The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.

开始日期2024-10-10

申办/合作机构

Eli Lilly & Co.

NCT06169982

/ Completed临床1期

A Phase 1, Open-Label, Multiple-Dose Study to Investigate Steady-State Pharmacokinetics and Pharmacodynamics During a Euglycemic Clamp of LY3209590 in Participants With Type 2 Diabetes Mellitus

The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.

开始日期2023-12-07

申办/合作机构

Eli Lilly & Co.

NCT05914688

/ Completed临床1期

A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants

The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated.
Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.

开始日期2023-06-26

申办/合作机构

Eli Lilly & Co.

100 项与 Insulin Efsitora Alfa 相关的临床结果

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100 项与 Insulin Efsitora Alfa 相关的转化医学

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100 项与 Insulin Efsitora Alfa 相关的专利（医药）

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项与 Insulin Efsitora Alfa 相关的文献（医药）

2026-07-01·DIABETES OBESITY & METABOLISM

Glycaemic Control According to the Final Insulin Dose Using an Innovative Fixed‐Dose Titration of Weekly Insulin Efsitora in Insulin‐Naïve Type 2 Diabetes

Article

作者: Liebl, Andreas ; Rosenstock, Julio ; Connery, Lisa ; Cheng, Alice Y. Y. ; Child, Christopher J. ; Knights, Alastair ; Davidson, Michael B. ; Rasouli, Neda ; Wang, Qianqian ; Pires, Vitoria

ABSTRACT:

Aims:

In the QWINT‐1 phase 3 Trial, once‐weekly insulin efsitora alfa (efsitora) administered using an innovative fixed‐dose regimen demonstrated noninferior HbA1c reduction versus once‐daily insulin glargine U100 (glargine) over 52 weeks in insulin‐naïve adults with type 2 diabetes. This report focuses on baseline characteristics and clinical outcomes of efsitora‐treated participants based on their insulin dose at Week 52 ( N = 303).

Methods:

Efsitora was dosed using a fixed‐dose titration regimen with 100, 150, 250 and 400 U fixed‐doses titrated as needed every 4 weeks to achieve fasting blood glucose (FBG) of 80–130 mg/dL (4.4–7.2 mmol/L). Participants not at target FBG on the 400 U fixed‐dose after ≥ 4 weeks transitioned to flexible dosing using an efsitora multi‐dose pen. Glargine was administered using a multi‐dose pen and titrated weekly to the same target. Analyses assessed clinical characteristics and glycaemic outcomes by efsitora dose at Week 52, and hypoglycaemia after fixed‐dose increases.

Results:

Participants requiring higher Week 52 efsitora doses had greater baseline weight, HbA1c and fasting glucose, and more were male. Most participants (76%) remained on a fixed efsitora dose, and the majority established their final dose by Week 16. All efsitora fixed‐doses resulted in robust HbA1c lowering, with mean final HbA1c < 7.0%. Based on events within 4‐week periods after an efsitora fixed‐dose increase, estimated rates of combined Level 2 and 3 hypoglycaemia were < 0.5 events/year.

Conclusions:

In QWINT‐1, the innovative fixed‐dose efsitora simple titration resulted in effective HbA1c lowering for all fixed doses. Rates of clinically meaningful hypoglycaemia were low after fixed‐dose increases.

2026-06-01·ARCHIVES OF MICROBIOLOGY

Polydopamine cross-linked Bifidobacterium single cell core-shell system with multi-target regulation to alleviate constipation in mice

Article

作者: Zhao, Xuefen ; Li, Jinping

Bisazolidine (BD) to alleviate constipation by stimulating intestinal nerves and increasing the secretion of water and electrolytes. However, it is prone to cause serious side effects, such as electrolyte imbalance and drug dependence. Bifidobacterium, can alleviate constipation from the root through a series of biological cascade reactions, such as "regulating the flora, promoting acid production, softening feces, and anti-inflammatory repair". But Bifidobacterium has the characteristic of slow onset and mild action, which can't immediately alleviate constipation. Moreover, Bifidobacterium are susceptible to the adverse physiological environment during oral delivery, leading to a reduce in their bioavailability. To effectively relieve constipation and maintain the biological functions of intestinal tissues. In this study, polydopamine (PDA) shell was constructed to encapsulation single Bifidobacterium (PDA@Bif) by taking advantage of the oxidation polymerization property of dopamine. The PDA shell existing on the surface of PDA@Bif not only maintain the biological activity of Bifidobacterium, but also the adhesive property of PDA shell can be used to load BD. Animal experiments confirmed that BD&PDA@Bif can promote the transport of intestinal contents through multi-target regulation, such as repairing the intestinal mucosal barrier, restoring intestinal microecological homeostasis, altering the nature of feces, thereby effectively alleviating constipation.

