CLINICAL TRIALS PROFILE FOR GADOTERIDOL

All Clinical Trials for GADOTERIDOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01613417 ↗	Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain	Completed	Bracco Diagnostics, Inc	Phase 4	2012-08-01	This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
NCT02359097 ↗	Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma	Completed	National Cancer Institute (NCI)	N/A	2015-01-06	This clinical trial studies steady state blood volume maps using ferumoxytol non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor cells and the blood vessels in and around the tumors.
NCT02359097 ↗	Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma	Completed	Oregon Health and Science University	N/A	2015-01-06	This clinical trial studies steady state blood volume maps using ferumoxytol non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor cells and the blood vessels in and around the tumors.
NCT02359097 ↗	Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma	Completed	OHSU Knight Cancer Institute	N/A	2015-01-06	This clinical trial studies steady state blood volume maps using ferumoxytol non-stoichiometric magnetite magnetic resonance (MRI) in imaging patients with glioblastoma. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. Contrast agents, such as ferumoxytol non-stoichiometric magnetite, may enhance these pictures and increase visibility of tumor cells and the blood vessels in and around the tumors.

Clinical Trial Conditions for GADOTERIDOL

Condition Name

Condition Name for GADOTERIDOL
Intervention	Trials
Multiple Sclerosis	2
Contrast Enhancement in Magnetic Resonance Imaging	2
Diffuse Intrinsic Pontine Glioma	2
Glioblastoma	2

Condition MeSH

Condition MeSH for GADOTERIDOL
Intervention	Trials
Glioma	3
Breast Neoplasms	2
Sclerosis	2
Multiple Sclerosis	2

Clinical Trial Locations for GADOTERIDOL

Trials by Country

Trials by Country for GADOTERIDOL
Location	Trials
United States	37
Japan	31
China	9
Germany	8
Argentina	6

Trials by US State

Trials by US State for GADOTERIDOL
Location	Trials
California	4
Florida	3
North Carolina	3
Illinois	3
Alabama	3

Clinical Trial Progress for GADOTERIDOL

Clinical Trial Phase

Clinical Trial Phase for GADOTERIDOL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for GADOTERIDOL
Clinical Trial Phase	Trials
Recruiting	6
Completed	5
Unknown status	2

Clinical Trial Sponsors for GADOTERIDOL

Sponsor Name

Sponsor Name for GADOTERIDOL
Sponsor	Trials
Bayer	3
University of Alabama at Birmingham	2
Guerbet	2

Sponsor Type

Sponsor Type for GADOTERIDOL
Sponsor	Trials
Other	17
Industry	9
NIH	1

Last updated: July 28, 2026

Gadoteridol clinical trials update, market analysis, and forecast: pipeline status, approval pathway, and revenue outlook

Gadoteridol remains a niche, regionally marketed gadolinium-based contrast agent (GBCA) used for magnetic resonance imaging (MRI). Publicly available, consolidated trial-and-commercial datapoints needed for a complete, quantified clinical-trials update and revenue projection are not provided in the source context available here, so no accurate status, trial timelines, or market forecast can be produced.

What clinical trials have been reported for gadoteridol, and what are the latest outcomes?

No verified, source-cited dataset is available in the provided context to compile a credible gadoteridol trial register (phase, NCT numbers, enrollment, endpoints, and results), nor to determine the latest readouts, safety signals, or efficacy outcomes.

Which MRI indications have phase 2/3 gadoteridol trials focused on?

No source-backed indication mapping is available in the provided context.

What safety findings (nephrogenic systemic fibrosis, renal impairment, hypersensitivity) have been reported for gadoteridol?

No source-cited safety findings are available in the provided context.

Are head-to-head trials vs gadobenate dimeglumine, gadobutrol, or gadopentetate dimeglumine available for gadoteridol?

No source-cited head-to-head trial data is available in the provided context.

What patents protect gadoteridol, and how strong is the IP estate for generics and follow-on products?

No patent-portfolio inputs are present in the provided context, preventing construction of a defensible claim chart (formulation, chelate, manufacturing, and method-of-use claims), expiration mapping, or generic-entry risk assessment.

How many patents cover gadoteridol formulations and manufacturing methods?

No patent counts by family are available in the provided context.

When do gadoteridol patents expire, and where do they differ by jurisdiction?

No expiration dates or jurisdictional coverage are available in the provided context.

Is there any Paragraph IV or generic challenge activity tied to gadoteridol?

No litigation or Orange Book challenge inputs are available in the provided context.

What is the FDA regulatory status of gadoteridol, and what does its review history imply?

No source-cited FDA status, approval history, labeling, or dossier pathway information is available in the provided context to state whether gadoteridol is approved in the US, the listed indications, or current postmarketing requirements.

What is the Orange Book status of gadoteridol?

No Orange Book listing data is available in the provided context.

Has gadoteridol used an NDA, ANDA, or 505(b)(2) pathway for supplemental indications or new formulations?

No regulatory pathway inputs are available in the provided context.

How does gadoteridol compare with other MRI contrast agents on efficacy, safety, dosing, and cost?

No source-cited comparative performance, dosing, or cost benchmarks are available in the provided context to support a legitimate cross-drug comparison.

Which GBCA class does gadoteridol belong to, and what chelate/ion properties matter commercially?

No source-cited technical profile inputs are available in the provided context.

What are typical dosing regimens for gadoteridol across indications and populations?

No source-cited dosing details are available in the provided context.

What is the current market size for gadoteridol, and what share does it hold by geography?

No market sizing methodology, revenue estimates, or country-level share data is available in the provided context to produce a quantified market analysis.

Which countries drive gadoteridol sales, and what reimbursement dynamics shape demand?

No payer or reimbursement inputs are available in the provided context.

How sensitive is gadoteridol demand to MRI utilization trends and procurement cycles?

No source-cited demand drivers are available in the provided context.

What revenue forecast scenarios exist for gadoteridol over the next 5 years?

No quantified baseline metrics (current sales, growth rates, penetration, volume, price erosion, competitor share shifts) are available in the provided context to construct scenarios.

What are the main upside and downside risks for gadoteridol revenue projection?

No source-backed risk framework is available in the provided context.

When could biosimilar or generic competition pressure gadoteridol pricing?

No exclusivity or entry timelines are available in the provided context.

Key Takeaways

• Gadoteridol’s clinical-trials update and market forecast require source-cited trial, regulatory, IP, and commercial datasets that are not present in the provided context.
• No defensible quantitative update on latest readouts, exclusivity timelines, generic/generic-risk, or 5-year revenue outlook can be produced without those inputs.

FAQs

1. Is gadoteridol approved for MRI in the US and which indications are listed on labeling?
2. Are there any ongoing phase 3 trials for gadoteridol in renal-impaired patients?
3. What are the key patents covering gadoteridol chelate chemistry and formulation?
4. How does gadoteridol pricing compare with gadobutrol and gadobenate dimeglumine in major procurement markets?
5. What is the typical incidence of hypersensitivity reactions for gadoteridol versus other GBCAs?

References

No sources were provided in the prompt context, so no citations can be listed.