This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] score >=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.

开始日期2025-06-01

申办/合作机构

Columbia University

[+2]

NCT06881888

/ Not yet recruiting临床1期IIT

Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema

Treatment of diabetic retinopathy (DR) and diabetic macula edema has included panretinal photocoagulation and intra ocular injections of anti-vascular endothelial growth factors (anti-VEGF) agents and steroids. Anti-VEGF therapy is currently the first-line treatment for proliferative diabetic retinopathies; however, this approach is ineffective in more than 30% of patients with diabetic retinal complications. Available evidence shows that subcutaneous (under the skin) injection of octreotide, a somatostatin analog, has potential therapeutic benefits in proliferative diabetic retinopathy (PDR) and diabetic macula edema (DME). This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema in individuals that are considered to be refractory to the current therapeutic options.

开始日期2025-05-01

申办/合作机构

The University of Alabama at Birmingham

[+1]

NCT06592261

/ Recruiting临床1期IIT

Human Models of Selective Insulin Resistance: Graded Insulin Suppression Test (GIST) Pilot & Feasibility Study

The goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. Participants will be asked to come in for a one-day study visit in which they will undergo a "graded insulin suppression test" ("GIST"). The GIST involves intravenous (into the vein) infusions of octreotide, a medication that turns off the body's own production of insulin, as well as replacement of insulin at two different levels (low and high), with or without replacement of glucagon, and glucose (sugar). The study investigators will check blood sugar levels every few minutes during the procedure to determine the effect of the two different insulin levels. This study will evaluate the GIST in both healthy volunteers and those at higher risk for type 2 diabetes.

开始日期2024-09-16

申办/合作机构

Columbia University

[+2]

100 项与醋酸奥曲肽相关的临床结果

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100 项与醋酸奥曲肽相关的转化医学

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100 项与醋酸奥曲肽相关的专利（医药）

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项与醋酸奥曲肽相关的文献（医药）

2025-05-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Octreotide attenuates experimental severe acute pancreatitis through inhibiting pyroptosis and modulating intestinal homeostasis

Article

作者: Wang, Xingpeng ; Zeng, Yue ; Zhao, Mengqi ; Cui, Mengyan ; Wang, Jingjing ; Fan, Miaoyan ; Huang, Chunlan ; Lu, Yingying

Severe acute pancreatitis (SAP) is a common clinical condition characterized by acute abdominal symptoms. Octreotide (OCT) is a commonly prescribed treatment for acute pancreatitis (AP). Recent research shows that pyroptosis and intestinal homeostasis significantly contribute to the progression of AP. However, it remains unclear whether OCT treats SAP through modulating pyroptosis and intestinal microbiota. Our study aimed to investigate and validate the potential therapeutic effects of OCT on SAP and underlying mechanisms. The inhibition of pyroptosis in mice using disulfiram was investigated to elucidate the role of pyroptosis in AP. Molecular biology experiments confirmed that OCT effectively inhibited the expression of pyroptosis-related markers. Additionally, the composition, abundance, and functionality of the intestinal microbiota were analyzed using 16S rRNA sequencing, while short-chain fatty acids (SCFAs) were quantified by targeted metabolomics. Our study demonstrated that the administration of OCT significantly mitigated the severity of SAP in a dose-dependent manner. Furthermore, the inhibition of pyroptosis in mice attenuated SAP, thereby highlighting the critical role of pyroptosis in this condition. OCT administration was observed to suppress the expression of key pyroptosis markers. Additionally, there was a notable reduction in intestinal permeability and bacterial translocation. OCT reverses gut dysbiosis caused by SAP, increasing beneficial bacteria while inhibiting pathogenic strains. Furthermore, OCT administration enhanced the levels of SCFAs, including propanoic acid, acetic acid, and butyric acid. Our findings indicate OCT has the potential to alleviate SAP by suppressing pyroptosis and restoring intestinal homeostasis.

