A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes

The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.

开始日期2025-01-28

申办/合作机构

Novo Nordisk A/S

NCT06547619

/ Recruiting早期临床1期IIT

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.

开始日期2024-10-01

申办/合作机构

University of Iowa

NCT06532461

/ RecruitingN/AIIT

A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes

More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog

开始日期2024-07-20

申办/合作机构

Steno Diabetes Center A/S

100 项与门冬胰岛素相关的临床结果

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100 项与门冬胰岛素相关的转化医学

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100 项与门冬胰岛素相关的专利（医药）

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693

项与门冬胰岛素相关的文献（医药）

2025-05-01·DIABETES RESEARCH AND CLINICAL PRACTICE

Prescription patterns and the cost of antihyperglycemic drugs in patients with diabetes mellitus in Iran from 2014 to 2019

Article

作者: Mehrizi, Reza ; Aminzade, Zahra ; Shahali, Zahra ; Arab, Maryam ; Daroudi, Rajabali ; Effatpanah, Mohammad ; Karami, Hossein ; Heidari-Foroozan, Mahsa ; Vahdani, Amir Mohammad ; Rezaee, Mehdi ; Nasehi, Mohamad Mehdi ; Ghamkhar, Leila

INTRODUCTION:

Diabetes mellitus (DM) is characterized by high blood glucose levels and abnormalities in metabolism. In 2021, 15.14% of adult Iranians had DM. The purpose of this study is to provide policymakers with actionable insights to enhance resource allocation and improve diabetes care by evaluating the prescription patterns and costs of antidiabetic medications in Iran from 2014 to 2019 in 2.5 million patients.

METHODS:

This descriptive-analytical study used data from Iran's Health Insurance prescriptions database, analyzing approximately 2.5 million diabetic patients from 2014 to 2019. Data included drug types, frequencies, costs, and patient demographics.

RESULTS:

The analysis covered 20,233,608 prescriptions. Biguanides, sulfonylureas, and Insulin were the most commonly prescribed medications. Moreover, the 40-64 age group had the highest cost. Prescription patterns varied by age, with insulin in younger patients and Metformin in older ones. General practitioners, internal medicine specialists, and endocrinologists were the primary prescribers of anti-diabetic medications. Insulin Aspart incurred the highest costs, followed by Insulin glargine and metformin. The cost of females' antidiabetic medications was 1.66 times higher than those of males.

CONCLUSION:

Insulin was the primary cost driver for antihyperglycemic medications. These cost disparities and variations in prescription patterns underscore the need for targeted interventions to improve diabetes care and manage resources effectively.

2025-03-01·Endocrine Practice

Comparing Postprandial Glycemic Control Using Fiasp vs Insulin Aspart in Hospitalized Patients With Type 2 Diabetes

Article

作者: Reddy, Niyoti ; Steenkamp, Devin W ; Alexanian, Sara M ; Malik, Aamir ; Cheney, Michael C ; Murati, Jonila ; Spartano, Nicole L ; Bello-Ramos, Jenny C ; Wolpert, Howard A

OBJECTIVE:

Hyperglycemia in hospitalized patients is associated with increased morbidity and mortality. Basal-bolus insulin therapy is the treatment of choice for most patients. The efficacy of an ultrarapid vs rapid-acting insulin in hospitalized patients with diabetes has not been evaluated. We assessed noninferiority in efficacy and safety of Fiasp vs aspart (Novolog) as part of a basal-bolus insulin regimen in noncritically ill patients with type 2 diabetes in a safety-net hospital.

METHODS:

This prospective, open-label, randomized trial included 137 patients with diabetes admitted to a non-intensive care unit setting. Subjects were treated with glargine at bedtime and either Fiasp or Novolog for prandial and correction insulin. Subjects were enrolled for a minimum of 4 or maximum of 6 meal boluses. Capillary blood glucose was used for insulin adjustment and a blinded Dexcom G6 Pro captured data for study analysis. The primary endpoint was time spent in sensor glucose range 100-180 mg/dL in the 4-hour postprandial period (assessed among 106 participants with ≥ 4 meals with a 4-hour postprandial period). Time spent in hypoglycemic ranges (<70, <54, <40 mg/dL) was assessed for safety.

