Drug Profile

Gadoquatrane - Bayer

Alternative Names: BAY-1747846

Latest Information Update: 03 Sep 2025

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At a glance

Originator Bayer
Class Contrast media; Gadolinium-containing contrast agents; Heavy metals; Macrocyclic compounds
Mechanism of Action Magnetic resonance imaging enhancers

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Highest Development Phases

Preregistration CNS disorders
Phase III Peripheral nervous system diseases

Most Recent Events

27 Aug 2025 US FDA accepts NDA for Gadoquatrane for CNS disorders for review
10 Jul 2025 Preregistration for CNS disorders (Diagnosis, In adolescents, In children, In adults, In infants, In neonates) in European Union (IV)
18 Jun 2025 Preregistration for CNS disorders (Diagnosis, In adults, In adolescents, In children, In infants, In neonates) in USA (IV)

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