The purpose of this study is to determine if measurements of active collagen deposition using [68Ga]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.

Start Date01 Nov 2024

Sponsor / Collaborator

The Massachusetts General Hospital

NCT06600880

/ Not yet recruitingPhase 1IIT

Neuronavigation-guided Focused Ultrasound-induced Blood-brain Barrier Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau

The primary purpose of this phase 1b study is to further assess the safety and reversibility of focused ultrasound induced blood-brain barrier opening (FUS-BBBO) in participants with Alzheimer´s Disease (AD) using a single-element transducer with neuronavigation guidance. Preliminary results from our phase 1a study demonstrate that our neuronavigation-guided FUS system was capable of safely and transiently open the BBB in participants with AD. The information collected in this new study may be used to design future clinical trials to ultimately provide a viable alternative for treatment of AD in a safe and noninvasive manner.
Our secondary objective includes the assessment of the therapeutic efficacy of FUS-BBBO in reducing amyloid beta and neurofibrillary tangles, the main hallmark pathologies of AD, using PET tracers. Based on our preclinical studies in AD transgenic mouse models, FUS-BBBO alone was able to reduce both the amyloid beta and tau protein load, resulting in improvements in behavioral tasks assessing memory. Therefore, in this new study, the effect of FUS-BBBO on the amyloid beta and tau protein load in patients with AD will be assessed through the use of PET tracers.

Start Date01 Oct 2024

Sponsor / Collaborator

The Trustees of Columbia University in The City of New York

100 Clinical Results associated with Gadoterate Meglumine

100 Translational Medicine associated with Gadoterate Meglumine

100 Patents (Medical) associated with Gadoterate Meglumine

866

Literatures (Medical) associated with Gadoterate Meglumine

29 Jan 2025·ACS Applied Materials & Interfaces

Electrochemical Filtration of Gadolinium from Patient Urine after Magnetic Resonance Imaging

Article

Author: Wijesinghe, Sethma ; Allen, Matthew J. ; Kovaci, Christa ; Wang, Bingwen ; Luo, Long ; Ranaweera, Ruchiranga ; Weerarathna, Udeshika

The widespread use of gadolinium-based contrast agents for magnetic resonance imaging (MRI) in recent decades has led to a growing demand for Gd and raised environmental concerns due to their direct discharge into wastewater systems. In response, we developed an electrochemical filtration method to recover Gd from patient urine following contrast-enhanced MRI. This method involves modifying a conventional vacuum filtration apparatus by introducing electrodes into the filter membrane, creating a strong electric field of ∼5 kV/m and a steep three-zone pH gradient within the filter membrane. These electric and pH fields facilitate the dissociation of Gd-based contrast agents, releasing Gd^III ions, electrophoretic separation of Gd^III and its ligand, and eventually precipitation and trapping of Gd^III as GdPO₄ and Gd(OH)₃ on the filter membrane. Using gadopentetate dimeglumine (GdDTPA) as a model Gd-based contrast agent, we achieved a Gd trapping efficiency of ∼70% for artificial and real urine samples. For macrocyclic Gd-based contrast agents such as gadoterate meglumine (GdDOTA), the Gd trapping efficiency decreased to 25.4% due to the slow dissociation kinetics of macrocyclic contrast agents. However, the trapping efficiency can be improved to ∼40% by allowing the macrocyclic contrast agent to predissociate in an acidic environment before electrochemical filtration. The Gd trapped on the filter membrane can be recovered by thermal treatment in a muffle furnace. After thermal treatment, the reclaimed Gd from the real urine sample was primarily identified as GdPO₄. This electrochemical filtration design offers a straightforward and practical approach to recovering Gd from contrast-enhanced MRI scans, addressing the increasing demand for Gd and helping alleviate concerns about Gd contamination in surface water.

13 Nov 2024·NANO LETTERS

One-Pot Fabrication of Kinetically Inert Ultrasmall Manganese(II) Chelate-Backboned Polymer Contrast Agents for High-Performance Magnetic Resonance Imaging

Article

Author: Fu, Shengxiang ; Liu, Li ; Ni, Guohua ; Younis, Muhammad Rizwan ; Ai, Hua ; Gu, Haojie ; Wu, Min ; Lui, Su ; Cai, Zhongyuan ; Song, Bin

