A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI

开始日期2026-07-28

申办/合作机构

Guerbet SA

[+1]

CTIS2025-524029-41-00

/ Recruiting临床3期IIT

A Pilot Study on the Use of Gadopiclenol for Enhanced Cardiac MRI in Children with Congenital Heart Conditions: A self-controlled, non-randomised, open-label study to compare the image quality and diagnostic performance of gadopiclenol versus gadoterate meglumine

开始日期2026-06-22

申办/合作机构-

NCT07415018

/ RecruitingN/AIIT

Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease

To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.

开始日期2026-06-10

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与 Gadopiclenol 相关的临床结果

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100 项与 Gadopiclenol 相关的专利（医药）

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项与 Gadopiclenol 相关的文献（医药）

2026-08-04·ACCOUNTS OF CHEMICAL RESEARCH

Design Strategies for Developing Chiral Macrocyclic Chelators as a Diagnostic Tool

Article

作者: Law, Ga-Lai ; Zhu, Yifan

Conspectus:

Macrocyclic chelators have become an indispensable part of the field of molecular imaging due to their ability to form highly stable complexes with various metal ions for diverse diagnostic and therapeutic applications. Among them, DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid), which serves as a gold standard in both stability and versatility, is extensively utilized in clinical contexts as contrast agents for a series of imaging modalities, including MRI (magnetic resonance imaging), PET (positron emission tomography), SPECT (single-photon emission computed tomography), and optical imaging. Despite its advantageous properties, in certain cases, DOTA still has limitations to be solved, such as slow radiolabeling kinetics and possible in vivo decomplexation, which have led to increased research interest in structural modifications of the DOTA ligand.To date, the most popular design strategy for DOTA analogues focuses on the modification of pendant arms, which can be simply achieved through the N-derivatization of the tetraaza macrocycle. Another strategy is to modify the macrocyclic ring structure, with the most successful example being the macrocycle pyclen, which contains a pyridine moiety. In 2022, pyclen-based Gd3+ complex gadopiclenol was approved by the U.S. FDA (United States Food and Drug Administration) as a next-generation MRI contrast agent for clinical use. However, reported studies on similar structural modifications of macrocyclic rings are relatively rare, as this requires the redesign of synthetic procedures that can be highly complicated.In this Account, we discuss our design strategies of various macrocyclic chelators with chiral substituents on the macrocyclic ring for different biomedical imaging applications. We start with structural modifications to the frequently used DOTA chelator through the introduction of four symmetrical chiral substituents on its macrocyclic backbone. Results of NMR studies confirmed that the incorporated chiral substituents can prevent the interconversion between two TSAP/SAP regioisomers formed in the complexation process of DOTA with lanthanides. The chiral substituents also provide increased ligand rigidity and can enhance the coordination geometry for better encapsulation of the metal, preventing possible dechelation and transmetalation, thereby achieving higher coordination stability. A series of DOTA analogues with different chiral substituents were studied, and we have revealed that the TSAP/SAP isomeric ratios and pharmacokinetics of chiral DOTA varied with the steric hindrance and polarity of attached chiral groups. In particular, the Gd3+ complexes of chiral DOTAs with symmetric aliphatic groups exhibit enhanced relaxivity over that of achiral DOTA, making them ideal contrast agents for MR imaging. Through the subsequent optimization of introduced chiral groups, various improved chelators were then developed for photoluminescence or for MRI.Next, we focused on further pendant arm modifications of these chiral DOTA platforms. Multiple functionalized pendant arms were attached to the chiral macrocycle as chromophores or targeting vectors, resulting in versatile chiral bifunctional chelators for targeted circularly polarized luminescence (CPL), PET/SPECT, and radiotherapy applications. Moreover, our chiral modifications are not limited to the 12-membered DOTA macrocycle. Recently, we broadened our design strategy to alter the macrocyclic ring sizes, an approach with relatively few literature examples. The chiral analogues of 9-membered NOTA and 10-membered DETA systems were synthesized for 68Ga radiolabeling, with the influence of cavity sizes and positions of chiral substitution investigated. Follow-up studies will go deeper into the metal ion selectivity effects of differently sized chiral macrocycles to pave the way for future designs on novel macrocyclic chelators.

2026-08-01·AMERICAN JOURNAL OF NEURORADIOLOGY

Dynamic Susceptibility Contrast MRI Using Gadopiclenol for Evaluation of Relative Cerebral Blood Volume at 3T: A Comparison with Gadobutrol

Article

作者: Hou, Ping ; Dagher, Richard ; Wintermark, Max ; Liu, Ho-Ling ; Taylor, Brian A ; Kaya, Diana ; Alizada, Sahar ; Al Qudah, Heba ; Sun, Peng

DSC MRI is widely used to assess relative cerebral blood volume (rCBV) in brain tumors using gadolinium-based contrast agents. Gadopiclenol, recently FDA-approved for use at half-dose due to its high relaxivity, offers a potential strategy to reduce overall gadolinium exposure. This retrospective study evaluated DSC MRI performance with 0.05 mmol/kg gadopiclenol compared with standard dose (0.10 mmol/kg) gadobutrol. Twenty patients with brain tumors underwent gadopiclenol-based DSC MRI on 3T scanners and were compared with 20 matched controls receiving gadobutrol. Analysis of normal-appearing thalamic, frontal cortical gray matter, and WM regions showed that gadopiclenol produced DSC time curves with shapes similar to gadobutrol, though with significantly smaller signal decreases and approximately one-half the peak change of effective transverse relaxation rate values, consistent with dose scaling. Importantly, normalized rCBV values did not differ significantly between contrast agents in gray matter regions. These findings support the use of half-dose gadopiclenol for reliable rCBV assessment while reducing gadolinium exposure.

2026-07-01·AMERICAN JOURNAL OF NEURORADIOLOGY

Prospective MR Evaluation of Endolymphatic Hydrops Using Half-Dose Gadopiclenol

Article

作者: Landegger, Lukas D ; Fu, Fanrui ; Blevins, Nikolas ; Christodoulou, Rafail ; Malik, Sachin ; Fischbein, Nancy ; Pham, Nancy

BACKGROUND AND PURPOSE:

Gadopiclenol is a next-generation macrocyclic gadolinium-based contrast agent (GBCA) distinguished by its high T1 relaxivity and kinetic stability. It was developed to address the clinical need for reduced gadolinium dosing while maintaining high diagnostic accuracy, thereby minimizing potential long-term risks associated with gadolinium retention. Although various neuroradiology applications have been explored, the potential benefits of gadopiclenol's increased T1 relaxivity have not been investigated for the purpose of evaluating endolymphatic hydrops (EH) using delayed contrast-enhanced inner ear imaging.

