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2026-02-02

申办/合作机构

Guerbet SA

[+1]

CTIS2025-523278-18-00

/ Not yet recruiting临床4期IIT

Phase IV, single-center, randomized, crossover clinical trial to validate the use of gadopiclenol versus gadobutrol in the evaluation of magnetic resonance imaging (MRI) diagnosis of perianal fistula associated with Crohn's disease

开始日期2025-12-01

申办/合作机构-

CTIS2025-521810-24-00

/ Active, not recruiting临床4期

Pilot study to explore the diagnostic value of gadopiclenol in pathological and radiological insights with multiparametric MRI enhancement in breast cancer.

开始日期2025-09-22

申办/合作机构-

100 项与 Gadopiclenol 相关的临床结果

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100 项与 Gadopiclenol 相关的转化医学

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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）

2025-12-01·Japanese Journal of Radiology

Pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers

Article

作者: Pitrou, Camille ; Taoka, Toshiaki ; Eto, Takashi ; Felices, Mathieu

Abstract:

Purpose:

The aim of this study was to evaluate the pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers. A population-based pharmacokinetic approach was used to compare pharmacokinetic parameters with a non-Japanese adult population.

Materials and methods:

In this double-blind, placebo-controlled phase I study, Japanese healthy volunteers were randomized to receive gadopiclenol (at 0.025, 0.05, or 0.1 mmol/kg) or a placebo. Blood and urine samples were collected up to 24- and 48-h post-administration, respectively. The pharmacokinetic profile of gadopiclenol was evaluated using standard non-compartmental analysis. Adverse events (AEs) were collected during the whole study period.

Results:

Overall, 27 participants were randomized (median [range] age: 22 [20–43] years; 52% male): 18 received gadopiclenol (6 in each dose group), and 9 received the placebo. The mean systemic exposure of gadopiclenol increased proportionally with the injected dose (area under the curve [AUC]: 215–1034 μg/mL.h) and was comparable between the three dose groups when normalized to dose (AUC/dose: 182–189 μg/mL/g.h) and to non-Japanese (168–183 μg/mL.h). The mean terminal half-life (1.43–1.86 h), and the distribution volume (11.3–15.2 L) were also similar to those of non-Japanese healthy volunteers (1.50–1.73 h and 13.0–15.5 L, respectively). The mean fraction of gadopiclenol excreted in urine was between 87 and 95%, depending on the administered dose. Most of gadopiclenol (median of 95.7%) was excreted within 24 h after administration. The mean total clearance was comparable between the different administered doses (5.3–5.6 L/h) and similar to the mean renal clearance. No gadopiclenol-related AEs were reported.

Conclusions:

The pharmacokinetic profile of gadopiclenol is similar in Japanese and non-Japanese healthy volunteers. The population pharmacokinetic analysis showed no significant ethnic disparities between these two populations and suggested that no dose adjustment was required for Japanese patients. Gadopiclenol had a very good tolerability in Japanese healthy volunteers with no adverse reactions reported.

2025-10-01·ANALYTICA CHIMICA ACTA

Interaction study between gadolinium-based contrast agents and lysozyme using frontal analysis continuous capillary electrophoresis

Article

作者: Chamieh, Joseph ; Rousseaux, Olivier ; Somnin, Chutintorn ; Leclercq, Laurent ; Cottet, Hervé ; Medina, Christelle

BACKGROUND:

Gadolinium-based contrast agents (GBCA) are widely used in magnetic resonance imaging (MRI) to enhance image contrast. However, their interactions with biological macromolecules remain an important area of investigation due to potential safety concerns. Developing robust analytical methods to study these interactions is essential for improving safety assessments and guiding the design of next-generation contrast agents.

RESULTS:

In this study, we employed Frontal Analysis Continuous Capillary Electrophoresis (FACCE) to investigate the binding interactions between lysozyme, a model protein, and several GBCA, including Gd-DTPA (Gadopentetate, Magnevist®), Gd-BOPTA (Gadobenate, Multihance®), Gd-DOTA (Gadoterate, Dotarem®), Gd-PCTA D2 (Gadopiclenol, Elucirem™) and Gd-HP-DO3A (Gadoteridol, Prohance®). Our results demonstrate that GBCA exhibit varying degrees of cooperative binding to lysozyme, with stoichiometry (n) of 4 for Gd-DTPA, Gd-BOPTA, and Gd-DOTA. The strength of interactions followed the trend: Gd-BOPTA (Multihance®) > Gd-DTPA (Magnevist®) > Gd-DOTA (Dotarem®), while Gd-PCTA D2 (Elucirem™) showed no significant binding. However, FACCE was unable to resolve interactions for Gd-HP-DO3A (Prohance®) due to interference with lysozyme.

SIGNIFICANCE:

FACCE is a well-adapted method to investigate GBCA-protein interaction. It requires low sample volumes and allows determining the stoichiometry, binding constant, and cooperativity of the interaction. This work emphasizes the cooperative nature of the GBCA-lysozyme interactions and indicates that the Hill model is suitable for analysing the interactions within the tested concentration range of GBCAs.

2025-10-01·EUROPEAN JOURNAL OF RADIOLOGY

Gadolinium concentration dependent signal enhancement profiles using routine clinical sequences with gadopiclenol, gadoterate, gadobutrol, and gadoxetate at 1.5, 3 and 7 Tesla

Article

作者: Froehlich, Johannes M ; Nanz, Daniel ; Sutter, Reto ; Marth, Thomas

PURPOSE:

Gadopiclenol, a new gadolinium-(Gd) based contrast agent (GBCA), exhibits a higher longitudinal relaxivity (r₁) than current standard GBCAs, and, thus, has the potential to be used at lower dose or to generate a brighter T1-weighted (T1w) signal at equivalent dose. As the relationship between enhancement and contrast agent concentration is non-linear, the signal profiles should be experimentally explored and compared to those of current GBCAs.

MATERIALS AND METHODS:

Standardized aqueous dilution series (0.0 to 25 mmol/L) of gadopiclenol, and current standard GBCAs gadoterate, gadobutrol, and gadoxetate were imaged with nine clinical sequences at 1.5, 3, and 7 Tesla(T). Signal intensities(SIs) were measured for each concentration and set in relation to the SI of water(rSI). Additionally, T1 relaxation times were measured at 3 T and r₁ was calculated.

RESULTS:

The maximum rSI in T1w fast-spin-echo images was observed at a lower Gd concentration (1.0 mmol/L) at all three field strengths in the gadopiclenol series than in the current standard GBCAs series (gadoterate and gadobutrol, 2.5 mmol/L, all field strengths, gadoxetate, 2.5 mmol/L at 1.5 and 3 T, 1.0 and 2.5 mmol/L at 7 T). The maximum rSI measured at 1.0 mmol/l gadopiclenol was comparable (±12 %rSI) to the rSI at 2.5 mmol/l of standard GBCAs. Molar gadopiclenol relaxivity, r₁, (13.5 ± 1.5 s^-1∙mM^-1) was three to four times higher than r₁ of gadoterate and gadobutrol (3.4 ± 0.4 and 4.1 ± 0.5 s^-1∙mM^-1, respectively), and 2.2 times higher than of that of gadoxetate (6.0 ± 0.7 s^-1∙mM^-1).

CONCLUSION:

Our results confirm the maximum signal intensity in clinical T1w images to be shifted to lower gadolinium concentrations of gadopiclenol compared to standard GBCAs at all field strengths.

项与 Gadopiclenol 相关的新闻（医药）

2026-01-27

·PRNewswire

New indication in children from birth for Guerbet's half-dose GBCA, Elucirem™ (Gadopiclenol) approved by European Commission

