This is an observational study to compare the utility of the novel aMRI approach in human brain to the standard of care imaging approach for diagnosing and assessing glioma. Tumor cells have altered metabolism compared to normal cells.This makes metabolic activity imaging useful for diagnosing and assessing neurological disease. However, current options for metabolic activity imaging are limited. Metabolic activity imaging is primarily conducted using positron emission tomography (PET) with a radioactive tracer called fludeoxyglucose F-18 (¹⁸FDG). A PET scan is a procedure in which a small amount of radioactive glucose (¹⁸FDG) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. PET imaging is very expensive and is usually much less available than other imaging techniques such as magnetic resonance imaging (MRI). MRI uses radiofrequency waves and a strong magnetic field to provide clear and detailed pictures of internal organs and tissues. While MRI is more available than PET, it isn't as useful in evaluating metabolic activity. Unlike standard MRI, the aMRI approach uses new ways of analyzing MRI images that provides information about tumor cell metabolic activity. Via direct comparison with a standard metabolic imaging approach, ¹⁸FDG PET, this clinical trial will assess the validity of aMRI as a metabolic imaging approach for evaluating neurological disease in patients with glioma.

Start Date11 Dec 2023

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+1]

NCT05915702 / CompletedPhase 3

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date24 Jul 2023

Sponsor / Collaborator

Bayer AG

NCT05915728 / CompletedPhase 3

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date24 Jul 2023

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Gadoterate Meglumine

100 Translational Medicine associated with Gadoterate Meglumine

100 Patents (Medical) associated with Gadoterate Meglumine

867

Literatures (Medical) associated with Gadoterate Meglumine

22 Oct 2024·ENVIRONMENTAL SCIENCE & TECHNOLOGY

Formation of Nitrosamines from the Heterogeneous Reaction of Nitrous Acid and Organic Amines in Indoor Environments

Article

Author: Yang, Xin ; Long, Shiqian ; Yuan, Wenting ; Zhao, Wangchao ; Zheng, Guomao ; Zhu, Lei ; Ye, Jianhuai ; Zhou, Li ; Xu, Jiwen ; Zhang, Lifang ; Liu, Chenglin ; Jiao, Xiaoqiao ; Shen, Huizhong ; Yang, Bo ; Huang, Weilin ; Wang, Chen ; Fu, Tzung-May

Carcinogenic nitrosamines have been widely studied due to their risk to human health. However, the universality and evolutionary processes of their generation, particularly concerning their secondary sources, remain unclear at present. We demonstrated through laboratory flow tube experiments that corresponding nitrosamines were generated from heterogeneous reactions of nitrous acid (HONO) with five structurally diverse amines commonly found indoors, including diphenylamine (DPhA), dibenzylamine (DBzA), dioctylamine (DOtA), N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD), and N-phenyl-1-naphthylamine (PANA). The heterogeneous reaction rate constants of DBzA and DOtA with HONO (∼70 ppb) were 1.21 × 10^-3 and 2.13 × 10^-3 min^-1 at 30% relative humidity (RH), resulting in a lifetime of 13.8 and 7.8 h. As compared to higher RH (∼80%), more nitrosamines were produced from the reaction of HONO with surface-sorbed DBzA, DOtA, 6PPD, and PANA at lower RH (30%), with product yields ranging from <0.1% to 0.5%. Furthermore, we observed the formation of nitroso-6PPDs and nitro-6PPDs during room air exposure of 6PPD in a genuine indoor environment, in addition to various other transformation products indicative of reactions of 6PPD with HONO, NOx, and ozone indoors. This study confirmed the universality of the heterogeneous reaction of surface-sorbed amine with HONO as a source of nitrosamines indoors.