Traditional macromolecules or nanoscale Mn²⁺ chelate-based magnetic resonance imaging (MRI) contrast agents (CAs) suffer from complicated and laborious synthesis processes, relatively low kinetic stability and T₁ relaxivity, limiting their clinical applications. Herein, we fabricated a series of kinetically inert Mn²⁺ chelate-backboned polymers, P(MnL-PEG), through a facile and one-pot polymerization process. Particularly, P(MnL-PEG)-3 demonstrates a significantly higher T₁ relaxivity of 23.9 Mn mM^-1 s^-1 at 1.5 T than that of previously reported small molecules and macromolecules or nanoscale Mn²⁺ chelate-based CAs. Due to its high T₁ relaxivity, extended blood circulation, hepatocyte-specific uptake, and kidneys metabolism, P(MnL-PEG)-3 presents significantly enhanced contrast in blood vessel, liver, and kidneys imaging compared to clinical Gd³⁺-based CAs (Gd-EOB-DTPA and Gd-DOTA) at a dosage of 0.05 mmol Mn/Gd kg^-1 BW, and can accurately diagnose orthotopic H22 liver tumors in vivo in animal models. We anticipate that this work will promote the development of clinically relevant MRI CAs.

01 Sep 2024·INVESTIGATIVE RADIOLOGY

Evaluation of the Contrast Enhancement Performance of Gadopiclenol for Magnetic Resonance Angiography in Healthy Rabbits and Pigs

Article

Author: Robert, Philippe ; Wintrebert, Mélody ; Arnould, Laurent ; Serfaty, Jean-Michel ; Adriaensen, Hans ; Hugon, Gaëlle

Objectives:

Unexpected accumulations of gadolinium in various organs were reported after the administration of gadolinium-based contrast agents, making desirable to reduce the dose while maintaining equivalent diagnostic performance. The aim of this study was to evaluate the contrast enhancement performance of high relaxivity gadopiclenol compared with gadoterate meglumine in abdominal contrast-enhanced magnetic resonance angiography (CE-MRA).

Materials and Methods:

In a first study in healthy rabbits, axial 3D gradient echo sequences were applied at 4.7 T to study arterial enhancement as a function of gadopiclenol dose (0.025, 0.05, 0.075, and 0.1 mmol Gd/kg) or gadoterate meglumine at 0.1 mmol Gd/kg (n = 5–6/group). The increase in signal-to-noise ratio (ΔSNR) in the aorta at the first pass was measured and compared. In a second, crossover study in 6 healthy pigs, abdominal CE-MRA sequences were acquired at 3 T with gadopiclenol at 0.05 mmol Gd/kg or gadoterate meglumine at 0.1 mmol Gd/kg at a 1-week interval. Quantitatively on the maximum intensity projection (MIP) images, the mean MIP SNR within the aorta of both groups was compared. Qualitatively, a blinded comparison of the angiograms was performed by an experienced radiologist to determine the preferred contrast agent.

Results:

In the rabbit, ∆SNR is linearly correlated with the gadopiclenol dose (P = 0.0010). Compared with gadoterate meglumine 0.1 mmol Gd/kg, an increase in the ∆SNR is observed after 0.05, 0.075, and 0.1 mmol Gd/kg of gadopiclenol (+63% P = 0.0731, +78% P = 0.0081, and +72% P = 0.0773, respectively), whereas at 0.025 mmol Gd/kg, ∆SNR is in the same range as with gadoterate meglumine 0.1 mmol Gd/kg (+15% P > 0.9999). In pigs, contrast enhancement after gadopiclenol at 0.05 mmol/kg is +22% superior to MIP SNR after gadoterate meglumine at 0.1 mmol Gd/kg (P = 0.3095). Qualitatively, a preference was shown for gadopiclenol images (3/6) over the gadoterate meglumine examinations (1/6), with no preference being shown for the remainder (2/6).

Conclusions:

First-pass CE-MRA is feasible with gadopiclenol at 0.05 mmol Gd/kg with at least the same arterial signal enhancement and image quality as gadoterate meglumine at 0.1 mmol Gd/kg.

News (Medical) associated with Gadoterate Meglumine

24 Oct 2024

·www.globenewswire.com

GUERBET : Revenue at September 30, 2024.

