作者: Ahmad, Omar ; Ibrahim, Ramzi ; Al-Kindi, Sadeer ; Abdelnabi, Mahmoud ; Elbenawi, Hossam ; Nasir, Khurram ; Fortuin, F David ; Sell-Dottin, Kristen A ; Farina, Juan ; Yang, Eric H ; Simper, David ; Bhakta, Mayurkumar D ; Lee, Kwan ; Arsanjani, Reza ; Pham, Hoang Nhat ; Salih, Mohammed ; Sweeney, John P ; Ayoub, Chadi

AIMS:

Acute myocardial infarction (AMI) is among the leading causes of mortality in patients with type 2 diabetes (T2DM). This study evaluated whether initiation of glucagon-like peptide-1 receptor agonists (GLP1RAs) post-AMI improves cardiovascular outcomes in this population.

METHODS:

This retrospective cohort study used the TriNetX Research Network to identify adult patients with T2DM who experienced an AMI between January 1, 2017, and December 31, 2023. Patients were included if they initiated tirzepatide or semaglutide within 14 days post-AMI. Propensity score matching (PSM) was performed to balance baseline characteristics. The primary outcome was recurrent coronary events, and secondary outcomes included all-cause mortality and hospitalizations, heart failure (HF) hospitalizations, acute kidney injury (AKI), and cardiac arrest. Hazard ratios (HR) were estimated using Cox proportional hazard models.

RESULTS:

5338 patients were included in each cohort. Mean follow-up was 327.7 days (GLP1RA group) vs. 307.9 days (non-GLP1RA group). GLP1RA use did not significantly reduce recurrent coronary events (3.7 % vs 3.8 %; HR 0.913, 95 % CI 0.750-1.111). GLP1RA use was associated with significantly lower all-cause mortality (HR 0.484, 95 % CI 0.413-0.567), HF hospitalizations (HR 0.578, 95 % CI 0.531-0.630), AKI (HR 0.688, 95 % CI 0.610-0.732), cardiac arrest (HR 0.549, 95 % CI 0.418-0.722), and all-cause hospitalizations (HR 0.673, 95 % CI 0.636-0.713).

CONCLUSIONS:

GLP1RA initiation in patients with T2DM post-AMI was not associated with a reduction in recurrent coronary events, but was linked to improvements in other cardiovascular outcomes, suggesting a potential role for GLP1RAs as part of a secondary prevention strategy.

2026-02-01·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Engineered choline–Salcaprozate ionic liquids for enhanced non-invasive delivery of macromolecular antidiabetics

Article

作者: Yu, Jiang ; Zhao, Min ; Cao, Enhao ; Li, Jinbo ; Liu, Hongzhuo ; Zhao, Yan ; Zhang, Baoyue ; Huang, Ruiping ; Wang, Yongjun ; Ran, Wen ; Ye, Jianying ; An, Ni

The management of diabetes relies heavily on macromolecular biologics, which are predominantly administered via subcutaneous injection. However, its invasiveness compromises patient compliance and leads to injection-related complications. Among all the clinically attractive alternatives, mucosal administration, while non-invasive and enabling rapid absorption, faces significant challenges from physiological barriers that limit drug permeability. Herein, we engineered a novel choline-salcaprozate ionic liquid (CS-IL) system that could overcome these limitations and enable efficient mucosal delivery of insulin and semaglutide. To evaluate its potential, comprehensive in vitro and in vivo studies were conducted, which revealed that CS-ILs significantly enhanced drug permeability and mucosal retention via both intranasal and sublingual routes, thereby achieving robust hypoglycemic effects comparable to subcutaneous injection. Notably, a key mechanistic insight uncovered that CS-ILs boost paracellular transport via the transient and safe modulation of intercellular junctions. Consequently, with its compelling biocompatibility profile and potent efficacy across mucosal routes, this versatile IL platform emerges as a promising strategy for clinical translation, potentially revolutionizing non-invasive delivery for diabetes therapeutics.

