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更新于：2026-05-26

Lutetium (177 Lu) Vipivotide Tetraxetan

镥[177Lu] 特昔维匹肽

更新于：2026-05-26

概要

基本信息

药物类型

多肽偶联核素、治疗用放射药物

别名

177-Lutetium-PSMA-617(RadioMedix, Inc.)、[Lu-177] vipivotide tetraxetan、Lu-177-PSMA-617 Lutetium-177-PSMA-617

+ [16]

靶点

PSMA

作用方式

抑制剂

作用机制

PSMA抑制剂(前列腺癌特异性膜抗原抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病消化系统疾病+ [2]

在研适应症

PSMA阳性去势抵抗性前列腺癌激素依赖性前列腺癌转移性前列腺癌+ [17]

非在研适应症-

原研机构

RadioMedix, Inc.

在研机构

Advanced Accelerator Applications SA

Novartis Pharmaceuticals Canada, Inc.

Novartis Pharmaceuticals Corp.

+ [13]

非在研机构-

权益机构

中国同辐股份有限公司

Endocyte, Inc.

原子高科股份有限公司

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (2022-03-23),

PSMA阳性去势抵抗性前列腺癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、优先审评 (中国)、孤儿药 (韩国)

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结构/序列

分子式C49H68LuN9O16

InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K

CAS号1703749-62-5

使用我们的ADC技术数据为新药研发加速。

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关联

项与镥[177Lu] 特昔维匹肽相关的临床试验

NCT06852820

/ Recruiting临床2期IIT

A Pilot Study of 68Ga-PSMA-11 PET-directed Radioligand Therapy in Patients With Metastatic Hepatocellular Carcinoma (HCC)

The purpose of this study is to look at the effects (good and bad) of a drug called 177Lu-PSMA-617 (also known as the study drug) when given to participants who have prostate specific membrane antigen (PSMA) positive liver cancer.

开始日期2026-06-01

申办/合作机构

The Case Comprehensive Cancer Center

[+1]

NCT06959433

/ Not yet recruiting临床3期IIT

Safety and Efficacy of Lu-177 PSMA Treatment in Metastatic Clear Cell Renal Carcinoma

Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest.
PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.

开始日期2026-05-01

申办/合作机构

Ankara University

NCT07550517

/ Not yet recruiting临床2期IIT

A Phase II Non-blinded Randomized Study Comparing External Beam Radiotherapy (EBRT), 177Lu-PSMA-617, and Short Term Androgen Deprivation Therapy (ADT) Versus EBRT and Long Term ADT in Men With High Risk Localized Prostate Cancer

This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.

开始日期2026-04-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

100 项与镥[177Lu] 特昔维匹肽相关的临床结果

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100 项与镥[177Lu] 特昔维匹肽相关的转化医学

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100 项与镥[177Lu] 特昔维匹肽相关的专利（医药）

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639

项与镥[177Lu] 特昔维匹肽相关的文献（医药）

2026-07-01·APPLIED RADIATION AND ISOTOPES

FAERS based pharmacovigilance study and network pharmacology analysis of Lutathera and Pluvicto

Article

作者: Zhang, Shilin ; Li, Shouying ; Feng, Jiaxin

BACKGROUND:

Lutetium Lu 177-based agents Lutathera (targeting SSTR in GEP-NETs) and Pluvicto (targeting PSMA in mCRPC) exhibited significant efficacy in clinical trials, yet real-world safety validation remains imperative.

METHODS:

We performed disproportionality analysis on FAERS reports and applied network pharmacology to identify drug targets, construct protein-protein interaction networks, and elucidate adverse event mechanisms through KEGG pathway enrichment.

