiology of this connection is crucial to implementing appropriate prevention strategies. Lately, there has been a paradigm shift in the care of individuals with diabetes toward the use of glucose-lowering medications with potential cardiovascular, cerebrovascular or cardiorenal benefits. The aim of this article is to provide a critical analysis of the role of diabetes in cerebrovascular disease and current evidence and recommendations for the use of glucose-lowering medication with particular focus on the sodium glucose cotransporter-2 inhibitor (SGLT2i) class.

RECENT FINDINGS:

Intensive glycemic control in individuals with diabetes reduces the risk of microvascular complications, but there is less clear evidence for decreasing risk of macrovascular events (e.g., stroke). A multifaceted management of diabetes addressing healthy lifestyle practices, glycemic control, and optimization of other cardiovascular risk factors is highly recommended. SGLT2i are the latest class of antihyperglycemic agents available for diabetes management. Canagliflozin and empagliflozin are associated with reduction in major adverse cardiovascular events (MACE). Dapagliflozin did not reduce the rate of MACE but is associated with reduction in heart-failure related death and hospitalization and has the potential to decrease dementia risk. Ertugliflozin decreases rates of hospitalization related to heart failure however it was non-inferior to placebo in reducing MACE. There is increasing evidence that the use of SGLT2i may reduce the risk of stroke, particularly hemorrhagic stroke, in individuals with type 2 diabetes and a high risk of cardiovascular events, and that SGLT2i may also be beneficial for brain health by decreasing risk of cognitive decline and dementia. Antihyperglycemic therapy should be tailored to patients' circumstances. SGLT2i treatment should be considered in patients with type 2 diabetes and established or high-risk cardiovascular disease, heart failure, or chronic kidney disease, to reduce the overall cerebro-cardiovascular and renal risks.

2025-10-01·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Ertugliflozin attenuates atherosclerosis in nondiabetic ApoE−/− mice by upregulating ABCA1 and LDLR via the PPARγ/LXRα pathway

Article

作者: Dong, Yuanbao ; Li, Bo ; Zhang, Baixue ; Wang, Yue ; Zhao, Faming ; Yang, Jing

PURPOSE:

Ertugliflozin is a potent, selective, and orally active inhibitor of sodium-dependent glucose cotransporter 2 (SGLT2), which is beneficial to cardiovascular health. We aimed to study the effect of Ertugliflozin on atherosclerosis (AS) in nondiabetic ApoE^-/- mice.

METHODS:

Eight-week-old apolipoprotein E knockout (ApoE^-/-) mice were randomly divided into two groups. Control group mice were fed high-fat diet (HFD), and the experimental group was fed HFD combined with Ertugliflozin (3.075 μg/g/d). Three months later, blood samples from all mice were collected to detect serum low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDLC). Aortic arch plaques were used for the assessment of plaque burden by hematoxylin-eosin staining (H&E staining). The relative lipid and macrophage contents of atherosclerotic plaques in two groups were assessed using Oil Red O staining and immunohistochemistry with an anti-MOMA2 (monocyte/macrophage) antibody. In the cell experiment, RAW264.7 cells were divided into 3 groups: a control group, induced with oxidized LDL (ox-LDL) group (50 μg/ml), and induced with ox-LDL combined with Ertugliflozin group (100 μM). Lipid accumulation was evaluated by Oil Red O staining; several adipogenesis markers were analyzed by real-time quantitative PCR (RT-qPCR) and western blotting (WB). Later, a specific inhibitor of this pathway (GW9662, 10 μM) was used to block its effect. The genes and proteins identified to be involved in this pathway were verified using RT-qPCR and WB.

RESULTS:

Ertugliflozin reduces lipid accumulation and arterial plaque formation in nondiabetic ApoE^-/- mice. H&E staining and Oil Red O staining of the two groups of mouse tissues indicated that the degree of AS in experimental mice was reduced, and the lipid components within the plaques were diminished following Ertugliflozin intervention. Histological staining showed plaque size in mouse aortic arch and abdominal aorta sections. Additionally, immunohistochemistry revealed that the expression of MOMA2 in the experimental mice plaques was significantly lower compared to that in the HFD group, suggesting that the plaques in the experimental mice were more stable. In vitro, Ertugliflozin upregulated the expression of low density lipoprotein receptor (LDLR) and ATP-binding cassette transporterA1 (ABCA1), upregulated the activity of the peroxisome proliferators-activated receptor γ/liver X receptor α (PPARγ/LXRα) pathway and downregulated the expression of cluster of differentiation 36 (CD36). When the PPARγ inhibitor (GW9662, 10 μM) was used to block the pathway, the effects of Ertugliflozin were also weakened.

