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2026-01-01

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2025-08-31

申办/合作机构

The University of Alabama at Birmingham

[+1]

NCT06974344

/ Not yet recruiting临床4期IIT

Randomized Controlled Trial Protocol Comparing Splenic Artery Ligation Versus Octreotide for Portal Flow Modulation (SCALOP) in Living Donor Liver Transplantation

The goal of this clinical trial is to compare two treatments for regulating blood flow in small liver grafts during living donor liver transplantation (LDLT). The main questions it aims to answer are:
* Is octreotide (a medication) as effective or better than splenic artery ligation (surgery) in reducing complications after transplantation?
* Which treatment better controls blood flow while causing fewer side effects?
Researchers will compare octreotide (given through an IV) to splenic artery ligation (performed during surgery) to see which approach works best for patients receiving small liver grafts.
Participants will:
* Be randomly assigned to receive either octreotide or splenic artery ligation during their transplant surgery
* Have their liver blood flow monitored closely during and after surgery
Be followed for 90 days and 1 year to track complications, hospital stay, recovery, and survival.
This study may help doctors choose safer, more effective treatments for patients needing small liver grafts.

开始日期2025-06-01

申办/合作机构

King Faisal Specialist Hospital & Research Centre

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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4,033

项与醋酸奥曲肽相关的文献（医药）

2025-07-01·Clinical Pharmacology in Drug Development

Pharmacokinetic and Bioequivalence Evaluation of Prolonged‐Release Octreotide Acetate Microspheres in Healthy Human Subjects

Article

作者: Hu, Haixun ; Fu, Yao ; Cao, Yu ; Hao, Chenxi ; Li, Yanzhi ; Yang, Qingmin ; Wang, Chenjing ; Liu, Yanping ; Lv, Zhaoguo ; Gu, Xingli ; Sun, Yanhua ; Li, Xin

Abstract:

Somatostatin analogs such as octreotide have been used in the treatment of acromegaly in the past decades, due to their efficacy in relieving symptoms and lowering growth hormone and insulin‐like growth factor 1 levels. Herein, the pharmacokinetic (PK) profile and safety of generic (test product) octreotide acetate microspheres and brand name (reference product) octreotide acetate microspheres in healthy volunteers were compared to assess the bioequivalence. Healthy volunteers were randomized 1:1 to receive single doses of the test product and reference product, respectively. Blood samples of each patient were collected at specific time intervals over an 82‐day period. Plasma drug concentrations were tested. The PK parameters were analyzed and compared. Analysis of variance on log‐transformed primary PK parameters was applied to analyze the bioequivalence between the test and reference product. The bioequivalence margin was 80%‐125%. The PK parameters between the 2 groups were numerically similar. All 90% confidence intervals of the geometric mean ratio for the primary PK parameters fell within 80%‐125%, confirming the bioequivalence of the 2 drugs. In this study, 172 (73.9%) adverse events, including 1 (0.4%) non‐treatment‐related serious adverse event in the test group, were reported. The test product is bioequivalent to the reference product with acceptable safety. The octreotide acetate microspheres provided by 2 sponsors are alternative products.

2025-05-01·PANCREATOLOGY

Somatostatin analogs for resectable pancreatic neuroendocrine tumors in high-risk surgical patients: Data from a single-center cohort

Article

作者: Landoni, Luca ; Cingarlini, Sara ; Corvino, Gaetano ; Gronchi, Federico ; Marchetti, Alessio ; Malleo, Giuseppe ; Casciani, Fabio ; Salvia, Roberto ; Cattelani, Alice ; Fontana, Michele ; Maistri, Giulia ; De Robertis Lombardi, Riccardo ; D'Onofrio, Mirko ; Paiella, Salvatore

OBJECTIVES:

To evaluate the use of long-acting somatostatin-analogs (SSA) for treating non-advanced, resectable pancreatic neuroendocrine tumors (PNETs) with indications to surgery, in high-risk patients who were not candidates for surgery.

METHODS:

Patients diagnosed with histology-proven, non-advanced G1/low-G2 68Ga-TC/PET-positive PNETs >20 mm who did not undergo surgery due to comorbidities/old age/high-risk surgical profile, which were treated with SSA at a single, high-volume institution were included. The efficacy of SSA was evaluated using the analysis of tumor growth rate (TGR). "Negative TGR_Tx-TpreSSA" was defined as the first time point after the initiation of SSA when a negative TGR_Tx-TpreSSA was observed.