MATERIALS AND METHODS:

We prospectively enrolled 26 consecutive patients at our institution's otology clinic based on the 2015 American Academy of Otolaryngology-Head and Neck Surgery criteria for Ménière disease (MD), including acute or fluctuating symptoms of vertigo, hearing loss, tinnitus, or aural fullness. Each patient underwent 4-hour delayed contrast-enhanced inner ear imaging at 3T with half-dose (0.05 mmol/kg) GBCA administration using gadopiclenol. The contrast-to-noise ratio (CNR) and SNR were determined. Assessment of blood-labyrinthine barrier permeability, utricle-saccule discrimination, and endolymphatic hydrops was performed by 2 head and neck neuroradiologists. Image quality, SNR, and CNR were compared with previously published data that utilized the same technical parameters with a contrast dose of 0.1 mmol/kg.

RESULTS:

Fifty-one ears were analyzed. One ear was excluded based on a prior history of left labyrinthectomy after failed medical management of MD. There were 31 symptomatic and 20 asymptomatic ears determined by clinical and hearing evaluation. Delayed contrast-enhanced inner ear imaging with gadopiclenol at 0.05 mmol/kg provided comparable CNR and SNR to gadobenate dimeglumine at 0.1 mmol/kg, with no statistically significant difference (P > .05). There was excellent interobserver agreement for the grading EH (κ > 0.80).

CONCLUSIONS:

Our study demonstrates that 3D-FLAIR inner ear imaging using gadopiclenol at 0.05 mmol/kg is a reliable method for detecting clinically concordant EH and that image quality, based on qualitative and quantitative metrics, is comparable with a previously published study using gadobenate dimeglumine at a single-dose of 0.1 mmol/kg.