VILLEPINTE, France, Jan. 27, 2026 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global specialist in contrast media and solutions for medical imaging, is delighted to announce the approval by European Commission of a new indication in children from birth for its macrocyclic high-relaxivity gadolinium-based contrast agent, Elucirem™ (gadopiclenol) in the European Union (EU). Born of Guerbet innovation, Elucirem™ (Gadopiclenol) is the first gadolinium-based contrast agent with the highest relaxivity, in comparison to other available gadolinium-based contrast agents (GBCA) [1]. Elucirem™ was initially approved in the EU in December 2023. It is produced in France and in the USA and is marketed by Guerbet in vials and prefilled syringes. In the European Union, Elucirem™ is indicated in adults and in children now from birth, for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of: the brain, spine, and associated tissues of the central nervous system (CNS); the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system. For these indications, an MRI examination with Elucirem™ requires half the conventional dose compared to that required with existing nonspecific contrast agents, thus answering a major concern of practitioners about gadolinium exposure.[2], [3], [4] " The new indication of Elucirem™ for pediatric patients from birth reflects our commitment to combining medical innovation and patient safety. European radiologists will be able to perform contrast-enhanced MR imaging using half the conventional gadolinium dose, which is critical for patients, especially those requiring serial MRI examinations during their lifetime, as it reduces cumulative gadolinium exposure", explains Valérie Brissart, Guerbet SVP Diagnostic Imaging. "Children are a very vulnerable group—they're still developing, and we want to be as safe as possible with everything we do. One key asset of Elucirem™ is that, thanks to its higher relaxivity, we can get very good image quality using only half the conventional gadolinium dose. That makes a real difference in terms of amount of gadolinium injected, especially for these young patients, without losing diagnostic accuracy.", says Dr. Emilio J Inarejos Clemente, Director and Pediatric radiologist, Hospital Sant Joan de Déu in Barcelona (Spain). About Guerbet At Guerbet, we build lasting relationships to enable better living. This is our Purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging.Pioneers in contrast agents for 99 years, with 2,905 employees worldwide, we continuously innovate and dedicate 9% of our revenue to Research & Development across four centers in France and the United States. Guerbet (GBT) is listed on Euronext Paris, Compartment B, and achieved €841 million in revenue in 2024. For more information, please visit . About Gadopiclenol Gadopiclenol, initially invented by Guerbet, with the subsequent contribution of intellectual property held by Bracco, is a new gadolinium-based macrocyclic contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI central nervous system, head and neck, chest, abdomen, pelvis and musculoskeletal system. The European Summary of Product Characteristics of Elucirem™ 0.5mmol/Ml solution for injection can be found at: About the Guerbet / Bracco Imaging collaboration Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol is commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. GBCA: Gadolinium-Based Contrast Agent 1 Robic C et al. Invest Radiol. 2019;54(8):475-484. 2 PRAC, European Medicines Agency, 2017 3 FDA Drug Safety Communication, 2017 4 Brunjes et al. Water Research, 2020 Contacts: Matthieu BRUNEAU - Global corporate communication manager Email: [email protected] WF PROM JAN 2026 I26004145 Logo - 21% more press release views with Request a Demo