CONCLUSIONS:

In summary, our results indicated that Ertugliflozin not only may reduce the area of atherosclerotic plaques in ApoE^-/- mice but also upregulate ABCA1 and LDLR via the PPARγ/LXRα pathway to play a role in macrophages. Ertugliflozin upregulates ABCA1 and LDLR via the PPARγ/LXRα pathway to hinder the formation of macrophage-derived foam cells and reduce MOMA2 expression in atherosclerotic plaques. Overall, our study reveals the potential medicinal value of Ertugliflozin in the treatment of AS, which provides a rationale for the use of Ertugliflozin in the clinical treatment of AS.

2025-09-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Ertugliflozin induces vasodilation by inhibiting AMPK-mediated mitochondrial fission in vascular smooth muscle cells

Article

作者: Liu, Jie ; Yan, Jie ; Cui, Jianlin ; Feng, Lifeng ; Qi, Zhi ; Zhang, Shengzheng ; Zhang, Xiaowen ; Wei, Han ; Li, Qiwen ; Li, Jing ; Yang, Liang ; Ren, Shan ; Xu, Yang ; Tian, Wencong ; Gao, Yang

Hypertension is a primary risk factor for cardiovascular disease. Recently, Ertugliflozin (Ertu), a new sodium-glucose cotransporter-2 (SGLT2) inhibitor, though primarily approved by the FDA as an antidiabetic agent, has been reported to lower blood pressure. However, whether Ertu directly regulates the contractility of arteries remains unknown. Here, we examined Ertu's effects on vascular function and underlying molecular mechanisms. Isometric tension of arteries was recorded using a multi-wire myograph system. In rat mesenteric arteries, Ertu acutely relaxed vessels constricted by phenylephrine (PE) and high K⁺ (KPSS), while pretreatment with Ertu inhibited PE- and KPSS- induced vascular constriction. Similar outcomes were observed in the mouse thoracic aorta. Notably, these vasodilatory effects of Ertu are mediated by vascular smooth muscle cells (VSMCs) rather than endothelial cells. Mechanistically, we found that Ertu activated AMP-activated protein kinase (AMPK) signaling pathway in VSMCs and rat thoracic aorta tissues by decreasing ATP levels and the ATP/ADP ratio. Using the AMPK inhibitor Compound C, we observed that Ertu-induced vasodilation was abolished. Furthermore, we found that Compound C reversed Ertu-mediated reductions in cytosolic calcium concentration ([Ca²⁺]i) and mitochondrial fission, which were accompanied by diminished mitochondrial membrane potential in VSMCs. In conclusion, this study demonstrates for the first time that Ertu inhibits AMPK-mediated mitochondrial fission in VSMCs, leading to vasorelaxation, suggesting its potential as a therapeutic agent for hypertension.