项与 Gadopiclenol 相关的新闻（医药）

2026-08-02

·消药津

FDA月度新药：2026年6月获批新药报告

点亮『星标』👆👆👆，关注我们不迷路好书推荐：How the Immune System Works, 7th " 最低剂量造影剂·口服碳青霉烯破局 5个新药，五大领域——从 60% 钆减量的 MRI 造影剂、首个口服碳青霉烯类抗生素，到全球首款工程化 Treg 细胞疗法，放射诊断、抗感染、内分泌眼科、代谢疾病和细胞治疗各一。月度概览MONTHLY OVERVIEW 2026年6月，FDA 共计批准了 5 个具有重要临床意义的新药/新适应症——其中新分子实体（NME）2 个、生物制品许可申请（BLA）2 个，以及 1 项里程碑式的重大适应症扩展。按审批机构划分，4 个来自药物评价与研究中心（CDER），1 个来自生物制品评价与研究中心（CBER）。从领域分布看，5 个药物横跨放射诊断、抗感染、内分泌眼科、代谢疾病和细胞治疗——没有一个月内扎堆同一赛道的集中现象，反映出 FDA 审批覆盖面的广度。两个「首创」药物尤为突出：全球首款口服碳青霉烯类抗生素 Utebzi，结束了该类抗生素只能住院静注的历史；全球首款精准工程化调节性 T 细胞（Treg）疗法 Tregzi，将异基因移植后慢性移植物抗宿主病（cGVHD）的 1 年无事件生存率从 38% 提升至 78%。 📌 本文看点 01 Ambelvist MRI造影·减钆60% 02 Utebzi 抗感染·口服碳青霉烯 03 Lumvoa 甲状腺眼病·双期覆盖 04 Tryngolza 降脂·防胰腺炎 05 Tregzi 细胞治疗·Treg精准工程 01 THE DISEASEgadoquatrane（Ambelvist）—— 最低剂量大环钆造影剂，开启 MRI「减钆」时代 Bayer（拜耳）｜大环钆基造影剂 · NME ｜ 2026-06-12 ｜标准审评疾病背景对比增强磁共振成像（CE-MRI）是临床最常用的影像学检查之一，在肿瘤随访、多发性硬化等神经系统疾病的长期监测中发挥着不可替代的作用。全球每年进行的 MRI 检查超过 1 亿次，其中约 40% 使用含钆造影剂（GBCA）增强。然而，自 2006 年确认钆是肾源性系统性纤维化（NSF）的致病因素以来，GBCA 的安全性始终是放射科的核心关注点。2014 年后，多个研究发现痕量钆可在脑组织及其他器官中沉积——即便患者肾功能正常。大环类 GBCA 因配体更稳定、游离钆释放更少，已成为临床首选，但「在保证诊断质量的前提下尽可能降低钆暴露」的 ALARA 原则仍驱动着剂量优化的持续探索。药物作用机制 gadoquatrane 是新一代大环类钆基造影剂，其核心创新在于四聚体分子结构——单个分子包含 4 个钆-螯合单元。这种设计带来了显著高于常规单核 GBCA 的弛豫率（relaxivity），即单位钆原子产生的 MRI 信号增强更强。高弛豫率意味着更少的钆即可获得同等的影像增强效果，从而在保持诊断质量的同时大幅减少钆用量。推荐剂量为 0.01 mmol/kg 实际体重（对应 0.04 mmol Gd/kg），相比标准剂量（0.1 mmol Gd/kg）减少 60% 的钆负荷，相比此前最低剂量的 g adopiclenol（Elucirem，0.05 mmol Gd/kg）进一步减少 20%。关键临床数据 FDA 批准基于全球 III 期 QUANTI 临床研究项目，纳入 800+ 名成人及儿童（含足月新生儿）受试者。主要终点：联合判读（增强前 + 增强后 MRI）的病变可视化评分。在 0.01 mmol/kg 剂量下，Ambelvist 的病变可视化评分和检出病灶数在描述性分析中与标准剂量的其他大环类 GBCA（0.1 mmol Gd/kg）相当。儿科数据：93 名 28 天至 18 岁以下儿童接受单次 0.01 mmol/kg 给药后，药代动力学和安全性数据支持了从成人疗效数据的外推。安全性：常见不良反应（≥0.2%）包括头晕、头痛、恶心、呕吐、注射部位反应、热感和瘙痒。黑框警告关注鞘内给药（非获批路径，可致死）和肾源性系统性纤维化风险。临床意义与竞争格局 Ambelvist 将钆基造影剂的竞争从「影像质量」推进到「剂量最小化」维度。Bayer 自 1988 年推出全球首款 GBCA Magnevist 以来，始终是该领域的主导企业之一；此次获批标志着其战略重心从市场维护转向技术领先。直接竞争对手为 Guerbet 的 gadopiclenol（Elucirem），后者此前保持着最低剂量纪录（0.05 mmol Gd/kg）。对于需要终身定期 MRI 监测的慢性病患者（如多发性硬化、脑肿瘤术后随访），累计钆暴露的减少具有明确的临床价值。gadoquatrane 已于 2026 年 3 月在日本获得全球首批，欧盟和中国的申请正在审评中。 02 THE MECHANISMtebipenem pivoxil（Utebzi）—— 美国首款口服碳青霉烯类抗生素 GSK / Spero Therapeutics ｜碳青霉烯前药 · NME ｜ 2026-06-17 ｜优先审评 · 快速通道 · QIDP 疾病背景复杂性尿路感染（cUTI）是临床上最常见的感染性疾病之一，包括肾盂肾炎（肾脏感染）。当感染由多重耐药（MDR）革兰阴性菌引起时，碳青霉烯类抗生素（如亚胺培南、美罗培南）是标准治疗选择。然而，碳青霉烯类药物长期以来只能通过静脉给药，意味着患者必须住院或每日前往门诊输液中心——这不仅增加了医疗成本，也显著降低了患者的生活质量。在美国，每年因 cUTI 住院的患者超过 100 万人次。对于病情稳定、可口服给药的患者群体，长期以来缺乏口服替代方案，迫使临床在「过度住院」和「降阶梯为疗效可能不足的口服药物」之间做出艰难选择。药物作用机制 tebipenem pivoxil 是一种口服碳青霉烯前药：pivoxil 酯基提高口服生物利用度，吸收后由肠细胞酯酶快速水解为活性成分 tebipenem。活性 tebipenem 通过抑制细菌细胞壁合成发挥杀菌作用，对多种革兰阴性菌（大肠埃希菌、肺炎克雷伯菌、阴沟肠杆菌复合群、产酸克雷伯菌）及粪肠球菌均具有广谱抗菌活性。其抗菌谱与静脉用碳青霉烯类药物高度一致。关键临床数据 FDA 批准基于 III 期 PIVOT-PO 研究，随机入组 1,694 名住院 cUTI 患者，1:1 接受口服 tebipenem pivoxil 600 mg q6h 或静脉亚胺培南-西司他丁 500 mg q6h，疗程 7-10 天。主要终点（TOC 访视时的总体成功率）：Utebzi 组 58.5%（261/446）vs 对照组 60.2%（291/483），校正后治疗差异 -1.3%（95% CI: -7.5% ~ +4.8%），达到预设的非劣效性界值（-10%）。安全性：最常见不良反应（≥1%）包括腹泻、头痛、恶心、腹痛和肝酶升高——均为轻至中度。禁忌用于对 β-内酰胺类抗生素过敏的患者。临床意义与竞争格局 Utebzi 的获批填补了口服碳青霉烯类药物在美国市场长达 17 年的空白。它的关键价值在于为符合口服条件的 cUTI 患者提供了不牺牲疗效的出院选择，有望显著缩短住院时间、降低院内感染风险和医疗成本。该药物获得了 FDA 的合格感染病产品（QIDP）认定，额外获得 5 年市场独占期。