Drugs / Gadobutrol
Gadobutrol
also known as
Gadavist · Gadovist · BAY86-4875 · Gd-DO3A-butrol · Gadograf · Gadovist (Gd-DO3A-butrol) contast agent · Protovist · ZK 135079
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | GADAVIST | — | 2014-06-11 – 2019-07-12 | fda.gov ↗ |
| Approved | US (FDA) | GADAVIST | — | 2011-03-14 | fda.gov ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07796360 | Oct 2026 → Mar 2028 expected | — | National Institute of Neurological Disorders and Stroke (NINDS) | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT01544166 | May 2012 → Nov 2013 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00468819 | May 2007 → Apr 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04307186 | Nov 2020 → Sep 2022 | central nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT02796729 | Oct 2016 → Dec 2018 | metastatic malignant neoplasm in the brain | British Columbia Cancer Agency | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00862459 | Aug 2005 → Mar 2007 | brain disorder, spinal cord disorder | Bayer | Completed | Mixed |
| Phase 2 | NCT01490294 | Mar 2004 → May 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 320 trials · 6 met primary | ||||||
| Phase 3 | NCT07275814 | Nov 2025 → Jun 2026 | — | Shanghai Shengdi Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT07275723 | Nov 2025 → Apr 2026 | — | Shanghai Shengdi Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT05915728 | Jul 2023 → May 2024 | nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT05915702 | Jul 2023 → May 2024 | central nervous system disorder | Bayer | Completed | Met primary |
| Phase 3 | NCT06010173 | Jul 2023 → May 2025 | peripheral nerve lesion | Guerbet | Completed | Met primary |
| Phase 3 | NCT03986138 | Aug 2019 → Dec 2020 | peripheral nerve lesion | Guerbet | Completed | Met primary |
| Phase 3 | NCT03996447 | Jun 2019 → Sep 2020 | — | Guerbet | Completed | Met primary |
| Phase 3 | NCT01890434 | Aug 2013 → Aug 2016 | coronary artery disorder | Bayer | Completed | Met primary |
| Phase 3 | NCT01890421 | Jul 2013 → Apr 2015 | coronary artery disorder | Bayer | Completed | Mixed |
| Phase 3 | NCT01660841 | Sep 2012 → Aug 2013 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01344447 | May 2011 → May 2014 | carotid stenosis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01344460 | May 2011 → Jul 2012 | renal artery obstruction | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01104584 | May 2010 → Sep 2011 | female breast carcinoma | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01067976 | Feb 2010 → Jul 2011 | breast cancer | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01050829 | Jan 2010 → Apr 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00709852 | Jun 2008 → Apr 2009 | central nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00623467 | Dec 2007 → Dec 2008 | central nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00522951 | Aug 2007 → Aug 2008 | metastatic malignant neoplasm in the brain | Bayer | Completed | Met primary |
| Phase 3 | NCT00395733 | Oct 2006 → Oct 2007 | vascular disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00395460 | Sep 2006 → Apr 2007 | central nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT03730051 | Mar 2021 → Dec 2025 | breast disorder | University of Massachusetts, Worcester | Completed | No outcome recorded |
| Phase 4 | NCT03602339 | Nov 2018 → Mar 2020 | — | Bayer | Completed | Met primary |
| Phase 4 | NCT02034708 | Jun 2014 → Sep 2015 | primary brain neoplasm | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT00828737 | Dec 2008 → Jan 2015 | impaired renal function disease | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00764387 | Mar 2008 → May 2009 | central nervous system neoplasm | Bayer | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT03057561 | Oct 2016 → Dec 2020 | cardiomyopathy, coronary artery disorder | The Methodist Hospital Research Institute | Completed | No outcome recorded |
| — | NCT02217280 | Apr 2015 → Mar 2016 | radiculopathy | University of Missouri-Columbia | Completed | No outcome recorded |
| — | NCT02156739 | Oct 2014 → Jun 2028 expected | hepatocellular carcinoma, metastatic malignant neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| — | NCT01995240 | Apr 2013 → Feb 2017 | malignant pancreatic neoplasm | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
| — | NCT02967380 | Dec 2011 → Oct 2014 | adult anaplastic ependymoma, adult brain ependymoma, adult brainstem glioma, adult choroid plexus neoplasm +19 | University of Southern California | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy22 trials | ||||||
| Phase 0 | NCT04369560 Background | May 2025 → Jan 2028 expected | urinary bladder neoplasm | Jodi Maranchie | Recruiting | No outcome recorded |
| Phase 0 | NCT04219904 Background | Sep 2018 → Sep 2027 expected | cervical carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06224543 Comparator | Jun 2023 → Jul 2025 | — | Subtle Medical | Completed | No outcome recorded |
| Phase 1 | NCT04893434 Background | May 2021 → May 2027 expected | female reproductive organ cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02274246 Background | Nov 2014 → Mar 2015 | — | Fundacion Clinic per a la Recerca Biomédica | Completed | No outcome recorded |
| Phase 2 | NCT06731829 Comparator | Dec 2024 → Apr 2025 overdue | — | Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04910425 Background | Jun 2023 → Jun 2026 | prostate carcinoma | Northwestern University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00375830 Background | Jan 2006 → Apr 2017 | cancer | Stanford University | Completed | No outcome recorded |
| Phase 2/3 | NCT07472491 Comparator | Apr 2026 → Nov 2027 expected | — | GE Healthcare | Recruiting | No outcome recorded |