Revenue at September 30, 2024 Continued growth momentum 9-month revenue: €620.5m, up 9.6% at CER1 In the third quarter, momentum remained strong (+5.4% at CER), driven by the Americas (+13.1%) and Asia (+8.1%), while performance in EMEA (-2.3%) was once again impacted by the continued implementation of the new supply chain in France 2024 annual targets confirmed Revenue: expected growth of over 9%on a like-for-like basis and at CERProfitability: re-stated EBITDA margin returnedto a higher level than in 2021 (14.4%) Villepinte, October 24, 2024, 5:45 p.m.: Guerbet (FR0000032526 GBT), a global specialist in contrast products and solutions for medical imaging, is publishing its revenue as at September 30, 2024. In the first nine months of the financial year, Group sales reached 620.5 million euros (€m), up 8.1% compared with the same period in 2023. This performance includes an unfavorable currency effect of €8.6m, mainly due to the depreciation of the Japanese yen and the Brazilian real. At constant exchange rates (CER1), Guerbet's revenue growth was 9.6% as at September 30, 2024. In the third quarter alone, sales were up 3.1% to €201.3m. At CER, growth was 5.4% over the period. Geographical breakdown of the Group's consolidated revenue (IFRS) In thousands of euros,at September 30, 20249 months 20239 months 2024% change9 months 2024at CER1% changeat CEREMEA sales258.5261.6+1.2%261.0+1.0%Americas sales160.9194.3+20.7%197.8+22.9%Asia sales154.4164.7+6.6%170.4+10.3%Total573.9620.5+8.1%629.1+9.6% At constant exchange rates: the impact of exchange rates was eliminated by recalculating sales for the period based on the exchange rates used for the previous year. In EMEA, the Group's revenue totaled €261.6m in the first nine months of the financial year, up 1.0% at CER despite the decline in sales in France. On this market, following the reform of the supply chain for contrast products on March 1, 2024, there has been an erratic trend in sales linked to the implementation of a new management system for flows between distributors and radiologists. These disruptions particularly affected activity in the third quarter, with EMEA down 2.3% at CER. In the Americas, sales at end-September 2024 were up 22.9% at CER to €194.3m. This momentum, fueled by the increase in both volumes and prices, was characterized by an outstanding performance in Latin America. In the third quarter, sales in the Americas were up 13.1%, following three quarters of exceptional growth (>20%) linked to the recovery at the Raleigh site. In Asia, 9-month sales reached €164.7m, up 10.3% at CER despite the contraction in activity in South Korea (-4.8%), which has been affected by a doctors' strike since February. In the third quarter alone, growth was 8.1% at CER, underpinned by very favorable momentum in China (+24.2% over the period). Breakdown of the Group's consolidated revenue by activity (IFRS) In thousands of euros,at September 30, 20249 months 20239 months 2024% change9 months 2024at CER1% changeat CERDiagnostic Imaging 506.4546.4+7.9%554.0+9.4%MRI187.3191.8+2.4%193.1+3.1%X-ray319.0354.6+11.2%360.9+13.1%Interventional Imaging67.574.1+9.9%75.1+11.3%Total573.9620.5+8.1%629.1+9.6% At constant exchange rates: the impact of exchange rates was eliminated by recalculating sales for the period based on the exchange rates used for the previous year. Sales at CER for the Diagnostic Imaging business were up 9.4% at September 30, 2024 and +6.9% in the third quarter. In the MRI division, 9-month revenue increased by 3.1% at CER, including a slight decline in the third quarter of 2024 (-1.1%). This change is the direct consequence of the temporary difficulties encountered on the French market, which particularly affected sales of Dotarem®. Revenue for the X-ray division reached €354.6m at September 30, 2024, up 13.1% at CER. Performance in the third quarter (+11.6%) was underpinned by continued strong sales of Xenetix® and in particular Optiray®. In Interventional Imaging, activity at CER was up 11.3% compared to the first nine months of 2023, thanks to strong sales of Lipiodol® in terms of both volumes and prices. The change in the third quarter alone (-4.6% at CER) is not significant from a full-year perspective. Confirmation of financial targets for 2024 In the wake of these first nine months marked by strong trends across the entire product portfolio and in the main geographical areas, except occasionally in France, Guerbet expects to continue positive momentum in the fourth quarter. In this context, the Group confirms that it is targeting sales growth of over 9% on a like-for-like and CER basis for 2024, as well as a restated EBITDA margin rate higher than that recorded in 2021 (14.4%). Next event: Publication of 2024 annual sales 6 February 2025 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 At constant exchange rates: the impact of exchange rates was eliminated by recalculating sales for the period based on the exchange rates used for the previous financial year.2 Excluding exceptional costs related to the optimization of the operational framework and changes to 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 Seitosei 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 10-24 CP GBT CA T3 VDef EN

Financial Statement

13 Sep 2024

·www.prnewswire.com

Zydus announces exclusive licensing and supply agreement for two Gadolinium based Magnetic Resonance Imaging (MRI) injectable, contrast agents in the US