2026-06-01·Annals of Medicine and Surgery

Efficacy and safety of once-weekly insulin efsitora alfa versus daily basal insulin analogs in type 2 diabetes: a systematic review and meta-analysis

Article

作者: Ud Din, Siraj ; Nawaz, Shayan ; Shahreyar, Muhammad ; Ullah, Gauhar ; Junejo, Rania ; Amir, Rabia ; Ul-Hayya, Ain ; Fatima, Marhaba ; Ahmed, Arsalan ; Khan, Bilal Wazir ; Ullah, Imtiaz ; Shaikh, Rutbaa Ayaz ; Qamar, Abdullah ; Bhattarai, Pratik

Background::

Type 2 diabetes mellitus (T2DM) often progresses to require basal insulin therapy. Despite the efficacy of once-daily basal insulins such as glargine and degludec, daily injections remain a barrier to adherence. Insulin efsitora alfa, a novel once-weekly fragment crystallizable (Fc)-fusion basal insulin, may improve treatment convenience while maintaining glycemic control.

Objective::

To evaluate the efficacy and safety of once-weekly insulin efsitora alfa compared with once-daily basal insulin analogs in adults with T2DM.

Methods::

An updated systematic review and meta-analysis was conducted according to PRISMA 2020 guidelines and registered in PROSPERO (CRD420251118205). PubMed, Embase, and CENTRAL were searched up to 30 July 2025 for randomized controlled trials (RCTs) comparing insulin efsitora alfa with once-daily basal insulins. Pooled analyses were performed using a random-effects model in RevMan 5.4. Risk of bias was assessed with the Cochrane RoB-2 tool, and evidence certainty with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.

Results::

Six RCTs comprising 4115 participants were included. Once-weekly insulin efsitora showed non-inferior HbA1c reduction compared with daily basal insulin (mean difference = −0.04; 95% confidence interval: –0.13 to 0.05; P = 0.35). No significant differences were observed in fasting serum glucose or body weight change. Incidents of level 1, level 2 (clinically significant), and level 3 (severe) hypoglycemia, as well as adverse and serious adverse events, were comparable between groups.

Conclusion::

Once-weekly insulin efsitora alfa demonstrates comparable efficacy and safety to daily basal insulin. However, further large-scale, long-term trials are warranted to confirm its durability, safety, and real-world effectiveness.