项与艾托格列净相关的新闻（医药）

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-08-23

·国际糖尿病idiabetes

名医荟萃论道DPP-4i持续创新——糖尿病治疗全国专家顾问会“森护糖安·格守胰康”成功举办

点击“蓝字”关注我们编者按：8月22日，值此中华医学会第二十二次内分泌学学术会议（CSE 2025）召开之际，由中国医药教育协会举办的“糖尿病治疗全国专家顾问会——森护糖安·格守胰康”顺利召开。本次会议由中山大学孙逸仙纪念医院严励教授、上海长征医院石勇铨教授、复旦大学附属华山医院李益明教授、上海交通大学医学院附属新华医院苏青教授联袂主持，汇聚全国多位临床一线专家，深入探讨新一代高选择性二肽基肽酶-4抑制剂（DPP-4i）磷酸森格列汀片（以下简称森格列汀）的创新机制、循证成果及临床价值，为优化2型糖尿病（T2DM）管理提供指导与实践参考。【严励教授、石勇铨教授、李益明教授、苏青教授现场照片轮播】立足需求、精研分子冲破格列汀森林迷雾的通幽小径余强博士盛世泰科生物医药技术（苏州）股份有限公司创始人余强博士着重分享了森格列汀的研发历程和结构创新。他指出，糖尿病已成为严重威胁我国国民健康的重大公共卫生问题，但在治疗方面仍存在巨大未满足的需求。DPP-4i的出现为T2DM治疗带来了突破性革新。西格列汀作为全球首款DPP-4i，已成为该类药物的优异代表。森格列汀在参考化合物西格列汀与DPP-4的共晶结构基础上，进行了进一步的分子优化，包括引入疏水基团、优化母核、限制构象、提高酰胺键稳定性，最终实现了更高活性、更低剂量、更佳安全性的中国原研DPP-4i。森格列汀创新分子设计森格列汀在III期临床试验表现出了优异的降糖效果，糖化血红蛋白（HbA1c）降幅达1.08%~1.23%，且未出现同类药物常见的不良反应，如急性胰腺炎、超敏反应、关节痛、低血糖等[1-2]。余强博士表示，据介绍这一更优的药效和安全性正是源自其创新性的分子设计。与西格列汀相比，森格列汀与DPP-4的亲合力更强、半衰期显著延长，且给药剂量减半；与二甲双胍联用时互补性更强，降糖效果更佳。此外，森格列汀作用于全身靶组织，对血浆DPP-4的抑制比西格列汀更平稳，有效覆盖全天血糖，持续降糖的同时减少了低血糖的发生。展望未来，森格列汀将在多个疾病领域展现潜在价值，特别是在糖尿病领域将持续推进复方制剂的研发布局，包括森格列汀与二甲双胍的二联制剂、森格列汀与钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）的二联制剂，以及森格列汀、二甲双胍与SGLT2i的三联制剂，旨在通过多机制协同作用，覆盖更广泛的口服用药人群，满足多阶段患者的临床需求。循证安降、权威解析新一代高选择性DPP-4i森格列汀临床数据全景陈海冰教授上海市同济大学附属第十人民医院陈海冰教授进一步详细解读了森格列汀的临床研究数据。在Ⅰ期临床研究[3-4]中，相较于西格列汀，森格列汀口服后血药浓度达峰快，半衰期长，较好的组织分布，有助于维持药效；同时，森格列汀的药效学重要参数半数效应浓度（EC50）值更低，对DPP-4酶抑制活性更高。值得强调的是，森格列汀50 mg即可实现与西格列汀100 mg相当的对DPP-4酶的抑制效果。森格列汀与西格列汀药效学数据比较森格列汀单药治疗的III期临床研究[1]共纳入了504例T2DM患者，旨在评估其经饮食和运动治疗后血糖控制不佳的在中国T2DM患者中的疗效和安全性。结果显示，森格列汀50 mg单药治疗24周HbA1c降低1.08%，相比安慰剂降低0.72%（P<0.05）；HbA1c<7%的患者比例是安慰剂组的近3.5倍，HbA1c<6.5%的患者比例是安慰剂组的近10倍。而且在不同基线HbA1c水平及不同糖尿病病程T2DM患者中均可有效改善HbA1c，基线HbA1c水平越高，疗效越显著。森格列汀单药治疗24周HbA1c水平变化森格列汀联合二甲双胍的III期研究[2]共纳入446例T2DM患者，旨在评估联合治疗在二甲双胍单药治疗血糖控制不佳患者中的疗效和安全性。结果显示，森格列汀联合二甲双胍治疗T2DM患者24周HbA1c降低1.23%，相比安慰剂降低0.79%（P<0.05）；HbA1c<7%的患者比例是安慰剂组的3.5倍，HbA1c<6.5%的患者比例是安慰剂组的5.5倍。与单药治疗相似，联合治疗同样可显著降低T2DM患者空腹血糖（FPG）、餐后血糖（PPG）；而且在不同基线HbA1c水平及不同糖尿病病程T2DM患者中均可有效改善HbA1c。此外，联合治疗还可显著改善T2DM患者的β细胞功能。