Friday, July 10, 2026

Drug profile · INN

gadoterate meglumine

gadoterate meglumine (GADOTERATE MEGLUMINE) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — gadoterate meglumine
US status
approved
Class
Route
INTRAVENOUS
Patents
0
Programs
5
Data quality
0.84

Quick answer

gadoterate meglumine (GADOTERATE MEGLUMINE) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN gadoterate meglumine
Brand GADOTERATE MEGLUMINE
Mechanism Diagnostic agent
Route INTRAVENOUS
Formulation SOLUTION

Mechanism of action

Diagnostic agent

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. GDX-102/GDX-44-017 Phase 3 · Guerbet · Suspected Vascular Disease of supra-aortic (carotid/vertebro
  2. DOTAREM for Breast Cancer Approved · Disc Medicine · Breast Cancer
  3. Dotarem® Approved · Guerbet · Primary Brain Tumor
  4. Gadoterate meglumine Approved · Guerbet · Hepatocellular Carcinoma
  5. HCB.2021.1309 Approved · George Institute for · Coronary artery chronic total occlusion

Frequently asked questions

What is gadoterate meglumine?

gadoterate meglumine (GADOTERATE MEGLUMINE) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for gadoterate meglumine?

GADOTERATE MEGLUMINE is a marketed brand name for gadoterate meglumine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of gadoterate meglumine?

gadoterate meglumine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.