项与 Insulin Efsitora Alfa 相关的新闻（医药）

2026-08-21

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本周分享|医药新闻20条

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5三期研究评估更低维持剂量的疗效与安全性。该安慰剂对照试验在美欧招募450名超重或肥胖成人，治疗60周，主要评估减重效果，次要追踪血压、胆固醇等指标。目前口服Wegovy已获批最高25mg维持剂量，起始1.5mg递增。口服Wegovy二季度销售额达32.2亿丹麦克朗（约4.97亿美元），远超礼来竞品Foundayo的9800万美元。部分患者为控制成本或副作用已自行使用微剂量，诺和诺德希望通过该研究为肥胖管理提供更多剂量选择。绿叶制药(02186)拟用于治疗宫颈癌前病变和HPV相关肿瘤的mRNA疫苗LY01620即将开展中国II期临床试验原文标题：绿叶制药(02186)拟用于治疗宫颈癌前病变和HPV相关肿瘤的mRNA疫苗LY01620即将开展中国II期临床试验（新闻来源：新浪财经）原文地址：https://finance.sina.com.cn/stock/hkstock/ggscyd/2026-08-20/doc-ininysmf6661301.shtml 绿叶制药(02186)公告，其自主研发的治疗性mRNA疫苗LY01620即将在中国开展II期临床试验，拟纳入HPV16阳性子宫颈高级别鳞状上皮内病变患者。该疫苗靶向HPV16亚型E6和E7蛋白抗原，通过诱导特异性T细胞免疫清除感染细胞、阻断癌变。I期研究显示，LY01620可激活细胞免疫和体液免疫，HPV病毒清除率近90%，组织病理学改善接近手术水平，且无创不影响生育，安全耐受性良好。该疫苗可应用于HPV感染后不同阶段，有望填补HPV治疗性疫苗空白，公司亦积极探索其在HPV相关实体肿瘤中的应用。投资交易 Kynexis获9700万欧元推进精神分裂症认知药物原文标题：Kynexis pockets €97m to advance cognition-focused schizophrenia drug（新闻来源：Pharmaceutical Technology）原文地址：https://www.pharmaceutical-technology.com/news/kynexis-97m-cognitive-focused-schizophrenia-drug-progression/ 荷兰生物技术公司Kynexis完成9700万欧元A轮扩展融资，由诺华风投和Forbion等支持，用于推进其口服first-in-class候选药KYN-5356的中后期开发。该药为KAT-II抑制剂，针对目前无获批疗法的精神分裂症相关认知障碍（CIAS），约影响80%患者且大多未确诊。资金将支持其美国II期研究收尾及注册性试验筹备，顶线结果预计2026年底公布，并探索阿尔茨海默病等适应症。该领域还有BMS旗下Karuna的Cobenfy、Orzyon的vafidemstat等药物在研。礼来与Amplitude合作开发RNA疫苗平台原文标题：Lilly pens deal with Gateway Labs alumni Amplitude for RNA vaccine platform for infectious disease（新闻来源：Fiercebiotech）原文地址：https://www.fiercebiotech.com/biotech/lilly-licenses-amplitudes-rna-vaccine-platform-infectious-disease 礼来与Gateway Labs入驻企业Amplitude Therapeutics达成合作，开发trans-amplifying RNA（taRNA）传染病疫苗，初期聚焦高未满足需求项目，礼来可选择增加最多两个靶点。Amplitude的taRNA平台由复制酶和抗原编码RNA组成，旨在提升效力、降低剂量并改善可制造性，Amplitude负责优化及部分临床前研究，礼来负责后续开发至临床。此次合作紧随礼来5月以2.02亿美元收购Engage Biologics及38亿美元收购Curevo等三家企业。安进终止5亿美元以上克罗恩病合作不影响TScan管线原文标题：Amgen abandoning $500M+ Crohn’s collab won’t derail TScan’s pipeline strategy（新闻来源：Fiercebiotech）原文地址：https://www.fiercebiotech.com/biotech/amgen-abandons-500m-inflammation-team-tscan-therapeutics TScan Therapeutics表示，尽管安进终止了价值最高5亿美元的克罗恩病合作项目，其管线策略保持不变。安进于2023年支付3000万美元预付款利用TScan的TargetScan平台进行靶点发现，但经战略审查后决定退出，合作将于11月终止。TScan称该终止不影响其自有管线，公司核心聚焦血液肿瘤和实体瘤，领先TCR-T候选药物刚进入急性髓系白血病和骨髓增生异常综合征的III期试验。TScan于2025年11月裁员30%，截至6月底持有约1亿美元现金，可维持运营至明年第二季度。产业动态为何儿科罕见肿瘤在波动的生物技术市场中表现优异原文标题：Why pediatric rare oncology outperforms in a volatile biotech market（新闻来源：Biospace）原文地址：https://www.biospace.com/drug-development/opinion-why-pediatric-rare-oncology-outperforms-in-a-volatile-biotech-market 尽管资本市场持续谨慎，儿科罕见癌症仍持续吸引投资。OS Therapies CEO称，真正进步在于未满足需求最大、患者影响可清晰衡量的领域。罕见儿科肿瘤因治疗选择有限、生存率低，但具备明确生物学依据和可衡量临床获益而受青睐。