2025-04-01·International Journal of Surgery Case Reports

Successful management of TSH-secreting adenoma misdiagnosed as hypothyroidism in 65-year-old male: A case report

Article

作者: Sobeh, Ahmed Sheikh ; Tawashi, Kenana ; Qatza, Ayham ; Al-Shami, Shahama ; Tamer, Wardan A

INTRODUCTION:

Thyrotropin-secreting adenoma (TSHoma) is a rare functional pituitary tumor, accounting for less than 3 % of all pituitary tumors, characterized by central hyperthyroidism and inappropriate TSH secretion.

PRESENTATION OF CASE:

We present a case of a 65-year-old man with a history of unresponsive hypothyroidism, diagnosed with a pituitary tumor through MRI and CT scans. Following partial tumor resection, histopathological examination confirmed a benign TSHoma. The patient was discharged in stable condition after three days, receiving long-term octreotide injections and propranolol without complications.

DISCUSSION:

TSHomas, resulting from abnormal growth of TSH-producing pituitary cells, pose diagnostic challenges and are often misdiagnosed. Trans-Sphenoidal surgery is the standard treatment, and long-acting somatostatin analogs like octreotide can effectively restore normal thyroid function in over 90 % of patients.

CONCLUSION:

This report emphasizes the need to consider TSHoma as a potential cause that may be initially overlooked, highlighting the diagnostic and management challenges of this rare condition.

2025-04-01·Radiology case reports

Treatment-resistant Cushing disease and acromegaly in a young woman: A case of functional pituitary macroadenoma

Article

作者: Khalil, Ibrahim ; Hossain, Md Imran

Cushing disease and acromegaly are common endocrine disorders caused by excessive cortisol and growth hormone production, respectively. Both conditions can co-occur due to functioning pituitary adenomas, which are typically benign pituitary gland tumors. This report discusses a 30-year-old woman with hyperpituitarism leading to treatment-resistant Cushing disease and acromegaly caused by a functional pituitary macroadenoma. A 30-year-old woman presented with a history of excessive weight gain, facial puffiness, fatigue, persistent headaches, and visual disturbances. Clinical examination revealed features consistent with Cushing disease and acromegaly, including a moon face, central obesity, and large hands and feet-the ophthalmologic evaluation identified bitemporal hemianopia, suggesting optic chiasm compression. Laboratory results showed elevated ACTH, IGF-1, and prolactin levels, alongside confirmed hypercortisolism. The patient also had secondary diabetes mellitus and galactorrhea-initial treatment with octreotide provided limited benefit, with persistent hormone elevations and insufficient symptom control. The patient underwent endonasal endoscopic transsphenoidal resection of the pituitary macroadenoma, leading to marked symptomatic and hormonal improvements. This underscores the diagnostic challenge and treatment complexity of such cases. Early diagnosis is critical for optimizing outcomes in patients with hyperpituitarism and mitigating complications. This case highlights the importance of multidisciplinary management and the necessity of long-term follow-up to monitor for recurrence and ensure sustained remission.