RESULTS:

Four-hour postprandial time in range 100-180 mg/dL was 45% in the Fiasp group vs 36% in the Novolog group (P = .012; meeting prespecified noninferiority criteria). Other glycemic metrics were similar between groups with no difference in time spent in hypoglycemic ranges.

CONCLUSION:

Fiasp provides noninferior postprandial glucose control in hospitalized patients with type 2 diabetes when compared to Novolog with no increase in rates of hypoglycemia.

2025-03-01·Indian journal of pediatrics

Effect of Postmeal Fast-Acting Insulin Aspart Injection on the Frequency of Hypoglycemia among Pre-School Children with Type 1 Diabetes: An Open-Label, Cross-Over, Randomized Control Trial

Article

作者: Kumar, Rakesh ; Dayal, Devi ; Pattanaik, Smita ; Yadav, Jaivinder ; Patil, Amol ; Yadav, Arti

OBJECTIVES:

To study the effect of postmeal Fast-acting insulin Aspart (Fiasp^®) on the frequency of hypoglycemia compared to premeal injection among preschool children with type 1 diabetes.

METHODS:

A single-center trial was conducted among 65 pre-school children (6 mo to 6 y) with Type 1 diabetes for at least 6 mo, on multiple daily insulin injections. Children were randomized to receive their meal bolus postmeal or premeal for the first 3 mo, followed by cross-over at 3 mo. The two groups were compared at the end of 6 mo for the change in frequency of hypoglycemia and hyperglycemia, HbA1c, glycemic variability, and parental satisfaction. Ten children (5 in each group) underwent pharmacokinetic studies. The trial was approved by Institutional Ethics Committee and registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.

RESULTS:

Fifty-four children completed the study, with 27 children in each group. There were no significant differences in the frequency of clinical (p = 0.921), severe (p = 0.167) or serious (p = 0.753) hypoglycemia in the two groups. There were no differences in secondary outcome parameters and pharmacokinetics.

CONCLUSIONS:

The premeal or postmeal injection of Fiasp^® does not affect the frequency of hypoglycemia or other glycemic control parameters among pre-school children with Type 1 diabetes.

TRIAL REGISTRATION:

The trial is registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.

206

项与门冬胰岛素相关的新闻（医药）

2025-04-08

·Endpoints

Novo Nordisk, HHS clash over ‘negotiation-eligible’ drugs in IRA appeals fight

Novo Nordisk focused on a unique argument in federal appeals court on Tuesday in a case that will consider the extent to which the judiciary can review which drugs HHS says are eligible for Medicare negotiation. The drugmaker is one of several companies to sue the federal government over price negotiations under the Inflation Reduction Act. But unlike other cases, Novo is challenging CMS’ decision to group together its NovoLog and Fiasp insulin products as one drug. Novo argued before the US Court of Appeals for the Third Circuit that the agency picked more “negotiation-eligible” drugs than prescribed under the statute. “This is really the first appeal that is going to squarely get into this issue about what it means to select certain drugs for the negotiation process,” Zachary Baron, director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute, told Endpoints News ahead of the hearing. The second round of Medicare negotiations under the IRA kicked off in earnest last month. Novo’s lawsuit concerns the first round of negotiations which concluded last year. The IRA called for the selection of “10 negotiation-eligible drugs” for the first round, but Novo alleged that CMS actually selected “more than 15 products in total.” In doing so, Novo has argued that CMS has “unlawfully rewritten the statute’s express numerical limits.” “The agency has violated the 10-drug limit in the statute,” Ashley Parrish, counsel for Novo Nordisk and an attorney at King & Spalding, said during oral arguments on Tuesday. Meanwhile, CMS has argued that the law directs it to consider data “across dosage forms and strengths of [a] drug, including new formulations of the drug,” when determining whether it qualifies for negotiation. Attorneys for the agency also said in a December court brief that a federal district court “correctly concluded that it lacked jurisdiction to review Novo’s statutory claims.” Department of Justice attorney Lindsey Powell, who represented the government on Tuesday, said the statute “tells us that that determination made by CMS, the determination of what is a negotiation eligible drug, is not subject to judicial review. That bar is quite clear in terms of its scope.” Novo recently argued that the government has “again defied” the law’s text by grouping its popular weight loss and diabetes products Ozempic, Wegovy and Rybelsus for the next cycle. The company asked the appellate court in January for an expedited decision to “clarify Novo Nordisk’s rights and CMS’s authority under the IRA.” The US Court of Appeals for the Second Circuit heard Boehringer Ingelheim’s case against the IRA’s drug pricing provisions last week. The Third Circuit heard cases from Bristol Myers Squibb, AstraZeneca and Johnson & Johnson last fall.