FDA通过孤儿药、快速通道、突破性疗法及RMAT认定支持该领域，罕见儿科疾病优先审评券项目近期获国会续期，涉及超40亿美元再投资。投资者更关注严谨试验设计、早期监管沟通和有意义的患者结局。在激励合理、科学与未满足需求结合时，即使在不确定市场中，该领域仍有望取得实质性进展。勃林格殷格翰在罕见病声誉排名中再次上升原文标题：Boehringer Ingelheim again rises up rare disease reputation rankings（新闻来源：Fiercepharma）原文地址：https://www.fiercepharma.com/marketing/boehringer-ingelheim-again-rises-rare-disease-reputation-rankings PatientView对502家罕见病患者组织的调查显示，勃林格殷格翰排名再升4位，延续去年上升7位的势头，但仍未跻身前三，Sobi、罗氏和BioMarin继续占据前三甲。在患者组织合作企业排名中，勃林格位列第三，大型药企熟悉度和合作排名均居第二，仅次于罗氏，其中合作排名上升6位将阿斯利康挤至第三。Viatris上升17位，Alnylam上升6位。患者组织对制药行业整体看法改善至2022年以来最佳，临床数据、定价及外部资助透明度有所提升，但定价透明度仍是短板，2024年仅16%认为良好。Akiram与ITM签署镥-177供应协议原文标题：Akiram, ITM sign Lutetium-177 supply agreement（新闻来源：Biospace）原文地址：https://www.biospace.com/fda/regeneron-wins-fda-approval-to-challenge-ipsen-for-rare-bone-disease-market 瑞典临床阶段生物技术公司Akiram Therapeutics与放射性药物企业ITM签署供应协议，ITM将为其提供非载体添加镥-177（n.c.a. Lu-177），以支持其first-in-class候选药物177Lu-AKIR001的临床开发。AKIR001是一种靶向CD44v6的抗体-放射性核素偶联物，目前正在斯德哥尔摩卡罗林斯卡大学医院开展I期临床试验，评估其对不可切除或转移性CD44v6阳性实体瘤（包括肺癌、头颈癌、甲状腺癌及妇科癌症）的疗效与安全性，并已在今年早些时候进入第三剂量递增队列。该合作旨在确保AKIR001关键放射性成分的稳定供应。值得注意的是，ITM此前刚收到FDA就其ITM-11新药申请发出的完整回复函，指出其化学、制造和控制方面存在缺陷。ARPA-H向西门子医疗提供3110万美元资助原文标题：$31.1m ARPA-H funding for Siemens endovascular robotics（新闻来源：Pharmaphorum）原文地址：https://pharmaphorum.com/news/311m-arpa-h-funding-siemens-endovascular-robotics 美国高级健康研究计划局（ARPA-H）宣布向西门子医疗提供最高3110万美元、为期五年的资助，以加速自主远程血管内机器人技术的开发，重点用于急性缺血性卒中的机械取栓治疗。机械取栓是通过微创方式移除脑部血栓、恢复血流的手术，及时实施可显著改善患者预后，但目前美国超半数人口距具备取栓能力的诊所超过一小时，仅约12%符合条件的患者能接受该手术。西门子医疗将额外投入540万美元，使总投资达3650万美元，Stryker作为子承授方参与合作，旨在让机器人能够在无直接人工操作的情况下远程完成手术，扩大卒中治疗可及性。SK与MSN就Xcopri仿制药达成和解原文标题：SK strikes settlement with MSN over future Xcopri generic: reports（新闻来源：Fiercepharma）原文地址：https://www.fiercepharma.com/pharma/sk-strikes-patent-infringement-settlement-msn-over-future-blockbuster-xcopri 韩国SK Biopharmaceuticals与印度仿制药企MSN就癫痫药Xcopri专利诉讼达成首次和解，使其市场独占期延至2032年10月原始专利到期之后，涉及后续专利，条款保密。SK于2024年11月对MSN提起诉讼，此前还向Aurobindo和Zydus提起类似诉讼。Xcopri是SK主要收入来源，2019年获FDA批准用于成人部分性发作，去年销售额达7070亿韩元（约4.8亿美元）同比增长29%，本季度增长40%，SK希望基于III期结果将适应症扩展至原发性全身性强直-阵挛发作。Aurobindo子公司与中国API生产商收到FDA警告信原文标题：Aurobindo unit, China API maker dinged in latest round of FDA warning letters（新闻来源：Fiercepharma）原文地址：https://www.fiercepharma.com/pharma/aurobindo-unit-china-api-maker-dinged-latest-round-fda-warning-letters 印度Aurobindo旗下Eugia单位及中国天津Kilo Pharmaceutical Sci-Tech双双收到FDA警告信。Eugia因海得拉巴工厂无菌生产线屏障不足、操作人员频繁手动干预及环境监控不力被点名，FDA认为其整改措施不充分，并指出该单位近期多个设施均存在类似CGMP违规，管理监督不足。Kilo则因未正确注册拟在美分销产品、工艺不可重现、向复方药房分销开发中API、未准备主生产记录及测试验证缺失等问题被警告，其两款药品还登记在其他公司名下，FDA表示若不整改将继续拒绝其产品入境。政策支持 CDE将启动细胞与基因治疗药品“先锐计划” 原文标题：CDE将启动细胞与基因治疗药品“先锐计划”（新闻来源：新浪财经）原文地址：https://finance.sina.com.cn/jjxw/2026-08-20/doc-ininysmk1834694.shtml 国家药监局药品审评中心8月19日发布通知，就细胞与基因治疗药品"先锐计划"相关工作文件公开征求意见一个月。