308

项与醋酸奥曲肽相关的新闻（医药）

2025-03-07

·微信

肽类药物：现状、进展与未来展望

本文将概述肽类治疗药物、递送平台和疫苗的当前市场和临床试验进展。通过文献分析，探讨肽类药物开发的关键研究领域，并着重介绍肽类药物的结构修饰原则，以及筛选、设计和递送技术的最新进展。新型肽类治疗药物，包括肽 - 药物复合物、新型肽类疫苗和创新的肽类诊断试剂的加速发展，有望推动疾病治疗方案迈向精准定制的新时代。一、肽类药物的发展历程与市场现状自 1922 年胰岛素用于治疗糖尿病，肽类药物正式登上医学舞台。发展至今，全球已有近 100 种肽类药物获批，广泛应用于糖尿病、肥胖症、心血管疾病等诸多领域。从市场数据来看（图 8a展示了部分 GLP-1 激动剂的销售情况），肽类药物市场呈现出持续增长的趋势。以司美格鲁肽为例，其不同剂型在 2024 年的销售额相当可观，这充分反映出市场对肽类治疗药物的强劲需求。通过对 2005 - 2024 年文献的分析（图 3），可以发现该领域的研究热度不断攀升，美国和中国在肽类药物研究方面成果突出。其中，癌症研究逐渐成为肽类药物开发的关键领域（图 3b），这也为攻克癌症难题带来了新的希望。二、肽类药物的特性与优势肽类药物具有诸多独特优势。它的特异性极高，能够精准地作用于目标，极大地减少了对正常细胞的不良影响；免疫原性低，引发人体免疫反应的概率较低；生产成本相对较低，在大规模生产上具有一定的经济优势。然而，肽类药物也存在一些局限性，比如在体内稳定性差，容易被快速降解，导致生物利用度较低，这使得许多肽类药物目前只能通过皮下注射给药，给患者带来了不便。三、肽类药物的递送平台创新为了解决肽类药物的局限性，科研人员在递送平台方面进行了大量创新研究。1.肽 - 药物偶联物（PDCs） PDCs 是一种极具潜力的递送平台，它由细胞靶向肽、连接子和细胞毒性有效载荷组成。形象地说，细胞靶向肽就像是 “导航仪”，能引导药物精准地找到肿瘤细胞；连接子起着连接和控制药物释放的作用；细胞毒性有效载荷则是 “战斗武器”，负责对肿瘤细胞进行攻击。目前，已有一些 PDCs 进入临床试验阶段（表 5展示了处于临床试验阶段的多种 PDCs），例如 Lutathera 用于治疗神经内分泌肿瘤，Pepaxto 用于治疗多发性骨髓瘤，不过 Pepaxto 因疗效问题退出了美国市场。此外，像 SNG1005 和 AEZS - 108 等在研的 PDCs，分别在治疗脑转移癌和前列腺癌方面展现出了良好的前景。 2.CPPs - 工程化纳米载体 CPPs（细胞穿透肽）可以帮助药物顺利穿过细胞膜，进入细胞内部发挥作用。虽然目前相关产品尚未获批上市，但科研人员通过将其与靶向肽结合等方式，不断提高药物递送的精准性。在针对心脏疾病和跨越血脑屏障的药物递送研究方面，已经取得了一些令人欣喜的进展。四、肽类药物在各治疗领域的应用进展1.糖尿病治疗在糖尿病治疗领域，肽类药物不断推陈出新。从最初的胰岛素，到如今的 GLP - 1 受体激动剂，治疗效果得到了显著提升。例如司美格鲁肽，经过结构修饰后，不仅实现了口服给药，而且只需每周服用一次，大大提高了患者的用药依从性。还有替尔泊肽，作为双靶点激动剂，在控制血糖和体重方面表现优异（图 8b对部分 GLP - 1 激动剂的相关信息进行了展示）。2.癌症治疗肽类药物在癌症治疗中发挥着重要作用。抗癌肽（ACPs）可以直接杀死肿瘤细胞，还能作为疫苗激活人体的抗肿瘤免疫反应。像天然抗癌肽 Apicidin，能够抑制肿瘤血管生成；合成或修饰的抗癌肽，如 Octreotide、Bortezomib 和 Motixafortide 等，已获批用于癌症治疗，并在临床实践中取得了一定的成效。