上市批准引进/卖出

2025-04-09

·DrugAI

J. Med. Chem. | 机器学习遇上药物动力学，让候选药物“提前亮相”

DRUGAI今天为大家介绍的是来自美国剑桥赛诺菲定量药理学研究负责人Panteleimon D. Mavroudis与Nikhil Pillai团队的一篇论文。这项研究主要关注药物动力学(pharmacokinetic, PK)特征的预测工作。传统预测方法需要通过体外或体内测试获取参数，这些方法不仅耗时耗力，还会涉及伦理问题。为克服这些限制，研究团队开发了基于机器学习（Machine Learning, ML）的数据驱动模型。研究人员从公开数据源收集了大量小分子的物理化学和药物动力学特性数据，并从文献中提取了约800种化合物的人体血浆浓度-时间曲线数据。他们提出了两种创新性的预测框架：一种是将机器学习与生理药代动力学模型相结合的混合框架，另一种是通过两个学习阶段来直接预测药物动力学特征的机器学习框架。在对106种药物的测试中，这些框架展现出优秀的预测性能。在药物血浆浓度-时间曲线下面积（AUC）和最高血药浓度（Cmax）这两个关键指标上，40-60%的化合物预测误差在2倍以内，80-90%的化合物预测误差在5倍以内。这些方法有望提升早期药物筛选和设计效率，推动药物研发能力的进步。药物研发是一个复杂且耗时的过程，其中预测新药在人体内的暴露情况对评估药物的有效性和安全性至关重要。传统的预测方法主要依赖生理药代动力学（Physiological Based PK, PBPK）等数学模型，这些方法需要大量实验室测试和动物实验，不仅成本高昂，还面临效率和伦理问题。图 1为了解决这些挑战，研究团队开发了两种创新性的预测框架（如图1所示）：一种是混合模型框架，它将机器学习与生理药代动力学模型相结合；另一种是分层机器学习框架。这两种框架都采用两步建模策略：第一步都是使用机器学习从化学结构预测药物的物理化学和药代动力学参数。在第二步中，混合框架将这些参数输入PBPK模型进行模拟，而分层框架则将这些预测参数输入另一个机器学习模型，直接预测药物在人体内的浓度变化曲线。为支持这项研究，团队建立了迄今为止最大的人体静脉注射药物数据库，收录了约800种药物的动力学曲线数据。这个庞大的数据库为开发准确的预测模型提供了坚实的基础，有望在药物早期研发阶段就能快速、准确地预测药物在人体内的表现，从而大幅提高新药研发的效率。数据获取图 2研究团队首先通过数字化处理文献中的药物动力学曲线，获得了773种静脉注射药物的数据（如图2所示）。为确保评估的客观性，他们将106种具有完整观测数据的化合物作为测试集，其余667种作为训练集。根据表1显示，训练集包含667种化合物在不同时间点的8715个浓度值，测试集则包含106种化合物的1351个浓度值。研究发现药物动力学参数的原始分布较为不均匀，特别是清除率（CL）和稳态分布容积（VDss）。为了优化模型效果，研究人员将这些值转换为以10为底的对数值。如图3A-E所示，测试集中所有物理化学和药物动力学参数的分布都落在训练集的范围内，这保证了模型预测的可靠性。图 3在参数选择方面，研究团队使用了计算机模拟获得的酸碱解离常数（pKa）和辛醇-水分配系数（logP）值，而不是实验测定值。这是因为在773种药物中，仅有29种具有实验测定的pKa值，83种具有实验测定的logP值，数据覆盖率过低。相比之下，ChEMBL数据库中约570种化合物与这些药物重叠，提供了更全面的计算值数据。研究还发现，计算值与实验值具有良好的相关性，且使用实验测定的logP值并未显著改善预测效果。这种选择不仅提高了数据的可用性，也为未来整合更多实验数据预留了优化空间。构建QSAR模型预测PC/PK参数图 4研究团队开发了定量构效关系（Quantitative Structure-Activity Relationship, QSAR）模型来预测药物的各项参数。他们使用3种机器学习算法和5种分子特征描述方法，共构建了15个独立模型，并通过组合这些模型的预测结果建立了集成模型。图4的热图展示了所有模型在测试集上的预测准确度（R²值）。表 2图 5如表2和图5所示，不同参数的最佳预测模型各不相同：对于药物游离分数（Fu），支持向量机（Support Vector Machine, SVM）算法表现最佳，60%的测试化合物预测误差在2倍范围内；对于药物清除率（CL）和稳态分布容积（VDss），集成模型效果最好，分别有64%和62%的化合物预测误差在2倍范围内；对于酸性解离常数（pKa acidic），极限梯度提升（XGBoost）算法配合RDKit分子描述符的模型最优，98%的测试化合物预测误差在2倍内；对于碱性解离常数（pKa basic），集成模型表现最佳，91%的化合物预测误差在2倍内。研究发现，使用分子结构描述符（如RDKit、Mordred等）训练的模型普遍优于使用分子指纹特征的模型。集成模型通过整合多个单一模型的优势，能够提供更稳定和准确的预测。由于酸碱性参数涉及的机制相对简单，其预测准确度较高。而游离分数、清除率和分布容积的预测则更具挑战性，因为这些参数受到蛋白质相互作用、生物过程和个体差异等多重因素的影响。尽管如此，这些模型的预测误差平均在2倍以内，达到了业界公认的标准，且优于已发表的同类研究成果。混合建模研究研究团队使用生理药代动力学软件PK-Sim开展了混合建模研究。