Spero Therapeutics 于 2022 年将 tebipenem pivoxil 的全球权益许可给 GSK。在日益严峻的抗菌素耐药性（AMR）全球危机背景下，新型口服抗生素的临床和公共卫生价值被高度关注。 03 THE DATAveligrotug-vvze（Lumvoa）—— 甲状腺眼病首个覆盖活动期与慢性期的生物制剂 Viridian Therapeutics ｜ IGF-1R全拮抗单抗 · BLA ｜ 2026-06-26 ｜优先审评 · 突破性疗法疾病背景甲状腺眼病（TED）是一种罕见的自身免疫性眼眶病，最常见于 Graves 病（一种自身免疫性甲亢）患者。其病理核心是眼眶成纤维细胞中胰岛素样生长因子-1 受体（IGF-1R）与促甲状腺激素受体（TSHR）的交叉激活，导致眼眶组织炎症、脂肪增生和纤维化，临床表现为眼球突出（proptosis）、复视（diplopia）、眼周疼痛，严重者可因压迫性视神经病变导致永久性视力丧失。 TED 的疾病过程分为活动期（以炎症为主）和慢性期（以纤维化和组织重塑为主），两者的治疗策略有本质区别。美国 TED 患病率约为每 10 万人中 16 例（女性）和 2.9 例（男性），中国流行病学数据类似。2020 年之前，TED 无获批的系统性治疗药物；teprotumumab（Tepezza，Amgen）作为首款 IGF-1R 抑制剂于 2020 年获批，但其关键试验主要入组活动期患者。药物作用机制 veligrotug-vvze 是一种全人源 IgG1 单克隆抗体，作为 IGF-1R 的全拮抗剂（full antagonist），通过完全阻断 IGF-1R 信号通路来抑制眼眶成纤维细胞的炎症激活和下游组织重塑。区别于部分拮抗剂，全拮抗理论上可实现对信号通路的更彻底抑制。药物每 3 周静脉输注一次，共 5 次，12 周完成全疗程。关键临床数据 FDA 批准基于两项 III 期研究——THRIVE（活动期 TED，n=113）和 THRIVE-2（慢性期 TED，n=188）。终点 THRIVE（活动期） THRIVE-2（慢性期）眼球突出应答率（veligrotug vs 安慰剂） 70% vs 5% 56% vs 8%总体应答率（ORR） 67% vs 5% 56% vs 7%复视完全缓解率 49% vs 12% 数据待期刊发表起效时间第 3 周出现突出改善 —52 周持久性 71% 维持应答 — 安全性：最常见不良反应为肌肉痉挛、头痛、听力损害、高血糖（12%，含非糖尿病患者）、疲劳、腹泻、输液反应（~9%）、血肌酸磷酸激酶升高等。听力损害有潜在不可逆性，需在治疗前及治疗期间进行听力监测。可能加重炎症性肠病。临床意义与竞争格局 Lumvoa 是首个在说明书上同时覆盖活动期和慢性期 TED 的 IGF-1R 抑制剂——慢性期 TED 此前在同类产品临床项目中缺乏系统性数据。此外，约 12 周的疗程（5 次输注）相比 teprotumumab 的 24 周（8 次输注）缩短了一半。其与 teprotumumab（Tepezza）的竞争将在疗效、安全性和患者可及性多维度展开。值得注意的是，两类药物均存在听力损害的类效应风险，但此为 IGF-1R 抑制剂靶点本身的特征，而非单一产品问题。目前两药之间尚无头对头比较数据。 04 THE RACEolezarsen（Tryngolza）—— 首个被证明可降低急性胰腺炎风险的严重高甘油三酯血症疗法 Ionis Pharmaceuticals ｜反义寡核苷酸 · sNDA适应症扩展｜ 2026-06-24 ｜优先审评 · 突破性疗法疾病背景严重高甘油三酯血症（sHTG）定义为空腹甘油三酯 ≥500 mg/dL（正常值 <150 mg/dL），在美国影响约 300 万成年人。sHTG 的核心威胁是急性胰腺炎——甘油三酯水平越高，风险越大。急性胰腺炎发作不仅造成剧烈腹痛，常导致反复住院和永久性器官损伤，且有致死风险。长期以来，sHTG 的治疗以生活方式干预（低脂饮食、限酒、减重）和传统降脂药物（贝特类、Omega-3 脂肪酸）为主，但这些手段对重度患者的甘油三酯控制效果有限。此前获批的降脂药物虽然在 FCS（家族性乳糜微粒血症综合征）中开展了临床试验，但均因样本量限制未能展示降低急性胰腺炎风险的证据。 Tryngolza 最初于 2024 年 12 月获批用于 FCS（一种超罕见病，仅影响约 3,000 名美国人）。本次 6 月 24 日的获批将其适应症从罕见病大幅扩展至 300 万人群，是一次具有行业意义的适应症扩展。药物作用机制 olezarsen 是一种配体偶联反义寡核苷酸（LICA-ASO），通过 RNase H1 介导的机制降解 APOC3 mRNA，从而降低肝脏载脂蛋白 C-III（apoC-III）的生成。apoC-III 是甘油三酯代谢的关键抑制蛋白——它抑制脂蛋白脂酶（LPL）活性并干扰肝脏对富含甘油三酯脂蛋白残余颗粒的清除。降低 apoC-III 可加速甘油三酯的分解代谢和肝脏清除，从而降低血浆甘油三酯水平。给药方式为每月一次皮下注射，使用预充式自动注射笔，患者可自行在家完成。关键临床数据 FDA 批准基于两项 III 期研究——CORE（CORE-TIMI 72a）和 CORE2（CORE2-TIMI 72b），共入组 1,061 名 sHTG 成人患者，平均基线甘油三酯 1,116 mg/dL。终点 CORE CORE26 个月 TG 降幅（50 mg 组 vs 安慰剂） -63% -49%6 个月 TG 降幅（80 mg 组 vs 安慰剂） -72% -55%12 个月 TG <500 mg/dL 达标率 86%（汇总数据） —急性胰腺炎事件减少91% （整合分析，率比 0.15，P<0.001） —NNT（预防 1 次胰腺炎）总体 20；高危亚组 4 — 安全性：最常见不良反应为注射部位反应和肝酶升高。建议在起始治疗或调整剂量前检测肝酶，如肝酶持续升高应考虑剂量中断或降低。已有过敏反应（皮疹、荨麻疹、面部肿胀、呼吸困难）的报告。临床意义与竞争格局 Tryngolza 是美国目前唯一获批且明确标示"降低急性胰腺炎风险"的 sHTG 治疗药物。NNT（number needed to treat，需治疗人数）为 20（总体人群）和 4（TG≥880 mg/dL 且有胰腺炎病史的高危亚组）的数据令人印象深刻：在高危亚组中，每治疗 4 名患者 1 年即可预防 1 次急性胰腺炎发作。竞争方面，Arrowhead Pharmaceuticals 的 plozasiran（Redemplo，siRNA 靶向 APOC3）已于 2025 年 11 月获批用于 FCS，正寻求 sHTG 适应症扩展。两种药物的机制（ASO vs siRNA）和给药频率（每月 vs 每季度）构成了差异化竞争的基础。心血管结局研究 Essence-TIMI 73b 正在进行中，其结果对 Tryngolza 的未来市场潜力至关重要。 05 THE FUTUREOrca-T（Tregzi）—— 全球首款精准工程化 Treg 细胞疗法，改写造血干细胞移植规则 Orca Bio ｜异体多组分Treg细胞疗法 · CBER BLA ｜ 2026-06-30 ｜孤儿药 · RMAT 疾病背景异基因造血干细胞移植（allo-HSCT）是多种高危血液恶性肿瘤（急性白血病、骨髓增生异常综合征等）的潜在治愈性手段。