CLINICAL TRIALS PROFILE FOR GADOBUTROL

505(b)(2) Clinical Trials for gadobutrol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT03602339 ↗	Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose	Completed	Bayer	Phase 4	2018-11-14	The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

All Clinical Trials for gadobutrol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00375830 ↗	Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases	Completed	Stanford University	Phase 2	2006-01-01	This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
NCT00395460 ↗	Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients	Completed	Bayer	Phase 3	2006-09-01	The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
NCT00395733 ↗	Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients	Completed	Bayer	Phase 3	2006-10-01	The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
NCT00522951 ↗	SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study	Completed	Bayer	Phase 3	2007-08-01	This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication.
NCT00623467 ↗	Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging	Completed	Bayer	Phase 3	2007-12-01	This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.
NCT00709852 ↗	Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging	Completed	Bayer	Phase 3	2008-06-01	This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.

Clinical Trial Conditions for gadobutrol

Condition Name

Condition Name for gadobutrol
Intervention	Trials
Magnetic Resonance Imaging	5
Coronary Artery Disease	3
Central Nervous System Diseases	3
Pancreatic Cancer	2

Condition MeSH

Condition MeSH for gadobutrol
Intervention	Trials
Brain Neoplasms	4
Nervous System Diseases	3
Myocardial Ischemia	3
Central Nervous System Diseases	3

Clinical Trial Locations for gadobutrol

Trials by Country

Trials by Country for gadobutrol
Location	Trials
United States	183
Germany	70
Japan	59
Italy	26
China	26

Trials by US State

Trials by US State for gadobutrol
Location	Trials
Illinois	16
Texas	14
California	14
Massachusetts	13
Pennsylvania	13

Clinical Trial Progress for gadobutrol

Clinical Trial Phase

Clinical Trial Phase for gadobutrol
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
PHASE2	1

Clinical Trial Status

Clinical Trial Status for gadobutrol
Clinical Trial Phase	Trials
Completed	29
Recruiting	15
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for gadobutrol

Sponsor Name

Sponsor Name for gadobutrol
Sponsor	Trials
Bayer	22
Guerbet	7
National Cancer Institute (NCI)	6

Sponsor Type

Sponsor Type for gadobutrol
Sponsor	Trials
Industry	36
Other	25
NIH	7

Gadobutrol Market Analysis and Financial Projection

Last updated: April 25, 2026

Gadobutrol: Clinical Trial Update, Market Analysis, and Projection

Gadobutrol is a gadolinium-based contrast agent (GBCA) used for MRI. Key branded products include Gadavist® (Bayer). Commercial trajectory and pipeline visibility vary by region due to patent and regulatory dynamics around competing GBCAs, but the active global market for IV gadobutrol has remained supported by radiology workflow adoption and broad labeling for CNS, body imaging, and angiography indications.

---

What is gadobutrol’s current clinical and regulatory status?

Commercial status by product form

• Route: Intravenous (IV)
• Class: Gadolinium-based contrast agent (GBCA)
• Reference product: Gadavist® (gadobutrol)
• Typical use setting: MRI diagnostic imaging, including contrast-enhanced MRI for CNS and body applications (labeling varies by jurisdiction)

Clinical trial activity: what is observable in the public record

Clinical trial volume for gadobutrol is typically lower than for small-molecule drugs because its primary innovation cycle is dominated by:

• formulation/packaging changes,
• comparative studies versus other GBCAs,
• pediatric and special population studies,
• labeling expansions and real-world evidence submissions.

In practice, public trial registries show a mix of:

• comparative imaging performance trials (e.g., lesion conspicuity),
• safety and tolerability studies,
• pharmacokinetic (PK) and distribution studies (often in special populations),
• investigator-initiated or sponsor-sponsored observational studies.

Actionable interpretation: the clinical development pattern for gadobutrol is incremental rather than innovation-led, so market access and uptake depend more on reimbursement, tendering, hospital formularies, and competitive GBCA pricing than on late-stage efficacy breakthroughs.

---

What is the competitive landscape for gadobutrol?

Primary competitive set

Gadobutrol competes within the IV GBCA market against other macrocyclic and linear agents. Competitive differentiation tends to show up in:

• market access and hospital formulary placement,
• gadolinium-related safety messaging (macrocyclic vs linear),
• concentration and injection volumes used in protocols,
• regional tender pricing.

Common comparator categories include:

• Macrocyclic GBCAs (often favored in procurement policies),
• Linear GBCAs (where available and reimbursed),
• Newer or higher-volume-pack formats (where they improve workflow economics).

How competition impacts procurement

Hospitals and national health systems often drive GBCA selection through:

• tender cycles,
• annual purchasing volume commitments,
• procurement policies tied to safety profiles,
• substitution rules and formulary restrictions.

Actionable implication: gadobutrol’s revenue outlook is more sensitive to competitive tender outcomes and substitution rates than to incremental clinical trial readouts.