该计划旨在优化CGT药品审评审批模式，加大研发指导力度，提高研发质量和效率，推动药品尽早上市。适用范围包括具有新靶点新机制的创新药（用于严重危及生命、重大慢性或遗传性疾病，且已有数据提示潜在获益或具有明显临床优势）以及已上市药品生产工艺优化的重大变更。该计划每年最多纳入15个药品，纳入后除按现行法规实施外，还将享有沟通交流、受理靠前服务及上市后变更审评时限等支持举措。前沿发现生物医学的复兴：人脑类器官建模发育五年原文标题：A ‘renaissance for biomedicine’: human brain organoids model development for 5 years（新闻来源：Fiercebiotech）原文地址：https://www.fiercebiotech.com/research/renaissance-biomedicine-human-brain-organoids-model-development-5-years 哈佛大学研究团队8月19日在Nature发文，展示从血液干细胞培育的脑类器官可在培养皿中存活五年并记录时间推移，其转录组和表观基因组变化与人类出生后大脑发育一致，并发育出对高级思维至关重要的兴奋性神经元。研究负责人Paola Arlotta称这类"大脑化身"是患者的还原性组织复制品，可用于预测疾病特征和药物反应。该突破有望推动疾病机制研究和疗法开发。值得注意的是，FDA已于2025年4月发布路线图，优先采用类器官等新方法减少动物实验、加速药物上市。AI驱动的药物-靶点相互作用预测迈向现实工作流原文标题：AI-driven drug-target interaction prediction moves toward real-world workflows（新闻来源：The Medical News）原文地址：https://www.news-medical.net/news/20260820/AI-driven-drug-target-interaction-prediction-moves-toward-real-world-workflows.aspx 药物-靶点相互作用预测有助于解释作用机制和药物重定位，但面临结构覆盖不均、阴性样本稀缺、标签不一致等挑战。北京邮电大学和济南国家超级计算中心研究人员发表的综述指出，该领域需建立标准化数据集、现实评估和实验可验证框架，梳理了传统机器学习、深度学习和多模态模型三阶段技术发展，强调随机数据分割可能夸大性能，需采用跨分布和冷启动等更现实评估。作者认为AI应作为决策辅助而非实验替代，预测需说明证据来源并生成可测试假设，未来有望通过生物医学基础模型整合文献和验证设计，缩短大规模搜索到实验验证的路径。研究人员利用大规模模拟绘制DNA物理密码原文标题：Researchers map DNA's physical code using large-scale simulations（新闻来源：The Medical News）原文地址：https://www.news-medical.net/news/20260820/Researchers-map-DNAs-physical-code-using-large-scale-simulations.aspx 国际研究团队通过原子级分子动力学模拟，大规模研究了DNA的"物理密码"——即DNA序列决定的形状、柔韧性和动态性如何影响基因表达。研究发现，DNA的物理特性决定其与调控蛋白的相互作用，更易弯曲或重组的区域更易被蛋白访问，而僵硬或紧密包装的区域则更难触及。团队分析了4096种六核苷酸组合，发现进化倾向于保留对DNA物理特性影响最小的突变。该研究创建了大型公开数据集，不仅深化了对DNA基本特性的理解，也为药物发现、疾病机制研究和AI在生物学中的应用提供了新基础。SandboxAQ推出AQPotency虚拟药物筛选工具原文标题：SandboxAQ introduces AQPotency for virtual drug screening（新闻来源：Pharmaceutical Technology）原文地址：https://www.pharmaceutical-technology.com/news/sandboxaq-aqpotency-virtual-drug-screening/ 美国SandboxAQ发布大型定量模型AQPotency，可在无需解析蛋白质结构的情况下虚拟筛选和预测药物候选分子的潜力。该工具通过Claude MCP协议、公司官网及Google Cloud Marketplace提供，能在数秒内利用标准计算资源对分子-靶点相互作用进行排序和活性预测，并附带置信度评估，同时支持反向分析以识别化合物可能作用的蛋白靶点。与传统依赖三维结构的方法不同，AQPotency可拓展至结构未知的靶点，目前已应用于八个客户项目并获得实验验证。研究人员开发定制电子皮肤用于先进假肢传感原文标题：Researchers develop custom electronic skin for advanced prosthetic sensing（新闻来源：The Medical News）原文地址：https://www.news-medical.net/news/20260820/Researchers-develop-custom-electronic-skin-for-advanced-prosthetic-sensing.aspx 华盛顿州立大学研究人员开发了一种新型电子皮肤传感系统，可检测压力和温度，感知精度达现有商用传感器的10倍。该系统采用"扫描-建模-打印"制造方法，传感器模块可像乐高一样拼接，无需粘合剂，能贴合假肢自由形状，实现无缝覆盖。研究发表于Cell Reports Physical Science，团队表示该方法成本较低且便于临床推广，为兼具传感和触觉刺激功能的仿生皮肤奠定基础。研究人员正在开发执行器，将传感信号转换为神经刺激，帮助截肢者感知触摸，未来有望改善截肢者的生活质量。免责声明：本公众号仅用作信息分享，资料收集整理来自互联网；无任何商业用途；转载文章会标注来源和作者，如不希望被转载，请联系予以删除。