26 Sep 2024·Journal of Physical Chemistry Letters

In Search of Covalency Measure of Gd(III)-Ligand Interactions

Article

Author: Starynowicz, Przemysław ; Siczek, Miłosz ; Janicki, Rafał

Experimental electron density distribution of the [C(NH₂)₃]₃[Gd(EDTA)F₂]·H₂O crystal was determined. The derived experimental and theoretical (DFT) topological parameters such as ∇²ρ_c, ρ_c, bond degree (BD), kinetics, and potential energy were used to study the nature of Gd-O, Gd-F, and Gd-N interactions. The natural charge of the Gd is 1.86; the natural configuration of the cation is [Xe]6s^0.134f^7.105d^0.83, and the covalency of the Gd-L bond is mainly connected with the transfer of charge from the sp^x ligand orbitals onto the 5d orbitals of the Gd cation. Simultaneously, the donation of charge onto the 6s and 4f orbitals occurs to a lesser extent. Moreover it was found that the donation of the ligand charges onto the Gd(III) is larger for compounds with a lower coordination number. The obtained topological parameters were analyzed in the context of the Gd(III) f-f transition properties, i.e., energy of the excited ^2S+1L_J states, Judd-Ofelt intensity parameters, and luminescence lifetimes, of 18 Gd(III) compounds with various O, N, and F donor ligands (DOTA, EDTA, CDTA, DTPA, NTA, EGTA, ODA, F^-, H₂O, and CO₃^2-). The calculated nephelauxetic β parameter may reflect the penetration degree of electron lone pairs of ligands inside the metal basin. Finally, it was found for the first time that the sum of the Gd(III)-L bond energy (∑E_GdL) is correlated with the position of the gravity center of the ⁸S_7/2 → ^2S+1L_J transitions and increase of covalency of the Gd(III)-L bonds is associated with decrease of their bond energy. The obtained results may shed light on chemical bonding in systems containing f-elements. Such subtle differences in the covalent contribution to the Ln-L or An-L bond may tune the selectivity of the partitioning processes of lanthanides and actinides.

01 Sep 2024·INVESTIGATIVE RADIOLOGY

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

Article

Author: Wintrebert, Mélody ; Robert, Philippe ; 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

License out/in

11 Jun 2024

·www.globenewswire.com

Monopar and NorthStar Amend & Extend Collaboration

Highlights: Builds on Companies’ respective core strengthsAligns intellectual property rightsEstablishes a long-term supply agreement under which NorthStar provides actinium-225 for Monopar’s development and potential future commercial programs WILMETTE, Ill. and Beloit, Wis., June 11, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company, and NorthStar Medical Radioisotopes, LLC, a global innovator in development and commercial production of medical radioisotopes, today announced an amendment and expansion to their existing collaboration. Under terms of the revised collaboration, the Companies entered into a long-term, non-exclusive master supply agreement for NorthStar to provide Monopar with the powerful therapeutic radioisotope actinium-225 (Ac-225). The amendment builds on NorthStar’s significant investment in Ac-225 manufacturing and Monopar’s promising preclinical therapeutic results with Ac-225 in its lead MNPR-101 radiopharma program. The amendment also clarifies certain economic terms and those related to jointly developed intellectual property rights for Monopar’s MNPR-101 for radiopharmaceutical use. Monopar has acquired those rights from NorthStar, together with certain broad, jointly developed intellectual property pertaining to MNPR-101, giving Monopar full ownership and title to its lead MNPR-101 radiopharmaceutical platform. Both companies will share ownership of the filed patent application on the use of PCTA as a linker with Ac-225, which has shown superior binding and yield with Ac-225 over the current industry-leading linker, DOTA. “We are excited about the evolution of our collaboration, the promising potential of the MNPR-101 radiopharma platform, and the long-term access to a high-quality source of Ac-225 that can support our current development programs and potential future commercial products,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer. “Using our proprietary electron accelerator technology, NorthStar is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) Ac-225. We’re delighted to continue and extend our collaboration with Monopar and support development of its exciting MNPR-101 radiopharma platform focused on therapeutic agents to treat aggressive cancers,” said Frank Scholz, PhD, NorthStar’s Chief Executive Officer. About Monopar Therapeutics Inc. (Monopar) Monopar Therapeutics is a clinical-stage radiopharmaceutical company focused on developing innovative treatments for cancer patients, including Phase 1-stage MNPR-101-Zr for imaging advanced cancers and late preclinical-stage MNPR-101 radio-immuno-therapeutic (RIT) for the treatment of advanced cancers. For more information, visit: www.monopartx.com. About NorthStar Medical Radioisotopes, LLC (NorthStar) NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: that NorthStar will provide actinium-225 for Monopar’s development and potential future commercial programs; the promising potential of Monopar’s MNPR-101 radiopharma platform, and the long-term access to a high-quality source of Ac-225 that can support Monopar’s current development programs and potential future commercial products; that NorthStar is poised to be the first commercial-scale producer of non-carrier added (n.c.a.) Ac-225; and that NorthStar will continue to support development of Monopar’s exciting MNPR-101 radiopharma platform focused on therapeutic agents to treat aggressive cancers. The forward-looking statements involve risks and uncertainties including, but not limited to: that Monopar’s and shared intellectual property may not result in allowed patents; that if allowed, the patents may be too narrow in scope to provide protection needed to successfully develop the radiopharma program; that NorthStar may not be able to supply Ac-225 at quantities needed, if at all; that NorthStar may not be the first commercial-scale producer of n.c.a. Ac-225; that Monopar may expend available funds sooner than anticipated or require additional funding due to change in circumstances or unanticipated events; that future preclinical or clinical data will not be as promising as the data to date; not successfully enrolling the MNPR-101-Zr Phase 1 clinical trial if at all; that MNPR-101-Zr and/or MNPR-101 conjugated to a therapeutic radioisotope may cause unexpected serious adverse effects or fail to image or be effective against the cancer tumors in humans; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s and/or NorthStar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CONTACTS: For Monopar Therapeutics Inc.Investor RelationsKim R. TsuchimotoChief Financial Officerkimtsu@monopartx.com Follow Monopar on social media for updates:X (formerly Twitter): @MonoparTx LinkedIn: Monopar Therapeutics For NorthStar Medical Radioisotopes, LLC :Investor Relations:Paul EstremExecutive Vice President and Chief Financial Officerpestrem@northstarnm.com Media/Corporate:Alison HessVice President, Chief of Staffahess@northstarnm.com