RESULTS:

Shared adverse reactions for both agents include pleural effusion (ROR 1.68, 95%CI: 1.03-2.74) and pulmonary embolism (ROR 1.06, 95%CI: 0.61-1.82). Lutathera shows higher risks of gastrointestinal toxicities such as intestinal obstruction (ROR 5.33, 95%CI: 3.82-7.43) and infection-related events like liver abscess (ROR 26.16, 95%CI: 15.73-43.51). Pluvicto is associated with subdural hematoma (ROR 6.91, 95%CI: 3.82-12.5) and loss of libido (ROR 16.29, 95%CI: 10.88-24.38). KEGG pathway enrichment analysis further delineates mechanistic divergence, revealing significant target enrichment in peptide GPCRs (-log10(P) = 62.44) and neuropeptide signaling pathway (-log10(P) = 23.63) for Lutathera versus predominant involvement of proteasome (-log10(P) = 80.59) and peptide ligand-binding receptors (-log10(P) = 22.84) for Pluvicto.

CONCLUSION:

This FAERS analysis characterizes agent-specific safety profiles, informing pharmacovigilance strategies. Mechanistic profiling of adverse drug reactions optimizes evidence-based treatment, enhancing medication safety and refining benefit-risk profiles in clinical practice.

2026-06-01·JOURNAL OF CONTROLLED RELEASE

Radiolabeled cyclic peptides in precision oncology: Current advances and future perspectives

Review

作者: Ai, Dingding ; Ge, Shushan ; Sang, Shibiao ; Shi, Jinyu ; Zhang, Bin ; Li, Jihui ; Deng, Shengming

In recent years, the regulatory approval of radiopharmaceuticals such as [¹⁷⁷Lu]Lu-DOTATATE and [¹⁷⁷Lu]Lu-PSMA-617, alongside their diagnostic counterparts [⁶⁸Ga]Ga-DOTATATE and [⁶⁸Ga]Ga-PSMA-11, has propelled theranostics into the clinical mainstream, marking a transformative shift in nuclear medicine and precision oncology. Amid this dynamic progress, cyclic peptides have emerged as indispensable vectors for targeted delivery in nuclear medicine, owing to their exceptional resistance to enzymatic degradation, superior conformational stability, and high receptor-binding affinity. These properties endow radiolabeled cyclic peptides with favorable pharmacokinetics, elevated tumor accumulation, and excellent target-to-background contrast, features that have enabled their widespread application in imaging and therapy targeting somatostatin receptors, integrins, FAP, PD-L1, and other tumor-associated biomarkers. With their molecular precision, structural versatility, and therapeutic adaptability, cyclic peptides are positioned at the forefront of next-generation radiopharmaceutical development. As the field continues to evolve toward increasingly personalized and molecularly targeted cancer therapies, radiolabeled cyclic peptides are poised to play a pivotal role in redefining the future landscape of radiotherapy.

2026-06-01·CLINICAL NUCLEAR MEDICINE

Outcome and Safety of Radioligand Therapy With [161Tb]Tb-PSMA-617 After Re-Progression in mCRPC Patients Previously Treated With [177Lu]Lu-PSMA-617

Article

作者: Bartholomä, Mark ; Hein, Connor ; Hoang, Sophia Phuong Thao ; Schaefer-Schuler, Andrea ; Speicher, Tilman ; Ezziddin, Samer ; Rosar, Florian ; Blickle, Arne ; Burgard, Caroline ; Bastian, Moritz B ; Maus, Stephan

Introduction::

To enhance the effectiveness of radioligand therapy (RLT), new prostate-specific membrane antigen (PSMA) targeting radiopharmaceuticals utilizing alternative radionuclides are under active investigation. One promising alternative to the established 177 Lu is the use of 161 Tb. A key advantage of 161 Tb is its emission of a higher proportion of low-energy conversion and Auger electrons, which may contribute to enhanced therapeutic effectiveness. This study provides a first exploratory evaluation of the efficacy and safety of [ 161 Tb]Tb-PSMA-617 in patients with progression after [ 177 Lu]Lu-PSMA-617, aiming to generate early clinical insights.