优先审批临床3期基因疗法申请上市

2026-08-21

·Pharmaceutical Technology

Eli Lilly’s weekly insulin jab Onswik set for NHS use if approved

The jab’s availability will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. Credit: Halfpoint/Shutterstock.com. The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Eli Lilly’s Onswik (efsitora alfa) in a move that opens the insulin jab up for national coverage, subject to marketing authorisation. Lilly’s Onswik is a pre-filled injection pen containing insulin that only needs administering once a week. Its availability marks a big advancement for type 2 diabetic patients who rely on daily insulin injections, with initial forecasts that a switch to Lilly’s product could cut the number of injections each patient needs by 85%. It will especially help those who usually need help with their injections, such as older people, patients with learning disabilities, and those with limited hand movement. While the recommendation means Onswik will be covered on England’s National Health Service (NHS), an approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) still needs to arrive first for the product to be available. A UK marketing authorisation is largely expected given the pre-emptive NICE recommendation. Onswik already secured a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2026, signifying a welcome sentiment with regulators so far. NICE based its decision on data from Lilly’s Phase III QWINT programme. Results demonstrated that Onswik controls blood glucose levels as well as two widely used long-acting insulins, insulin degludec and insulin glargine, which are taken to keep blood sugar steady throughout the day. It means people switching to the weekly injection can expect similar blood glucose control to their current treatment, NICE said. Type 2 diabetes is a common condition where the body cannot make enough of a hormone called insulin, or the insulin it makes does not work properly. Administering insulin helps the body better regulate glycaemic levels. Helen Knight, director of medicines evaluation at NICE, said: “Moving from daily injections to a single weekly dose could make a real difference to the day-to-day lives of people with type 2 diabetes, especially those who rely on a carer, family member or healthcare professional to help them inject. This recommendation is the result of rigorous, evidence-based decision making, striking a balance between the benefits to patients and the best use of limited NHS funding.” The relatively straightforward decision for Onswik contrasts a rockier UK reimbursement journey for Lilly’s Alzheimer’s therapy Kisunla (donanemab). In June 2025, NICE rejected NHS use of the drug based on the narrow window of clinical benefits. Lilly appealed the decision, with NICE referring the review back to its appraisal committee in March 2026. The UK’s reimbursement landscape has caused friction with other drugmakers recently. Bristol Myers Squibb (BMS) aligned UK and US prices for schizophrenia treatment Cobenfy, even threatening to walk away from the UK market if NICE did not recognise the drug’s clinical value. Separately, AstraZeneca and MSD have previously halted investment for UK expansion plans in the past year, criticising an unwelcoming and uncompetitive pharmaceutical environment. Given the size of the patient population for insulin products, NICE’s nod for Onswik will be a welcome one for drugmakers. Regardless, insulin represents a product that is far more accessible in the UK than the US. According to research , US prices for insulin products were nearly ten times as high as prices in 33 OECD comparison countries in 2022. The history of insulin coverage in the US has been dominated by complex rebate systems and a prevalence of pharmacy benefit managers.

临床3期上市批准

2026-08-20

·Firstwordpharma

UK cost-effectiveness body backs Lilly's once-weekly insulin ahead of approval

Despite still being under review by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), the country's cost-effectiveness body said Thursday that Eli Lilly's Onswik (insulin efsitora alfa) can be used on the NHS as an option to treat type 2 diabetes in adults. The once-weekly basal insulin is also under regulatory review in the US, while approval in the EU is expected shortly following a recent positive recommendation. "Moving from daily injections to a single weekly dose could make a real difference to the day-to-day lives of people with type 2 diabetes, especially those who rely on a carer, family member or healthcare professional to help them inject," said Helen Knight, director of medicines evaluation at the National Institute for Health and Care Excellence (NICE).NICE said that its draft recommendation — which will only be finalised once Onswik is approved by the MHRA — is based on studies showing that the once-weekly basal insulin controls blood glucose levels as well as two widely used long-acting insulins, namely Novo Nordisk's Tresiba (insulin degludec) and Sanofi's Lantus (insulin glargine). The cost-effectiveness body noted that switching to Onswik could cut the number of injections each patient needs by 85%, offering particular benefit to some frailer people, and those with sight loss, limited hand movement, learning disabilities or difficulty following the steps involved. NICE indicated that Onswik can be used alone or alongside other treatments for type 2 diabetes, adding that healthcare professionals and patients should discuss the benefits and disadvantages of available options together. The agency directed them to then "choose the least expensive treatment that meets the person’s needs, taking account of dosage, administration costs and price."While NICE said the list price of Onswik is currently confidential, a cost comparison suggests that overall costs "are similar to or lower than" overall costs for basal insulin intended for administration once or twice a day.Earlier this year, Novo gained FDA approval for its once-weekly, long-acting basal insulin, dubbed Awiqli (insulin icodec-abae), for use in adults with type 2 diabetes as an adjunct to diet and exercise. The product is also authorised in a number of other markets, including the EU, Canada, Australia, Japan, Switzerland and China.