在这个框架中，他们将机器学习预测的药物参数输入到生理药代动力学（PBPK）模型进行模拟。为了评估效果，研究人员还进行了对照实验：使用实验观测到的参数进行PBPK模拟。图 6如图6A所示，在预测药物血浆浓度-时间曲线下面积（AUC）和最高血药浓度（Cmax）时，对照组在2倍误差范围内的准确率更高。但在3倍和5倍误差范围内，混合方法的表现与对照组相当或更优。图 7图7展示了几个典型案例：当物理化学和药代动力学参数的预测误差在2倍以内时，两种方法都能准确预测药物浓度变化曲线；预测效果不佳通常是因为游离分数（Fu）和清除率（CL）预测不准，例如化合物ID 240的清除率预测值比实际值低41倍，导致预测的药物浓度显著偏高；在某些情况下，混合方法反而比使用实验参数的预测更准确，如化合物ID 789和1325的案例。研究还比较了不同药物分布模型的效果。有些药物（如ID 31和72）在各种模型中预测结果相近，而其他药物（如ID 315和461）则因模型选择而差异显著。这是因为不同模型考虑的因素不同，例如有些模型会特别考虑药物的酸碱性与人体pH值的相互作用。考虑到新药机制往往不明确，难以预先确定最适合的分布模型，研究团队采用了多个模型预测结果的平均值。这种平均策略的效果优于单一模型：43%的AUC和39%的Cmax预测误差在2倍以内，80%的AUC和82%的Cmax预测误差在5倍以内。分层ML建模研究研究团队使用667种化合物的数据开发了分层机器学习模型，用于预测药物在不同时间点的浓度。最佳表现来自随机森林（Random Forest, RF）算法，该算法综合考虑了药物的酸碱解离常数、游离分数、清除率、分布容积和给药时间等特征。在106种测试化合物中，55%的浓度预测误差控制在2倍范围内。图 8如图8所示，这种方法在预测药物暴露水平方面表现出色：60%的血药浓度曲线下面积（AUC）和59%的最高血药浓度（Cmax）预测误差在2倍以内，超过90%的预测误差在5倍以内。特别是对于某些复杂案例，如图9中的化合物ID 219和315，分层方法的预测比传统方法更准确。这可能是因为分层方法能够从大量真实数据中学习复杂的药物-人体相互作用模式，而不受预设机制的限制。图 9研究还尝试通过定义模型的适用范围来提高预测准确度，即根据待测化合物与训练集化合物的结构相似度来判断预测的可靠性。但这种方法未能显著改善预测效果，这反映出药物结构与其在体内行为之间的关系十分复杂。当前框架的主要局限在于将每个时间点的浓度预测作为独立任务处理，忽略了浓度随时间变化的连续性。这可能导致预测结果出现不连贯的情况，例如在化合物ID 789、1167和1210的案例中，某些时间点的预测浓度低于后续时间点，这与药物在体内的实际表现不符。这种问题可能源于数据处理误差，也可能反映了模型在捕捉时间序列特征方面的不足。使用最近批准的药物进行外部验证图 10为了进一步验证模型的实用性，研究团队选择了7种FDA在2019-2023年间新批准的药物进行测试。如图10所示，分层机器学习模型展现出优秀的预测能力：所有药物的血药浓度曲线下面积（AUC）和最高血药浓度（Cmax）预测误差都控制在4倍以内，其中4种药物的误差更是在2倍范围内。相比之下，混合方法的表现较差，特别是在预测Abrocitinib和Gadopiclenol时。例如，模型低估了Abrocitinib的清除率（实测：0.722，预测：0.240 L/h/kg），导致预测的药物浓度偏高。这种误差可能源于基础PBPK模型未考虑主动转运体和其他代谢信息。在研究规模和数据质量方面，本研究建立了约800种化合物的人体药物动力学数据库，这是目前同类研究中最大的数据集之一。与其他研究相比，如Geci等人的工作（在5倍误差范围内达到71%的AUC和78%的Cmax预测准确率），本研究的混合建模框架展示了相当的性能。在方法选择上，研究采用了传统的机器学习算法而非复杂的深度学习模型。这是因为临床研究中的药物浓度数据通常采样时间不规则，而循环神经网络（Recurrent Neural Network, RNN）等深度学习模型往往需要均匀采样的数据。虽然神经常微分方程（Neural Ordinary Differential Equation, Neural-ODE）可以处理不规则数据，但这类深度学习方法计算复杂，且在小样本情况下容易过拟合。结论研究团队开发了两种药物动力学预测框架：一种结合机器学习和机制建模的混合框架，另一种直接从分子结构预测药物浓度的分层机器学习框架。在大量公开数据的支持下，两种方法都展现出良好的预测能力，其中分层方法表现更优。本研究利用大量公开的人体药物动力学研究数据，为药物开发提供了新的预测工具。这些模型为未来研究奠定了基础，通过引入更先进的机器学习算法，如科学机器学习方法，可以整合多源信息并从真实世界数据中识别系统特征，有望进一步提高预测准确度。研究的最终目标是帮助制药企业在药物开发早期就能预测候选化合物的药物动力学特征，从而更高效地筛选和优化潜在药物，加速新药研发进程。编译|于洲审稿|王梓旭参考资料Jia X, Teutonico D, Dhakal S, et al. Application of Machine Learning and Mechanistic Modeling to Predict Intravenous Pharmacokinetic Profiles in Humans[J]. Journal of Medicinal Chemistry, 2025.

