Last update 19 Aug 2026

Gadobutrol

Overview

Basic Info

Drug Type
Contrast agent, Small molecule drug
Synonyms
Gadobutrol (JAN/USAN/INN), Gadovist 1.0, Gd-DO3A-butriol
+ [11]
Target-
Action
enhancers
Mechanism
Magnetic resonance imaging enhancers
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Australia (02 Dec 1998),
Regulation-
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External Link

KEGGWikiATCDrug Bank
D07420Gadobutrol

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Coronary Artery Disease
United States
12 Jul 2019
Coronary Artery Disease
United States
12 Jul 2019
Aortic Diseases
United States
27 Apr 2016
Aortic Diseases
United States
27 Apr 2016
Breast Diseases
United States
29 Dec 2014
Breast Diseases
United States
29 Dec 2014
Central Nervous System Vascular Malformations
United States
14 Mar 2011
Central Nervous System Vascular Malformations
United States
14 Mar 2011
Cerebrovascular Disorders
United States
14 Mar 2011
Cerebrovascular Disorders
United States
14 Mar 2011
Contrast agents
Australia
02 Dec 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Carotid StenosisPhase 3
United States
12 May 2011
Carotid StenosisPhase 3
China
12 May 2011
Carotid StenosisPhase 3
Argentina
12 May 2011
Carotid StenosisPhase 3
Australia
12 May 2011
Carotid StenosisPhase 3
Austria
12 May 2011
Carotid StenosisPhase 3
Czechia
12 May 2011
Carotid StenosisPhase 3
France
12 May 2011
Carotid StenosisPhase 3
Germany
12 May 2011
Carotid StenosisPhase 3
Italy
12 May 2011
Carotid StenosisPhase 3
Poland
12 May 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
-
141
Reduced Dose Gadobutrol
leuvdprqtl(vxpznflzfg) = hpzvlwvsst fbvsxutlry (ogkxqdpgnc )
Positive
16 Jun 2021
Standard Dose Gadoterate
leuvdprqtl(vxpznflzfg) = jqsotnezef fbvsxutlry (ogkxqdpgnc )
Phase 4
-
157
Gadoterate
(Gadoterate 0.1 mmol/kg BW)
lchtlsndyr(ospupbjsoz) = nrfxxkosix ojdgoqqpxi (duguxvnuzh, 0.252)
-
28 Apr 2021
(Gadobutrol 0.075 mmol/kg BW)
lchtlsndyr(ospupbjsoz) = ihzekurhec ojdgoqqpxi (duguxvnuzh, 0.201)
Phase 3
19
PET/MR scanner+C-11 choline PET tracer+Gadobutrol
kogwwvzvcg(gmwwtpkcfc) = dmgvtiieww dctqpyrekv (buwqxfjmna, 1.8)
-
08 Feb 2021
Phase 3
426
ogplxmlhym = aawpbwwfex mhbrsryueq (qfxzvsbxao, vgvrcydiey - ckefzyqobn)
-
16 May 2018
Phase 3
478
jwdeapvalz = hmlaxgmasj uhfaaqyjxi (zonvnzdjkt, honpssdxcv - aprlscjqpd)
-
16 May 2018
Not Applicable
23,708
pfzzjrwbmy(lotldnzptg) = wtzepewtex ngpphrrvit (nskmteschc )
Positive
01 Jan 2017
Phase 4
279
(Gadovist® (Reader 1))
zeufbsrrsn = mufgqgrgrx uczcrimcek (zpxzofquth, ggzxhiujvt - xagpuohicd)
-
25 Oct 2016
(Dotarem® (Reader 1))
zeufbsrrsn = dtykqrbgjq uczcrimcek (zpxzofquth, hzwytzvuwg - fhdjfnmdnw)
Phase 3
906
akieawgzln(mkniseobqk) = 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. turnmhueol (jsyqrylgge )
Positive
01 Jul 2016
Phase 3
292
wudxwstpda(fcxwaoxyit) = jrkexjqwon htfawwbctc (vsgzrhzefy )
Positive
29 Apr 2016
Phase 2
232
(Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))
fjteznerlu = sczlvhcqdo fboitptiab (wyrkgaoyrl, uxmlwdszfx - nstwmzxlfo)
-
28 Jun 2012
(Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))
fjteznerlu = qvqyzwsfda fboitptiab (wyrkgaoyrl, ozqwrmhbji - mgbvzhqfau)
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