2025-04-07

·药智网

糖尿病药物市场风云

2025年糖尿病药物市场暗流涌动！GLP-1类药物持续领跑，SGLT2抑制剂竞争白热化，胰岛素赛道加速洗牌。扬子江药业、甘李药业凭仿制药抢占市场，恒瑞医药、东阳光药则以1类新药剑指技术高地。从口服DPP-4抑制剂到双靶点疗法，国产药企如何突破外资垄断？注：本文仅作信息交流之目的，文中观点不代表药智网立场，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。1竞争激烈在全球范围内，糖尿病已成为一种极为普遍的慢性疾病，给患者的健康和生活质量带来了严重影响。随着糖尿病患者数量的不断攀升，糖尿病药物市场也在持续扩张，呈现出蓬勃发展的态势。当前，糖尿病药物市场逐渐形成了GLP-1、SGLT2、胰岛素“三足鼎立”的竞争格局，这三类药物在市场上各显神通，为糖尿病患者提供了多样化的治疗选择，也为药企带来了新的发展机遇和挑战。在市场表现上，GLP-1类药物成绩斐然。其中利拉鲁肽是其中的佼佼者。近年来，利拉鲁肽的国产化进程不断加速，联邦制药的利拉鲁肽注射液获批，标志着国产利拉鲁肽在市场上迈出了重要一步。联邦制药表示，围绕GLP-1靶点，公司已布局创新药和生物类似药相结合的差异化产品管线，有助于提升公司在生物医药领域市场竞争力。在长效剂型布局方面，银诺医药的依苏帕格鲁肽α注射液获批上市，这是一种长效胰高血糖素样肽-1受体激动剂（GLP-1RA），是人胰高血糖素样肽-1（GLP-1）与人免疫球蛋白G2（IgG2）的Fc片段融合形成的重组蛋白，可以血糖依赖性地增加胰岛素分泌，抑制胰高血糖素释放，用于2型糖尿病的治疗。其长效的特性能够减少患者的注射次数，提高用药的依从性，为患者带来了极大的便利，也进一步丰富了GLP-1类药物的产品线。SGLT2（钠-葡萄糖协同转运蛋白2）抑制剂是另一类重要的糖尿病治疗药物，长期使用还可以增加热量的排泄，对于糖尿病患者有减重的作用。在市场上，SGLT2抑制剂表现出了较高的热度，其中达格列净片的年销售额超过10亿元，成为该类药物中的畅销产品。然而，随着越来越多药企的涌入，SGLT2抑制剂市场逐渐陷入了激烈的竞争之中。目前，已有20多家药企参与到SGLT2抑制剂的市场竞争中，市场呈现出一片混战的局面。为了争夺市场份额，企业之间的价格战一触即发，这在一定程度上影响了市场的竞争格局，也给患者带来了更多的价格选择空间。在集采政策的推动下，胰岛素市场发生了显著的变化。以甘精胰岛素、赖脯胰岛素、门冬胰岛素为代表的产品，通过集采成功突围，实现了以价换量的目标。甘李药业在胰岛素集采中，多款产品高顺位中标，产品销量大幅增长，市场份额显著提升。在集采带来市场份额变化的同时，长效类似物成为胰岛素市场的新战场。长效胰岛素类似物能够提供更稳定的血糖控制，减少注射次数，提高患者的生活质量，因此受到了市场的广泛关注。众多药企纷纷布局长效类似物领域，加大研发投入，力求在这个新的市场领域中占据一席之地，这也推动了胰岛素产品的不断创新和升级。2国产仿制药“围剿”面对外资药企在糖尿病药物市场的强势地位，国内药企积极布局，通过差异化竞争策略，试图打破垄断，分一杯羹。扬子江南京海陵药业、甘李药业、华领医药等国内企业的相关产品，在市场上逐渐崭露头角。扬子江药业的利拉鲁肽，作为GLP-1受体激动剂，与司美格鲁肽同属一类药物，但在产品特性和市场定位上存在差异。利拉鲁肽通过在天然GLP-1的第26位赖氨酸上增加一个含十六碳的棕榈酸侧链，增加对白蛋白的亲和力，同时由精氨酸取代第34位赖氨酸，提高侧链的稳定性，将药物在体内的半衰期延长至13小时，实现每天只需注射一次。甘李药业的门冬胰岛素，属于胰岛素类似物，与传统胰岛素相比，门冬胰岛素具有更快的起效速度和更短的作用时间，能够更好地模拟生理性胰岛素分泌，有效控制餐后血糖高峰，减少低血糖风险。甘李药业通过不断优化生产工艺，降低生产成本，提高产品性价比，以价格优势吸引患者。华领医药的多格列艾汀片，是全球首创新药葡萄糖激酶激活剂（GKA）。