RESULTS:

Between 2014 and 2024, 20 patients were treated with long-acting SSA. The median age was 76 (IQR 72-80), and the median ASA score was 3 (IQR 3-3). Fifteen patients (75 %) received Lanreotide, and five (25 %) octreotide acetate (Sandostatin® LAR). The median overall survival was 68.5 months (IQR 60-99). In four patients (20 %), SSA were interrupted when the tumor had shrunk below 2 cm. In one of them, SSA reintroduction was necessary due to disease progression (after 14 months). In two patients (10 %), the treatment was interrupted due to side effects. In one of these, the disease progressed until death at 87 years old. At the last follow-up, sixteen patients were alive, 3 had died (1 death of disease), and 13 were receiving SSA. T2 PNETs presented a significantly faster response to SSA therapy compared to T3 (Median time to "Negative TGR_Tx-TpreSSA": 6 [95 % CI 5, na] vs 52 [95 % CI 19, na] months, respectively; p = 0.0092) CONCLUSION: In patients at high surgical risk, with localized, resectable, G1 or low-G2, 68Ga-TC/PET-positive PNETs >20 mm, SSA can obtain disease control with a manageable safety profile.

2025-01-10·JOURNAL OF ORGANIC CHEMISTRY

Synthesis and Application of 1-[¹⁸F]Fluoro-4-isothiocyanatobenzene for Radiofluorination of Peptides in Aqueous Medium

Article

作者: Gundam, Surendra Reddy ; Callstrom, Mathew R. ; Pandey, Mukesh K.

Conjugation of radiofluorinated prosthetic groups to primary amines of peptides in an aqueous medium is still considerably challenging. Herein, we report a one-pot cascade synthesis of 1-[¹⁸F]fluoro-4-isothiocyanatobenzene ([¹⁸F]2d), an isothiocyanate-functionalized prosthetic group for radiolabeling of various peptides in aqueous medium. The developed compound [¹⁸F]2d was synthesized in >99% radiochemical purity with 22.9 ± 3.8% (n = 12) decay-corrected yield having molar activity of 0.65 ± 0.19 (n = 12) GBq/μmol. Various clinically important peptides including prostate-specific membrane antigen vector, octreotide acetate, biotin analogue, Arg-Gly-Asp analogue, and bradykinin were successfully conjugated with [¹⁸F]2d in an aqueous medium in a good to moderate radiochemical yield. The overall synthesis of [¹⁸F]2d and its conjugation with a peptide take around 155 min, including purification.