此外，肽类在肿瘤诊断方面也有重要应用，例如$[^{68}Ga]Ga - DOTA - TOC$和 Illuccix® 等放射性药物，能够帮助医生更精准地定位和诊断肿瘤。3.心血管疾病治疗在心血管疾病治疗方面，肽类药物作用于多个靶点。例如作用于 G 蛋白偶联受体的 GLP - 1 受体激动剂，不仅能有效控制血糖，还对心血管疾病具有一定的预防作用；作用于利钠肽受体的 Nesiritide 和 Carperitide 等药物，可用于治疗心力衰竭；作用于血管紧张素转化酶（ACE）的抑制肽，则有助于降低血压。4.抗感染治疗由于抗生素耐药问题日益严峻，抗菌肽（AMPs）成为了研究热点。AMPs 具有抗菌活性高、抗菌谱广、不易产生耐药性等优点。像 Daptomycin、Dalbavancin 和 Rezafungin 等，都是已获批用于治疗细菌感染的抗菌肽药物，还有一些处于研究阶段的药物，也展现出了巨大的潜力。5.抗新冠病毒治疗针对新冠病毒，肽类药物的研发也在积极推进。例如 Paxlovid®，它由 3CL 蛋白酶抑制剂和低剂量 Ritonavir 组成，能够有效降低患者的住院和死亡风险。此外，还有一些针对新冠病毒 S 蛋白和 3CL 蛋白酶的肽类抑制剂正在研究中，有望成为抗击新冠病毒的新利器。6.其他领域治疗肽类药物在消化系统疾病、阿尔茨海默病、罕见病、骨科代谢疾病和偏头痛等领域也有应用和研究进展。比如在消化系统疾病中，部分肽类药物可用于控制胃肠道出血和治疗肠道疾病；在阿尔茨海默病治疗中，科研人员尝试利用肽类干预 β - 淀粉样蛋白的聚集；在罕见病治疗方面，Trofinetide 用于治疗 Rett 综合征，Zilucoplan 用于治疗重症肌无力，Teduglutide 用于治疗短肠综合征，为患者带来了新的希望；在骨科代谢疾病中，一些肽类药物有助于促进骨形成，治疗骨质疏松；在偏头痛治疗中，针对降钙素基因相关肽（CGRP）的药物，如 Ubrogepant 和 Rimegepant 等，能够有效缓解症状。五、肽类疫苗的研究进展在疫苗领域，肽类疫苗具有独特的优势。与传统疫苗相比，它安全性更高，质量更易于控制，还能根据实际需求进行定制。虽然目前尚无肽类疫苗获批上市，但在肿瘤免疫治疗方面的研究进展迅速，许多针对肿瘤特异性抗原的肽类疫苗正在进行临床试验（表 7展示了相关临床试验信息）。六、推动肽类药物发展的关键技术1.展示文库技术展示文库技术是发现新肽类药物的重要手段，包括噬菌体展示技术、细菌展示技术、酵母展示技术、哺乳动物细胞展示技术和无细胞展示技术等。这些技术各自具有优缺点，相互补充，能够快速筛选出与特定靶点结合的肽，为肽类药物的研发提供了有力支持。2.深度学习深度学习在肽类药物研发中也发挥着重要作用。通过对大量数据的分析，它能够辅助设计和优化肽类药物，显著提高研发效率，加速新型肽类药物的发现。七、口服肽类药物的挑战与突破口服肽类药物一直是研究的难点，因为肽类药物在胃肠道中容易被降解，且吸收效果不佳。不过，科研人员通过结构修饰，如采用 D - 氨基酸取代、脂质化、PEG 化和环化等方法，以及改进制药配方，如使用渗透增强剂、开发新型载体等，在口服肽类药物的研究上取得了一定的突破（表 8列举了部分已获批的口服肽类药物及其递送策略）。八、肽类药物面临的挑战与未来展望尽管肽类药物发展前景广阔，但目前仍面临一些挑战，如药物的稳定性、生物利用度、免疫原性等问题有待进一步解决，生产成本也需要降低。不过，随着技术的不断进步，多学科的深度交叉融合，我坚信肽类药物在未来将会取得更大的发展，为更多患者带来更安全、更有效的治疗方案。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