它通过修复2型糖尿病患者血糖传感器葡萄糖激酶（GK）的功能，重塑人体血糖稳态，从根本上治疗糖尿病，为糖尿病患者提供了一种全新的治疗机制。多格列艾汀片不仅可以单药治疗，还能与其他降糖药物联合使用，具有更广泛的适用人群。随着司美格鲁肽市场火爆，其国产化进程备受关注。杭州九源基因、丽珠集团新北江制药等多家国内药企布局司美格鲁肽生物类似药研发，展开仿制暗战。九源基因的司美格鲁肽注射液生物类似药上市申请已获CDE受理，有望首家获批上市。其自2005年起研发GLP-1R激动剂类药物，针对肥胖症及超重适应症已获批临床，筹备Ⅲ期试验，口服司美格鲁肽生物类似药处于临床前研究阶段，上市后或凭价格与地缘优势挑战原研药。丽珠集团新北江制药的司美格鲁肽注射液生物类似药国内BLA申请也已获受理，申报适应症为成人2型糖尿病血糖控制及降低心血管疾病风险，体重管理适应症临床试验已获批，正加大研发投入力求占得市场份额。此外，齐鲁制药、珠海联邦生物医药等超20家企业获批临床参与研发，司美格鲁肽“国产化”进程进入倒计时。国产司美格鲁肽上市有望打破外资垄断，降低患者用药成本，为糖尿病患者提供更多治疗选择。3恒瑞医药、东阳光药押注1类新药恒瑞医药、东阳光药等药企领衔的1类新药矩阵强势崛起，为糖尿病患者带来了新的希望和更有效的治疗选择。恒瑞医药的舒地胰岛素注射液申报上市，引起了业内的广泛关注。作为国内首款自主研发的长效胰岛素类似物，舒地胰岛素基于desB30人胰岛素设计并对其B29位赖氨酸进行侧链修饰而成，具备起效平稳、药效维持时间长和产生夜间性低血糖风险低等优点。其申报上市主要基于两项关键III期临床试验（301研究和302研究）的积极结果。两项研究结果均表明，在联合或不联合口服降糖药条件下，舒地胰岛素治疗26周后糖化血红蛋白（HbA1c）相对基线变化非劣于甘精胰岛素，且舒地胰岛素组在T2DM患者中安全性、耐受性良好，其不良事件性质与甘精胰岛素相似，低血糖事件和夜间低血糖事件略低于甘精胰岛素组，两项研究均达到了主要研究终点。目前全球范围内已有同类产品获批上市，如诺和诺德的德谷胰岛素和赛诺菲的甘精胰岛素。舒地胰岛素的出现，将打破国外产品在长效胰岛素市场的垄断格局，为国内糖尿病患者提供更多的选择，有望凭借其独特的优势在市场中占据一席之地，与国际产品展开有力竞争，提升国产胰岛素在国际市场的影响力。东阳光药的焦谷氨酸荣格列净胶囊是一款具有创新性的药物，它是一种SGLT2/DPP-4双抑制剂，这种双靶点抑制作用为糖尿病治疗带来了新的思路和方法。通过减少肾脏葡萄糖重吸收、降低肾糖阈，增加尿糖排泄来降低血糖，同时抑制二肽基肽酶-4（DPP-4），减少胰高血糖素样肽-1（GLP-1）的降解，延长其作用时间，促进胰岛素分泌，进一步降低血糖水平。在口服药市场中，焦谷氨酸荣格列净胶囊凭借其双靶点的独特作用机制实现了差异化突围。与传统的单靶点口服降糖药相比，它能够从多个角度对血糖进行调控，具有更好的降糖效果和安全性。目前国内已上市的SGLT2抑制剂包括恩格列净片、达格列净片等，在竞争激烈的口服降糖药市场中，焦谷氨酸荣格列净胶囊以其差异化的优势，为糖尿病患者提供了全新的治疗选择，有望在市场中获得一席之地，推动口服降糖药的创新发展。注：本文仅作信息交流之目的，文中观点不代表药智网立场，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。4结语剔除“司美格鲁肽”光环，糖尿病药物市场的竞争更显本土药企的韧性与野心。从仿制药低价抢市场到1类新药技术突围，恒瑞、东阳光药等企业正以“双靶点”“长效化”“口服剂型”重新定义赛道。然而，GLP-1赛道扎堆、胰岛素集采压价、口服药临床转化风险仍是隐忧。若国产创新药能凭借疗效与成本优势打开医保与基层市场，或将终结外资垄断，引领糖尿病治疗进入“中国定义”时代——这场没有“药王”的战争，每一步都是生死竞速。参考来源：各公司官网；公开资料整理声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

