Relaxivity in serum

Explore VUEWAY® 
(gadopiclenol) 
 

Contrast enhancement at least non-inferior at half the gadolinium dose (0.05 mmol/kg) 
vs. a macrocyclic GBCA at a dose of 0.1 mmol/kg in approved indications.1

 

A lower gadolinium dose for similar visualization can help address the unmet medical need to minimize Gd exposure per MRI procedure and reduce the overall lifetime dose.10,11

properties table corr
Table based on products' SmPCs

Effective enhancement at half the Gd dose1-3,12

 

 

Preclinical measurements confirmed the extremely high relaxivity and good stability of gadopiclenol,4 whereas the Phase IIb dose-finding study showed VUEWAY®'s non-inferior effectiveness at a reduced Gd dose (0.05 mmol/kg) in MRI of the CNS vs. MultiHance (gadobenate dimeglumine) at the standard recommended US dose of 0.1 mmol/kg.12 

Subsequent to trials from Phases I & II,9,13,14 over 500 adult patients were included in two pivotal Phase III studies to undergo MRI with both VUEWAY® (gadopiclenol) at 0.05 mmol/kg and Gadovist® (gadobutrol) at 0.1 mmol/kg.2,3

In the CNS study (PICTURE):

Primary endpoints were met, demonstrating that VUEWAY® provides non-inferior, or comparable contrast enhancement at half the gadolinium dose (0.05 mmol/kg) vs. gadobutrol in qualitative assessments by experienced readers for all lesion visualization criteria,2 while secondary endpoints showed measured contrast enhancement percentage over unenhanced imaging superior for VUEWAY than for Gadovist by all readers (p<0.0001), superior contrast-to-noise ratio for 2 out of 3 readers (p<0.01), and superior lesion-to-background contrast ratio for all readers (p<0.0001). 

In the Body study (PROMISE):

Primary endpoints were met, demonstrating superiority of VUEWAY® at 0.05 mmol/kg to unenhanced MRI and non-inferiority of VUEWAY® at 0.05 mmol/kg to gadobutrol at 0.1 mmol/kg for all lesion visualization endpoints. Secondary objectives: two of three readers yielded higher percentage enhancement for gadopiclenol (P<0.001). Lesion-to-background ratio did not differ. For most participants (75%–83%), readers reported no preference between 0.05 mmol/kg gadopiclenol and 0.1 mmol/kg gadobutrol images.3

References

 

1VUEWAY® SmPC 2023 (EMA).

2 Loevner L, et al. Invest Radiol. 2023 May;1;58(5):307-313.

3 Kuhl C, et al. Radiol. 2023 Jul;308(1).

4 Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate with High T1 Relaxivity. Invest Radiol. 2019 Aug;54: 475-484.

5 GADOVIST® (gadobutrol) SmPC, 07/2022.

6 ProHance® (gadoteridol) SmPC UK, Nov 2021.

7 DOTAREM® (gadoterate meglumine) SmPC 07/2022.

8 CLARISCAN™ (gadoterate meglumine) SmPC UK, 05/2023.

9 Tweedle MF, Kanal E and Muller R. Considerations in the Selection of a New Gadolinium-Based Contrast Agent. Applied Radiology. Supplement May 2014.

10 Runge VM and Heverhagen, JT. Advocating the Development of Next-Generation High-Relaxivity Gadolinium Chelates for Clinical Magnetic Resonance. Invest Radiol. 2018 Jul;53(7):381-389.

11 Lancelot E, Raynaud JS, Desché P. Current and Future MR Contrast Agents: Seeking a Better Chemical Stability and Relaxivity for Optimal Safety and Efficacy. Invest Radiol. 2020 Sep;55(9):578-588.

12 Bendszus M, et al. Invest Radiol. 2020;55(3):129-137.

13 Bradu A, et al. Invest Radiol. 2021;56(8):486-493. 

14 Funck-Brentano C, et al. Br J Clin Pharmacol. 2020;86(11):2174-2181.