---

Where does gadobutrol generate revenue in practice?

Demand drivers

The demand base for gadobutrol is driven by MRI utilization plus contrast-enhanced protocol adoption. Key operational drivers:

• high MRI throughput in radiology centers,
• increasing use of contrast-enhanced MRI in oncology and CNS workflows,
• repeat imaging cycles for monitoring (where clinically relevant),
• expansion of diagnostic MRI access in outpatient and community settings (varies by country).

Supply and utilization

As a contrast agent, consumption scales with imaging volumes rather than patient counts tied to chronic therapy. This means market growth typically tracks:

• MRI procedure growth,
• dose standardization and protocol trends,
• replacement of alternative GBCAs due to formulary decisions.

---

How large is the global gadobutrol/GBCA market opportunity and what is the projection?

Market framing

The GBCA market is large and internationally standardized. Gadobutrol’s share is determined by:

• brand and tender access,
• macrocyclic positioning,
• regional patent/registration status and substitution dynamics,
• reimbursement policies.

Projection approach used for business planning

Because GBCA products do not behave like disease-modifying therapies, projections are typically built from:

1. MRI procedure volume growth,
2. contrast-enhanced protocol share,
3. GBCA class mix shift (macrocyclic share),
4. gadobutrol’s share within macrocyclic tenders by region,
5. price and volume from tender cycles.

Base-case projection logic (directional, planning-oriented)

• Base case: steady-to-moderate growth in gadobutrol revenue as MRI volumes rise and macrocyclic preferences persist.
• Bear case: share loss due to aggressive tendering from competing macrocyclic GBCAs or substitution to lower-priced alternatives.
• Bull case: formulary wins in high-volume regions and sustained macrocyclic policy momentum lift market share faster than procedure growth.

Actionable projection conclusion: gadobutrol should be modeled as a “volume-and-tender” product with growth primarily tied to MRI utilization and procurement retention, not to blockbuster-style indication expansion.

---

Clinical trial update: which trial themes matter for commercial outcomes?

Trial themes that move market behavior

Even where clinical outcomes do not materially change clinical standard of care, trials influence:

• labeling and reimbursement eligibility,
• safety narratives for institutional adoption,
• pediatric and renal-population confidence for protocol standardization,
• comparative performance dossiers used in tenders.

Typical endpoints that procurement screens

• Tolerability and adverse event profile
• Diagnostic image quality measures (lesion conspicuity, enhancement measures)
• Efficacy endpoints tied to imaging detectability
• Safety outcomes in special populations (where studies are required by regulators)

Commercial linkage: if new trials support broader or clearer use in a segment that drives high volume (oncology follow-up, CNS imaging, pediatrics), the product can gain formulary inclusion even without a new “blockbuster” claim.

---

Business risk and upside factors for gadobutrol

Key downside risks

• Tender price pressure from competing GBCA brands and authorized generics (region-dependent).
• Formulary substitution in institutions running macrocyclic-to-macrocyclic switching based on procurement terms.
• Regulatory and safety policy tightening around gadolinium deposition narratives, affecting class preferences and imaging protocol choices.

Key upside factors

• MRI utilization growth across public and private settings.
• Macrocyclic GBCA policy reinforcement in procurement.
• Hospital protocol standardization that locks in gadobutrol dosing and workflow patterns.

---

Key Takeaways

• Gadobutrol’s market trajectory is driven by MRI procedure growth and hospital procurement cycles rather than late-stage efficacy innovation.
• Competitive dynamics in macrocyclic and linear GBCA categories shape share more than clinical trial readouts alone.
• Clinical activity is typically incremental and tends to influence labeling, safety dossiers, and institutional adoption.
• Projections should be modeled as a volume-and-tender product with base-case steady growth, downside from share erosion during tendering, and upside from macrocyclic policy and formulary wins.

---

FAQs

1) What is gadobutrol used for?
Gadobutrol is used as an IV contrast agent for MRI to enhance diagnostic imaging.

2) What determines gadobutrol’s market share most?
Hospital and payer procurement decisions, including tender outcomes, formulary placement, and substitution rules.

3) Do clinical trials for gadobutrol materially change outcomes for radiologists?
They often focus on safety, tolerability, special populations, and comparative imaging quality, which can support adoption and reimbursement but usually do not redefine clinical standards broadly.

4) What is the main growth driver for gadobutrol revenue?
Growth in MRI volumes and the proportion of MRI studies performed with contrast.

5) How should a projection be modeled for gadobutrol?
Use procedure volume growth, contrast-enhanced utilization rates, macrocyclic mix shifts, and gadobutrol’s expected tender share and price to forecast revenue.

---

References

[1] U.S. Food and Drug Administration. (n.d.). Gadavist (gadobutrol) prescribing information. FDA.
[2] European Medicines Agency. (n.d.). Gadavist: product information. EMA.
[3] Bayer. (n.d.). Gadavist (gadobutrol) product label and clinical information. Bayer.