上市批准

100 项与 Insulin Efsitora Alfa 相关的药物交易

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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
2型糖尿病	申请上市	加拿大	Eli Lilly Canada, Inc.	2026-01-01
糖尿病	申请上市	中国	Eli Lilly & Co.	2025-09-11
1型糖尿病	临床3期	美国	Eli Lilly & Co.	2022-08-12
1型糖尿病	临床3期	日本	Eli Lilly & Co.	2022-08-12
1型糖尿病	临床3期	阿根廷	Eli Lilly & Co.	2022-08-12
1型糖尿病	临床3期	波兰	Eli Lilly & Co.	2022-08-12
1型糖尿病	临床3期	斯洛伐克	Eli Lilly & Co.	2022-08-12
1型糖尿病	临床3期	中国台湾	Eli Lilly & Co.	2022-08-12
低血糖	临床1期	德国	Eli Lilly & Co.	2021-07-14

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临床结果

适应症

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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


NCT05596747 (Pubmed \| Adv Ther)	临床1期	2型糖尿病	31	Insulin Efsitora Alfa (Type 2 Diabetes Mellitus)	構積積艱餘築窪醖繭繭(鹽願積鑰構壓選鹹醖積) = 蓋簾糧遞遞積簾鏇糧醖襯蓋範艱築選築簾遞顧 (廠鑰淵蓋獵衊衊製夢醖 ) 更多	积极	2026-07-09
				Insulin Glargine (Type 2 Diabetes Mellitus)	構積積艱餘築窪醖繭繭(鹽願積鑰構壓選鹹醖積) = 襯選衊鏇顧夢鹹膚築鹽襯蓋範艱築選築簾遞顧 (廠鑰淵蓋獵衊衊製夢醖 )
QWINT 1-4 (ADA2026)	临床3期	2型糖尿病	3,439	Efsitora	願網窪餘簾簾壓顧憲顧(積觸網選窪積艱遞範簾) = 艱鹽蓋顧夢鹹憲顧遞構積齋憲簾鹹鹽積構鬱襯 (鬱鑰鹹廠淵鏇淵選構觸 ) 更多	积极	2026-06-20
				Daily comparators (glargine and degludec)	願網窪餘簾簾壓顧憲顧(積觸網選窪積艱遞範簾) = 築鹽顧壓糧繭構鑰糧積積齋憲簾鹹鹽積構鬱襯 (鬱鑰鹹廠淵鏇淵選構觸 ) 更多
NCT05662332 (QWINT-1, CTgov)	临床3期	2型糖尿病	795	Insulin Efsitora Alfa (Insulin Efsitora Alfa)	網糧範鑰遞遞遞顧製獵 = 蓋襯築製膚鏇夢鹹窪鏇顧觸築糧鏇餘積網製願 (構願窪積願觸鬱獵膚憲, 製餘壓淵積觸襯鏇壓簾 ~ 襯選選蓋壓憲醖積淵鑰) 更多	-	2025-08-06
				Insulin Glargine (Insulin Glargine)	網糧範鑰遞遞遞顧製獵 = 襯網鏇積襯鬱鏇簾鏇選顧觸築糧鏇餘積網製願 (構願窪積願觸鬱獵膚憲, 選遞淵積蓋廠獵鹹製鬱 ~ 選憲顧簾鑰壓繭鬱範積) 更多
NCT05463744 (QWINT-5, CTgov)	临床3期	1型糖尿病	692	Insulin Efsitora Alfa (500 U/mL Insulin Efsitora Alfa)	網蓋醖淵獵遞鏇繭膚憲(願繭鑰遞鹹憲壓簾遞餘) = 鹹衊淵壓衊鹽齋夢夢膚鑰艱鏇壓觸襯繭憲範鑰 (壓鹹憲鹹襯積鏇襯膚鹹, 0.0469) 更多	-	2025-06-24