343

项与醋酸奥曲肽相关的新闻（医药）

2025-09-05

·生物制药小编

Q2百济股东Baker Bros的新建仓的11家biotech

在上一篇文章中我们介绍了百济股东Baker Bros Q2清仓的多家Biotech，本文将围绕Baker Bros Q2新建仓的多家Biotech展开阐述。 1.Viridian Therapeutics Viridian Therapeutics主打的开发甲状腺眼病（TED）和一些自免疾病。核心管线是IGF-1R单克隆抗体VRDN-001（veligrotug）这家公司最近预报了多个下半年的里程碑。这或许是Baker Bros新建仓该公司的理由。一方面是核心管线VRDN-001的日本权益授权给了Kissei Pharmaceutical。另外一方面今年下半年公司还打算向FDA提交VRDN-001的上市申请。另外一款管线FcRn抑制剂VRDN-006将在2025年第三季度公布健康志愿者临床数据。公司目前持有5.634亿美元现金头寸，不过现金消耗速度较快，能维持现金流赛道到2027年上半年。 2.Blueprint Medicines Corporation Blueprint Medicines Corporation在今年6月2日被赛诺菲收购，Baker Bros可能看中了收购的溢价进行布局，公司最后在7月17日被赛诺菲正式收购，理论上，应该能在Q3的清仓名单中看到Baker Bros的实际收益。抛开收购的布局不谈，Blueprint Medicines本身已有上市管线Ayvakit/Ayvakyt（avapritinib），已获批用于治疗胃肠道间质瘤（GIST）和系统性肥大细胞增多症（SM）以及伴有血液肿瘤的SM（SM-AHN）和肥大细胞白血病（MCL），2024年销售额达4.79亿美元，2025年Q1销售额约1.5亿美元。 Ayvakit是首个且目前唯一获批用于晚期和惰性系统性肥大细胞增多症（ASM和ISM）的药物，填补了这项罕见病市场多年无人问津的空白，这或许是赛诺菲收购该公司的主要原因。值得一提的是这家公司在国内的合作方是基石药业，公司被收购的消息同时带动了当天基石的股价。 3.Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals或许是Sarepta事件的最大受益人，在2024年11月时，Sarepta 和Arrowhead签订了多项合作协议，协议内容包括：Sarepta支付5亿美元首付款及3.25亿美元股权投资，获得七项在研项目的权益。根据协议条款，Sarepta需在未来五年内每年支付5000万美元，并针对DM1试验进展支付3亿美元里程碑款项。可没想到，还没过1年呢，Sarepta就暴雷了，现金牛基因治疗出现患者死亡，商业化全线停止，公司背负10亿美元债务，外界最开始担心Sarepta付不起里程碑付款，Arrowhead会亏，然而后来事实证明，Sarepta是打算将战略全部倚靠在Arrowhead身上了，Sarepta干脆把之前投资Arrowhead的股权卖了大半来抵消付款，开发策略和战略侧重也将Arrowhead作为救命稻草。 11月时，Sarepta通过子公司购买Arrowhead的11,926,301股普通股。当时股权投资的定价为每股27.2507美元，而现在出售股票的价格低于20美元/每股，Sarepta是亏麻了。 Arrowhead成为了整个事件的最大赢家。 4.Cidara Therapeutics Cidara Therapeutics这家公司主打开发抗感染药物，Baker Bros布局这家公司的原因可能和该公司抗病毒偶联药物（AVC）CD388的临床试验有关。公司在2025年6月发布了新闻稿，宣布CD388的II期试验达到所有主要和次要终点，所有剂量组均显示显著的保护效果，且安全性良好。单剂量CD388（450mg、300mg、150mg）在24周内预防症状性流感的有效性分别为76.1%、61.3%和57.7%，显著高于安慰剂组（2.8%）这一消息直接导致公司在2025年6月完成4.025亿美元公开募资（每股44美元），缓解了公司一直以来的资金缺口。目前基于II期临床数据，公司已向FDA提交End of Phase 2会议请求，计划2026年春季启动III期试验，重点针对存在临床未满足状态的高风险人群（如免疫缺陷患者）。 5.Arcellx Arcellx是在这名单中少数的细胞治疗公司，该公司被Baker bros建仓的原因可能来自于该公司BCMA CAR-T管线anito-cel的积极临床数据。这家公司从技术路线角度来说，主打的是安全性和成本优势。其ddCAR技术平台采用的是一种小型、稳定的结合域（仅8kDa），可替代传统CAR-T中的单链可变片段（scFv），转染效率更高，并降低非特异性激活。另外由于无二硫键和糖基化修饰，适合大规模生产。今年5月公司公布anito-cel II期iMMagine-1的最新临床数据，数据相当积极，结果显示在12.6个月的中位随访中，ORR为97%，CR/sCR为68%；6个月、12个月和18个月的PFS率分别为92%、79%和66%，更未观察到迟发性神经毒性。由于公司在2023年被吉利德旗下的Kite投资，因此anito-cel的成败可以说直接和BCMA CAR-T的市场竞争偶联，如果数据呈现出比较优势，或许是强生/传奇Carvykti的强劲竞争对手。公司目前手握5.376亿美元现金、现金等价物和有价证券，足够维持运营到2028年。 6.Nuvalent Nuvalent主打的是开发激酶靶点（如ROS1、ALK、HER2等）来治疗癌症，公司被Baker Bros建仓可能主要和核心管线Zidesamtinib（NVL-520）和Neladalkib（NVL-655）的里程碑相关。 Zidesamtinib是第三代ROS1靶向药，可针对ROS1突变耐药以及脑转移患者。