但移植后的两大主要风险——疾病复发和移植物抗宿主病（GVHD）——长期困扰着临床医生。慢性 GVHD（cGVHD）是移植后最主要的远期并发症，发生率约 30-70%，可累及皮肤、口腔、眼睛、肝脏、肺等多个器官，严重影响患者的生活质量和长期生存。预防 cGVHD 的标准方案包括钙调磷酸酶抑制剂（他克莫司）联合甲氨蝶呤或霉酚酸酯，但这些方案的疗效有限且伴随免疫抑制相关毒性。近年来，移植后环磷酰胺（PTCy）逐渐成为标准预防方案，但 cGVHD 的控制仍未达到理想水平。药物作用机制 Tregzi 是一种个性化制造的精准工程化细胞疗法，使用来自匹配供者的活细胞为每位患者单独制备。其核心创新在于「三组分精确配比」的回输策略：造血干细胞和祖细胞（HSPCs）：重建受者的造血和免疫系统高度纯化的调节性 T 细胞（Tregs）：抑制 GVHD，保护正常组织免受供者 T 细胞的攻击常规 T 细胞（Tcons）：加速免疫重建并介导移植物抗白血病（GVL）效应这相当于将传统移植中「混杂的」供者细胞成分进行精细分选和精确配比，在保留抗白血病效应的同时系统性地降低 GVHD 风险。GVHD 预防方案仅需单药他克莫司，而对照组需他克莫司+甲氨蝶呤联合方案。关键临床数据 FDA 批准基于 III 期 Precision-T 研究，入组 187 名急性白血病或 MDS 患者（中位年龄 43.6 岁，范围 19-65 岁），随机接受 Tregzi + 单药他克莫司或常规 allo-HSCT + 他克莫司/甲氨蝶呤。终点（12 个月） Tregzi 组对照组 HR P 值慢性 GVHD 无事件生存率（cGFS） 78% 38% 0.26 <0.00001中重度 cGVHD 累积发生率 12.6% 44.0% 0.19 —cGVHD 发生率（任意级别） 13% 44% — — 安全性：不良反应总体上与干细胞移植患者的预期一致，最常见为感染。Tregzi 输注期间无严重反应，研究期间未观察到移植物失败病例。临床意义与竞争格局 Tregzi 是 FDA 批准的首个利用高度纯化 Treg 细胞作为核心治疗组分的细胞疗法，也是首个在随机对照 III 期试验中展示出将 cGVHD 无事件生存率翻倍（从 38% 到 78%）的移植工程产品。cGFS 的直接比较结果为 HR 0.26——意味着 Tregzi 组的 GVHD 或死亡风险仅为对照组的四分之一。这一批准验证了「精准工程化移植产品」的概念可行性，其意义不只在于产品本身，更在于为整个细胞治疗领域开辟了一条全新路径：从「输注后用药预防并发症」转向「在输注前精确设计回输产品的细胞组成」。Orca Bio 管线中的后续产品（如 Orca-Q）正在扩展至更多血液肿瘤适应症。趋势观察THE OUTLOOK R REFERENCES参考来源 1 [Bayer 新闻稿] Bayer's AMBELVIST (gadoquatrane) Receives FDA Approval for Contrast-Enhanced MRI — June 15, 2026 2 [FDA Label] Ambelvist Prescribing Information — June 12, 2026 3 [行业分析] RT Medical Systems — Bayer wins FDA nod for low-dose MRI contrast agent — June 2026 4 [GSK/Spero 新闻稿] U.S. FDA Approves Utebzi — First Oral Carbapenem for cUTI — June 17, 2026 5 [NeoDrop 深度报告] FDA approvals week of June 13–19, 2026 — neodrop.ai 6 [FDA 信息] Priority Review, Fast Track, and QIDP designations — NDA 215960 7 [Viridian 新闻稿] FDA Approval and Launch of Lumvoa for Thyroid Eye Disease — June 26, 2026 8 [AJMC] Treatment for Thyroid Eye Disease Approved by FDA — June 2026 9 [Ophthalmology Times] Lumvoa gains US FDA approval for TED with class-first broad label — June 2026 10 [期刊文献] Yen MT et al. THRIVE: Phase 3 study of veligrotug for active TED. Ophthalmology. 2026 (in press) 11 [Ionis 新闻稿] TRYNGOLZA approved by FDA as first treatment to reduce triglycerides and acute pancreatitis risk in sHTG — June 24, 2026 12 [FDA 新闻] FDA Approves First Treatment Shown to Reduce Acute Pancreatitis Risk in sHTG — June 24, 2026 13 [NEJM 文献] Marston NA et al. Olezarsen for Managing Severe Hypertriglyceridemia and Pancreatitis Risk. N Engl J Med. 2026;394:429-441 14 [Pharmacy Times] Olezarsen Receives FDA Approval to Reduce Triglycerides in sHTG — June 2026 15 [Orca Bio 新闻稿] TREGZI Receives U.S. FDA Approval as First Precision-Engineered Cell Therapy — June 30, 2026 16 [FDA 新闻] FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications — June 30, 2026 17 [FDA 审评] FDA approves allogeneic regulatory T cell-based immunotherapy — June 30, 2026 18 [CancerNetwork] Orca-T Approval Is "Important Advance" for Graft Engineering in Transplant — June 2026 免责声明：本文仅作学术信息交流之用，不构成任何投资或治疗建议。所有临床数据均来源于 FDA 官方文件、企业新闻稿和同行评审期刊。如需获得治疗方案指导，请咨询执业医师。 END 如果你觉得今天这篇有收获，欢迎点赞、在看、转发三连，我们下篇见。版权声明来源：图片版权属于原作者，仅用于学术分享。

细胞疗法临床研究

2026-07-30

·PRNewswire

Bracco Receives Approval in Mexico for VUEWAY® injection (gadopiclenol), Advancing Its Commitment to Lower-Dose MRI Across Global Markets

Approval supports responsible imaging through effective contrast enhancement at a lower gadolinium dose MEXICO CITY, July 21, 2026 /PRNewswire/ -- Bracco Imaging, a global leader in diagnostic imaging, today announced the commercial availability of VUEWAY® injection (gadopiclenol), which received approval in September 2025 from the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), Mexico's regulatory authority, for use in contrast-enhanced magnetic resonance imaging (CE-MRI) in adults and children aged 2 years and older. VUEWAY® has demonstrated effective contrast enhancement resulting in reduced gadolinium exposure for patients.1,2,3 This approach aligns with clinical guidance from radiology societies, which emphasizes the use of the lowest effective GBCA dose when contrast-enhanced imaging is required.3 "The launch of VUEWAY® injection in Mexico represents an important milestone in the consolidation of our strategy in Latin America," said Tommaso Montemurno, General Manager for Latin America at Bracco Imaging. "This innovative contrast agent expands access to advanced MRI imaging in Mexico, supporting high-quality diagnostic performance and addressing the evolving needs of clinical practice. With VUEWAY® injection, we continue to strengthen our MRI portfolio, broaden the options available to healthcare professionals, and contribute to the advancement of diagnostic imaging across the region." "The introduction of VUEWAY® injection in Mexico marks a key milestone in strengthening innovation in diagnostic imaging. As a next-generation contrast agent, VUEWAY® injection offers a differentiated profile that enables healthcare providers to achieve high-quality imaging with confidence, while maintaining a strong commitment to patient safety," said Hector Sanchez, Commercial Director for Mexico at Bracco Imaging. The COFEPRIS approval follows other regulatory milestones in the European Union (EU), United States (US) and Canada. VUEWAY® injection is now approved in 38 countries worldwide, where more than 4 million patient doses have been administered. In the EU and the US, the approved indication has been extended to include neonates and infants.4,5,6 About Gadopiclenol Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the Central Nervous System, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (refer to the approved USPI and Core SPC for full information). The product has been also approved for use on paediatric population from birth by FDA in US and EMA in Europe. Details on Phase III clinical trials are available on : Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View –gov THE BRACCO IMAGING AND GUERBET COLLABORATION Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol is being commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Both companies manufacture the product. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. About Bracco Bracco Group, founded in 1927, is a global leader in diagnostic imaging, committed to advancing healthcare and improving people's lives by shaping the future of prevention and precision medicine. The company operates in the healthcare sector across more than 100 countries with a workforce of over 4,000 employees and consolidated annual revenues of approximately €2 billion, 88% generated by international markets. With a strong commitment to innovation - investing around 9% of its reference turnover in Research & Development - Bracco develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging, including contrast agents for X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI), as well as microbubbles for Contrast Enhanced Ultrasound (CEUS), and Molecular Imaging through radioactive tracers and novel PET imaging agents, alongside AI-based solutions. It is also a global market leader in advanced contrast management technologies for cardiovascular angiography and radiology imaging. Discover more at . VUEWAY is a registered trademark of Bracco Imaging S.p.A. All other trademarks and registered trademarks are the property of their respective owners. ©2026 Bracco Diagnostics Inc. All Rights Reserved. Media Contact: Monica Rentschler Bracco Diagnostics Inc., Assoc. Director, Marketing Communications, Americas T +1 609.514.2382 [email protected] MX-VW-2600011 5/26 1Robic C, Port M, Rousseaux O, Louguet S, Fretellier N, Catoen S, Factor C, Le Greneur S, Medina C, Bourrinet P, Raynal I, Idée JM, Corot C. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol. 2019; 54(8):475-484. 2Hao J, Pitrou C, Bourrinet P. A Comprehensive Overview of the Efficacy and Safety of Gadopiclenol: A New Contrast Agent for MRI of the CNS and Body. Invest Radiol. 2024; 59(2):124-130. 3Kanal E, Maki JH, Schramm P, Marti-Bonmati L. Evolving Characteristics of Gadolinium-Based Contrast Agents for MR Imaging: A Systematic Review of the Importance of Relaxivity. J Magn Reson Imaging. 2025; 61(1):52-69. 4Data on file 4 million VW Calculator (19-MAR-2026). 5U.S. Food and Drug Administration: 2022 Novel Drug Approvals (gadopiclenol). 6European Medicines Agency European Commission decision on VUEWAY. SOURCE Bracco Group 21% more press release views with Request a Demo

上市批准临床3期

2026-06-18

·BioSpace

Bayer’s AMBELVIST® (gadoquatrane) Receives FDA Approval for Contrast-Enhanced MRI to Detect and Visualize Lesions with Abnormal Vascularity in the Central Nervous System and Non-CNS Body Regions

Key Facts: Bayer’s AMBELVIST ® (gadoquatrane) becomes the lowest-dose macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) approved in the U.S., with a recommended dose of 0.01 mmol/kg actual body weight delivering 0.04 mmol Gd/kg body weight 1 Approval is supported by data from the Phase III QUANTI clinical studies, which demonstrated efficacy at a fraction of the dose compared to mGBCAs dosed at 0.1 mmol Gd/kg body weight 1 WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) approved AMBELVIST ® (gadoquatrane), a new, intravenous macrocyclic gadolinium (Gd)-based contrast agent (mGBCA) indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. 1 AMBELVIST is a next-generation mGBCA with a novel tetrameric structure and high relaxivity (a measure of signal enhancement). 1 With this approval, AMBELVIST becomes the lowest-dose mGBCA in the U.S. AMBELVIST has a recommended dose of 0.01 mmol/kg actual body weight (which delivers 0.04 mmol Gd/kg body weight), representing 60% less Gd compared to mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight and 20% less Gd compared to gadopiclenol with a Gd content of 0.05 mmol Gd/kg body weight. 1,2 WHY THIS APPROVAL MATTERS: Contrast-enhanced MRI is a medical imaging examination often used by clinicians to gain insight into what’s happening in the human body. This type of study can play an important role in detecting abnormalities, monitoring disease progression and informing treatment decisions. 3 For some adults and children with chronic diseases or conditions that require close, long-term monitoring—such as multiple sclerosis, other neurological or spinal conditions as well as different types of cancer—regular, serial images may be required. “I often rely on contrast-enhanced MRI exams to inform clinical decision making,” said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies. “With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need.” KEY CLINICAL TRIAL FINDINGS: The FDA approval is based on the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of A MBELVIST in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI. 1 Key findings demonstrated: Increased lesion visualization with the combined pre-contrast and post-contrast MRI sets with the decreased Gd dose in AMBELVIST compared with only pre-contrast MRI images. 1 Visualization scores and number of lesions identified per blinded independent reader for AMBELVIST dosed at 0.01 mmol/kg body weight (which delivers 0.04 mmol Gd/kg body weight) were similar to other tested mGBCAs with a Gd content of 0.1 mmol Gd/kg body weight in descriptive analyses. 1 The safety and effectiveness of AMBELVIST for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system) have been established in pediatric patients, including term neonates. Use of AMBELVIST in this age group is supported by evidence from adequate and well-controlled studies of AMBELVIST in adults, with additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to less than 18 years who received one 0.01 mmol/kg dose of AMBELVIST and underwent MRI of any body region. 1 AMBELVIST is associated with a Boxed Warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis and is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST. Additionally, there are Warnings and Precautions related to hypersensitivity reactions, gadolinium retention, acute kidney injury and interference with lesion visualization. Please see AMBELVIST Important Safety Information below for additional information. BAYER PERSPECTIVE ON AMBELVIST APPROVAL: Bayer has played a pioneering role in MRI contrast agent development, having launched the first GBCA in 1988, and is now adding AMBELVIST to its radiology portfolio as the lowest-dose mGBCA approved in the U.S. “At Bayer, our focus has always been on enhancing patient care, and we are proud to introduce AMBELVIST as our next-generation option for contrast-enhanced MRI,” said Jill Carbone, Vice President and Head of Radiology, North America Product & Pipeline, Bayer. “As a lower-gadolinium-dose GBCA, AMBELVIST supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients.” 4 INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS AMBELVIST ® (gadoquatrane) is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) IMPORTANT SAFETY INFORMATION WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. AMBELVIST is not approved for intrathecal use. Nephrogenic Systemic Fibrosis GBCAs increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of AMBELVIST in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR 60 years, hypertension, or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended AMBELVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration. Contraindication and Important Information about Hypersensitivity Reactions: AMBELVIST ® is contraindicated in patients with a history of severe hypersensitivity reactions to AMBELVIST ® . Serious hypersensitivity reactions have occurred with GBCAs. Before AMBELVIST ® administration, assess all patients for any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to AMBELVIST ® . Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, retention varies among the linear agents. Retention is lowest and similar among the macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent and minimize repetitive GBCA studies, when possible. Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses. Interference with Lesion Visualization As with other GBCAs, AMBELVIST ® may obscure certain lesions that are visible on non-contrast MRI. When available, non-contrast MRI images should be reviewed during the interpretation of AMBELVIST ® MRI scans. Adverse Reactions: The most frequently observed adverse reactions (incidence ≥ 0.2%) were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus. Please click here for the Full Prescribing Information for AMBELVIST ® . About Radiology at Bayer Bayer’s Radiology business is a world leader among medical imaging solutions providers. The business transforms insight into technology and services with the goal of providing radiology solutions to help its customers enhance patient care. Its leading radiology portfolio features contrast agents and devices to help enable precise dose administration across modalities, equipment services, informatics and connected solution offerings. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on Facebook: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. __________________________ 1 Bayer Pharmaceuticals. AMBELVIST (gadoquatrane) [package insert]. U.S. Food and Drug Administration. Available at: . 2 Bracco. Vueway (gadopiclenol) package insert. U.S. Food and Drug Administration. Available at: . 3 National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health. Magnetic Resonance Imaging (MRI). Available at: . Accessed: 15 April 2026. 4 ACR manual on contrast media (2026) ACR . Available at: . Accessed: 15 April 2026. Contacts Contact for media inquiries: Elaine Colón Phone: +1-732-236-1587 Email: elaine.colon@bayer.com Contact for investor inquiries: Bayer Investor Relations Team Phone: +49 214 30-72704 Email: ir@bayer.com

临床结果上市批准临床3期

100 项与 Gadopiclenol 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12435	-	-	-

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
血管畸形	加拿大	Bracco Imaging SpA	2026-04-17
造影剂	英国	Bracco Imaging SpA	2024-01-19
诊断试剂	欧盟	Bracco Imaging SpA	2023-12-07
诊断试剂	欧盟	Guerbet SA	2023-12-07
诊断试剂	冰岛	Bracco Imaging SpA	2023-12-07
诊断试剂	冰岛	Guerbet SA	2023-12-07
诊断试剂	列支敦士登	Bracco Imaging SpA	2023-12-07
诊断试剂	列支敦士登	Guerbet SA	2023-12-07
诊断试剂	挪威	Bracco Imaging SpA	2023-12-07
诊断试剂	挪威	Guerbet SA	2023-12-07
中枢神经系统疾病	美国	Guerbet LLC	2022-09-21
血管疾病	美国	Guerbet LLC	2022-09-21

未上市

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适应症	最高研发状态	国家/地区	公司	日期
先天性心脏缺损	临床3期	美国	Bracco Imaging SpA	2024-05-01
脑干胶质瘤	临床3期	匈牙利	Guerbet LLC	2023-09-07
脑干胶质瘤	临床3期	意大利	Guerbet LLC	2023-09-07
脑干胶质瘤	临床3期	波兰	Guerbet LLC	2023-09-07
胶质瘤	临床3期	匈牙利	Guerbet LLC	2023-09-07
胶质瘤	临床3期	意大利	Guerbet LLC	2023-09-07
胶质瘤	临床3期	波兰	Guerbet LLC	2023-09-07
血脑屏障缺陷	临床3期	美国	Guerbet LLC	2019-06-03
血脑屏障缺陷	临床3期	比利时	Guerbet LLC	2019-06-03
血脑屏障缺陷	临床3期	法国	Guerbet LLC	2019-06-03

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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


NCT06010173 (CTgov)	临床3期	中枢神经系统疾病	240	Gadopiclenol (Patients With Gadopiclenol Paired Images)	憲蓋積簾夢夢願積鑰鹹(膚願蓋築鹽壓醖鏇夢窪) = 觸鑰簾醖糧鬱製鏇窪簾夢繭鬱觸窪膚繭齋憲範 (選繭積壓鏇網壓網範蓋, 0.04) 更多	-	2026-06-25
				Gadobutrol (Patients With Gadobutrol Paired Images)	憲蓋積簾夢夢願積鑰鹹(膚願蓋築鹽壓醖鏇夢窪) = 襯齋繭糧餘願鹹膚壓鑰夢繭鬱觸窪膚繭齋憲範 (選繭積壓鏇網壓網範蓋, 0.04) 更多
NCT06057168 (GDX-44-016, CTgov)	临床3期	胶质瘤 \| 脑干胶质瘤	138	Elucirem (Elucirem)	憲齋願鏇衊獵積衊醖築 = 鹽構蓋顧網鑰艱鬱獵蓋網廠願顧餘願構窪構淵 (憲網範糧艱鬱襯廠願夢, 製鹽構憲遞鏇齋鏇簾選 ~ 網願選鏇製醖遞憲遞願) 更多	-	2026-01-29
				Dotarem (Dotarem)	憲齋願鏇衊獵積衊醖築 = 淵繭壓壓夢壓膚選選鑰網廠願顧餘願構窪構淵 (憲網範糧艱鬱襯廠願夢, 衊膚鬱構夢廠餘積顧築 ~ 艱鹹糧網簾窪願窪願醖) 更多
NCT05590884 (CTgov)	临床2期	中枢神经系统疾病	36	Gadopiclenol (Age Group 1: Patients Aged 3 to 23 Months)	鑰繭蓋觸餘廠願糧膚築(積選糧範築齋範襯簾糧) = 鑰繭廠餘鹽遞艱襯顧鹽鹽餘鹹構淵膚齋簾膚繭 (鏇遞鬱衊製衊獵廠壓範, 27.6) 更多	-	2025-10-28
				Gadopiclenol (Age Group 2: Patients Aged 28 Days to Less Than 3 Months)	鑰繭蓋觸餘廠願糧膚築(積選糧範築齋範襯簾糧) = 憲淵憲製餘積選窪範積鹽餘鹹構淵膚齋簾膚繭 (鏇遞鬱衊製衊獵廠壓範, 9.9) 更多
NCT03986138 (PROMISE, CTgov)	临床3期	-	324	Gadopiclenol (Patients With Gadopiclenol Paired Images)	鬱顧願選憲顧簾醖餘鹽(鬱壓鹽憲膚廠夢網積築) = 觸壓遞製壓膚壓壓簾築齋遞築鏇簾鑰醖窪齋願 (鬱窪夢顧鬱窪範鏇製廠, 0.03) 更多	-	2025-10-27
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	鬱顧願選憲顧簾醖餘鹽(鬱壓鹽憲膚廠夢網積築) = 範願淵構繭膚簾糧糧蓋齋遞築鏇簾鑰醖窪齋願 (鬱窪夢顧鬱窪範鏇製廠, 0.03) 更多
NCT03996447 (PICTURE, CTgov)	临床3期	血脑屏障缺陷	260	Gadopiclenol (Patients With Gadopiclenol Paired Images)	膚糧製鏇遞壓夢簾選窪(夢遞積觸壓積選餘鏇獵) = 構築膚鬱憲獵鹽鹹餘膚鑰觸衊衊齋壓繭憲齋鏇 (選選顧淵壓憲顧鏇簾蓋, 0.02) 更多	-	2025-09-22
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	膚糧製鏇遞壓夢簾選窪(夢遞積觸壓積選餘鏇獵) = 範餘製蓋網製廠壓餘夢鑰觸衊衊齋壓繭憲齋鏇 (選選顧淵壓憲顧鏇簾蓋, 0.02) 更多
phase IIb study (ASCO2024)	临床2期	脑转移瘤	13	Gadopiclenol 0.1 mmol/kg	顧顧鬱獵窪鏇蓋憲積觸(網範積襯窪遞淵醖餘築) = 廠觸鹽鑰蓋鬱獵選獵憲積廠構製糧鬱鬱鏇網醖 (簾繭膚窪鑰鑰鹽廠鬱願 ) 更多	积极	2024-05-24
NCT03749252 (CTgov)	临床2期	中枢神经系统囊肿	80	P03277 (CNS Cohort 2-6 Years)	製鹹繭構膚願鏇蓋築鏇(鑰鹹憲壓糧鑰壓鏇製鹹) = 廠壓獵願齋願網艱築膚膚選壓鏇鑰顧繭築遞壓 (憲醖範窪鏇衊簾範簾簾, 顧衊衊簾獵鏇廠繭鑰遞 ~ 觸齋顧淵網繭淵製艱網) 更多	-	2022-06-01
				P03277 (CNS Cohort 7-11 Years)	製鹹繭構膚願鏇蓋築鏇(鑰鹹憲壓糧鑰壓鏇製鹹) = 積繭獵遞壓襯醖範齋選膚選壓鏇鑰顧繭築遞壓 (憲醖範窪鏇衊簾範簾簾, 遞簾製獵鏇窪繭積廠簾 ~ 簾願鹹壓衊積範鹹窪構) 更多
NCT02973516 (CTgov)	临床2期	肝细胞癌 \| 慢性肝病	41	Gadopiclenol (Cohort 1)	築範壓繭糧鑰獵齋獵獵 = 齋簾獵醖艱構願糧糧餘憲鹽蓋窪夢鹹衊壓繭艱 (淵餘願遞餘衊齋積廠醖, 鑰糧鏇憲淵壓製廠鹹鹽 ~ 膚築獵壓襯醖醖憲鹽鑰) 更多	-	2021-10-06
				Gadopiclenol (Cohort 2)	築範壓繭糧鑰獵齋獵獵 = 範壓獵選齋鹹壓觸築齋憲鹽蓋窪夢鹹衊壓繭艱 (淵餘願遞餘衊齋積廠醖, 憲艱襯窪蓋醖築鹽繭醖 ~ 鹹構鏇廠襯夢範鑰鏇齋) 更多
NCT03657784 (Pubmed \| Invest Radiol)	临床1期	肾功能不全	40	Gadopiclenol (Healthy subjects)	廠築衊繭願簾艱鬱憲製(獵鏇壓鏇築簾膚淵蓋餘) = 窪觸窪齋築蓋鏇鬱繭顧鹹襯構遞齋網艱壓淵築 (齋顧選糧蓋範網窪膚窪 )	-	2021-08-01
				Gadopiclenol (Subjects with mild renal impairment)	廠築衊繭願簾艱鬱憲製(獵鏇壓鏇築簾膚淵蓋餘) = 願顧獵窪願鬱範壓壓襯鹹襯構遞齋網艱壓淵築 (齋顧選糧蓋範網窪膚窪 )
NCT03996447 \| NCT03986138 (PICTURE \| PROMISE, Corporate Publications) 人工标引	临床3期	造影剂	560	Gadopiclenol+gadobutrol	鏇製憲製鑰繭簾糧醖網(製築襯獵簾夢鬱簾廠鑰) = the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied. 範築構醖網衊鏇範憲獵 (壓膚糧艱憲齋範鹹襯獵 ) 更多	积极	2021-03-24
				Gadobutrol+Gadopiclenol