Overview
A complex of gadolinium with a chelating agent, diethylenetriamine penta-acetic acid (DTPA see pentetic acid), that is given to enhance the image in cranial and spinal MRIs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p706)
Indication
For use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues as well as lesions with abnormal vascularity in the head and neck. Also used to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart).
Associated Conditions
No associated conditions information available.
Research Report
Gadopentetic Acid (Gd-DTPA): A Comprehensive Pharmacological, Clinical, and Safety Review of a First-Generation MRI Contrast Agent
I. Introduction: The Advent of Paramagnetic Contrast in Magnetic Resonance Imaging
Historical Context: The Need for Contrast Enhancement in Early MRI
Magnetic Resonance Imaging (MRI) emerged as a revolutionary medical imaging modality by providing unparalleled soft tissue detail without the use of ionizing radiation. The fundamental principle of MRI relies on detecting signals from hydrogen protons within the body's water molecules after they are manipulated by strong magnetic fields and radiofrequency pulses.[1] The resulting image contrast is derived from intrinsic tissue properties, primarily the proton density and the relaxation time constants known as T1 (longitudinal or spin-lattice relaxation) and T2 (transverse or spin-spin relaxation).[4] However, in the early stages of its clinical application, a significant limitation became apparent: the inherent differences in these properties between various tissues, particularly between healthy and pathological tissues, were often subtle. This frequently resulted in insufficient contrast to confidently delineate, characterize, and diagnose disease.[4] This challenge created a clear and pressing need for exogenous pharmaceutical agents that could selectively alter the relaxation properties of tissues, thereby increasing the informational content of the diagnostic images and improving both the sensitivity and specificity of the examination.[2]
Gadopentetic Acid: The First-in-Class Gadolinium-Based Contrast Agent (GBCA)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2019/04/10 | N/A | Completed | |||
2015/02/26 | Not Applicable | Withdrawn | |||
2014/10/30 | Early Phase 1 | Completed | Michael Vogelbaum, MD, PhD | ||
2014/03/06 | Not Applicable | Completed | |||
2014/02/07 | Not Applicable | Terminated | |||
2013/10/08 | Phase 4 | UNKNOWN | |||
2011/08/15 | Not Applicable | Withdrawn | |||
2011/06/20 | N/A | Completed | |||
2010/12/15 | Phase 3 | Completed | |||
2010/09/30 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
MAGNEVIST gadopentetate dimeglumine 7.035 g/15mL injection vial | 48494 | Medicine | A | 5/4/1994 | |
MAGNEVIST gadopentetate dimeglumine 4.69g/10mL injection syringe | 54671 | Medicine | A | 4/4/1996 | |
MAGNEVIST gadopentetate dimeglumine 14.07g/30mL injection vial | 59542 | Medicine | A | 6/3/1997 | |
MAGNEVIST gadopentetate dimeglumine 7.035g/15mL injection syringe | 54670 | Medicine | A | 4/4/1996 | |
MAGNEVIST gadopentetate dimeglumine 46.9g/100mL injection bottle | 90883 | Medicine | A | 9/17/2002 | |
MAGNEVIST gadopentetate dimeglumine 9.38g/20mL injection vial | 48495 | Medicine | A | 5/4/1994 | |
MAGNEVIST gadopentetate dimeglumine 4.69g/10mL injection vial | 10697 | Medicine | A | 8/19/1991 | |
MAGNEVIST gadopentetate dimeglumine 9.38g/20mL injection syringe | 54669 | Medicine | A | 4/4/1996 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MAGNEVIST | Bayer Inc | 01989987 | Solution - Intravenous | 469 MG / ML | 12/31/1992 |
GADOPENTETATE DIMEGLUMINE INJECTION | avir pharma inc. | 02497883 | Solution - Intravenous | 469 MG / ML | N/A |
GADOPENTETATE DIMEGLUMINE INJECTION, USP | 02431513 | Solution - Intravenous | 469 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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