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Guerbet’s Elucirem (gadopiclenol) Receives the US FDA’s Approval for Contrast-Enhanced Magnetic Resonance Imaging

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Guerbet’s Elucirem (gadopiclenol) Receives the US FDA’s Approval for Contrast-Enhanced Magnetic Resonance Imaging

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  • The US FDA has approved Elucirem for contrast-enhanced MRI
  • The approval was based on the 2 P-III studies of gadopiclenol (0.05mmol/kg) vs gadobutrol (0.1mmol/kg) which demonstrated that gadopiclenol leads to non-inferior results in brain and body MRI, contrast enhancement & diagnostic efficacy at half of the gadolinium dosing of other GBCAs, no safety signals were reported & the adverse reactions were similar for both products
  • Elucirem is a new macrocyclic gadolinium-based contrast agent with high relaxivity indicated for adults & children aged ≥2yrs. & can be utilized with MRI to detect lesions with abnormal vascularity in CNS & other areas. The product will be marketed by Guerbet in the US in a bottle and pre-filled syringe form

Ref: Guerbet | Image:  Guerbet

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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