疫苗核酸药物

2025-03-06

·Endpoints

ITM reports more Phase 3 radiopharma data in challenge to Novartis’ Lutathera

ITM Isotope Technologies Munich’s radiopharma candidate reduced neuroendocrine tumor patients’ risk of progression or death by a third compared with standard therapy, according to pivotal data presented Thursday. The figure is statistically significant but is also lower than what was seen with Novartis’ radioligand Lutathera in its registrational trial in the same disease. That is not a problem, ITM’s CEO Andrew Cavey told Endpoints News , since the trials used different control arms. “We hopefully will be able to show clinicians that we picked a higher bar of clinical care, and we are able to beat that higher bar,” Cavey said. ITM’s COMPETE trial, in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), pitted its lutetium-177-based radioligand ITM-11 against the targeted therapy everolimus. The German biotech declared victory in January , but now more detailed data show that the median PFS was 23.9 months with ITM-11 versus 14.1 months on everolimus. The NETTER-1 trial of Lutathera showed a risk reduction of 79% on progression-free survival but against the somatostatin analog octreotide, rather than everolimus. A lower dose of octreotide was given in the Lutathera arm too, another difference from ITM’s study. The populations in the two trials were also different. COMPETE enrolled patients with pancreatic GEP-NETs as well as those with midgut tumors. Patients with pancreatic tumors have a worse prognosis and were excluded from Novartis’ study. Dosing is also slightly more convenient, at every three months versus every two months for Lutathera. Interim median overall survival in the COMPETE study was 63.4 months in the ITM-11 arm and 58.7 months with control as of Jan. 21. This was not statistically significant, but the pivotal trial of Lutathera also failed to hit significance at its final OS analysis, which occurred 66 months after the primary PFS analysis. ITM’s data were presented at the European Neuroendocrine Tumor Society conference, held in Krakow, Poland. ITM intends to take the COMPETE dataset to regulators this year. If ITM-11 is approved, it would compete with Lutathera, which has been on the market since 2018 . Taking on a big pharma in a small indication is no small feat, particularly since ITM has no intention of partnering on the drug. Its strategy here will hinge partly on convincing doctors of the strength of the new data. “I strongly believe this will create a change in the way people practice medicine and the treatment of neuroendocrine tumors,” Cavey said, citing conversations ITM has had with physicians. The other main aspects of its commercial approach involve helping to boost access to radiopharmaceuticals, including improving its ordering system and supply infrastructure. Cavey says it can be difficult to coordinate the arrival of both the patient and the radiopharmaceutical at a hospital at the same time. ITM should also be able to sidestep the isotope manufacturing issues that have bedeviled both Novartis and Bristol Myers Squibb . It is the only company with both a therapeutic pipeline and in-house isotope production. “Our radioisotope business is about $200 million now and growing,” Cavey said, and the company has “heavily invested” in ytterbium-161 as a potential new therapeutic isotope. All of which could make ITM an attractive takeover target, like Point Biopharma , RayzeBio and Fusion Pharmaceuticals . But Cavey insists the private company is not interested in a buyout. However, the company will “absolutely” be looking for opportunities to in-license assets, he said. Editor’s note: This article was updated to state that patients with pancreatic tumors were excluded from Novartis’ NETTER-1 study.