2026-02-01·EXPERIMENTAL NEUROLOGY

Semaglutide attenuates Alzheimer's disease model progression by targeting microglial NLRP3 inflammasome-mediated neuroinflammation and ferroptosis

Article

作者: Siebert, Hans-Christian ; Zhang, Ruiyan ; Han, Jun ; Zheng, Mingxiao ; Wen, Min ; Wang, Qingpeng ; Zhang, Qianye ; Loers, Gabriele ; Zhang, Ning

Microglial activation driven by NOD-, LRR- and pyrin domain-containing protein 3 (NLRP3) inflammasome signaling exacerbates Alzheimer's disease (AD) pathology through enhanced neuroinflammation and amyloid beta (Aβ) accumulation. Semaglutide (SEM) has attracted growing attention for its potential therapeutic effects in AD, while its underlying mechanisms remain unclear. In this study, we investigated the neuroprotective effects of SEM in both APP/PS1 transgenic mice and LPS + ATP-stimulated BV2 microglia. Our results demonstrate that SEM treatment rescued APP/PS1 mice from cognitive impairment and suppressed Aβ aggregation and tau hyper-phosphorylation in the hippocampus of APP/PS1 mice. Furthermore, we found that SEM inhibited microglial NLRP3 activation, promoted microglial M2 polarization and alleviated ferroptosis via NLRP3/nuclear factor kappa B (NF-κB) and nuclear factor erythroid 2-related factor 2 (Nrf2)/heme oxygenase 1 (HO-1)/ cystine/glutamate antiporter SLC7A11 (xCT)/glutathione peroxidase 4 (GPX4) pathways in APP/PS1 mice and LPS + ATP-stimulated BV2 microglia. These findings were further corroborated by microglia-specific NLRP3 knockdown, which reduced Aβ deposition, promotied M2 polarization, attenuated neuroinflammation, and suppressed ferroptosis. Our findings provide further theoretical support for the clinical application of SEM in AD treatment, while also establishing a scientific foundation for AD therapeutic strategies targeting the microglial NLRP3 pathway.

项与 Semaglutide(Anya Biopharma) 相关的新闻（医药）

2025-12-18

·ETPharma

US FDA issues 'Official Action Indicated' status to Sun Pharma’s Baska facility after inspection

Sun Pharmaceutical Industries Ltd on Thursday said the US Food and Drug Administration (FDA) has classified its Baska manufacturing facility under Official Action Indicated (OAI) following a recent inspection, even as the company said supplies to the US market from the plant will continue. In an exchange filing, Sun Pharma said, “This is to inform that the US FDA conducted an inspection at the Company’s Baska facility from 8 September 2025 to 19 September 2025. The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI).” The drugmaker, however, sought to reassure investors on business continuity. “We continue to manufacture and supply approved products from the facility to the US market. We will work with the regulator to achieve fully compliant status,” the company said in the filing. According to the US FDA, inspection classifications fall into three categories. Official Action Indicated (OAI) means that regulatory and/or administrative actions are recommended based on the agency’s inspection findings. The regulatory update comes against the backdrop of heightened investor focus on Sun Pharma’s overseas manufacturing footprint, particularly as the company pursues export-led opportunities in high-value therapies. Last week, the Delhi High Court allowed Sun Pharma to manufacture its version of the diabetes and anti-obesity drug semaglutide in India and export it, while restraining domestic sales until March 2026, when Danish drugmaker Novo Nordisk’s secondary patent expires. Justice Manmeet Pritam Singh Arora permitted exports but barred sales in the Indian market, directing Sun Pharma to file an affidavit within two weeks and submit export-related account details. The matter is scheduled for further hearing on February 19. Sun Pharma’s shares were trading at Rs 1,778.20, up 0.12%, following the court’s order. Novo Nordisk had moved the High Court seeking to restrain Sun Pharma from manufacturing and selling semaglutide, alleging patent infringement of its blockbuster weight-loss drug sold under the brand name Wegovy. The Danish drugmaker continues to hold a secondary patent in India related to specific formulations and delivery mechanisms of semaglutide, valid until March 2026, even though its primary compound patent expired in September 2024--an expiry that has opened the door for Indian drugmakers to pursue export-focused generic versions.