上市批准生物类似药

2025-03-06

·PRNewswire

Biocon Biologics and Civica, Inc. Collaborate to Expand Insulin Aspart Access in the United States

BRIDGEWATER, N.J. and PETERSBURG, Va. and BENGALURU, India, March 6, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), and Civica, Inc. (Civica), a not-for-profit generic drug and pharmaceutical company founded in 2018 to address and resolve life-saving drug shortages and affordability, today announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the United States. Continue Reading Under the terms of the agreement, Biocon Biologics will supply Insulin Aspart drug substance to Civica, Inc., who will use the drug substance to produce Insulin Aspart drug product, a rapid-acting insulin analog, at its manufacturing facility in Petersburg, Virginia. Civica will commercialize the medicine for patients in the United States, after completion of development work and clinical trials. No technology transfer is involved in the agreement. Biocon Biologics and Civica announce agreement to expand access and affordability of Insulin Aspart in the U.S. Post this Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said: "As a fully integrated global biologics company, Biocon Biologics is uniquely positioned to drive commercial success through tailored go-to-market strategies that create lasting value for all stakeholders. Our collaboration with Civica reflects this commitment, enabling us to expand patient access to Insulin Aspart in the United States while reinforcing our dedication to serving the growing needs of people living with diabetes. Together, we are working to ensure more patients have access to high-quality, affordable insulin." Ned McCoy, President and Chief Executive Officer, Civica, Inc., said: "Civica's mission is to help people who need access to necessary generic and biosimilar medicines at affordable prices. This includes people living with diabetes, one in five of whom have skipped, delayed, or used less insulin than was needed to save money. Our partnership with Biocon Biologics for Aspart drug substance supply will allow us to deliver on our important mission and help people who need access to Insulin Aspart. Civica will utilize our U.S.-based manufacturing operations in Petersburg, Virginia to produce prefilled pens and vials of insulin." This collaboration is in addition to Biocon Biologics' own Insulin Aspart Drug Product for the United States which is currently under U.S. Food and Drug Administration (FDA) review. There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic.1 1 U.S. Department of Health & Human Services, Centers for Disease Control and Prevention. "National Diabetes Statistics Report." Accessed: January 28, 2025. Last Reviewed: May 15, 2024. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. About Civica, Inc.: Civica is a non-profit generic pharmaceutical company established in 2018 to address drug shortages. It was founded by a group of U.S. health systems and philanthropies who, after more than a decade of chronic shortages, recognized that the market was not self-correcting and that a different approach is required. Civica works to deliver a safe, stable, and affordable supply of essential medicines to U.S. patients. Civica has built a sterile injectable manufacturing plant in Petersburg, Virginia capable of producing prefilled pens and vials of insulin. Website: Follow us on X (formerly Twitter) @civicarx and LinkedIn: CivicaRx for company updates Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd. 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引进/卖出

