Gadobutrol clinical trials
Gadobutrol is named as an intervention in 4 current clinical trials in our Israel, USA, South Korea, Germany, France, Italy, Canada, Brazil and China registers. 3 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Guerbet (1). The most-studied condition is Motor Function. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Gadobutrol is approved
All regulators →Of the three regulators tracked here, the first to approve Gadobutrol was Canada, on 8 Nov 1999. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Gadobutrol
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
Patient leaflets for Gadobutrol
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Gadobutrol
- ATC code
- V08CA09
- ChEMBL
- CHEMBL2218860
- DrugBank
- DB06703
- PubChem CID
- 70678987
- CAS number
- 770691-21-9
- Wikidata
- Q2570844
- Wikipedia
- Gadobutrol
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Gadobutrol
4 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Gadobutrol in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Gadobutrol. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients
2025-522453-20-00 · Neoplasms
|
Phase 2 | Authorised | Oslo University Hospital HF | Norway |
|
Phase IV, single-center, randomized, crossover clinical trial to validate the use of gadopiclenol versus gadobutrol in the evaluation of magnetic resonance imaging (MRI) diagnosis of perianal fistula associated with Crohn's disease
2025-523278-18-00 · CTIS ↗ · Diagnosis
|
Phase 4 | Authorised | Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca | Spain |
Gadobutrol across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
4 single-substance products containing Gadobutrol on the HPRA medicines list.
- Gadovist 1.0 mmol/ml solution for injection in prefilled syringeBayer Limited · PA1410/018/002 · Marketed
- Gadovist 1.0 mmol/ml solution for injectionBayer Limited · PA1410/018/003 · Not marketed
- Gadovist 1.0 mmol/ml solution for injectionBayer Limited · PA1410/018/001 · Not marketed
- Gadovist 1.0 mmol/ml solution for injection in prefilled cartridgeBayer Limited · PA1410/018/004 · Not marketed
Supply shortages
- Gadobutrol InjectionUS (FDA) · Resolved · updated 30 Jun 2026
Conditions studied with Gadobutrol
9 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Guerbet | 1 |
| GE Healthcare | 1 |
| Jiangsu HengRui Medicine Co., Ltd | 1 |
| Brigham and Women's Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Gadobutrol trials
How many clinical trials are testing Gadobutrol?
4 current trials in our Israel, USA, South Korea, Germany, France, Italy, Canada, Brazil and China registers name Gadobutrol (also registered as BAY86-4875) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Gadobutrol trials recruiting patients?
Yes. 3 of the 4 trials are recruiting: 3 with sites in Israel, 2 with sites in USA, 2 with sites in South Korea, 1 with sites in Germany, 1 with sites in France, 1 with sites in Italy, 1 with sites in Canada and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Gadobutrol clinical trials?
Guerbet (1), GE Healthcare (1), Jiangsu HengRui Medicine Co., Ltd (1) and Brigham and Women's Hospital (1). The number in brackets is how many trials each organisation leads.
Is Gadobutrol licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Gadobutrol, for example Gadovist 1.0 mmol/ml solution for injection in prefilled syringe (Bayer Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Gadobutrol shortage?
The registers we track list 1 entry for Gadobutrol: US FDA: resolved. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Gadobutrol works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Gadobutrol works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Gadobutrol (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.