专利侵权专利到期

2025-11-26

·药明康德

司美格鲁肽再向FDA递交监管申请；一线治疗胃癌，FDA再批准阿斯利康单抗组合……

司美格鲁肽再向FDA递交监管申请诺和诺德（Novo Nordisk）今日宣布，已向美国FDA提交7.2 mg Wegovy（semaglutide，司美格鲁肽）注射剂的补充新药申请（sNDA），拟用于联合低热量饮食和增加体力活动，以帮助肥胖成人进行长期体重管理。7.2 mg Wegovy的监管申请也正在接受欧洲药品管理局（EMA）审评，预计2026年第一季度公布结果。本次申请主要基于来自STEP UP的研究结果，这是一项为期72周的3期、随机、双盲、安慰剂对照试验，入组1407名身体质量指数（BMI）≥30 kg/m²的肥胖成年人，患者均无糖尿病史。试验结果显示，在患者依从治疗的前提下，每周一次7.2 mg Wegovy使患者（基线平均体重249磅）在72周后实现了平均20.7%的体重下降，明显优于接受2.4 mg剂量患者的17.5%降幅及安慰剂组的2.4%。此外，33.2%的7.2 mg组患者体重降幅达到或超过25%，远高于2.4 mg组的16.7%与安慰剂组的0%。在将中途停药者纳入分析后，7.2 mg组患者的平均体重下降仍达18.7%，同样优于2.4 mg组的15.6%与安慰剂组的3.9%。此外，7.2 mg组中有90.7%的患者实现≥5%体重下降，亦高于2.4 mg组的89.9%和安慰剂组的36.8%。 Wegovy是一种GLP-1受体激动剂，它能够刺激胰岛素的生成，并抑制胰高血糖素分泌，降低食欲和食物摄入量。2021年6月FDA批准其用于治疗普通肥胖患者，它是自2014年以来美国FDA批准的首款用于控制普通肥胖症或超重的新药。该药物并在同年晚些时候再获欧盟批准治疗肥胖适应症。一线治疗胃癌，FDA再批准阿斯利康单抗组合美国FDA近日批准了阿斯利康（AstraZeneca）旗下Imfinzi（durvalumab）联合标准FLOT化疗（fluorouracil、leucovorin、oxaliplatin、docetaxel），用于可切除的胃癌或胃食管结合部腺癌（GC/GEJC）成人患者的术前及术后治疗，并在术后继续使用Imfinzi单药维持治疗。此次批准主要基于3期MATTERHORN研究的结果，该研究共纳入948名未经治疗、可切除的II期至IVA期GC/GEJC患者，按1：1随机接受Imfinzi联合FLOT或安慰剂联合FLOT的治疗方案。研究主要终点为盲法独立中心评估的无事件生存期（EFS），并评估了患者的总生存期（OS）及病理学完全缓解（pCR）。结果显示，Imfinzi联合FLOT组的中位EFS尚未达到（95% CI：40.7，不可估计[NE]），显著优于对照组的32.8个月（95% CI：27.9，NE），风险比为0.71（95% CI：0.58，0.86；p<0.001）。OS方面，两组中位OS均未达到，但Imfinzi联合组同样展现获益（HR=0.78；95% CI：0.63，0.96；p=0.021）。在病理学评估中，Imfinzi联合FLOT实现19.2%的pCR率，明显高于对照组的7.2%（p<0.001）。 Imfinzi是一种人源化的单克隆抗体。通过与PD-L1的结合，阻断PD-L1与PD-1和CD80蛋白的结合，进而抑制肿瘤的免疫逃逸机制。参考资料： [1] Novo Nordisk files for FDA approval of a higher dose of Wegovy® injection 7.2 mg. Retrieved November 26, 2025 from https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-a-higher-dose-of-wegovy-injection-7-2-mg-302626162.html [2] FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma. Retrieved November 26, 2025 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果加速审批临床成功临床2期