目前该药物针对ROS1阳性NSCLC的NDA提交已启动（预计2025Q3完成），其ARROS-1试验数据显示，在TKI预治疗患者中ORR达44%，且对劳拉替尼/瑞波替尼耐药患者有效，填补了ROS1耐药后治疗空白。公司预计在2026年获批。 Neladalkib是一种ALK酪氨酸激酶抑制剂，ALKOVE-1试验数据显示，在TKI预治疗ALK阳性NSCLC患者中深度缓解（CNS穿透性优异），且无TRK相关神经毒性，安全性优势显著。目前该药物的III期试验选的是头对头阿来替尼（ALK NSCLC标准治疗常用药），一旦成功，将奠定Neladalkib作为一线标准疗法的地位。公司预计在Q4发布ALKOVE-1的顶线数据。另外，10月的ESMO大会上，公司预计将发布该药物在其他癌种中的疗效数据。截至2025Q2，公司现金、现金等价物及有价证券为10亿美元。可以期待Zidesamtinib的具体商业化进程。 7.Spyre Therapeutics Spyre Therapeutics主打开发炎症性肠病（IBD）及其他免疫介导疾病的新型抗体疗法。目前核心管线有四，分别为α4β7单抗 SPY001，TL1A单抗SPY002，SPY072，抗IL-23 p19单抗 SPY003。今年下半年到明年上半年，公司将迎来数个项目的重点里程碑，决定公司的具体前途。 2025年Q4该公司将发布SPY003（抗IL-23 p19单抗）在健康志愿者中的中期数据，验证其半衰期延长技术（NHP模型中半衰期达30天）和安全性。若数据积极，将推进至Phase 2试验。 2026年，公司将发布SPY001、SPY002、SPY003单药在UC患者中的临床数据，以及发布SPY072在RA患者中的12周数据。财务状况还不错。截止Q2，公司现金及现金等价物为5.266亿美元，预计支撑至2028年。 8.Crinetics Pharmaceuticals Crinetics主打的是内分泌疾病药物，主要针对肢端肥大症、神经内分泌肿瘤（NETs）、先天性肾上腺增生症（CAH）等疾病开发口服小分子药物。核心管线是针对肢端肥大症的Paltusotine（CRN00808），这是首个口服、非肽类SST5激动剂，目前肢端肥大症标准治疗常用的是SST多肽类药物如奥曲肽和长效制剂，一方面不是口服的可能不便捷，长期使用副作用强，注射部位常有反应。虽然2020年时强生的口服用奥曲肽Mycapssa上市，缓解了该领域存在的巨大未满足临床需求，2024年销售额2.4亿美元，然而其本身仍然有可能引发胆囊结石、胆道疾病，一天内的服用频率高也容易导致患者忘服，漏服，还需要配合进餐时使用来提升生物利用度。而Paltusotine无严重不良事件（SAE），无需饮食限制，可以大幅提升患者依从性。上市后可能是Mycapssa的强劲竞争对手。 2025年9月公司将迎来FDA的PDUFA日，这对于Crinetics至关重要，可能是Baker Bros看准建仓的理由。目前公司截止Q2现金储备12亿美元，足够支撑Paltusotine上市。 9.CytomX Therapeutics Cytomx Therapeutics是前抗体先驱，这是一种条件激活的抗体平台，前抗体技术通过掩蔽抗体活性，使其在肿瘤微环境中特异性激活，从而减少对正常组织的毒性。可惜的是，这家公司的技术转化一直不是很顺利，多项管线如CX-2009，CX-904相继折戟，被大厂抛弃。不过最近它似乎时来运转了，公司EpCAM ADC CX-2051在末线结直肠癌中取得优异疗效。2026年Q1公司将更新CX-2051的I期数据，这对于仅剩下两条管线的公司来说是个好消息。或许Baker Bros看准了公司CX-2051的未来发展。 CytomX目前现金、现金等价物和投资合计1.581亿美元。 10.Agios Pharmaceuticals Agios Pharmaceuticals也是一家成立很久的Biotech了，2007年成立，2013年上市。如今公司已经处于重要的商业化节点上，这关乎公司业务能否从小的适应症做大做强。 2025年9月7日，PYRUKYND®（mitapivat）将迎来FDA的PDUFA日，该药物本身是一款治疗丙酮酸激酶缺乏症（PKD）的丙酮酸激酶（PK）激动剂，若获批将扩大适应症至非输血依赖性和输血依赖性α/β地中海贫血，成为全球首个针对该适应症的口服疗法。如欧盟，沙特，阿联酋等国同步推动的审查工作也值得关注。另外，今年年底，公司还将发布mitapivat在镰刀细胞贫血（SCD）患者中疗效的顶线数据也值得关注，这关乎适应症扩展，2026年有望实现商业化投放。公司目前现金储备13亿美元，可以期待商业化转化后的成果。 11.Rapport Therapeutics Rapport Therapeutics算是这群名单中较为新兴的公司了，2022年才成立，主打开发CNS疾病。Rapport的创始人David Bredt 对RAP（受体相关蛋白）的功能进行了开创性研究，发现TARPγ8等RAP在脑内的选择性表达。基于此，公司开发了RAP技术平台，能够设计出特异性结合这些蛋白的小分子药物。目前核心管线为RAP-219，这是一款AMPA受体（AMPAR）负性变构调节剂（NAM），可选择性靶向TARPγ8蛋白，适应症为癫痫。目前针对耐药性局灶性发作癫痫患者的RAP-219 2a期试验已完全注册，并有望在2025年9月获得顶线结果。这是公司最近最关键的一项临床里程碑。目前公司截止Q2的现金、现金等价物和短期投资为2.604亿美元，然而只够运营到2026年年末，对于Rapport Therapeutics来说，9月的顶线结果可能对公司整体运营产生重要影响。总结总的来说，可以看出，Baker Bros新建仓的Biotech在今年下半年到明年上半年均有很明显的重点里程碑。这或许是我们能从中窥得的基本逻辑。参考来源：各公司官网注：本文不具有任何投资建议或医学意见。

