gadobutrol
Trade name: gadavist
Small moleculeapproved
Approved
Mar 14, 2011
Gadobutrol is a gadolinium-based MRI contrast agent (GBCA). It received marketing approval in Canada and the United States. As of 2007, it was the only GBCA approved at 1.0 molar concentrations. — Wikipedia
Clinical trial activity
58 trials · 33 clinical orgs · 3 marketing orgs
Phase 1
11
Phase 2
27
Phase 3
20
Phase 4
13
Earliest trial started Mar 1, 2004 (NCT01490294)
Timeline
2000s
2010s
2020s
- Nov 17, 2022
Hengrui Therapeutics, Inc. — Marketing Organization
- Mar 15, 2023
Hainan Poly Pharm — Marketing Organization
Indications
Approved for
Studied for
- Arthritis, Rheumatoid · Phase 1
- Body Image · Phase 4
- Brain Diseases · Phase 4
- Brain Neoplasms · Phase 4
- Breast Diseases · Phase 4
- Breast Neoplasms · Phase 3
- Carotid Stenosis · Phase 3
- Central Nervous System Diseases · Phase 3
- Cognition · Phase 4
- Contrast Media · Phase 4
- Coronary Artery Disease · Phase 3
- Cystitis · Early Phase 1
- Diagnostic Imaging · Phase 3
- Fibrosis · Phase 4
- Genital Neoplasms, Female · Phase 1
- Glioma · Early Phase 1
- Heart Failure · Phase 1
- Kidney Failure, Chronic · Phase 4
- Lymphoma · Early Phase 1
- Magnetic Resonance Imaging · Phase 4
- Motor Activity · Phase 4
- Multiple Sclerosis · Phase 4
- Myocardial Infarction · Phase 2
- Myocardial Perfusion Imaging · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 4
- Pathology · Phase 3
- Peripheral Arterial Disease · Phase 4
- Prostatic Neoplasms · Phase 3
- Renal Artery Obstruction · Phase 3
- Spinal Cord Diseases · Phase 2
- Urinary Bladder Neoplasms · Early Phase 1
- Uterine Cervical Neoplasms · Phase 1
- Vascular Diseases · Phase 3
Mechanism of action
- Unspecified targetOTHER
Diagnostic agent
- gadoliniumSupplementation
gadolinium supplementation
Approval history
- approvedMar 14, 2011
Chemistry & pharmacology
- Mol. weight
- 604.72 g/mol
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaGadobutrol ↗
- ChEMBLCHEMBL2218860 ↗
Also known as
- gadavist
- gadavist
- gadavist
- gadavist
- gadavist
- gadobutrol
- gadobutrol
- gadobutrol
- gadobutrol
- gadobutrol
- gadobutrol
- gadobutrol
- gadobutrol
- gadobutrol
- gadograf
- gadolinium-do3a-butriol
- gadolinium(iii) 2,2',2''-(10-((2r,3s )-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl)triacetate
- gadolinium(iii) 2,2',2''-(10-((2r,3s )-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl)triacetate
- gadovist
- gadovist
- gadovist
- gadovist
- gd-do3a-butriol
- gd-dtpa-st
- protovist
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07275814 | Phase 3 | Nov 17, 2025 | Government of China |
| NCT07275723 | Phase 3 | Nov 14, 2025 | Government of China |
| NCT07040865 | Phase 4 | Aug 18, 2025 | University of Bern |
| NCT06854458 | N/A | Mar 31, 2025 | Harvard University |
| NCT06846853 | Phase 4 | Mar 1, 2025 | University of Connecticut |
| NCT06731829 | Phase 2 | Dec 31, 2024 | Hengrui Therapeutics, Inc. |
| NCT05915728 | Phase 3 | Jul 24, 2023 | Bayer |
| NCT05915702 | Phase 3 | Jul 24, 2023 | Bayer |
| NCT06224543 | Phase 1 | Jun 16, 2023 | Subtle Medical |
| NCT05811377 | Early Phase 1 (Phase 1) | Mar 29, 2023 | Lipella Pharmaceuticals, Inc., National Institutes of Health (NIH), University of Pittsburgh |
| NCT04949321 | N/A | Jul 31, 2021 | University of Grenoble |
| NCT04910425 | Phase 2 | Jun 17, 2021 | National Cancer Institute (NCI), Northwestern University |
| NCT04893434 | Phase 1 | May 13, 2021 | Memorial Sloan-Kettering Cancer Center |
| NCT04373564 | Phase 4 | Jul 1, 2020 | Bayer, Bracco, General Electric, Guerbet, IQVIA |
| NCT04307186 | Phase 2 | Jun 30, 2020 | Bayer |
| NCT04369560 | Early Phase 1 (Phase 1) | Jun 15, 2020 | National Cancer Institute (NCI), University of Pittsburgh |
| NCT04132843 | Early Phase 1 (Phase 1) | Jan 31, 2020 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT05215132 | Phase 4 | Dec 19, 2019 | Northwestern University |
| NCT03986138 | Phase 3 | Jun 30, 2019 | Guerbet |
| NCT03730051 | Phase 4 | Jun 30, 2019 | Boston University |
Showing 20 of 58 trials
Page 1 / 3
Organizations
Research & Development (33)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bayer | For profit | 24 | 23 | 4 | 2004 |
| Guerbet | For profit | 5 | 5 | 2 | 2009 |
| National Cancer Institute (NCI) | Government | 5 | 0 | 3 | 2011 |
| Bracco | For profit | 3 | 2 | 1 | 2009 |
| British Columbia Cancer Agency | Academic/Hospital | 2 | 2 | 2 | 2014 |
| GlaxoSmithKline | For profit | 2 | 2 | 1 | 2014 |
| Government of China | Government | 2 | 2 | 1 | 2025 |
| Northwestern University | Academic/Hospital | 2 | 2 | 2 | 2019 |
| University of Amsterdam | Academic/Hospital | 2 | 2 | 1 | 2013 |
| University of Pittsburgh | Academic/Hospital | 2 | 2 | 1 | 2020 |
| University of Texas at Houston | Academic/Hospital | 2 | 2 | 1 | 2018 |
| Boston University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Dutch Cancer Society | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Erasmus University Rotterdam | Academic/Hospital | 1 | 0 | 1 | 2013 |
| General Electric | For profit | 1 | 0 | 1 | 2020 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Hengrui Therapeutics, Inc. | For profit | 1 | 1 | 1 | 2024 |
| IQVIA | For profit | 1 | 0 | 1 | 2020 |
| Lipella Pharmaceuticals, Inc. | For profit | 1 | 0 | 1 | 2023 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2017 |
33 organizations
Page 1 / 2
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bayer | For profit | NDA2 | Mar 14, 2011 |
| Bayer | For profit | NDA | Mar 14, 2011 |
| Hainan Poly Pharm | For profit | MKTG | Mar 15, 2023 |
| Hengrui Therapeutics, Inc. | For profit | MKTG | Nov 17, 2022 |