Methods::

The study included 15 patients with mCRPC, who were enrolled in the “prospective registry to assess outcome and toxicity of targeted radionuclide therapy in patients with mCRPC in clinical routine“ (REALITY Study; NCT04833517). All patients had received conventional PSMA RLT using [ 177 Lu]Lu-PSMA-617, which resulted in initial biochemical response (PSA decline ≥50%), followed by a biochemical relapse, prompting the re-initiation of PSMA RLT using [ 161 Tb]Tb-PSMA-617. Patients received a median of 3 (range: 2–7) cycles with mean administered activity of 5.4 ± 1.1 GBq and mean cumulative activity of 19.2 ± 6.4 GBq [ 161 Tb]Tb-PSMA-617. Treatment response was assessed both biochemically by serum PSA levels and through molecular imaging by total lesion PSMA (TLP) on [ 68 Ga]Ga-PSMA-11 PET/CT scans. Adverse events were assessed at baseline and follow-up using the “Common Terminology Criteria for Adverse Events“ (Version 5.0).

Results::

[ 161 Tb]Tb-PSMA-617 RLT showed response rates of 66.7% (10/15 patients) based on biochemical assessment and 86.7% (13/15 patients) based on molecular imaging assessment. Beginning with the initiation of [ 161 Tb]Tb-PSMA-617 RLT, the median progression-free survival (PFS) was 6.4 months, and the median overall survival (OS) was 15.5 months. In total, 6 CTCAE grade deteriorations from grade 2 to grade 3 or from grade 3 to grade 4 were observed. No discontinuation of PSMA RLT due to adverse events was reported.

Conclusions::

[ 161 Tb]Tb-PSMA-617 RLT emerges as a promising treatment option, demonstrating encouraging response rates, preliminary clinical outcomes, and a favorable safety profile as second-line RLT in progressing patients who previously benefited from [ 177 Lu]Lu-PSMA-617 RLT.

1,619

项与镥[177Lu] 特昔维匹肽相关的新闻（医药）

2026-05-26

·BioSpace

Niowave, fresh from Novartis deal, starts building $75M radioisotope plant

iStock/ Booblgum Having secured deals with AstraZeneca and Novartis, Niowave is constructing a second facility to meet rising demand for actinium-225, which can be used to develop next-generation radiopharmaceuticals. Niowave has started building a $75 million facility in Lansing, Michigan, to increase its capacity to make a radioisotope. The company already operates a site in Lansing. Adding a second dedicated production facility at the site will increase Niowave’s capacity to support growing global demand for actinium-225 and other medical isotopes. The company expanded its agreement to deliver actinium-225 to AstraZeneca in December and struck a deal to supply actinium-225 to Novartis in February. Niowave is installing multiple proprietary superconducting linear accelerators at its latest actinium-225 plant, which will also house processing and quality systems. The facility is scheduled to start operations in 2028 and create about 70 jobs in R&D, engineering and quality assurance. Radiopharmaceuticals The future of radiopharma is being built by nuclear geeks in SLC Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals. May 18, 2026 · 6 min read · Annalee Armstrong Read more The construction project is part of a broader effort boost actinium-225 production. Historically, Oak Ridge National Laboratory met demand for actinium-225 by making the radioisotope through the decay of thorium-229 left over from nuclear programs in the 1940s and 1950s. However, rising investment in actinium-225 drug development has necessitated the addition of new sources of the radioisotope. In recent years, companies such as AstraZeneca, Bristol Myers Squibb and Eli Lilly have invested in drug candidates based on the alpha-emitting radioisotope actinium-225. The choice of isotope differentiates the candidates from approved products such as Novartis’ Lutathera and Pluvicto, which deliver the beta emitter lutetium-177. Compared to lutetium-177, actinium-225 emits more energy over a smaller area. The differences extend to the supply chain, with the nuclear research reactor used to generate lutetium-177 unable to produce actinium-225. Shortages of actinium-225 drove BMS’ RayzeBio to pause a Phase 3 trial in 2024, Endpoints News reported. Since then, companies have invested in adding production capacity for the radioisotope. In the past two months alone, Cardinal Health has reported a significant expansion of its actinium-225 production capabilities at a site in Indianapolis, and TerraPower Isotopes has broken ground on a $450 million plant in Philadelphia that will make the radioisotope. Niowave’s deals with AstraZeneca and Novartis are part of a series of agreements that drug developers have formed in recent years to secure supplies of actinium-225. Bayer agreed to source the isotope from BWXT , Ionetix , NorthStar Medical Radioisotopes and PanTera between 2022 and 2024. Lilly invested in actinium-225 manufacturer Ionetix in 2024.