疫苗

2024-07-25

·GlobeNewswire-Health Care

GUERBET : H1 2024 revenue.

H1 2024 revenue Half-yearly activity H1 revenue: €419.2m, up 11.8% at CER1, including an acceleration in Q2 (+14.5%)This acceleration was driven by continued catch-up in the Americas, the normalisation of orders in France and MRI sales Annual targets confirmed Revenue: expected growth of over 8% like-for-like and at CERProfitability: restated EBITDA margin rate2 higher than in 2021 (14.4%) Villepinte, 25 July 2024, 5.45 pm: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for first-half 2024. As of June 30th, 2024, the Group’s sales totalled €419.2m, up 10.7% compared with the same period in 2023 (€378.6m). Earnings reflected a negative forex effect of €4.1m. At constant exchange rates (CER1), Guerbet’s growth over the first six months was 11.8%. This trend includes an acceleration in the second quarter (+14.5% at CER), following what was already a highly positive momentum in the first quarter (+8.8%). Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 30 June 2024H1 2023*H1 2024% changeH1 2024At CER1% changeSales in EMEA178.5183.4+2.7%182.8+2.4%Sales in the Americas98.6127.3+29.2%127.2+29.1%Sales in Asia101.5108.5+6.8%113.2+11.5%Total378.6419.2+10.7%423.3+11.8% In the EMEA region, Group revenue amounted to €183.4m in the first half, up 2.4% at CER. The decline in the first quarter (-6.2% at CER) was fully offset in the second (+11.0% at CER) as business returned to normal in France after the disruptions linked to the March 1st 2024 reform of the supply circuit for contrast products. Guerbet revenue in the Americas caught up strongly for the third consecutive quarter, with growth of 37.4% in the second quarter at CER, reflecting record production levels at the Raleigh site in North Carolina. Total H1 revenue in the Americas came out at €127.3m, up 29.1% at CER. Asia posted growth of 6.8% over the period, at €108.5m, including a persistent negative currency effect. At CER, growth totalled 11.5% in the first half, despite a slowdown in the second quarter stemming from the contraction in sales in South Korea, where access to care has been paralysed since mid-February by an unprecedented doctor strike. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 30 June 2024H1 2023*H1 2024% changeH1 2024At CER1% changeDiagnostic Imaging 336.5368.8+9.6%372.3+10.7%MRI125.0131.1+4.8%131.5+5.2%X-ray211.4237.7+12.4%240.8+13.9%Interventional Imaging42.250.4+19.5%50.9+20.8%Total378.6419.2+10.7%423.3+11.8% Diagnostic Imaging revenue amounted to €368.8m in H1 2024, up 10.7% at CER. MRI sales increased 5.2% at CER in the first half of the year thanks to a solid performance in the second quarter (+13.5%). Over this period, business was driven by a strong performance by the MRI franchise, and particularly the development of EluciremTM in the United States, together with the initial sales in Germany. X-ray revenue grew 13.9% at CER in H1 2024 as part of a positive business dynamic fuelled by sales of Xenetix® and Optiray®. In Interventional Imaging, revenue at mid-year was up 20.8% at CER. This remarkable performance reflects a strong pick-up in the second quarter (+33.8% at CER) on continued positive momentum for Lipiodol®, in terms both of volumes and prices. Solid visibility for H2 - Confirmation of financial targets for 2024 Having achieved a sustained growth trajectory in the first half of the year, Guerbet enters the second half in full peace of mind. Beyond the catch-up in sales in the Americas, business continues to benefit from firmly established growth drivers firmly across the entire portfolio: in X-rays (Optiray® in particular), Interventional Imaging (strong momentum with Lipiodol®) and the MRI franchise. The latter is now reinforced by the expansion in Europe of EluciremTM, which, after receiving an extremely favourable reception in Germany in Q2 2024, will be launched in in the UK and France in the second half. Guerbet also remains confident in improving its operating profitability, driven by the adjustment of the product mix and price increases, and in its ability to bring cash generation into positive territory. Given these circumstances, the Group is confirming its forecast of sales growth of over 8% in 2024 like-for-like and at CER and expects its adjusted EBITDA margin rate to exceed that of 2021 (14.4%). Free cash flow is expected to be in positive territory for the full year. Next event: Publication of 1st half 2024 results 25 September 2024 after market close About GuerbetAt Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 97 years, with more than 2,920 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, the United States and Israel. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Forward-looking statementsCertain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control. These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.24-0224 on April 3, 2024, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Restated EBITDA margin rate: excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Contacts: Guerbet Jérôme Estampes, Chief Financial Officer +33 1 45 91 50 00 / jerome.estampes@guerbet.comChristine Allard, Head of Communications +33 6 30 11 57 82 / christine.allard@guerbet.com Actifin Marianne Py, Financial Communications +33 1 80 48 25 31 / marianne.py@seitosei-actifin.com Jennifer Jullia, Press +33.1.56.88.11.19 / jennifer.jullia@seitosei-actifin.com Attachment 24 07-25 CP Guerbet CA S1 2024 VDef EN