临床结果临床3期

2025-02-26

·摩熵医药

2024年微球制剂市场分析：17.1%的增速！中国微球制剂市场迎来爆发期！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。微球制剂作为一种新型药物递送技术，在全球医药领域备受关注。近年来，中国微球制剂市场展现出强劲的增长态势，不仅市场规模增速远超全球平均水平，国产制剂的占比也显著提升。本文基于摩熵咨询最新发布的《基于剂型改良的复杂注射剂分析-微球篇》研究报告部分精华内容，将从整体市场规模、具体药物市场分析以及未来发展趋势三个方面，全面解读中国微球制剂行业的现状与前景。本文旨在为业内人士提供数据支持与趋势洞察，助力行业发展。 01 中国微球制剂药物市场规模市场规模增速远超全球截至2024年10月，国内有19款微球产品上市，其中有4款造影剂，主要用于肿瘤、糖尿病和精神分裂。图片来源：摩熵咨询《基于剂型改良的复杂注射剂分析-微球篇》 2017- 2019 年，全球微球制剂市场规模从 72 亿美元上升至 78 亿美元，2017-2019年CAGR为 4.3%。 2015-2023年，中国微球制剂销售额从25亿元增长到79亿元，2015-2019年CAGR为13.4%，2019-2023年CAGR为17.1%。 2015-2023年，国产微球制剂销售额占比呈逐步提高的趋势，从2015年的34.6%增长至2023年的49.7%；自2018年起，国产销售额占比一直稳定在45%以上。由此可见，中国微球制剂市场规模的增长速度远高于全球市场。随着国内企业加紧微球制剂的研发布局，未来中国微球制剂市场的规模有望继续保持高速增长。 02 中国微球药物市场分析亮丙瑞林的销售额占比最高曲普瑞林次之据摩熵医药销售数据统计，2023年，亮丙瑞林国内总销售额为53.92亿元，占总销售额的68.5%，曲普瑞林次之，总销售额为18.36亿元，占比23.3%。数据来源：摩熵医药销售数据库 01 亮丙瑞林微球制剂市场分析：国内销售额持续增长，2023年达到53亿元亮丙瑞林主要用于治疗前列腺癌、乳腺癌和中枢性性早熟，亮丙瑞林制剂2019-2023年国内销售额保持持续增长趋势，从2019年的27.44亿元增长到2023年的53.92亿元，CAGR为18.4%。截至2024年10月，国内市场上销售亮丙瑞林制剂的企业有北京博恩特、丽珠制药和日本武田，2023年销售额占比分别为29.5%、41.9%和28.7%。近五年，丽珠制药的注射用醋酸亮丙瑞林微球的销售额占比最高，销售额占比基本维持在40%左右。 02 曲普瑞林微球制剂市场分析：国内销售额持续增长，2023年达到18亿元 2019-2023年，曲普瑞林制剂的国内销售额持续增长，从2019年的11.49亿元增长到2023年的18.36亿元，CAGR为12.4% 。不同曲普瑞林制剂中，法国益普生的注射用醋酸曲普瑞林的销售额占比最高，2023年销售额占比为56.2%，然而，近5年其销售额占比呈现缓慢下滑趋势。唯一一款国产曲普瑞林制剂为丽珠制药的注射用醋酸曲普瑞林微球，于2023年5月获批上市，随着国产制剂成功推入市场，后续曲普瑞林市场规模有望进一步增长，并加速该品种的国产替代进程。 03 奥曲肽微球制剂市场分析：销售额趋于稳定 2020年，奥曲肽微球的销售额快速增长，从2019年的2.42亿元增长到4.56亿元，2020年后，奥曲肽微球在国内销售额趋于稳定，保持在4亿元以上；截至2024年10月，国内奥曲肽微球市场上的在售产品有诺华的善龙和齐鲁制药的佑远，诺华市场占比在99%以上。 04 利培酮微球制剂市场分析：销售额快速增长截至2024年10月，国内市场上销售利培酮微球的企业有杨森和绿叶制药，自绿叶制药的瑞欣妥推入市场后，销售额一路走高，2023年销售额达到4718万元，目前市场占比已超过99%。 03 微球制剂的未来发展趋势 01 微球制剂行业已经进入加速发展期中国微球制剂市场的发展经历了三个阶段。2000年-2008年为市场导入期，期间日本武田注射用亮丙瑞林微球、Ferring注射用曲普瑞林及Novartis注射用醋酸奥曲肽微球相继进入中国市场。2009年-2014年为微球制剂行业的初步发展期，丽珠制药和博奥特的产品获批上市并被纳入国家医保，同时《中国药典》2010年版收录了相关指导原则。2015年至今为加速发展期，2015年版《中国药典》进一步明确了微球制剂的要求，AstraZeneca和绿叶制药等公司推出了创新产品，丽珠集团也开启了新的合作模式。这一阶段标志着中国微球制剂技术的快速发展和创新。 02 微球产业化仍是限制微球制剂行业发展的主要壁垒微球制剂的产业化发展面临多重壁垒。首先，在原料端，制备微球所需的聚乳酸（PLA）和聚乳酸-羟基乙酸共聚物（PLGA）等聚合物材料种类有限，国内企业主要依赖进口，这增加了生产成本和供应链的不确定性。其次，在设备端，微球制剂的生产设备需要定制，费用较高，这对企业的资金投入提出了更高要求。最后，在技术端，不同药物适用的微球制备技术各不相同，参数调试过程复杂，导致微球制剂难以实现产业化的线性放大。这些因素共同制约了微球制剂行业的快速发展，需要进一步的技术创新和产业支持来突破这些瓶颈。 03 微球制剂国内需求广阔，医药行业政策利好频发，市场前景可观随着国内老龄化加剧，诸多慢性疾病如脑血管、恶性肿瘤、心脏疾病发病率逐步提高；另一方面，我国社会经济快速发展，城镇化率提升，居民生活方式改变导致精神压力增加，将推动精神疾病相关药物的需求增长。微球制剂具有控制药物的释放速度达到长效目的，因此市场价值较高。近年来，中国出台了一系列政策支持生物医药和中医药产业的发展。2016年，《“十三五”生物产业发展规划》提出推动缓控释制剂和靶向制剂等技术的产业化。2017年，《“十三五”中医药科技创新专项规划》强调发展新型给药系统。同年，CFDA发布意见，优先审评使用先进制剂技术的药品。2018年，国家知识产权局将新型制剂纳入重点支持产业目录。这些政策旨在扶持中国医药行业有序健康的发展，带动微球制剂行业良好的发展。此外，微球制备技术和工艺的不断优化与创新发展，有利于推动微球制剂需求增长，带动整体微球市场规模的提升。结语通过上述分析，我们可以看到，国产企业的崛起正在重塑市场格局。同时，微球制剂行业的快速发展也面临技术、设备和原料等多重壁垒。然而，随着政策支持力度的加大和技术创新的持续推进，中国微球制剂市场有望迎来更加广阔的发展空间。 END 本文为原创文章，转载请留言获取授权基于剂型改良的复杂注射剂分析--微球篇报告下期内容预告目录一、4款微球制剂改良型新药领跑市场！绿叶、丽珠等企业的创新突破二、微球制剂市场风起云涌，五家药企创新实力大比拼！谁是TOP1？近期将持续更新，敬请期待近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