临床3期

2026-05-25

·医药智投

趋势丨药王之后，中国力量打开GLP-1新战局？

2026年的生物医药圈，ADC（抗体偶联药物）的内卷已成共识——热门靶点扎堆、临床同质化严重、资本审美疲劳。但就在市场苦于"找不到下一个差异化出口"时，核药（Radiopharmaceuticals）这条沉寂多年的冷僻赛道，却以一种近乎戏剧性的方式完成了"热启动"。治疗端的增长弹性远大于诊断端诺华用一组数字把天花板钉在了所有人眼前：Pluvicto（镥-177 PSMA）2025年全年销售额19.94亿美元，同比增长43%，成为史上增速最快的肿瘤靶向疗法之一。FDA更在2025年3月将其适应症向前线推进——从"化疗后"挪到了"ARPI后、化疗前"。这意味着放射配体疗法（RLT）不再只是终末期患者的"最后手段"，而是一个正在向前线治疗迁移的大品类。市场数据同样佐证了这一趋势：2025年全球放射性药物市场规模约95.2亿美元，2026年突破100.7亿美元，其中治疗性核药（RDC/PRC）的CAGR高达14.3%，远超诊断性核药的平缓增速。中国核药市场2026年预计达139.61亿元，产值同比增速约12%，且治疗端的增长弹性远大于诊断端。为什么偏偏是"此时"？三个变量同时成熟真实生物的选择并非拍脑袋式的赛道追逐，而是踩在三个正在同步成熟的结构性变量上： ① 全球商业化验证已经跑通 Pluvicto用不到三年时间证明了一件事：靶向放射性药物不仅能成药，还能形成数十亿美元的体量和40%+的持续高增长。当MNC们——BMS（收购RayzeBio布局锕-225）、阿斯利康（2026年3月宣布在广州黄埔建RDC生产基地）、拜耳（Xofigo后继管线）——开始用真金白银下注时，赛道已经从"概念验证期"进入了"军备竞赛期"。 ② 中国供应链与监管正在补齐短板这是最关键的底层变化。2025年6月，中核集团秦山核电基地商用堆产Lu-177正式供应市场，年辐照产能超万居里；2026年初，我国实现医用阿尔法同位素居里级量产，打破进口依赖。CDE也围绕放射性体内治疗药物陆续发布临床评价与风险管理指导原则。核素"有米下锅"+"合规框架清晰"，才让PRC从纸面设计变成可执行的IND路径。 ③ ADC内卷倒逼差异化，PRC仍是蓝海当国内ADC管线数以百计地涌向HER2、TROP2、CLDN18.2等几个靶点，临床资源的挤兑和支付端的疑虑同步上升。而PRC的核心逻辑——"诊断核素筛患者→治疗核素递送辐射"的诊疗一体化——在国内几乎没有玩家真正跑通全链路。真实生物锁定的GRPR更是连全球竞品都没有的处女地。从阿兹夫定的"应急商业化"到ZS-2004的"十年硬核创新"，这家河南公司的转身未必轻松——核药的时间线远比小分子漫长，IIT之后还有IND、临床、核素供应链爬坡、医院准入……但至少方向选在了产业演进的河流里，而不是在ADC的红海中随波逐流。高壁垒的代价是慢，但慢的背面，是别人进不来。部分信息来源转：deepseek 本公众号所刊发稿件来源于网络，仅用于交流使用，如有侵权请联系回复，我们收到信息后会在24小时内处理商务合作和转载请联系小编：18948782064