2025-10-23

·EndPoints

Ventyx's stock soars on cardiovascular data for NLRP3 drug

Ventyx Biosciences’ Phase 2 data showed a significant reduction in cardiovascular risks in patients with obesity through NLRP3 inhibition, a closely-watched target in neurologic and cardiometabolic drug development. After the readout was announced on Wednesday, the biotech’s stock $VTYX was up more than 85% on Thursday morning. That said, the future of VTX3232 could hinge on the ambitions of Sanofi, which paid $27 million in September 2024 to snag the rights to first negotiation for the once-daily oral NLRP3 inhibitor. Sanofi has acted on similar rights, having bought Vigil Neuroscience earlier this year after getting the negotiation rights to the biotech’s Alzheimer’s disease drug in 2024. “This is the first time we’re publicly disclosing this data, so [Sanofi] has not had a chance to see it. I’m hoping some of them have seen it today,” Ventyx CEO Raju Mohan said Wednesday during an analyst call. It’s unclear how long Sanofi gets to “review the results and determine if they have an interest in the molecule,” according to a Stifel note. A Sanofi spokesperson didn’t respond to a request for comment. The company is scheduled to report its third-quarter results on Friday. “Ultimately, NLRP3 could be a high-value target for big pharma,” Jefferies analysts wrote in a note. NLRP3 inhibitors tamp down on inflammation to lower cardiovascular risks, but they may also have the potential to treat neurological disorders. VTX3232 has completed a Phase 2 biomarker trial in patients with early forms of Parkinson’s disease. The target has attracted the interest of both drug giants and small biotechs working in cardiometabolic and neurologic R&D. That includes Novo Nordisk-partnered Ventus Therapeutics , Tenvie and NodThera , which is backed by Sanofi Ventures. Roche is also working on a Phase 1b oral candidate called selnoflast from its acquisition of Inflazome in 2020 for $448 million upfront. In the Phase 2 trial results, Ventyx said VTX3232 led to “significant reductions” in cardiovascular disease threats. The trial tested the experimental medicine alone and in combination with Novo Nordisk’s GLP-1 semaglutide. The primary endpoint of the trial was safety and tolerability. Ventyx said rates of adverse events for patients on its drug were “comparable to placebo.” On the key secondary endpoint, looking at inflammation, patients taking VTX3232 had a 64% reduction in high-sensitivity C-reactive protein (hsCRP) in the “full analysis set” at week 12 relative to baseline. There was a 3% increase in that measure in the placebo group. The p-value came in at p<0.0001. Meanwhile, the drug also led to statistically significant drops in lipoprotein(a) and liver inflammation, and it helped move interleukin-6 levels below the threshold for cardiovascular risk, according to Ventyx. The drug did not lead to weight loss, either as a single agent or in combination with semaglutide. The data are “now showing conclusively that NLRP3 inhibition has no effect in humans in promoting weight loss,” Mohan said on the call. Stifel analysts said it was “puzzling” that there was no effect on weight, given the signals in mouse models. But “the impact on biomarkers could support a path forward” for the drug in reducing cardiovascular risks, they wrote. Novartis bet $1.4 billion last month to get an anti-IL-6 drug via its acquisition of Tourmaline Bio , and Novo is also developing an IL-6 called ziltivekimab, which is in Phase 3 trials . “The potential for an ‘oral IL-6’ clearly has wide-ranging potential across a range of CV diseases with ongoing outcomes studies expected over the 2026/27 timeframe for Novo’s ziltivekimab, which represents a meaningful datapoint for the space,” the Stifel analysts wrote.

并购临床结果临床2期临床3期AHA会议

100 项与 Semaglutide(Anya Biopharma) 相关的药物交易

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