并购基因疗法申请上市

2025-09-04

·药事纵横

基于FluidCrystal 技术！Camurus的Oczyesa先获欧盟许可再拿英国MHRA批文，革新肢端肥大症维持治疗

2025年8月28日，Camurus公司宣布英国药品和医疗保健产品监管局（MHRA）已批准 Oczyesa（奥曲肽皮下储库制剂）的上市许可，该药品适用于对生长抑素类似物治疗有反应并耐受的成年肢端肥大症患者的维持治疗。 Oczyesa®（CAM2029）概述 Oczyesa 是首款每月一次给药的奥曲肽皮下注射制剂，已被证实能有效且持续地控制肢端肥大症，患者可通过自动注射笔自行给药.此前，欧盟委员会已于2025年 6月30日授予 Oczyesa欧盟上市许可。其还未获美国 FDA 批准，按现有进度预计于2026年初有审批结论，此前它还获FDA授予用于治疗常染色体显性多囊性肝病的孤儿药资格。 Oczyesa采用Camurus公司专有的 FluidCrystal（流体晶体）技术制备。该产品设计为每月一次便捷皮下自行注射，使用带有隐藏式细针头的预充式自动注射笔，该产品可在室温下储存，无需冷藏。针对肢端肥大症的 Oczyesa临床项目包含7项临床试验，其中包括4项1期研究、1项2期研究，以及ACROINNOVA临床项目中的两项3期研究。数据显示，与目前已获批的长效肌内注射（IM）奥曲肽微球相比，Oczyesa的生物利用度约提高5倍。ACROINNOVA 1 研究表明，与安慰剂组相比Oczyesa 治疗组中胰岛素样生长因子-1（IGF-1）水平达到正常范围的患者比例显著更高；ACROINNOVA 2 研究则证实，在52周的治疗期内，患者的平均 IGF-1水平持续稳定，症状持续减轻。此外，该研究还显示与基线时的标准治疗（SoC）相比，患者接受Oczyesa治疗52周后，在症状、生活质量及治疗满意度评分方面均有改善。Oczyesa 最常见的不良反应包括胃肠道疾病、神经系统疾病、肝胆疾病、代谢与营养障碍，以及注射部位反应。 Camurus公司的FluidCrystal技术 FluidCrystal 技术由一种含有溶解活性成分的脂质液体组成，可以使用带有细针头或注射笔的注射器轻松皮下注射。与组织中的液体接触后，脂质溶液转化为液晶凝胶，有效包载活性成分。随着液晶基质在组织中逐渐降解，药用化合物会缓慢释放，并且根据成分的不同，释放可以控制在几天到几周或几个月之间。FluidCrystal 适用于小分子、肽和蛋白质药物。 Camurus公司的采用FluidCrystal技术研发上市的制剂包括用于治疗阿片类药物依赖的每周一次/每月一次的丁丙诺啡缓释注射液，以及一种基于脂类的不含防腐剂的益普舒口腔凝胶，该凝胶接触到口腔黏膜时会自动聚集排列，在5分钟内迅速形成一层保护膜，对口腔敏感和溃疡上皮形成机械性保护，从而缓解疼痛，疗效长达8小时。在研药物包括与礼来合作的长效胰岛素药物，针对遗传性肥胖症开发的每周一次的setmelanotide 制剂等。目前，Oczyesa 针对胃肠胰神经内分泌肿瘤（GEP-NET）和多囊肝病（PLD）的研发仍在推进，同时美国FDA 的审批也有望在2026年初迎来结果。随着这些进程的推进，这款依托 FluidCrystal 技术的创新制剂，未来或将覆盖更多适应症、惠及更广泛患者群体。而 Camurus 公司凭借该技术平台也将持续强化其在长效药物研发领域的竞争力，为全球慢性疾病治疗领域注入更多创新动力。信息来源：Camurus官网立即扫码加入药事纵横交流群