Phase 1License out/in

100 Deals associated with Gadoterate Meglumine

External Link

KEGG	Wiki	ATC	Drug Bank
D03355	Gadoterate Meglumine	V08CA02	DB09132

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Central Nervous System Diseases	Phase 3	AR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	AT	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	BR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	CL	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	FR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	DE	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	IT	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	KR	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	ES	Guerbet LLC	01 Sep 2010
Central Nervous System Diseases	Phase 3	GB	Guerbet LLC	01 Sep 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2020	Not Applicable	Kidney Tubular Necrosis, Acute \| Fanconi Syndrome	-	Dotarem (Gadobutrol)	dptbtjpbml(roiiidslwe) = Renal tissue was characterized by tubular damage, pathologic lipid vacuolization, and diffuse mitochondrial toxicity bknvxipfee (qjwlaobnkr ) View more	Negative	19 Oct 2020
NCT01806740 (DCE-MRI, CTgov)	Phase 4	Advanced Hepatocellular Carcinoma	37	Gadoterate meglumine	lcwbcvpfpr(pjypghovxi) = yqmechxkkx bmewsltgdd (embvjvhvja, jxhppteruv - yjmyfsefzx) View more	-	08 Aug 2019
NCT02411201 (CTgov)	Phase 4	-	51	DOTAREM	ctckxdcqzn(enetrpjlyv) = xuquwbzzgk wdakmoyvlw (sovtndaomv, ybyhudcvvs - sgkyjavqbg) View more	-	09 Mar 2017
NCT02070380 (BENEFIT, CTgov)	Phase 4	Brain Diseases	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 1))	wsmrjxeyqx(wddznpmlrs) = lvkhkelaur fivsnymygs (xydqtcxltd, wpbyvyesgt - kosmkzxtlk) View more	-	10 Jan 2017
NCT02070380 (BENEFIT, CTgov)	Phase 4	Brain Diseases	179	Dotarem (MultiHance 0.1 mmol/kg Arm (Reader 2))	wsmrjxeyqx(wddznpmlrs) = agvvwapdmf fivsnymygs (xydqtcxltd, svxexqsviw - uetvujgfkn) View more	-	10 Jan 2017
NCT01211873 (SENTIO, CTgov)	Phase 3	Central Nervous System Diseases	416	Dotarem (gadoterate meglumine) (Dotarem (Gadoterate Meglumine ))	tvczwtzziu(ifrtrpqwog) = zzzcufazwg ozxtdzwvus (gbkfnwuuvt, crbsedvpjc - aksxrbbcnf) View more	-	29 May 2014
NCT01211873 (SENTIO, CTgov)	Phase 3	Central Nervous System Diseases	416	Magnevist (gadopentetate dimeglumine) (Magnevist (Gadopentetate Dimeglumine))	tvczwtzziu(ifrtrpqwog) = syyxptyvwm ozxtdzwvus (gbkfnwuuvt, ysanxdjfqs - rpnrincifc) View more	-	29 May 2014
NCT01026389 (DALIA, CTgov)	Phase 4	vascular arterial disease \| Peripheral Arterial Disease	189	Gadovist (Gadovist)	xcsntfapkq(vnxftjverc) = jbemnxhpsk srbjawbsax (zkhqfdhwik, jgtvgxqvuy - hawvktdwmj) View more	-	11 Dec 2012
NCT01026389 (DALIA, CTgov)	Phase 4	vascular arterial disease \| Peripheral Arterial Disease	189	Dotarem (Dotarem, Interventional)	xcsntfapkq(vnxftjverc) = tfhosptkuy srbjawbsax (zkhqfdhwik, tmrqqyfiib - psltknjobh) View more	-	11 Dec 2012

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis