Delving into the Latest Updates on Gadobutrol with Synapse

Overview

Basic Info

Drug Type

Contrast agent, Small molecule drug

Synonyms

Gadobutrol (JAN/USAN/INN), Gadovist 1.0, Gd-DO3A-butriol

+ [10]

Target-

Action

enhancers

Mechanism

Magnetic resonance imaging enhancers

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [2]

Active Indication

Coronary Artery DiseaseAortic DiseasesBreast Diseases+ [3]

Inactive Indication

Blood brain barrier defectBrain metastasesBreast Cancer+ [5]

Originator Organization

Bayer AG

Active Organization

Schering Deutschland Gmbh

Bayer HealthCare Pharmaceuticals, Inc.

Bayer AG

+ [1]

Inactive Organization

Bayer Schering Pharma AG

Bayer Healthcare Co., Ltd.Bayer Vital GmbH

License Organization

Viwit Pharmaceutical Co., Ltd.

Zydus Lifesciences Ltd.

Drug Highest PhaseApproved

First Approval Date

Australia (02 Dec 1998),

Contrast agents

Regulation-

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Structure/Sequence

Molecular FormulaC18H31GdN4O9

InChIKeyZPDFIIGFYAHNSK-ZCTZICQLSA-K

CAS Registry770691-21-9

This research aims to investigate whether symptoms of chest pain or shortness of breath among the study population are arising due to a heart problem, particularly any reduction of blood flow to the heart muscle from blockages in the coronary blood vessels or inflammation of the heart using cardiac magnetic resonance imaging that measures the amount of blood flow during a stress state meant to simulate vigorous exercise. At present, doctors use standard magnetic resonance imaging pictures of blood flow patterns to treat heart disease. The investigators want to study if detailed blood flow measurements, in addition to the standard blood flow pattern, could diagnose heart disease more accurately and allow more doctors to understand the severity of heart disease. Early research has demonstrated that detailed blood flow measurements may be more accurate in diagnosing heart disease in some patients, but doctors need more information to know how to use these measurements.

Start Date01 Mar 2025

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

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 Gadobutrol

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100 Translational Medicine associated with Gadobutrol

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100 Patents (Medical) associated with Gadobutrol

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813

Literatures (Medical) associated with Gadobutrol

01 Jun 2025·Radiological Physics and Technology

Development of estimation method for T1 and T2 values using the relaxivity of contrast agent and coagulant for a magnetic resonance imaging phantom

Article

Author: Okada, Hiroki ; Yamamoto, Shohei ; Komatsuzaki, Tetsuya ; Fuse, Hiraku ; Shimizu, Hatsune ; Yasue, Kenji ; Miyakawa, Shin ; Sasaki, Kota ; Takahashi, Masato ; Koori, Norikazu

The T₁ and T₂ values of magnetic resonance imaging phantoms used by researchers should be equivalent to those of the target tissue. However, this is difficult to achieve because of variations in the phantoms depending on the type and concentration of contrast agents and coagulants. The aim of this study was to elucidate the utility of a determination equation derived using the relaxivity of the contrast agent and coagulant. We prepared phantoms using 0.05-10 mmol L^-1 contrast agent (Gadovist^®; Bayer Yakuhin, Ltd., Osaka, Japan) and 0.1-5.0 wt% agar (agar, powder [010-15815]; Fujifilm Wako Pure Chemical Corporation, Osaka, Japan) and measured their T₁ and T₂ values. Determination equations for T₁ and T₂ values were derived using the relaxivity calculated from the T₁ and T₂ values of the contrast agent and coagulant. Subsequently, the determined values were compared with the measured values. The error rate of the determined T₁ and T₂ values were 7.66 ± 6.60% and 5.66 ± 4.05%, respectively, with correlation coefficients of 0.996 and 0.999. These results indicate that this method enables easy and highly accurate estimation of T₁ and T₂ values in MRI phantoms.