2026-05-25

·药时代

70亿美元！核药赛道最大并购来了？

出海机会来了！现征集天然免疫领域的口服小分子创新药，适应症为炎症或免疫，要求中美已申报IND或处于I期临床。需机制新颖、靶点明确、差异化显著，知识产权清晰，数据完整可快速推进临床。欢迎感兴趣的药企立即联系药时代BD团队！ BD@drugtimes.cn 2026年5月22日，据彭博社援引知情人士报道，由私募股权基金CapVest Partners控股的放射性药物企业Curium Pharma，已向纳斯达克上市公司Lantheus Holdings提出收购要约，交易估值高达约70亿美元。若这笔交易最终落地，将一举刷新2023年百时美施贵宝以41亿美元收购RayzeBio的纪录，成为全球核药行业史上规模最大的并购案。消息传出后，资本市场迅速作出反应。截止当日收盘，Lantheus股价应声上涨9.03%，股价强势突破100美元大关，总市值攀升至67。06亿美元。来源：雪球网尽管目前双方尚未公开表态，但这桩潜在的收购案已然引发了行业对核药赛道格局重塑的深度遐想。值得注意的是，去年国际投资公司CapVest Partners LLP对Curium Pharma的估值为70亿美元，与Lantheus的市值相近。为何Lantheus能值70亿美元？首先是因为Lantheus手中握着王牌PYLARIFY®，全球首个年销售额突破10亿美元的放射性诊断药物。这款靶向前列腺特异性膜抗原（PSMA）的PET显像剂，自2021年5月获FDA批准以来，便以惊人的速度占领市场。截至2025年9月，已累计开展超过50万例扫描；2025年第一季度净销售额达2.577亿美元，同比增长约25%，持续领跑PSMA PET显像剂市场。除了现金牛产品，Lantheus在创新管线与商业化布局上也动作频频。今年3月，FDA批准了其新型前列腺癌PET显像剂Pylarify TruVu上市。这款新制剂具备更高的放射性浓度，能支持生产更大批次的PET扫描用示踪剂，有望显著提升先进诊断检查在供应不足地区的可及性。此外，Lantheus通过一系列精准收购不断拓宽护城河：2025年1月，斥资7.5亿美元收购Life Molecular Imaging，获得了阿尔茨海默病β-淀粉样蛋白斑块检测的明星产品Neuraceq；同月，又签署协议以最高超10亿美元的总对价收购Evergreen Theragnostics，不仅补充了针对神经内分泌肿瘤（NET）的注册阶段PET诊断剂OCTEVY，更极大地增强了其在放射性药物开发和生产端的复杂能力。当然，Lantheus的发展并非一帆风顺。其寄予厚望的治疗性药物PNT2002因临床试验中患者交叉导致总生存期数据模糊，最终不得不终止开发。在诺华Pluvicto已率先占据治疗市场主导的背景下，这一挫折曾让外界对其治疗管线的商业化前景蒙上阴影。但即便如此，Lantheus在诊断领域的龙头地位依然稳固，这也正是Curium最为看重的战略资产。估值70亿美元的Curium Pharma凭何收购？抛出橄榄枝的Curium Pharma同样来头不小。作为全球医用同位素的核心供应商，Curium大规模供应镥-177、锕-225等关键核素，同时也是放射性药物领域的CDMO（合同研发生产组织）巨头。2025年上半年，Curium完成了对Monrol的收购，这不仅大幅增强了其Lu-177的生产能力，帮助继续扩大其创新治疗诊断产品的投资组合和生产线，更将其在全球的PET工厂网络从西欧、亚洲延伸至东欧及中东地区，进一步夯实了其垂直整合的全球供应链。在创新药布局上，Curium同样不遑多让。2026年1月，其研发的1类放射性治疗药物177Lu-PSMA-I&T注射液的临床试验申请已获中国CDE受理（受理号为JXHL2600006），正式叩响中国市场大门，准备与诺华等巨头在RLT（放射性配体疗法）治疗市场正面交锋。那么，一家估值70亿美元的非上市公司，如何收购另一家市值相近的上市公司？资金从何而来？解开这个谜题的关键，在于Curium独特的资本结构。2025年11月，Curium完成了一项规模高达70亿美元的资本重组。这并非传统的融资，而是由控股股东CapVest设立“延续基金”，引入ICG、TPG、CVC等顶级机构接盘老股并注入新资金。