AHMEDABAD, India, Sept. 13, 2024 /PRNewswire/ -- Zydus Lifesciences Ltd., a global innovation driven healthcare company announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Viwit Pharmaceuticals (Viwit), an innovation driven biopharmaceutical and healthcare company, for gadobutrol injection (generic version of GADAVISTTM) and gadoterate meglumine injection (generic version of DOTAREM®) for the US market. As per the terms of the agreement, Viwit will be responsible for ANDA submission, manufacturing and supplying the generic versions of GADAVISTTM and DOTAREM®, following the receipt of requisite regulatory approval. Zydus will exclusively market, distribute, and sell these products in the US market. Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus' injectable portfolio for the US market. The total addressable market opportunity for gadobutrol injection is estimated at US$ 120 million, and for gadoterate meglumine injection at US$ 117 million in the US market (as per IQVIA MAT Jul - 2024). About Zydus Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit About Viwit Pharmaceuticals Viwit is an innovation driven biopharmaceutical and healthcare company with integrated research and development, production and marketing systems. Viwit is committed to building a platform for pharmaceutical innovation and commercialization, and establishing an ecosystem that serves the healthcare needs of the general public. Viwit started as Boranes producing company and has evolved into a healthcare company offering API and Drug Product development and manufacturing as well as CDMO services. Viwit has three integrated product R&D centers, three cGMP US FDA inspected production facilities. By continuously improving the level, depth and scope of innovation, Viwit makes every effort to provide people with better health products and services, and to fulfil Viwit vision of "Innovation for a Better Life". For more details visit . Logo: SOURCE Zydus Lifesciences Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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25 Apr 2024

·www.globenewswire.com

Guerbet : Q1 2024 revenue.

Q1 2024 revenue Quarterly activity Revenue: €194.3m, up 8.8% at CER1Growth remains particularly strong in Asia (+26.8% at CER) and the Americas (+20.1% at CER); the EMEA region (-6.2% at CER) was temporarily impacted by the reform of the supply of contrast products in France 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 April 2024, 5.45 pm: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the first fiscal quarter. At 31 March 2024, the Group’s sales totalled €194.3m, up 7.6% compared with the same period in 2023. Given an unfavourable foreign exchange effect of €2.2m, largely linked to Asian currencies, revenue at CER1 was up 8.8% over the period. Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeSales in EMEA89.083.9-5.8%83.6-6.2%Sales in the Americas47.557.4+21%57.0+20.1%Sales in Asia44.152.9+20%55.9+26.8%Total180.6194.3+7.6%196.5+8.8% *Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. In the EMEA region, the Group generated revenue of €83.9m in the first quarter, down 5.8% (-6.2% at CER) mainly owing to the dip in sales volumes in France. This trend stems directly from the implementation on 1 March 2024 of the reform of the supply circuit for contrast products, which caused difficulties in order intakes with radiologists. The Group expects to largely catch up on the resulting delays in sales in the second quarter of 2024. In the Americas, sales totalled €57.4m, up 21.0% over the period (+20.1% at CER). Sales caught up strongly for the second consecutive quarter following the return to historic production levels at the Raleigh site in North Carolina. Group revenue in Asia was €52.9m, with continued strong growth momentum (+20%) driven by the performances of China, South Korea and Japan. The total includes a negative currency effect (-€3.0m) linked in particular to the further depreciation of the yen. At CER, sales in Asia rose 26.8% in first-quarter 2024, confirming the Group’s ambitions in this region. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeDiagnostic Imaging 160.8173.6+7.9%175.5+9.1%MRI60.758.2-4.1%58.4-3.7%X-ray100.2115.4+15.2%117.1+16.9%Interventional Imaging19.820.7+4.4%21.0+6.1%Total180.6194.3+7.6%196.5+8.8% 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.*Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. Diagnostic Imaging revenue increased 7.9% in Q1 2024 (+9.1% at CER) to €173.6m. MRI activity was down 3.7% at CER. This decline resulted from the postponement of several substantial orders in the MRI franchise (Dotarem® / EluciremTM) in France, all of which will be booked in the second quarter of 2024.X-ray revenue increased 16.9% at CER over the period, a remarkable increase driven by all the division’s products, particularly Xenetix®. In Interventional Imaging, revenue rose 6.1% at CER in Q1 2024 on continued favourable momentum for Lipiodol®, fuelled by volumes and prices alike. All financial targets confirmed for 2024 The highly positive trend overall at the start of the year boosts Guerbet’s confidence for the full year. In a buoyant contrast products market, Group business will be bolstered by the ramp-up of the MRI franchise, growth in Optiray® sales, and continued favourable momentum for Lipiodol®. At the same time, operating profitability will benefit from the change in the product mix and the continued rise in prices, while cash generation will improve considerably, particularly as inventory levels return to normal. Given these circumstances, Guerbet 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 events : Annual Shareholders' Meeting for fiscal year 202324 May 2024 Publication of 1st half 2024 revenue 25 July 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. Attachment CP CA T1 2024_VFinale EN