森格列汀联合二甲双胍治疗24周HbA1c水平变化在这两项III期研究[1-2]中，森格列汀安全性良好，均未见低血糖事件及严重不良反应。陈海冰教授表示，无论从疗效还是安全性，森格列汀在同类药物中均表现突出，为优化中国T2DM患者的血糖管理提供了更佳选择，具备广泛的临床应用价值。森格列汀单药与联合二甲双胍治疗24周的安全性临床驱动、臻于至善从早期联合到老年安全降糖的优选策略陈燕燕教授中国医学科学院阜外医院陈燕燕教授从“早联合、久获益”的角度，阐述了DPP-4i在早期联合治疗及老年患者管理中的重要价值。她指出，在多项循证支持与指南更新的指导下，血糖管理正从“传统序贯治疗”转向“早期联合治疗”。DPP-4i可安全降糖，是多种降糖药物联合治疗的理想搭档。一项Meta分析[5]显示，与磺脲类药物联合二甲双胍方案相比，DPP-4i联合二甲双胍可更有效降低HbA1c和餐后2小时血糖（2h-PPG）水平，同时在安全性方面表现更佳；与其他基于二甲双胍的口服降糖药联合方案相比，DPP-4i+二甲双胍同样具有良好疗效和耐受性。研究表明，DPP-4i是二甲双胍联合治疗的优选方案。此外，多项研究表明DPP-4i与SGLT2i联合治疗可有效降糖，并且具有良好安全性[6-8]。 DPP-4抑制剂联合二甲双胍与其他药物联合二甲双胍治疗的疗效比较除二联治疗外，二甲双胍基础上加用DPP-4i和SGLT2i的三联治疗亦被证实可有效控制二甲双胍单药治疗失败的T2DM患者血糖水平[9]。《成人2型糖尿病患者口服降糖药物三联优化方案（二甲双胍+二肽基肽酶Ⅳ抑制剂+钠-葡萄糖共转运蛋白2抑制剂）中国专家共识（2025年更新版）》[10]指出，二甲双胍、DPP-4i与SGLT2i这3种口服降糖药物组成的三联方案具有互补的作用机制，可覆盖T2DM 的多重病理生理缺陷，能改善多种代谢指标，且安全性良好，适用于多数T2DM患者。二甲双胍+DPP-4抑制剂+SGLT2抑制剂三联方案临床应用主要推荐意见汇总陈燕燕教授进一步介绍到，鉴于老年糖尿病患者低血糖风险高，且常伴多种并发症和合并症，《中国老年糖尿病诊疗指南（2024版）》[11]提出，老年患者的疾病管理应遵循分层、个体化、简约化及去强化治疗的原则。DPP-4i具有降糖机制温和、不良反应少、依从性好、可及性高以及经济负担低等优势，与老年T2DM患者的治疗需求高度契合。因此，该指南推荐DPP-4i作为老年糖尿病患者降糖治疗的首选药物之一。此外，对于合并动脉粥样硬化性心血管疾病（ASCVD）或高危因素、心力衰竭（HF）或慢性肾脏病（CKD）的老年T2DM患者单药治疗控糖不达标时，DPP-4i作为联合治疗的一级推荐药物。不合并 ASCVD 或高危因素、HF或 CKD 的老年 T2DM 患者非胰岛素治疗路径图合并 ASCVD或高危因素、HF或 CKD的老年 T2DM 患者非胰岛素治疗路径图陈燕燕教授总结指出，森格列汀作为新一代高选择性DPP-4i，凭借机制上的独特优势，在单药或联合治疗中均表现出更优的降糖效果与安全性。其半衰期达49小时，支持每日一次给药，且吸收不受进食影响[12]，更是为T2DM早期联合治疗及老年患者管理提供了“高效、安全、简单方便”的理想治疗选择。智汇森谈启新思，共话降糖新篇章！南方医科大学珠江医院陈容平教授、武汉大学人民医院高凌教授、上海交通大学医学院附属同仁医院黄珊教授、大连医科大学附属第二医院刘海霞教授、南昌大学第二附属医院刘建萍教授、大连医科大学附属第二医院刘立朝教授、浙江大学医学院附属第一医院李成江教授、大连医科大学附属第二医院苏本利教授、中国医科大学附属第一医院滕晓春教授、浙江大学医学院附属邵逸夫医院周嘉强教授、河北医科大学第三医院周慧敏教授围绕森格列汀的创新分子设计、临床疗效及多场景应用展开讨论。专家们一致认为，凭借稳定的血糖控制、优异的组织分布及与多种口服降糖药的协同优势，森格列汀不仅满足早期联合治疗需求，更为老年及复杂病程的T2DM患者提供了切实可行的个体化治疗新策略与实践范本。总结会议尾声，四位主持教授高屋建瓴地凝炼共识：森格列汀不仅为中国T2DM患者带来新的治疗选择，也为复方制剂研发、多机制联合用药及个体化治疗奠定了坚实基础，彰显了DPP-4i在精准糖尿病管理中的持续创新与临床价值。会场花絮参考文献：（上下滑动查看更多） [1] Ji L, Lu J, Gao L, Ying C, et al. Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled phase 3 trial. Diabetes Obes Metab, 2023, 25(12):3671-3681. [2] Ji L, Lu J, Gao L, et al. A randomized, double-blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of cetagliptin added to ongoing metformin therapy in patients with uncontrolled type 2 diabetes with metformin monotherapy. Diabetes Obes Metab, 2023, 25(12):3788-3797. [3]Lu J, Wang L, Zhou S, et al. A double-blind, randomized, placebo and positive-controlled study in healthy volunteers to evaluate pharmacokinetic and pharmacodynamic properties of multiple oral doses of cetagliptin. Br J Clin Pharmacol, 2022, 88(6):2946-2958. [4]Zhou C, Zhou S, Wang J, et al. Safety, tolerability, pharmacokinetics and pharmacokinetic-pharmacodynamic modeling of cetagliptin in patients with type 2 diabetes mellitus. Front Endocrinol (Lausanne), 2024, 15:1359407. [5]Chen R, Li J, Chen D, et al. Efficacy and Safety of DPP-4 Inhibitors and Metformin Combinations in Type 2 Diabetes: A Systematic Literature Review and Network Meta-Analysis. Diabetes Metab Syndr Obes， 2024, 17:2471-2493. [6]Katsiki N, Ofori-Asenso R, Ferrannini E, et al. Fixed-dose combination of empagliflozin and linagliptin for the treatment of patients with type 2 diabetes mellitus: A systematic review and meta-analysis. Diabetes Obes Metab, 2020 , 22(6):1001-1005. doi: 10.1111/dom.13989. , [7]Miller S, Krumins T, Zhou H, et al. Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. Diabetes Ther, 2018, 9(1):253-268. [8]Katsiki N, Ofori-Asenso R, Ferrannini E, et al. Fixed-dose combination of empagliflozin and linagliptin for the treatment of patients with type 2 diabetes mellitus: A systematic review and meta-analysis. Diabetes Obes Metab, 2020, 22(6):1001-1005. [9]DeFronzo RA, Lewin A, Patel S, et al. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care, 2015, 38(3):384-393. [10]中国研究型医院学会糖尿病学专业委员会.成人2型糖尿病患者口服降糖药物三联优化方案（二甲双胍+二肽基肽酶Ⅳ抑制剂+钠-葡萄糖共转运蛋白2抑制剂）中国专家共识（2025年更新版）[J]. 中华糖尿病杂志,2025, 17(8):934-949. [11]国家老年医学中心,中华医学会老年医学分会,中国老年保健协会糖尿病专业委员会.中国老年糖尿病诊疗指南(2024版)[J]. 中华糖尿病杂志, 2024, 16(02):147-189. [12]磷酸森格列汀片说明书。声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床3期临床结果临床成功