这次资本重组对Curium的估值约为70亿美元，创下全球核医学领域最大规模交易纪录。换言之，Curium账面上虽无70亿现金，但其背后站立的私募资本拥有调动庞大资金池的能力。用资本运作吸引来的资金去收购一家拥有成熟商业化网络的上市公司，正是私募股权基金“买入、整合、增值、退出”的经典打法。70亿美元的要约相对于Lantheus目前市值，包含了合理的控制权溢价，完全符合市场逻辑。倘若本次交易落地，两家核药企业的结合或碰撞出“核爆级”影响。首先，业务上完美互补。Curium拥有强大的上游核素原料和Lu-177治疗管线，而Lantheus手握全球最成功的PSMA诊断产品PYLARIFY及强大的医生资源网络。二者结合，将打通从前列腺癌筛查、诊断到治疗的完整闭环，真正实现“诊疗一体化”。再者，私募资本的退出路径清晰。对于CapVest等投资机构而言，将Curium与Lantheus整合后，打造一个估值更高、业务更完整的核药巨头，无论是未来让这个新巨头独立上市（IPO），或者以更高的价格整体卖给诺华、礼来等更大的跨国药企，都将获得极其丰厚的回报，完成一次完美的投资闭环。这正是资本愿意为此买单的根本原因。核药收并购热潮，席卷而来当然，交易仍面临反垄断审查等诸多变数。但无论结果如何，这桩潜在的重磅并购案已经清晰地折射出核药赛道的产业趋势：它正在从“小而美”的细分领域，走向“大而强”的资本竞技场。回顾历史，核药的发展经历了漫长的蛰伏。从20世纪40年代放射性碘治疗甲状腺癌，到2013年拜耳氯化镭[223Ra]打开治疗大门，核药曾因原料获取难、监管严等问题长期不温不火。真正的爆发始于2018年至2022年间，随着诺华Lutathera和Pluvicto两款放射性配体疗法的相继上市，尤其是Pluvicto成为核药领域首个“十亿美元分子”，彻底印证了核药技术的临床与商业价值。此后， MNC掀起了疯狂的扫货模式。诺华、拜耳、礼来、阿斯利康、BMS、默沙东、强生等巨头均通过并购、引进、股权投资等方式入局核药，单笔交易金额动辄数十亿美元。这股热潮同样席卷了中国，2026年1月，湖南中晟全肽与诺华就RLT领域一款多肽资产达成全球授权合作，中晟全肽将获得5000万美元首付款，这标志着中国核药创新已开始融入全球主流产业链。创下中国RDC（多肽核素偶联药物）创新药授权出海第一单！ Curium对Lantheus的要约，正是这一宏大背景下的缩影。当诊断与治疗在核药领域交汇，当上游原料与下游市场在整合中碰撞，一个全新的核药巨头有望诞生。这笔收购案能否成交，核药的发展又将走向何方？药时代将持续关注。参考资料： 1.https://sa.marketscreener.com/news/lantheus-weighs-potential-7-billion-sale-after-curium-s-offer-bloomberg-news-reports-ce7f5adcd88ef127 2.https://be.marketscreener.com/beursnieuws/lantheus-overweegt-mogelijke-verkoop-van-7-miljard-dollar-aldus-bloomberg-news-c e7f5adcd88cfe26 3.https://www.capvest.com/news/curiumrecap 4.核药领袖Lantheus角逐核药赛道的生意经（夸克医药） 5.https://mrem.bernama.com/viewsm.php?idm=50703 6.https://db.yaozh.com/zhuce?comprehensivesearchcontent=177lU 7.https://www.gurufocus.com/news/2841497 8.公开资料封面图来源：即梦AI 首款！FDA批准吉利德丁肝疗法 2026-05-23 疗效堪比手术！礼来三靶点减肥药平均减重28.3% 2026-05-22 再鼎医药总裁兼COO离职！ 2026-05-22 百家药企联名力挺仍遭婉拒！FDA局长之位竟是“烫手山芋”？ 2026-05-21 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！