孤儿药临床2期上市批准

2025-08-28

·PRNewswire

Camurus announces approval of Oczyesa® for the treatment of acromegaly in the UK

LUND, Sweden, Aug. 28, 2025 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Oczyesa®, octreotide subcutaneous depot, marketing authorization for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.1 "Oczyesa, the first once-monthly subcutaneous octreotide treatment, has shown effective and sustained control of acromegaly and can be self-administered by patients using an autoinjector pen", says Fredrik Tiberg, President & CEO, CSO at Camurus. "Camurus plans to launch the treatment in the UK in the fourth quarter of 2025." The MHRA's marketing authorization of Oczyesa is based on the results from a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies within the ACROINNOVA program. Oczyesa is formulated using Camurus' proprietary FluidCrystal® technology. The product is designed for convenient once-monthly, subcutaneous self-administration using a pre-filled autoinjector pen with a hidden, thin needle. Oczyesa was granted marketing authorization in the EU by the European Commission on 30 June 2025. For more information Fredrik Tiberg, President & CEO Tel. +46 (0)46 286 46 92 [email protected] Fredrik Joabsson, Chief Business Development Officer Tel. +46 (0)70 776 17 37 [email protected] About acromegaly Acromegaly is a rare, progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.2 Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.3,4 The prevalence of acromegaly is estimated to about 60 cases per million.5 About Oczyesa® (CAM2029) Oczyesa® (CAM2029) is a ready-to-use, long-acting subcutaneous depot of octreotide indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogs.1 The product is stored at room temperature and should not be refrigerated. The CAM2029 clinical program for acromegaly comprises seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide.6 The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to placebo. The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study. Furthermore, the study showed improvements in symptoms, quality of life, and treatment satisfaction scores after 52 weeks of treatment with Oczyesa compared to standard of care (SoC) at baseline.7,8 The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.1 CAM2029 is under development for two additional chronic and severe disease indications: gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD). About Camurus Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund, Sweden. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit and LinkedIn. References Oczyesa® SmPC. Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111. Fleseriu M., et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63. Summary of Product Characteristics, Sandostatin LAR 20 mg: Ferone, D., et al. J Clin Endocrinol Metab. Published 8 October, 2024. Press release 15 July, 2024: This information was submitted for publication at 4.45 pm CET on 28 August 2025. CONTACT: This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期上市批准寡核苷酸临床2期

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
肝肾综合征	临床3期	加拿大	Novartis AG	2005-10-01
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
肥胖	临床2期	美国	Novartis AG	2002-01-01

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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