01 May 2025·NEUROLOGY INDIA

Gadolinium Deposition in the Rat Brain after Repeated Administration of the Liver-Specific Gadolinium-Based Contrast Agent Gadoxetic Acid

Article

Author: Zhu, Kai ; Xu, Yikai

Background::

Studies on gadolinium deposition have recently been reported.

Objective::

The objective of this study was to investigate whether there is an increased magnetic resonance signal intensity (SI) of the dentate nucleus (DCN) and quantification of gadolinium (Gd) brain concentrations by inductively coupled plasma-mass spectrometry (ICP-MS) test in rats who had undergone multiple administrations of gadoxetic acid and gadobutrol.

Materials and Methods::

Sprague–Dawley rats (24) were equally divided into three groups. Eight animals per group received 20 intravenous injections of gadoxetic acid (0.15 mmol/kg) and gadobutrol (0.6 mmol/kg) per injection. MRI was performed at 0, 5, and 20 weeks. Subsequently, all animals were euthanized and their brains were dissected for Gd quantification by ICP-MS.

Results::

ICP-MS revealed higher Gd content in cerebellum tissue after administration of gadoxetic acid compared to gadobutrol (P < 0.05). The mean Gd concentrations in the cerebellum were 0.48 nmol/g gadoxetic acid and 0.26 nmol/g gadobutrol after intravenous administration. No visually evident enhancement was found after administration of gadoxetic acid, gadobutrol, or saline at any time point. The DCN-to-pons SI ratios for gadoxetic acid and gadobutrol were not different from the saline control group (P > 0.05, saline vs. gadoxetic acid and saline vs. gadobutrol, respectively).

Conclusions::

Our results demonstrated that gadolinium concentrations in the cerebellum after intravenous gadoxetic acid administration were higher than for gadobutrol. Multiple administrations of gadoxetic acid disodium are not associated with increased SI in DCN.

01 Apr 2025·CLINICAL IMAGING

A review of gadolinium-based contrast agents in the setting of repeated MRI for high risk breast cancer screening

Review

Author: Reichman, Melissa ; Foshag, Kelcie ; Prince, Martin ; Tsiouris, Apostolos John

Women who are considered high risk for breast cancer are recommended to undergo supplemental breast cancer screening annually with MRI. There are primarily three safety concerns associated with gadolinium-based contrast agents which include allergic reactions, nephrogenic systemic fibrosis and gadolinium deposition. In this review, we discuss how these risks are affected by molecular structure, will specifically review the difference between the two commonly used agents, gadobutrol and gadoterate, and discuss the most recent FDA approved contrast agent on the market, gadopiclenol.

20

News (Medical) associated with Gadobutrol

15 Sep 2024

·www.pharmaindustrial-india.com

Zydus Signs Licensing and Supply Agreement with Viwit Pharmaceuticals

Zydus Lifesciences Ltd. has announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has signed an exclusive licensing and supply agreement with Viwit Pharmaceuticals (Viwit) 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 USD 120 million and for gadoterate meglumine injection at USD 117 million in the US market. Zydus Lifesciences Ltd., with an overarching purpose of empowering people with the freedom to live healthier and more fulfilled lives, is an innovative, global life sciences 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 life sciences through quality healthcare solutions that impact lives.

License out/in

15 Sep 2024

·www.pharmaindustrial-india.com

Zydus Signs Licensing and Supply Agreement with Viwit Pharmaceuticals

Zydus Lifesciences Ltd. has announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has signed an exclusive licensing and supply agreement with Viwit Pharmaceuticals (Viwit) 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 USD 120 million and for gadoterate meglumine injection at USD 117 million in the US market. Zydus Lifesciences Ltd., with an overarching purpose of empowering people with the freedom to live healthier and more fulfilled lives, is an innovative, global life sciences 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 life sciences through quality healthcare solutions that impact lives.