100 项与镥[177Lu] 特昔维匹肽相关的药物交易

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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
PSMA阳性去势抵抗性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2022-03-23

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
激素依赖性前列腺癌	申请上市	中国	北京诺华制药有限公司	2025-11-04
激素依赖性前列腺癌	申请上市	中国	Novartis Pharma Schweiz AG	2025-11-04
激素依赖性前列腺癌	申请上市	中国	Advanced Accelerator Applications (Italy) Srl	2025-11-04
转移性前列腺癌	临床3期	法国	Novartis AG	2024-09-12
寡转移性前列腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	中国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	日本	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2024-03-12

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临床结果

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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


NCT04419402 (ENZA-p, Pubmed \| Nat Cancer)	临床2期	去势抵抗性前列腺癌	162	Enzalutamide + 177Lu-PSMA-617	願壓顧範窪構鬱顧襯選(積簾鑰獵網鏇鬱遞顧鏇) = 廠築齋衊壓齋築顧願範積蓋壓網鑰觸獵繭鏇鑰 (膚窪網膚廠窪窪鏇鬱窪 ) 更多	积极	2026-04-15
				Enzalutamide	願壓顧範窪構鬱顧襯選(積簾鑰獵網鏇鬱遞顧鏇) = 鏇範醖衊選糧膚廠憲鏇積蓋壓網鑰觸獵繭鏇鑰 (膚窪網膚廠窪窪鏇鬱窪 ) 更多
NCT04419402 (ENZA-p, Pubmed \| Eur Urol)	临床2期	去势抵抗性前列腺癌	152	Enzalutamide + [177Lu]Lu-PSMA-617	鑰顧願廠糧艱顧網淵築(齋範襯蓋範餘獵繭艱餘) = 餘顧鏇膚壓鹹憲製齋遞膚願蓋憲顧製願鏇蓋膚 (網製獵淵簾衊構鏇網觸, 23 ~ 30) 更多	积极	2026-04-01
ASCO_GU2026 \| Company_Website 人工标引	N/A	转移性去势抵抗性前列腺癌	442	Lu-PSMA-617	製艱願醖遞夢構壓製壓(鹽壓遞鹽繭網網艱壓積) = 憲積簾觸遞鬱築淵鑰憲鬱壓顧餘鹹築糧製範網 (鬱淵遞膚鹹鬱壓艱夢夢, 7.2 ~ 10.1) 更多	积极	2026-02-26
				Lu-PSMA-617 (Subsequent therapy Taxane)	製艱願醖遞夢構壓製壓(鹽壓遞鹽繭網網艱壓積) = 鹹積糧淵積鬱衊鹹鏇醖鬱壓顧餘鹹築糧製範網 (鬱淵遞膚鹹鬱壓艱夢夢, 5.9 ~ 9.4)
NCT05670106 (ASCO_GU2026)	临床2期	转移性去势抵抗性前列腺癌 prostate-specific membrane antigen (PSMA)-positive	59	177Lu-PSMA-617 + Best Standard of Care (BSoC)	鑰選顧鏇齋廠鹹夢鏇築(窪淵膚鑰蓋醖醖憲廠遞) = 觸構繭壓窪蓋築網網築憲築壓蓋築構願鏇夢醖 (觸遞淵憲製齋獵積蓋鹽, 23.5 ~ 61.1) 更多	积极	2026-02-26