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适应症	国家/地区	公司	日期
造影剂	韩国	Guertbet Korea Ltd	2026-01-12
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	Guerbet SA	2023-12-07
诊断试剂	冰岛	Bracco Imaging SpA	2023-12-07
诊断试剂	列支敦士登	Guerbet SA	2023-12-07
诊断试剂	列支敦士登	Bracco Imaging SpA	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

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适应症	最高研发状态	国家/地区	公司	日期
血管畸形	申请上市	加拿大	Bracco Imaging SpA	2025-04-01
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

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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


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)	製餘網簾網鬱構鹽築構(襯觸憲鹽壓簾膚夢淵蓋) = 襯壓艱範獵窪糧構網齋簾範窪觸鏇網鹽餘壓網 (襯憲範選鏇膚夢窪繭鬱, 27.6) 更多	-	2025-10-28
				Gadopiclenol (Age Group 2: Patients Aged 28 Days to Less Than 3 Months)	製餘網簾網鬱構鹽築構(襯觸憲鹽壓簾膚夢淵蓋) = 鏇網衊築網淵範餘艱壓簾範窪觸鏇網鹽餘壓網 (襯憲範選鏇膚夢窪繭鬱, 9.9) 更多
NCT03986138 (PROMISE, CTgov)	临床3期	-	324	Gadopiclenol (Patients With Gadopiclenol Paired Images)	構構襯襯膚製獵夢鑰蓋(顧顧鏇淵膚願餘憲糧壓) = 製觸簾鹽顧積築憲憲憲膚膚衊積願憲廠醖壓淵 (鏇鑰選顧窪鹹願廠顧餘, 0.03) 更多	-	2025-10-27
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	構構襯襯膚製獵夢鑰蓋(顧顧鏇淵膚願餘憲糧壓) = 壓餘築夢憲鏇鏇醖夢範膚膚衊積願憲廠醖壓淵 (鏇鑰選顧窪鹹願廠顧餘, 0.03) 更多
NCT03996447 (PICTURE, CTgov)	临床3期	血脑屏障缺陷	260	Gadopiclenol (Patients With Gadopiclenol Paired Images)	構淵製膚齋憲遞齋鑰蓋(壓遞鹹廠廠顧蓋網餘憲) = 願鏇醖遞範繭襯衊餘選糧築積簾鑰壓構網壓憲 (製艱艱艱鹹鬱鏇願繭獵, 0.02) 更多	-	2025-09-22
				Gadopiclenol (Patients With Gadopiclenol Pre Images)	構淵製膚齋憲遞齋鑰蓋(壓遞鹹廠廠顧蓋網餘憲) = 窪艱觸網選鏇憲糧廠襯糧築積簾鑰壓構網壓憲 (製艱艱艱鹹鬱鏇願繭獵, 0.02) 更多