MACRO Registry (ENDO2024)	N/A	肢端肥大症	230	Oral Octreotide Capsules (OOC)	獵壓鑰蓋範齋遞鬱淵憲(獵夢願淵醖淵糧鬱壓齋) = 遞蓋襯壓鏇壓憲鏇簾鬱壓襯範網簾簾構簾鏇憲 (窪網窪遞鹹襯網範網範, 0.8) 更多	-	2024-06-01
				Monotherapy with OOC	窪膚築齋鑰願襯範鏇鏇(繭構構齋淵觸獵衊繭餘) = 構蓋憲顧鑰鑰鑰構糧範衊構糧憲築顧築選獵餘 (製積鑰壓糧廠膚構餘壓 )
UEGW2023	N/A	血管发育不良	-	Long-acting release-octreotide (LAR-OCT)	糧積窪襯製構衊夢艱顧(窪淵築衊鬱簾觸選網壓) = Adverse events were registered in 2 patients, leading to drug suspension in only 1 (dysrhythmia) 壓廠憲鹹齋夢鏇鑰糧鬱 (網網繭憲糧選築鬱觸壓 )	-	2023-10-15
UEGW2022	N/A	-	-	Octreotide	糧襯窪網蓋壓範獵膚蓋(蓋網製範壓淵醖製製醖) = 願膚壓獵鏇構餘廠選繭衊壓餘艱糧醖膚齋簾夢 (遞範膚膚觸窪願艱製淵, -0.1 ~ 0.7) 更多	-	2022-10-09
				OCTREOTIDE (Standard Care)	糧襯窪網蓋壓範獵膚蓋(蓋網製範壓淵醖製製醖) = 齋鑰夢鏇襯積願膚齋憲衊壓餘艱糧醖膚齋簾夢 (遞範膚膚觸窪願艱製淵, 0.8 ~ 1.6) 更多
ESMO_GI2021	临床2期	二线	56	Lenvatinib + Octreotide acetate LAR	艱齋餘窪築積積膚簾簾(觸鹹構蓋鑰鬱築網廠衊) = 膚鑰膚齋鑰選鏇淵構簾範積鏇簾鏇憲餘構選選 (醖觸築網廠觸壓憲願餘 ) 更多	-	2021-07-03
MPOWERED (ENDO2021)	临床3期	肢端肥大症	146	Oral Octreotide Capsules (OOC)	鑰選窪鹽衊鏇積範窪夢(夢蓋觸艱夢淵衊鹽夢窪) = 糧鏇壓夢窪顧鏇餘鹹選夢範築壓範鏇選範簾獵 (鏇膚築淵顧夢齋繭壓鏇 ) 更多	积极	2021-05-03
				Injectable Somatostatin Receptor Ligands (iSRLs)	鑰選窪鹽衊鏇積範窪夢(夢蓋觸艱夢淵衊鹽夢窪) = 糧繭憲顧積願製築鹹觸夢範築壓範鏇選範簾獵 (鏇膚築淵顧夢齋繭壓鏇 ) 更多
MPOWERED (ENDO2021)	临床3期	维持 insulin-like growth factor I \| mean integrated growth hormone	146	Oral Octreotide Capsules (OOC)	鑰淵鏇鏇遞繭鑰餘壓齋(蓋積淵壓鹹選壓膚遞膚) = the OOC group did not experience injection site reactions 憲鏇夢壓網積鬱積鹽憲 (遞廠糧鹹鹽網鑰壓艱憲 )	积极	2021-05-03
				Injectable Somatostatin Receptor Ligands (iSRLs)
MPOWERED (ENDO2021)	临床3期	肢端肥大症	-	Oral Octreotide Capsules (OOC)	繭網顧繭範獵齋廠夢範(鏇製膚鹽繭衊積淵鏇淵) = 簾鑰鏇繭鬱壓醖齋蓋獵簾觸簾簾鏇醖顧築獵淵 (廠積膚鑰繭築鹹顧鹽遞 ) 更多	积极	2021-05-03
				Injectable somatostatin receptor ligands (iSRLs)	襯蓋蓋獵鏇鏇夢範齋膚(繭夢繭製鏇構遞範獵積) = 襯餘餘顧鹽鏇鹽淵鑰築憲網糧艱齋獵淵築鹽醖 (顧蓋齋襯鬱鹹蓋壓網淵 ) 更多
CHIASMA OPTIMAL (ENDO2020)	临床3期	肢端肥大症 IGF-I	56	Octreotide capsules	廠鬱衊夢衊餘獵鬱蓋願(襯糧觸廠糧鹽壓衊廠窪) = 60.7% 選醖範壓選鹽積鬱窪齋 (窪築獵遞繭鑰夢範願構 ) 更多	积极	2020-05-08
				Placebo
CHIASMA OPTIMAL (ENDO2020)	临床3期	肢端肥大症	56	Octreotide capsules	夢顧簾鹹憲築淵願繭願(範餘積範顧窪膚積獵鹹) = GI disorders were the most common TEAE, reported in 64% of all patients (36/56) and at similar rates between octreotide capsule (68%) and placebo groups (61%) 蓋糧襯廠醖蓋觸壓遞繭 (積繭襯選夢壓艱範獵製 ) 更多	积极	2020-05-08
				Placebo