Mangafodipir

Overview

Mangafodipir is a contrast agent used as a diagnostic tool administered intravenously to enhance contrast in magnetic resonance imaging (MRI) of the liver and pancreas. This drug is made up of paramagnetic manganese (II) ions combined with the chelating agent fodipir (dipyridoxyl diphosphate, DPDP). Manganese absorption into the tissues that makes the normal tissue appear brighter in MRI is limited in abnormal or cancerous tissue. Enhanced contrast by mangafodipir improves visualization and detection of lesions of the liver formed from metastatic disease or hepatocellular carcinomas. The contrast agent is present as mangafodipir trisodium marketed under the name Teslascan. Teslascan has been removed from the Drug Product List by FDA in 2003, and withdrawn from the European market in 2012.

Indication

Indicated for use as an organ-specific paramagnetic contrast agent developed for imaging of the hepatobiliary system and detecting lesions in liver and pancreas.

Associated Conditions

Hepatic Lesions

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Mangafodipir - an Intracellular Contrast Agent for Magnetic Resonance Imaging (MRI): Measuring Manganese Uptake Rate in Heart Failure Patients With Preserved Ejection Fraction (HFpEF) Patients.	2024/12/12	NCT06731738	Phase 2	Recruiting	IC TARGETS AS
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy	2015/08/25	NCT02531880	Phase 1	Recruiting	National Institute of Neurological Disorders and Stroke (NINDS)
Manganese-Enhanced Magnetic Resonance Imaging in Healthy Volunteers and People With Multiple Sclerosis	2011/03/31	NCT01326715	Phase 1	Completed	National Institute of Neurological Disorders and Stroke (NINDS)
Mangafodipir as an Adjunct to Percutaneous Coronary Intervention	2009/08/27	NCT00966563	Phase 2	Completed	Egetis Therapeutics
Protective Effect of Mangafodipir Against Oxaliplatin Neurotoxicity	2008/08/04	NCT00727922	Phase 2	Completed	Assistance Publique - Hôpitaux de Paris
Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Colon Cancer Stage Dukes' C	2008/05/06	NCT00671996	Phase 2	Completed	Egetis Therapeutics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TESLASCAN	ge healthcare canada inc	02241555	Solution - Intravenous	37.9 MG / ML	9/15/2000

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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