License out/in

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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100 Deals associated with Gadobutrol

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External Link

KEGG	Wiki	ATC	Drug Bank
D07420	Gadobutrol	V08CA09	DB06703

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Coronary Artery Disease	United States	Bayer HealthCare Pharmaceuticals, Inc.	12 Jul 2019
Aortic Diseases	United States	Bayer HealthCare Pharmaceuticals, Inc.	27 Apr 2016
Breast Diseases	United States	Bayer HealthCare Pharmaceuticals, Inc.	29 Dec 2014
Central Nervous System Vascular Malformations	United States	Bayer HealthCare Pharmaceuticals, Inc.	14 Mar 2011
Cerebrovascular Disorders	United States	Bayer HealthCare Pharmaceuticals, Inc.	14 Mar 2011
Contrast agents	Australia	Bayer Australia Ltd.	02 Dec 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Carotid Stenosis	Phase 3	United States	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	China	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Argentina	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Australia	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Austria	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Czechia	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	France	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Germany	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Italy	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Poland	Bayer AG	12 May 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	Phase 4	-	141	Reduced Dose Gadobutrol	rdkkjkuoro(xpmbhimaem) = lhxehrfgit lhyaszeoij (dbknjdytmk ) View more	Positive	16 Jun 2021
NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	Phase 4	-	141	Standard Dose Gadoterate	rdkkjkuoro(xpmbhimaem) = yyogovhapv lhyaszeoij (dbknjdytmk ) View more	Positive	16 Jun 2021
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	Phase 4	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	xmgtdaktlo(furqllperl) = ytfoxxvxuf sinvwglhff (qyzksqvqmc, 0.252) View more	-	28 Apr 2021
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	Phase 4	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	xmgtdaktlo(furqllperl) = iimmlivmvw sinvwglhff (qyzksqvqmc, 0.201) View more	-	28 Apr 2021
NCT03404648 (CTgov)	Phase 3	Advanced Prostate Carcinoma \| Adenocarcinoma of prostate	19	PET/MR scanner+C-11 choline PET tracer+Gadobutrol	awjeiribev(igifmnjvbc) = lxfytkwjem djnwowmmjh (qhctrxhedi, 1.8) View more	-	08 Feb 2021
NCT01890434 (GadaCAD 2, CTgov)	Phase 3	Coronary Artery Disease	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	jyhejdqjkk = vbmzkjjxgw fdxgfxanfe (rbgrqazbsv, ajwcloaanm - nuwbyugiwn) View more	-	16 May 2018
NCT01890421 (GadaCAD 1, CTgov)	Phase 3	Coronary Artery Disease	426	Gadovist	wcghtcrycy = dbmvdjanqu oibcadwvkk (qivghufken, ymmfspypts - ksovdcooco) View more	-	16 May 2018
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) Manual	Not Applicable	Contrast agents	23,708	gadobutrol	gtukjebwgn(jsdkmpibhy) = uyukwsvxfm ldarwthoxc (efwarjmxgf ) View more	Positive	01 Jan 2017
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) Manual	Phase 3	Neoplasms	906	Gadobutrol	mrmrnebncv(qsrbjplroc) = the detection rate of malignant disease extent per patient, ranged from 80% to 89% for CE-BMRI and was significantly superior to unenhanced breast MRI alone (37%-73%) and to mammography alone (68%-73%) for all readers in both trials. qcmbmxiabm (hkyuahrllf )	Positive	01 Jul 2016
NCT01344460 (GRAMS, Biospace) Manual	Phase 3	Vascular Diseases	292	Gadobutrol	xhuitwbynt(xzgwgegval) = kimvobfmos izuoxddhwy (hbnkhihcgx ) View more	Positive	29 Apr 2016
NCT01490294 (CTgov)	Phase 2	Cardiovascular Diseases	232	Gadovist (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))	aahfgvftql = fujxlenowi hppvuxxfkp (vogmlvjebv, fhtmpbmjjv - gxizyqdpmv) View more	-	28 Jun 2012
NCT01490294 (CTgov)	Phase 2	Cardiovascular Diseases	232	Gadovist (Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))	aahfgvftql = opbptkzkkp hppvuxxfkp (vogmlvjebv, jfkyffuzys - haxlfheamt) View more	-	28 Jun 2012