phase IIb study (ASCO2024)	临床2期	脑转移瘤	13	Gadopiclenol 0.1 mmol/kg	簾鏇蓋鏇網膚獵蓋願蓋(觸積壓艱鑰廠醖餘鏇糧) = 齋製構壓壓願糧鹽壓製壓構繭艱繭鬱窪窪簾襯 (蓋網遞鹹廠獵醖範夢積 ) 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)	艱廠簾鹽鬱醖鏇窪範鑰(鑰選廠網願艱願壓糧鏇) = 衊鏇選願遞齋醖窪繭獵鏇製鹽淵鏇積構獵壓衊 (築簾膚遞餘顧築膚鹹齋, 製願廠淵網構簾網淵餘 ~ 範糧繭遞鏇膚淵鹹糧膚) 更多	-	2022-06-01
				P03277 (CNS Cohort 7-11 Years)	艱廠簾鹽鬱醖鏇窪範鑰(鑰選廠網願艱願壓糧鏇) = 艱製鏇齋鹽顧餘簾積鬱鏇製鹽淵鏇積構獵壓衊 (築簾膚遞餘顧築膚鹹齋, 構築糧繭淵範窪餘餘醖 ~ 蓋鏇網餘淵齋鑰醖鹽鹽) 更多
NCT02973516 (CTgov)	临床2期	肝细胞癌 \| 慢性肝病	41	Gadopiclenol (Cohort 1)	築獵鹹鏇糧構齋製築鑰 = 蓋網顧積窪構齋憲鑰衊築顧糧壓鹹齋鏇淵繭網 (鑰鏇顧壓糧憲壓範醖鹹, 糧膚齋夢繭願窪鬱鹽築 ~ 餘夢齋艱廠鬱遞願壓顧) 更多	-	2021-10-06
				Gadopiclenol (Cohort 2)	築獵鹹鏇糧構齋製築鑰 = 鑰膚遞範蓋鏇鹹遞夢鏇築顧糧壓鹹齋鏇淵繭網 (鑰鏇顧壓糧憲壓範醖鹹, 繭憲顧鑰窪構構糧願鹽 ~ 鑰壓糧夢範淵夢鹽簾簾) 更多
NCT03657784 (Pubmed \| Invest Radiol)	临床1期	肾功能不全	40	Gadopiclenol (Healthy subjects)	鏇壓襯鑰積鏇鹹廠衊鏇(積鑰選範觸簾選鏇獵網) = 艱膚餘網淵鹽糧艱顧觸齋膚衊鬱範獵淵觸窪繭 (鹽糧鹽襯廠積艱顧鹹糧 )	-	2021-08-01
				Gadopiclenol (Subjects with mild renal impairment)	鏇壓襯鑰積鏇鹹廠衊鏇(積鑰選範觸簾選鏇獵網) = 積憲鹽鏇鬱範壓壓簾鑰齋膚衊鬱範獵淵觸窪繭 (鹽糧鹽襯廠積艱顧鹹糧 )
NCT03996447 \| NCT03986138 (PICTURE \| PROMISE, Corporate Publications) 人工标引	临床3期	造影剂	560	Gadopiclenol+gadobutrol	簾窪鹽遞夢夢鏇夢窪範(鹽壓製鑰範顧齋襯壓膚) = 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. 鏇積壓網襯積鑰襯鏇窪 (壓艱衊壓衊壓鹽蓋製繭 ) 更多	积极	2021-03-24
				Gadobutrol+Gadopiclenol
NCT03657264 (CTgov)	临床1期	-	48	P03277 (P03277 0.1 mmol/kg)	蓋夢窪淵鬱衊製遞襯願(製糧憲襯製繭糧衊餘鹹) = 糧憲獵顧壓積壓夢鏇齋選鹹膚蓋糧遞獵觸壓憲 (衊廠鹹鑰膚繭選蓋夢鑰, 0.88) 更多	-	2019-08-22
				P03277 (P03277 0.3 mmol/kg)	蓋夢窪淵鬱衊製遞襯願(製糧憲襯製繭糧衊餘鹹) = 觸齋構憲衊夢壓遞壓淵選鹹膚蓋糧遞獵觸壓憲 (衊廠鹹鑰膚繭選蓋夢鑰, 0.89) 更多
NCT03603106 (Pubmed \| Invest Radiol)	临床1期	可见病灶	142	Gadopiclenol	衊網鏇範衊糧醖顧選壓(醖簾願選範艱齋築製鏇) = 觸壓夢顧醖鏇憲夢鏇選鏇餘餘網鏇製淵鑰襯廠 (襯廠網鬱壓齋獵淵壓壓 )	-	2019-07-01