2025-06-26

·米内网

【市场】38款新药进院可期，60亿独家注射剂入选

精彩内容近日，邛崃市医疗中心医院发布公告，决定引入部分需变更药品及部分药品品种以保证临床用药需求，包括5款需变更药品、38款新药。其中，38款新药以化学药为主，科伦药业、人福等独家品种在列。从药品类型看，38款新药中包含了26款化学药、11款生物药及1款中成药；从剂型上看，以注射剂为主，占比超过60%，口服常释剂（普通片剂、胶囊剂等）紧接在后，占比超过30%。从治疗类别看，此次引进的新药种类丰富，共涉及10个治疗大类，包括9个全身用抗感染药物、5个神经系统药物、5个消化系统及代谢药、4个肌肉-骨骼系统药物等。独家品种占比接近50%，包括科伦药业的ω-3甘油三酯(2%)中/长链脂肪乳/氨基酸(16)/葡萄糖(36%)注射液及注射用头孢他啶阿维巴坦钠/氯化钠注射液，人福医药的盐酸氢吗啡酮缓释片、默沙东的艾托格列净片、诺和诺德的司美格鲁肽注射液、众生药业的来瑞特韦片等。从市场规模看，在2024年中国三大终端六大市场（统计范围详见本文末）中，司美格鲁肽注射液销售额超过60亿元，枸橼酸舒芬太尼注射液、苯磺酸氨氯地平片（络活喜）销售额均超30亿元，注射用美罗培南（美平）、地舒单抗注射液、盐酸达泊西汀片、比克恩丙诺片、注射用人生长激素等品种销售额均超10亿元。拟引进新药目录来源：邛崃市医疗中心医院、米内网数据库司美格鲁肽注射液是诺和诺德开发的一款GLP-1激动剂，最早于2021年获批进入国内市场，获批第2年在中国三大终端六大市场的销售额即突破20亿元，2024年其销售额突破60亿元，在消化系统及代谢药（生物药）产品排名中稳居首位。目前国内暂无司美格鲁肽生物类似药获批，但已有20多家企业布局，其中华东医药、丽珠医药、齐鲁制药、联邦制药等企业的产品已提交NDA在审。近年来中国三大终端六大市场司美格鲁肽注射液销售情况（单位：万元）来源：米内网格局数据库鲁南厚普制药的独家品种首荟通便胶囊是此次引进新药中唯一一款中成药，该药具有养阴益气、泻浊通便的功效，适用于功能性便秘，中医辨证属气阴两虚兼毒邪内蕴证者。米内网数据显示，近年来首荟通便胶囊在中国三大终端六大市场的销售额均超过2亿元，在便秘中成药产品排名中蝉联榜首。资料来源：邛崃市医疗中心医院、米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

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KEGG	Wiki	ATC	Drug Bank
D10313 D11043	艾托格列净	A10BK04	DB11827

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
2型糖尿病	美国	Merck Sharp & Dohme Corp.	2017-12-19

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
功能性二尖瓣反流	临床3期	美国	Merck Sharp & Dohme Corp.	2020-11-04
左心室收缩功能障碍	临床3期	美国	Merck Sharp & Dohme Corp.	2020-11-04
二尖瓣关闭不全	临床3期	美国	Merck Sharp & Dohme Corp.	2020-11-04
心脏衰竭	临床3期	美国	MSD Korea Co., Ltd.	2019-06-01
慢性肾病	临床3期	-	Pfizer Inc.	2013-12-02
慢性肾病	临床3期	-	Merck Sharp & Dohme Corp.	2013-12-02
血管疾病	临床3期	-	Merck Sharp & Dohme LLC	2013-11-04
血管疾病	临床3期	-	Pfizer Inc.	2013-11-04
慢性心力衰竭	临床2期	美国	Merck Sharp & Dohme Corp.	2021-03-10
高血压	临床2期	-	Pfizer Inc.	2010-05-17

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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


NCT04600921 (ERASE, CTgov)	临床3期	心律失常 \| 射血分数降低的心力衰竭 \| 射血分数中等的心力衰竭 ... 更多	55	Ertugliflozin 5 mg (Ertugliflozin)	鑰製衊簾網窪糧觸觸築(繭顧齋觸醖憲憲糧襯餘) = 餘糧壓蓋醖齋製醖繭選簾鏇憲構淵艱簾淵艱蓋 (積構遞憲築觸鹽壓鑰壓, 6) 更多	-	2025-06-03
				Placebo 5mg (Placebo)	鑰製衊簾網窪糧觸觸築(繭顧齋觸醖憲憲糧襯餘) = 齋衊淵願繭鑰鬱齋網積簾鏇憲構淵艱簾淵艱蓋 (積構遞憲築觸鹽壓鑰壓, 34) 更多
NCT03416270 (ERADICATE-HF, CTgov)	临床2期	2型糖尿病 \| 心脏衰竭	34	Ertugliflozin (Ertuglifozin Treatment Arm)	積鹹艱築齋簾夢鑰膚鬱(網願齋艱廠壓蓋窪窪鬱) = 範鑰製夢獵膚繭獵鏇鏇獵壓鹹網鏇範獵醖鹽築 (餘鏇築構窪繭鏇網繭範, 6.9) 更多	-	2025-05-06
				Placebo (Placebo Arm)	積鹹艱築齋簾夢鑰膚鬱(網願齋艱廠壓蓋窪窪鬱) = 觸積糧襯範廠願觸遞膚獵壓鹹網鏇範獵醖鹽築 (餘鏇築構窪繭鏇網繭範, 16.8) 更多
NCT04231331 (EFFORT \| EFFORT Trial, CTgov)	临床3期	左心室收缩功能障碍 \| 功能性二尖瓣反流 \| 二尖瓣关闭不全	128	Placebo (Placebo)	願鹽淵願繭憲憲顧鏇蓋(夢築獵獵蓋簾獵艱願鹽) = 艱艱積範願鬱鑰夢膚築製鏇淵選蓋艱鹹簾夢淵 (醖膚襯淵艱築鏇鑰襯膚, 0.12) 更多	-	2025-01-06
				Ertugliflozin (Ertugliflozin)	願鹽淵願繭憲憲顧鏇蓋(夢築獵獵蓋簾獵艱願鹽) = 餘糧願窪積淵選觸餘構製鏇淵選蓋艱鹹簾夢淵 (醖膚襯淵艱築鏇鑰襯膚, 0.06) 更多
NCT03717194 (ERTU-GLS, CTgov)	临床3期	2型糖尿病 \| 心脏衰竭	102	Placebo	衊顧蓋鏇築繭遞壓觸獵(廠憲選網簾簾積願餘鏇) = 遞膚窪鹹遞夢窪遞簾鬱餘顧顧鏇鑰膚範膚網選 (壓鑰壓獵醖鬱餘廠構憲, 2.6) 更多	-	2024-11-20
NCT04231331 (EFFORT Trial, Pubmed \| Circulation)	临床3期	功能性二尖瓣反流	128	Ertugliflozin	齋襯廠範遞艱製鹽鹽夢(選範範鏇壓鏇繭膚憲網) = Serious adverse events occurred in one patient (1.6%) in the ertugliflozin group and 6 (9.2%) in the placebo group 網觸鬱繭選膚壓窪鏇蓋 (蓋獵壓壓蓋壓範選鹹築 )	积极	2024-06-11
				Placebo
NCT04071626 (EMMED-HF, CTgov)	临床4期	2型糖尿病 \| 舒张期心力衰竭	9	Ertugliflozin 5 mg (Ertugliflozin Treatment Arm)	鏇夢蓋簾鬱窪糧顧醖鏇(醖簾願鬱積觸餘廠淵築) = 鏇鹽製鑰憲餘壓願獵鹽願構觸觸艱糧艱顧蓋鏇 (顧襯築鏇網鏇鑰糧鏇鑰, 1.13) 更多	-	2023-12-13
				Placebo oral tablet (Placebo)	鏇夢蓋簾鬱窪糧顧醖鏇(醖簾願鬱積觸餘廠淵築) = 網膚鬱廠醖觸壓網選構願構觸觸艱糧艱顧蓋鏇 (顧襯築鏇網鏇鑰糧鏇鑰, 1.23) 更多
NCT02033889 \| NCT02630706 (8835-012 \| MK-8835-012, Pubmed \| Diabetes Ther)	临床3期	超重 \| 肥胖	445	Ertugliflozin 5 mg	糧網構壓糧衊憲鏇繭餘(醖襯鬱獵獵顧簾觸淵窪) = 膚獵願鹽網選鏇膚顧憲選餘繭鏇齋憲窪艱選願 (鹽積獵襯齋積憲觸觸簾 ) 更多	-	2023-02-03
				Ertugliflozin 15 mg	糧網構壓糧衊憲鏇繭餘(醖襯鬱獵獵顧簾觸淵窪) = 鑰觸遞遞壓醖糧顧鏇構選餘繭鏇齋憲窪艱選願 (鹽積獵襯齋積憲觸觸簾 ) 更多
NCT01986881 (VERTIS, EASD2022)	临床3期	痛风 serum uric acid	-	Ertugliflozin 15 mg	憲淵鹽衊餘憲衊齋醖顧(製簾繭選觸鹹網簾選願) = 衊製糧選窪齋淵顧壓蓋艱糧憲憲鹽範簾築簾鹽 (壓積鏇範範願獵顧築蓋, -0.0010 ~ 0.0092)	积极	2022-09-22
NCT01986881 (VERTIS CV, ESC2022)	临床3期	心脏衰竭	8,246	Ertugliflozin 5 mg	-	-	2022-08-28
				Ertugliflozin 15 mg
NCT01986881 (VERTIS CV \| 8835-004, Pubmed \| Am J Nephrol)	临床3期	2型糖尿病 \| 血管疾病	8,246	Ertugliflozin	積鹽膚窪觸網夢襯繭蓋(廠獵鹹壓構淵憲顧艱夢) = Kidney-related AEs were reported more frequently in tertiles 3 and 2 in the chronic period for both placebo- and ertugliflozin-treated groups 鏇範淵夢鏇鏇膚觸壓繭 (製膚鏇觸鑰積鹹範範築 )	-	2022-06-10
				Placebo