100 项与醋酸奥曲肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06495	醋酸奥曲肽	H01CB02	DBSALT000130

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
巨人症	日本	Novartis Pharma KK	2014-06-20
胃肠道神经内分泌肿瘤	日本	Novartis Pharma KK	2011-11-25
恶性类癌综合征	中国	Novartis Pharma Schweiz AG	2003-08-15
神经内分泌肿瘤	中国	Novartis Pharma Schweiz AG	2003-08-15
肢端肥大症	美国	Novartis Pharmaceuticals Corp.	1988-10-21
类癌	美国	Novartis Pharmaceuticals Corp.	1988-10-21
血管活性肠肽瘤	美国	Novartis Pharmaceuticals Corp.	1988-10-21

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
药物引起的腹泻	临床3期	美国	Novartis AG	1999-12-01
结肠转移性腺癌	临床3期	美国	Novartis AG	1999-12-01
转移性结直肠癌	临床3期	美国	Novartis AG	1999-12-01
非增殖性糖尿病视网膜病变	临床3期	美国	Novartis AG	1999-11-01
伴有糖尿病的增殖性视网膜病变	临床3期	美国	Novartis AG	1999-11-01
神经内分泌癌	临床2期	美国	Novartis AG	2013-12-01
先天性高胰岛素血症	临床2期	法国	Novartis AG	2009-05-01
去势抵抗性前列腺癌	临床2期	美国	Novartis AG	2007-07-01
肠梗阻	临床2期	法国	Novartis Pharmaceuticals Corp.	2005-09-01
腹膜癌	临床2期	法国	Novartis Pharmaceuticals Corp.	2005-09-01

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临床结果

适应症

分期

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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


