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Magnevist

Phase 3FDA approved 2000

Brain Neoplasms | Small molecule | Oncology |Bayer AG|Trials Updated: Dec 15, 2014

Magnevist development status

FDA approval Mar 10, 2000
Approval holderBayer Hlthcare
ApplicationNDA021037
Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2006

Magnevist target and mechanism

ModalitySmall molecule

Also known as Magnevist (SH L 451A)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment118

FDA Designations

No designations recorded

Magnevist clinical trials

Magnevist · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00681551Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain MetastasisBrain Neoplasms
COMPLETED45 Analytics
PHASE3COMPLETED
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis
Brain NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Diagnostic ability
MRI image in blinded read
Quantitative measurement of the total area of delayed enhancement
30 min post injection

Secondary Endpoints

Visibility
MRI image in blinded read
Diagnostic confidence
MRI image in blinded read
Quantitative measures of area of delayed enhancement and signal intensities
At 5, 10 and 20 minutes post injection
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Magnevist (SH L 451A)DRUGMagnevist at a dose of 0.1 mmol/kg
Magnevist (Gadopentetate dimeglumine, BAY86-4882)DRUGOne intravenous injection per period. Period 1 and 2 are separated by 4 to 14 days.period1:Magnevist 0.1 mmol/kg body weightperiod 2: Magnevist 0.2 mmol/kg body weight
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patients who are confirmed to have 1-5 metastatic brain tumor by the latest contrast-enhanced cerebral CT or contrast-enhanced cerebral MRI, and the lesion(s) have not been treated by surgery or by stereotactic radiosurgery. Exclusion Criteria: * Patients who are scheduled t...

Countries:JapanUnited StatesArgentina
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Frequently asked questions about Magnevist

What is Magnevist used for?

Magnevist is a gadolinium-based contrast agent used to enhance magnetic resonance imaging. In clinical development it has been studied in patients with brain neoplasms, including brain metastasis, and in patients with documented myocardial infarction, where it is used to help depict delayed enhancement of heart tissue on MRI.

Who makes Magnevist?

Magnevist is developed and manufactured by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer is the sponsor responsible for the clinical studies of the agent in brain neoplasms and myocardial infarction.

What phase is Magnevist in?

Magnevist has been studied in Phase 3 clinical development, with one completed Phase 3 trial in patients with brain metastasis. A separate completed Phase 2 study evaluated the agent in patients with documented myocardial infarction. No active trials of Magnevist are currently listed.

What clinical trials is Magnevist in?

Magnevist has been evaluated in two completed studies. NCT00681551 was a Phase 3 intra-individual dose comparison study in patients with brain metastasis conducted in Japan. NCT00310544 was a Phase 2 study of delayed enhancement depiction in patients with documented myocardial infarction run in the United States and Argentina.

Is Magnevist the same as gadopentetate dimeglumine?

Yes. Magnevist is the brand name for gadopentetate dimeglumine, and the compound has also been referenced by the development codes BAY86-4882 and SH L 451A. Searches for any of these names refer to the same gadolinium-based MRI contrast agent from Bayer.

How many patients were enrolled in Magnevist trials?

The Magnevist clinical program listed here enrolled a total of 73 patients across its completed studies. The Phase 3 brain metastasis trial, NCT00681551, enrolled 45 patients, and the Phase 2 myocardial infarction study, NCT00310544, enrolled 73 patients.