Friday, July 10, 2026

Drug profile · INN

gadobutrol

gadobutrol (GADAVIST) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved NMPA: clinical trials
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — gadobutrol
US status
approved
Class
Route
INTRAVENOUS
Patents
0
Programs
3
Data quality
0.84

Quick answer

gadobutrol (GADAVIST) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN gadobutrol
Brand GADAVIST
Mechanism Diagnostic agent
Route INTRAVENOUS
Formulation SOLUTION

Mechanism of action

Diagnostic agent

Approval history

Authority Status Date
FDA approved
NMPA clinical trials

Pipeline programs

  1. 91782 Phase 3 · Bayer HealthCare Animal · Breast Cancer
  2. TG1101-RMS401 Phase 3 · TG THERAPEUTICS · Relapsing multiple sclerosis
  3. ACT16753 Phase 2 · Sanofi-Aventis U.S · Multiple sclerosis

Frequently asked questions

What is gadobutrol?

gadobutrol (GADAVIST) is a diagnostic agent. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for gadobutrol?

GADAVIST is a marketed brand name for gadobutrol. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of gadobutrol?

gadobutrol 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.