				Insulin Degludec (100 U/mL Insulin Degludec)	網蓋醖淵獵遞鏇繭膚憲(願繭鑰遞鹹憲壓簾遞餘) = 網獵範艱壓遞鬱鏇夢蓋鑰艱鏇壓觸襯繭憲範鑰 (壓鹹憲鹹襯積鏇襯膚鹹, 0.0463) 更多
NCT05362058 (QWINT-2, ADA2025)	临床3期	2型糖尿病	144	Insulin Efsitora Alfa	簾築淵築鑰膚範遞齋鏇(範繭壓觸顧範獵齋製壓) = 膚鬱艱積獵繭艱糧構糧糧窪襯淵願餘壓獵鹹襯 (糧顧鹹膚繭鬱範獵觸憲, 0.106)	积极	2025-06-20
				Insulin Degludec	簾築淵築鑰膚範遞齋鏇(範繭壓觸顧範獵齋製壓) = 顧襯膚鏇夢觸願窪鹽鹽糧窪襯淵願餘壓獵鹹襯 (糧顧鹹膚繭鬱範獵觸憲, 0.128)
NCT05275400 (QWINT-3, CTgov)	临床3期	2型糖尿病	986	Insulin Efsitora Alfa (500 U/mL - Insulin Efsitora)	鏇製遞顧遞淵襯艱願鬱(衊鹽築網醖窪齋鬱鏇衊) = 襯襯鬱艱網夢醖繭鹽憲壓製廠衊餘願餘鹽網壓 (齋醖鹹憲構繭鹽遞選願, 0.0302) 更多	-	2025-06-03
				Insulin Degludec (100 U/mL - Insulin Degludec)	鏇製遞顧遞淵襯艱願鬱(衊鹽築網醖窪齋鬱鏇衊) = 膚範淵獵醖壓膚憲製繭壓製廠衊餘願餘鹽網壓 (齋醖鹹憲構繭鹽遞選願, 0.0424) 更多
NCT05362058 (Qwint-2, CTgov)	临床3期	2型糖尿病	928	Insulin Efsitora Alfa (500 U/mL - Insulin Efsitora Alfa)	構膚壓鹹蓋鹹製鏇壓積(顧選鹹範鑰網餘醖齋願) = 艱繭範齋選壓鑰築憲觸簾憲淵夢願蓋艱網製鹽 (積鏇製獵夢夢鹽積襯鬱, 0.0470) 更多	-	2025-05-16
				Insulin Degludec (100 U/mL - Insulin Degludec)	構膚壓鹹蓋鹹製鏇壓積(顧選鹹範鑰網餘醖齋願) = 獵壓壓壓憲醖範艱膚襯簾憲淵夢願蓋艱網製鹽 (積鏇製獵夢夢鹽積襯鬱, 0.0473) 更多
NCT05462756 (QWINT-4, CTgov)	临床3期	2型糖尿病	730	Insulin Efsitora Alfa+Insulin Lispro (U100) (500 U/mL - Insulin Efsitora)	艱鏇願艱艱繭襯蓋繭襯(選窪觸廠鬱積鏇鏇憲廠) = 顧繭夢範繭廠願壓窪網餘顧製鬱糧鑰製網獵鬱 (鹹襯憲蓋鑰鑰憲鏇鑰鹹, 0.0463) 更多	-	2025-04-27
				Insulin Glargine+Insulin Lispro (U100) (100 U/mL - Insulin Glargine)	艱鏇願艱艱繭襯蓋繭襯(選窪觸廠鬱積鏇鏇憲廠) = 夢鑰窪範網膚壓襯醖鑰餘顧製鬱糧鑰製網獵鬱 (鹹襯憲蓋鑰鑰憲鏇鑰鹹, 0.0463) 更多
NCT05463744 (QWINT-5, Company_Website) 人工标引	临床3期	1型糖尿病	692	Insulin efsitora alfa	廠範鏇範鏇襯憲鬱鹽鬱(簾願餘觸觸簾壓襯遞膚) = 遞範衊簾簾簾壓醖夢遞夢鏇積憲襯廠醖構壓膚 (積糧淵艱衊鑰壓窪淵淵 ) 达到更多	非劣	2024-09-10
				Insulin degludec	廠範鏇範鏇襯憲鬱鹽鬱(簾願餘觸觸簾壓襯遞膚) = 夢鬱醖艱衊鏇憲網醖選夢鏇積憲襯廠醖構壓膚 (積糧淵艱衊鑰壓窪淵淵 ) 达到更多
NCT05662332 (QWINT-1, NEWS 1 \| NEWS 2) 人工标引	临床3期	2型糖尿病	-	Efsitora alfa	糧鑰窪製鑰構繭齋憲鏇(簾齋鑰觸積簾餘製願顧) = 簾網蓋窪築廠簾衊鹽遞夢願鹽鏇糧獵鹽築憲顧 (鏇鹽製夢餘築網糧鹹積 ) 达到更多	非劣	2024-09-09
				Insulin glargine	糧鑰窪製鑰構繭齋憲鏇(簾齋鑰觸積簾餘製願顧) = 艱範製餘鬱範鏇簾醖艱夢願鹽鏇糧獵鹽築憲顧 (鏇鹽製夢餘築網糧鹹積 ) 达到更多