Financial Statement

100 Deals associated with Gadoterate Meglumine

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KEGG	Wiki	ATC	Drug Bank
D03355	Gadoterate Meglumine	V08CA02	DB09132

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vascular Diseases	United States	Guerbet LLC	20 Mar 2013
Contrast agents	Japan	Guerbet Japan KK	22 Sep 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Central Nervous System Diseases	Phase 3	Argentina	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	Austria	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	Brazil	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	Chile	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	France	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	Germany	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	Italy	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	South Korea	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	Spain	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	United Kingdom	Guerbet LLC	01 Sep 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2020	Not Applicable	Kidney Tubular Necrosis, Acute \| Fanconi Syndrome	-	Dotarem (Gadobutrol)	jevpqnotdl(xxposvqabt) = Renal tissue was characterized by tubular damage, pathologic lipid vacuolization, and diffuse mitochondrial toxicity hwnxzbrtnw (fmcjontexl ) View more	Negative	19 Oct 2020
NCT01806740 (DCE-MRI, CTgov)	Phase 4	Advanced Hepatocellular Carcinoma	37	Gadoterate meglumine	rgithuwabe(lyexslbyzd) = etwxhlctto ithqzkmqzi (ktyccktiys, xjbilzukfr - zvbzieijnp) View more	-	08 Aug 2019
NCT02411201 (CTgov)	Phase 4	-	51	DOTAREM	eerikbpcsc(lvarssevdv) = kuejbifkea zsvrkknzoe (unzqhddwua, ccqzjufnwf - ootewsrfqi) View more	-	09 Mar 2017
NCT02070380 (BENEFIT, CTgov)	Phase 4	Brain Diseases	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 1))	idunavasqs = zcljycnlwc ruewgiofux (xhhtslnxve, tvtgcfpjyl - unwrlppgrc) View more	-	10 Jan 2017
NCT02070380 (BENEFIT, CTgov)	Phase 4	Brain Diseases	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 2))	idunavasqs = dmnptehtxj ruewgiofux (xhhtslnxve, shpxakcnef - lvlzhqbzmg) View more	-	10 Jan 2017
NCT01211873 (SENTIO, CTgov)	Phase 3	Central Nervous System Diseases	416	Dotarem (gadoterate meglumine) (Dotarem (Gadoterate Meglumine ))	axwnjlzdya(bvemlcghrl) = wsydwnizdq fxzheftagr (vleowaxilt, vrzelztdae - lqgxvdrrce) View more	-	29 May 2014
NCT01211873 (SENTIO, CTgov)	Phase 3	Central Nervous System Diseases	416	Magnevist (gadopentetate dimeglumine) (Magnevist (Gadopentetate Dimeglumine))	axwnjlzdya(bvemlcghrl) = ozkdhfmesb fxzheftagr (vleowaxilt, wrrtulnzdy - zjgcjjbkzs) View more	-	29 May 2014
AAAAI2014	Not Applicable	-	-	Contrast Radio Media (CR) (Negative Skin Test for Radiocontrast)	nsrclaiddb(kuikuiarzz) = Only 1 (2.43 %) patient, with negative test, presented a minor reaction 12 hours after RC administration (rash) xeochjevpl (tfwbpwsbsy )	-	01 Feb 2014
ASN2013	Phase 1	-	10	Gadoterate Meglumine	irmxzkngxs(vfrsmxhqei) = No Aes related to gadoterate were reported. No Aes occurred at the injection site during the observation period. There were no clinically relevant changes in mean laboratory values and vital signs. No cases of Nephrogenic Systemic Fibrosis have been reported so far. nvmpodqpnx (vzymhjqlcz )	Positive	05 Nov 2013
NCT01026389 (DALIA, CTgov)	Phase 4	vascular arterial disease \| Peripheral Arterial Disease	189	Gadovist (Gadovist)	nqpsaewrux(cmdoqdtwbo) = jugojbrzwa jnbduutdua (ilkvpfflrw, 19.6) View more	-	11 Dec 2012
NCT01026389 (DALIA, CTgov)	Phase 4	vascular arterial disease \| Peripheral Arterial Disease	189	Dotarem (Dotarem, Interventional)	nqpsaewrux(cmdoqdtwbo) = osnrvnhstz jnbduutdua (ilkvpfflrw, 16.1) View more	-	11 Dec 2012

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