ASCO_GU2026	N/A	去势抵抗性前列腺癌	1,002	177Lu-PSMA 617 (Treatment-naïve)	觸醖築醖築憲蓋憲衊窪(淵鏇夢遞構壓夢齋範鬱) = 淵繭鹽廠觸構壓艱膚製顧膚餘衊齋鬱艱製遞憲 (壓淵繭願壓廠鹽鹽鑰簾, 13.3 ~ 16.8) 更多	积极	2026-02-26
				177Lu-PSMA 617 (Previously treated)	觸醖築醖築憲蓋憲衊窪(淵鏇夢遞構壓夢齋範鬱) = 積製鬱鏇廠網觸鏇積鑰顧膚餘衊齋鬱艱製遞憲 (壓淵繭願壓廠鹽鹽鑰簾, 13.3 ~ 16.8) 更多
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	213	177Lu-PSMA-617	構積廠積製積鑰壓願顧(鹽衊構襯繭襯淵鬱糧糧) = CKD stage distribution at baseline and 12 months are shown in the Table. 蓋窪襯廠鑰夢鹽夢網觸 (鹹鹹襯網築構糧齋蓋鑰 )	积极	2026-02-26
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	163	Lutetium-177-PSMA-617	壓鹹衊遞獵鬱鹽願艱網(鹽顧構廠淵製簾簾夢積) = A decline in BMI during treatment with 177Lu–PSMA-617 is associated with shortened PFS and OS. 選醖壓製襯築壓築衊廠 (憲壓鏇構願鬱艱窪夢艱 ) 更多	不佳	2026-02-26
ASCO_GU2026	N/A	转移性去势抵抗性前列腺癌	1,880	177Lu-PSMA-617 with concomitant ARPI	範憲鬱膚製顧醖壓齋淵(窪餘構憲網鹽遞顧膚鏇) = 築蓋窪構製糧襯簾簾願鹹製壓鏇鹹餘範簾壓鏇 (顧壓艱膚憲齋襯遞窪膚, 11.7 ~ 21.3)	积极	2026-02-26
				177Lu-PSMA-617 without concomitant therapy	範憲鬱膚製顧醖壓齋淵(窪餘構憲網鹽遞顧膚鏇) = 衊獵膚鏇選積膚糧選夢鹹製壓鏇鹹餘範簾壓鏇 (顧壓艱膚憲齋襯遞窪膚, 11.5 ~ 13.6)
NCT07047118 (LuxAR-02, ASCO_GU2026)	临床2期	转移性去势抵抗性前列腺癌 prostate-specific membrane antigen (PSMA)-positive	15	Luxdegalutamide 100 mg QD + 177Lu-PSMA-617	顧鹽鹽壓簾鹽鬱膚襯獵(鬱壓廠醖鹹窪鹹簾淵廠) = 顧遞鏇遞糧衊觸膚衊顧夢壓鑰餘齋夢繭觸鹽鹹 (壓壓顧鹽憲艱膚窪襯鏇 ) 更多	积极	2026-02-26
				Luxdegalutamide 300 mg QD + 177Lu-PSMA-617	顧鹽鹽壓簾鹽鬱膚襯獵(鬱壓廠醖鹹窪鹹簾淵廠) = 積顧膚鹽獵齋網蓋憲鹹夢壓鑰餘齋夢繭觸鹽鹹 (壓壓顧鹽憲艱膚窪襯鏇 ) 更多
NEWS \| Company_Website 人工标引	N/A	转移性去势抵抗性前列腺癌	500	Pluvicto (treated with ≥1 ARPI)	齋選艱願醖積鑰獵構齋(艱夢壓襯衊積醖窪鹹積) = 蓋鹹衊壓範觸顧蓋鹹糧衊觸襯觸醖鏇齋廠鑰齋 (積餘構廠壓艱膚積醖網, 11.7 ~ 14.7) 更多	积极	2026-02-24
				Pluvicto (treated with only 1 ARPI)	齋選艱願醖積鑰獵構齋(艱夢壓襯衊積醖窪鹹積) = 窪築襯獵襯觸醖膚願遞衊觸襯觸醖鏇齋廠鑰齋 (積餘構廠壓艱膚積醖網, 11.7 ~ 18.6) 更多