| Phase 3 | NCT03404648 Background | Nov 2017 → Jan 2020 | prostate adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT07040865 Comparator | Aug 2025 → Jun 2027 expected | — | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 4 | NCT06846853 Comparator | Mar 2025 → Jun 2026 overdue | — | UConn Health | Recruiting | No outcome recorded |
| Phase 4 | NCT04373564 Background | Mar 2021 → Dec 2028 expected | cognitive disorder | Guerbet | Recruiting | No outcome recorded |
| Phase 4 | NCT05215132 Background | Dec 2019 → Jan 2028 expected | — | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01613417 Comparator | Aug 2012 → Apr 2014 | brain disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT01026389 Comparator | Oct 2009 → Jun 2011 | peripheral arterial disease | Guerbet | Completed | No outcome recorded |
| Phase 4 | NCT00907530 Comparator | Sep 2009 → Mar 2011 | — | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| — | NCT07415018 Background | Jun 2026 → Jul 2027 expected | neoplastic meningitis | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| — | NCT06854458 Background | Jun 2025 → Jan 2029 expected | ischemic disease | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| — | NCT04132843 Background | Jan 2020 → Sep 2022 | lymphoma, metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT03504956 Background | Jul 2018 → Dec 2025 overdue | coronary atherosclerosis | Cedars-Sinai Medical Center | Recruiting | No outcome recorded |
| — | NCT01989000 Comparator | Nov 2013 → Dec 2017 | malignant pancreatic neoplasm | Academic Medical Center - University of Amsterdam | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-10-01 | Bayer | Results Bayer’s Gadovist™ (Gadobutrol) at a Reduced Dose Demonstrates Non-Inferiority Compared to a Standard Dose of Gadoterate for CNS Imaging bayer.com ↗
Bayer published today the results of its LEADER-75 (LowEr Administered Dose with highEr Relaxivity) study, demonstrating the clinical efficacy of a reduced dose of gadobutrol compared to a standard dose of gadoterate in patients undergoing a steady-state contrast-enhanced MRI of the CNS. |
| 2021-03-24 | Guerbet | Results Gadopiclenol: positive results for Phase III clinical trials guerbet.com ↗
Gadopiclenol: positive results for Phase III clinical trials |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-10-01 | Bayer | Bayer’s Gadovist™ (Gadobutrol) at a Reduced Dose Demonstrates Non-Inferiority Compared to a Standard Dose of Gadoterate for CNS Imaging bayer.com ↗ |
| 2021-03-24 | Guerbet | Gadopiclenol: positive results for Phase III clinical trials guerbet.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadobutrol | “Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2...” NCT02217280 ↗ |
| Known as | BAY86-4875 | “Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)” NCT00862459 ↗20“Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT01104584 ↗ “Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00468819 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00522951 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT01067976 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00395733 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00623467 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT01890434 ↗ “Gadobutrol (Gadovist, Gadavist, BAY86-4875)” NCT01890421 ↗ “gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00709852 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00395460 ↗ |
| Known as | Gadavist | “Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2...” NCT02217280 ↗25“Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients including term neonates to detect and visualize areas with disrupted blood...” NCT06224543 ↗ “The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).” NCT03504956 ↗ “Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures” PMID 25300984 ↗ Oct 2014 “the intravenous injection of the GBCA Gadobutrol (Gadavist, Bayer Healthcare)” NCT04893434 ↗ “Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.” NCT02034708 ↗ “Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)” NCT00862459 ↗ “Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00468819 ↗ “Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT01104584 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00395733 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00623467 ↗ |
| Known as | Gadograf | ChEMBL registry synonym — accepted as the source's own label CHEMBL2218860 ↗ |
| Known as | Gadovist | “the current standard gadolinium-based contrast agent (GBCA, gadobutrol, trade name Gadovist, will be used).” NCT02796729 ↗25“Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)” NCT00862459 ↗ “Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00468819 ↗ “Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT01104584 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT01067976 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00522951 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00395733 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00395460 ↗ “Gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT01890434 ↗ “gadobutrol (Gadavist, Gadovist, BAY86-4875)” NCT00709852 ↗ “Gadobutrol (Gadovist, Gadavist, BAY86-4875)” NCT01890421 ↗ |
| Known as | Gadovist (Gd-DO3A-butrol) contast agent | “Gadovist® (Gd-DO3A-butrol) contast agent” NCT03057561 ↗ |
| Known as | Gd-DO3A-butrol | “Brand of Gd-DO3A-butrol; contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI” NCT03057561 ↗1“Gadobutrol (INN) (Gd-DO3A-butrol) is a gadolinium-based MRI contrast agent (GBCA).” NCT02796729 ↗ |
| Known as | Protovist | ChEMBL registry synonym — accepted as the source's own label CHEMBL2218860 ↗ |
| Known as | ZK 135079 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2218860 ↗ |
| Modality | Diagnostic / imaging agent | “A gadolinium-based contrast agent for MRI” NCT00375830 ↗ |
| Route | Intravenous | “by intravenous injection at a rate of 1.0 mL/sec” NCT00395460 ↗ |