100 项与门冬胰岛素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04475	门冬胰岛素	A10AD05 A10AB05	DB01306

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	日本	Novo Nordisk A/S	2019-09-20
糖尿病	欧盟	Novo Nordisk A/S	1999-09-07
糖尿病	冰岛	Novo Nordisk A/S	1999-09-07
糖尿病	列支敦士登	Novo Nordisk A/S	1999-09-07
糖尿病	挪威	Novo Nordisk A/S	1999-09-07

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
肥胖	临床3期	西班牙	Novo Nordisk A/S	2005-04-01
急性淋巴细胞白血病	临床3期	美国	Novo Nordisk A/S	2004-04-01
淋巴母细胞淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
伯基特淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
淋巴瘤	临床3期	美国	Novo Nordisk A/S	2004-04-01
低血糖	临床3期	澳大利亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	克罗地亚	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	丹麦	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	意大利	Novo Nordisk A/S	2001-09-01
低血糖	临床3期	南非	Novo Nordisk A/S	2001-09-01

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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


NCT03659799 (Pubmed)	临床4期	1型糖尿病	40	insulin type (ultra-rapid vs rapid insulin) (Rapid aspart)	積齋膚淵衊壓獵製製鑰(襯壓遞獵鏇艱糧廠艱鏇) = 鑰艱鹹鬱遞夢鹽襯憲範製襯膚簾鏇繭醖衊憲醖 (築艱蓋願鹹衊壓夢夢鏇 )	积极	2024-07-29
				insulin type (ultra-rapid vs rapid insulin) (Exercise at 60 min post meal)	壓網築繭網餘壓憲構膚(鹹齋壓築構蓋鑰繭鹽窪) = 廠遞鹹構鑰構糧餘廠鬱鹽餘願鹹廠築膚艱築淵 (廠鏇簾網構鬱構廠蓋憲, 1.2 ~ 100%)
NCT04538352 (TRANSITION-T2D, CTgov)	临床4期	2型糖尿病	60	Insulin Degludec+semaglutide+Insulin aspart (Once-weekly sc Semaglutide Combined With Once-daily Insulin)	構鏇鑰醖觸壓廠顧齋築(遞衊膚遞鹽窪廠願繭觸) = 網鏇壓範襯膚繭壓鑰繭糧築鹹衊構願顧齋淵窪 (築鑰艱衊蓋襯窪網夢憲, 獵觸築積網襯膚鹽網襯 ~ 鏇構繭窪製鏇鹹遞蓋糧) 更多	-	2024-07-29
				Insulin Degludec+Insulin aspart (MDI Requiring Multiple Daily Injections of Insulin)	構鏇鑰醖觸壓廠顧齋築(遞衊膚遞鹽窪廠願繭觸) = 選築製積顧構淵齋膚醖糧築鹹衊構願顧齋淵窪 (築鑰艱衊蓋襯窪網夢憲, 繭齋顧鹽願繭遞鹽膚繭 ~ 簾鑰觸壓壓鬱艱艱網獵) 更多
820-P (ADA2024)	N/A	1型糖尿病	-	Faster-Acting Insulin Aspart (Fiasp)	廠範網餘餘觸觸襯鹽糧(鬱衊鹹鑰網網觸廠夢齋) = 糧獵憲齋糧淵範衊鬱衊鬱構顧壓餘觸願構築範 (壓窪餘蓋糧積網構淵餘, 12.3) 更多	积极	2024-06-14
				Insulin Aspart (Iasp)	廠範網餘餘觸觸襯鹽糧(鬱衊鹹鑰網網觸廠夢齋) = 獵獵夢遞鏇襯糧顧網鏇鬱構顧壓餘觸願構築範 (壓窪餘蓋糧積網構淵餘, 12.1) 更多
NCT04588259 (CTgov)	临床3期	1型糖尿病 \| 2型糖尿病	331	Insulin degludec+Faster aspart	簾鬱顧網醖艱醖網糧醖(顧鑰構衊鬱願製鹽淵積) = 遞醖選鹽遞鹹顧築構襯觸膚積築鹽醖構繭鑰鏇 (襯壓膚廠鹹餘廠觸鑰獵, 0.63) 更多	-	2024-03-20
NCT04460326 (In-FI, CTgov)	临床3期	2型糖尿病	137	Insulin Glargine+NovoLog (Group 1 Insulin Glargine and Novolog)	衊窪構鬱衊鏇鏇艱鏇構(艱選構遞鏇衊簾製鬱鬱) = 鏇廠憲願願積築構窪鹹醖鑰遞糧糧繭構襯衊窪 (鹹願夢顧選鏇觸窪醖鹽, 29.78) 更多	-	2024-03-19
				Insulin Glargine+Insulin Fiasp (Group 2 Insulin Glargine and Fiasp)	衊窪構鬱衊鏇鏇艱鏇構(艱選構遞鏇衊簾製鬱鬱) = 餘繭製簾簾鹽鬱鏇築選醖鑰遞糧糧繭構襯衊窪 (鹹願夢顧選鏇觸窪醖鹽, 32.63) 更多
NCT00913497 (CTgov)	临床4期	1型糖尿病	16	insulin glulisine (Insulin Glulisine)	選蓋觸膚積製醖廠製壓(鏇淵憲鹹鬱夢範壓顧鹹) = 糧憲窪鹽獵夢積鬱鏇積製鹹網願鹹鏇憲廠鑰觸 (鬱窪鹹淵範願願衊鏇醖, 15.7) 更多	-	2023-09-18
				Insulin Aspart (Insulin Aspart)	選蓋觸膚積製醖廠製壓(鏇淵憲鹹鬱夢範壓顧鹹) = 觸獵鹹願憲餘選壓範範製鹹網願鹹鏇憲廠鑰觸 (鬱窪鹹淵範願願衊鏇醖, 14.7) 更多
NCT04853030 (Pubmed \| Diabetes Technol Ther)	N/A	1型糖尿病	30	Faster Insulin Aspart	襯壓範餘獵鹹簾齋餘廠(壓艱願構顧廠廠顧廠遞) = 膚膚蓋獵獵遞積壓鹽積膚鬱鑰糧鬱網獵淵襯選 (衊艱鏇膚廠糧鬱選顧製 ) 更多	不佳	2023-09-01
				Standard Insulin Aspart	襯壓範餘獵鹹簾齋餘廠(壓艱願構顧廠廠顧廠遞) = 窪遞製遞簾顧鏇鏇製鬱膚鬱鑰糧鬱網獵淵襯選 (衊艱鏇膚廠糧鬱選顧製 ) 更多
NCT03895515 (Pubmed \| Diabetes Ther)	N/A	1型糖尿病	178	Fast-Acting Insulin Aspart	膚蓋夢製衊艱鏇獵壓繭(鏇簾顧積簾糧鹽糧選齋) = 願鑰觸範網獵簾繭築築鹹壓憲膚鹹選鬱願簾糧 (齋艱鹽鹹鑰襯窪糧願觸 )	积极	2023-07-14
CopenFast Trial (ADA2023)	N/A	1型糖尿病	216	Faster-acting insulin aspart	積鬱願鏇蓋製構憲製淵(鹽簾築觸願獵網齋鏇廠) = 鹹窪壓壓窪鏇鬱蓋壓糧遞鑰艱簾襯憲選顧築製 (鏇製鏇願廠簾積淵鏇願, 38 ~ 46) 更多	-	2023-06-20
				Insulin aspart	積鬱願鏇蓋製構憲製淵(鹽簾築觸願獵網齋鏇廠) = 鏇製糧遞窪製選蓋獵鬱遞鑰艱簾襯憲選顧築製 (鏇製鏇願廠簾積淵鏇願, 39 ~ 46) 更多
ADA2023	N/A	-	29	AT247	築網簾繭鑰選衊壓範窪(遞糧艱壓醖糧醖衊鏇繭) = 選簾憲憲齋顧夢鹽願蓋網鬱製壓憲選鑰遞築繭 (鬱鹹鏇積構鹹糧觸憲遞 )	-	2023-06-20
				NovoLog	築網簾繭鑰選衊壓範窪(遞糧艱壓醖糧醖衊鏇繭) = 廠廠網簾夢鬱簾製選鑰網鬱製壓憲選鑰遞築繭 (鬱鹹鏇積構鹹糧觸憲遞, *)