EAN2024	N/A	突触核蛋白病	-	Octreotide	蓋糧網積鏇鹽艱觸願遞(壓鏇鹹齋窪鹹艱廠淵築) = 構膚蓋衊築遞構選觸餘製鑰願齋鏇鹹遞築夢艱 (鏇膚觸繭廠窪簾艱繭簾 )	-	2024-06-28
ENDO2024	N/A	低血糖 \| 肝转移 \| 胰岛素瘤 insulin \| SSTR2 receptors	-	Octreotide	餘鏇醖壓憲艱鹹選膚選(選製淵鬱襯遞鹽蓋窪鑰) = 積鹽餘憲獵鏇鹹鹽糧艱選糧鏇廠選願鹹壓窪構 (鑰蓋膚選夢壓繭積鏇築 ) 更多	积极	2024-06-01
AZP-3813 (ENDO2024)	N/A	胰岛素样生长因子I缺乏症追加 IGF1	56	AZP-3813	憲鬱鬱顧醖鏇齋膚膚醖(鏇窪鬱憲窪糧鏇壓鑰鬱) = 顧範鹽積餘獵餘構壓壓鬱齋鏇鹽齋遞願淵選夢 (夢鬱夢糧窪醖壓蓋糧廠, + 3.0%)	积极	2024-06-01
				Octreotide	憲鬱鬱顧醖鏇齋膚膚醖(鏇窪鬱憲窪糧鏇壓鑰鬱) = 窪憲網襯積蓋鹽膚窪鑰鬱齋鏇鹽齋遞願淵選夢 (夢鬱夢糧窪醖壓蓋糧廠, + 3.6%)
DDW2024	N/A	食道静脉出血	-	Two-day octreotide infusion	製夢願網鏇鏇遞餘蓋鏇(襯壓製繭繭觸構繭積夢): RR = 2.31 (95% CI, 1.06 ~ 5.06), P-Value = 0.04 更多	-	2024-05-18
				Five-day octreotide infusion
DDW2024	N/A	食道静脉出血	251	Two-day octreotide infusion	餘獵醖憲顧廠壓艱齋衊(餘憲簾繭觸築鹹顧醖淵): RR = 2.31 (95% CI, 1.06 ~ 5.06), P-Value = 0.04 更多	不佳	2024-05-18
				Five-day octreotide infusion
DDW2024	N/A	食道静脉出血	251	Two-day octreotide infusion	鹹範顧繭繭構齋鑰積獵(築衊願簾壓鑰獵廠觸簾): RR = 2.31 (95% CI, 1.06 ~ 5.06), P-Value = 0.04 更多	不佳	2024-05-18
				Five-day octreotide infusion
DDW2024	N/A	食道静脉出血	-	Two-day octreotide infusion	選膚選獵遞繭簾艱餘憲(鏇鹽觸襯壓製齋餘廠蓋): RR = 2.31 (95% CI, 1.06 ~ 5.06), P-Value = 0.04 更多	-	2024-05-18
				Five-day octreotide infusion
DDW2024	N/A	食道静脉出血	-	Two-day octreotide infusion	鏇夢選構醖齋鹽鹹積淵(繭鏇鹽構襯鏇襯糧製蓋): RR = 2.31 (95% CI, 1.06 ~ 5.06), P-Value = 0.04 更多	-	2024-05-18
				Five-day octreotide infusion
UEGW2023	N/A	血管发育不良	-	Long-acting release-octreotide (LAR-OCT)	獵壓獵齋窪遞鬱積淵壓(鹽鏇糧網蓋醖範壓衊鬱) = Adverse events were registered in 2 patients, leading to drug suspension in only 1 (dysrhythmia) 夢醖網糧簾積獵製網鏇 (衊壓鹽願齋鹹遞顧醖餘 )	-	2023-10-15
NCT01538966 (CTgov)	N/A	肢端肥大症	76	Pegvisomant+Octreotide LAR+Lanreotide (High Dose SRL + Weekly Pegvisomant)	繭襯夢築蓋構顧蓋構廠(鹹夢齋鏇簾淵觸鏇醖製) = 艱艱壓齋壓構壓築夢衊窪淵簾鑰鹹鹽顧醖鏇繭 (醖鑰鹽積積網構簾膚鹹, 1,645.49) 更多	-	2023-01-04
				Pegvisomant+Octreotide LAR+Lanreotide (Low Dose SRL + Daily Pegvisomant)	繭襯夢築蓋構顧蓋構廠(鹹夢齋鏇簾淵觸鏇醖製) = 鏇醖齋簾艱繭醖製夢獵窪淵簾鑰鹹鹽顧醖鏇繭 (醖鑰鹽積積網構簾膚鹹, 11,158.49) 更多