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MRI contrast-enhancing agents

Medical University of Vienna · Phase 3 active Small molecule Under review

MRI contrast-enhancing agents is a MRI contrast agent Small molecule drug developed by Medical University of Vienna. It is currently in Phase 3 development for Enhancement of MRI imaging in central nervous system lesions, Enhancement of MRI imaging in cardiovascular and musculoskeletal pathology, General diagnostic imaging enhancement across multiple organ systems.

MRI contrast-enhancing agents improve visualization of anatomical structures and pathology by altering the magnetic properties of nearby water molecules during magnetic resonance imaging.

MRI contrast-enhancing agents are used in clinical trials to study various conditions, including Ovarian Cancer, Brain Tumor, and DLBCL - Diffuse Large B Cell Lymphoma. These agents are part of the O-RADS MRI system, which is being studied for its potential in early detection of Ovarian Cancer in a prospective, multicenter study.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	MRI contrast-enhancing agents
Sponsor	Medical University of Vienna
Drug class	MRI contrast agent
Modality	Small molecule
Therapeutic area	Diagnostic Imaging
Phase	Phase 3

Mechanism of action

These agents work by shortening the relaxation times (T1 or T2) of hydrogen nuclei in tissue, thereby increasing signal intensity in MRI scans. Gadolinium-based agents are most common, accumulating in areas of interest and enhancing image contrast to reveal lesions, tumors, or vascular abnormalities that would otherwise be difficult to visualize.

Approved indications

Enhancement of MRI imaging in central nervous system lesions
Enhancement of MRI imaging in cardiovascular and musculoskeletal pathology
General diagnostic imaging enhancement across multiple organ systems

Common side effects

Gadolinium retention in tissues
Nephrogenic systemic fibrosis (in patients with severe renal impairment)
Hypersensitivity reactions
Headache
Nausea

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

MRI contrast-enhancing agents CI brief — competitive landscape report
MRI contrast-enhancing agents updates RSS · CI watch RSS
Medical University of Vienna portfolio CI

Frequently asked questions about MRI contrast-enhancing agents

What is MRI contrast-enhancing agents?

MRI contrast-enhancing agents is a MRI contrast agent drug developed by Medical University of Vienna, indicated for Enhancement of MRI imaging in central nervous system lesions, Enhancement of MRI imaging in cardiovascular and musculoskeletal pathology, General diagnostic imaging enhancement across multiple organ systems.

How does MRI contrast-enhancing agents work?

MRI contrast-enhancing agents improve visualization of anatomical structures and pathology by altering the magnetic properties of nearby water molecules during magnetic resonance imaging.

What is MRI contrast-enhancing agents used for?

MRI contrast-enhancing agents is indicated for Enhancement of MRI imaging in central nervous system lesions, Enhancement of MRI imaging in cardiovascular and musculoskeletal pathology, General diagnostic imaging enhancement across multiple organ systems.

Who makes MRI contrast-enhancing agents?

MRI contrast-enhancing agents is developed by Medical University of Vienna (see full Medical University of Vienna pipeline at /company/medical-university-of-vienna).

What drug class is MRI contrast-enhancing agents in?

MRI contrast-enhancing agents belongs to the MRI contrast agent class. See all MRI contrast agent drugs at /class/mri-contrast-agent.

What development phase is MRI contrast-enhancing agents in?

MRI contrast-enhancing agents is in Phase 3.

What are the side effects of MRI contrast-enhancing agents?

Common side effects of MRI contrast-enhancing agents include Gadolinium retention in tissues, Nephrogenic systemic fibrosis (in patients with severe renal impairment), Hypersensitivity reactions, Headache, Nausea.

Drug class: All MRI contrast agent drugs
Manufacturer: Medical University of Vienna — full pipeline
Therapeutic area: All drugs in Diagnostic Imaging
Indication: Drugs for Enhancement of MRI imaging in central nervous system lesions
Indication: Drugs for Enhancement of MRI imaging in cardiovascular and musculoskeletal pathology
Indication: Drugs for General diagnostic imaging enhancement across multiple organ systems

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing