MedPath

Gadobutrol

Generic Name
Gadobutrol
Brand Names
Gadavist, Gadovist
Drug Type
Small Molecule
Chemical Formula
C18H31GdN4O9
CAS Number
770691-21-9
Unique Ingredient Identifier
1BJ477IO2L

Overview

Intravenous gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA (gadolinium-based contrast agent) used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. It may help visualize and detect vascular abnormalities in the blood brain barrier (BBB) and central nervous system (CNS). In patients with impaired renal function, gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF). A physician should be contacted if symptoms of NSF are encountered, such as dark or red patches on the skin; stiffness in joints; trouble moving, bending or straightening arms, hands, legs or feet; burning, itching, swelling, scaling, hardening and tightening of skin; pain in hip bones or ribs; or muscle weakness. Common adverse reactions that may be experienced include headache, nausea, feeling hot, abnormal taste, and warmth, burning or pain local to the injection site. General precautions should be taken in patients who are pregnant or breastfeeding, or who have a history of allergic reaction to contrast media, bronchial asthma or an allergic respiratory disorder.

Background

Intravenous gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA (gadolinium-based contrast agent) used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. It may help visualize and detect vascular abnormalities in the blood brain barrier (BBB) and central nervous system (CNS). In patients with impaired renal function, gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF). A physician should be contacted if symptoms of NSF are encountered, such as dark or red patches on the skin; stiffness in joints; trouble moving, bending or straightening arms, hands, legs or feet; burning, itching, swelling, scaling, hardening and tightening of skin; pain in hip bones or ribs; or muscle weakness. Common adverse reactions that may be experienced include headache, nausea, feeling hot, abnormal taste, and warmth, burning or pain local to the injection site. General precautions should be taken in patients who are pregnant or breastfeeding, or who have a history of allergic reaction to contrast media, bronchial asthma or an allergic respiratory disorder.

Indication

Gadobutrol is indicated for use with magnetic resonance imaging for the following diagnostic processes:

Associated Conditions

  • Arterial Occlusive Diseases of the Supra-aortic arteries
  • Coronary Artery Disease (CAD)
  • Malignant Breast Neoplasm
  • Renal artery occlusion

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/03
Not Applicable
Not yet recruiting
2025/02/26
Phase 4
Recruiting
UConn Health
2024/12/12
Phase 2
Not yet recruiting
2024/01/25
Phase 1
ENROLLING_BY_INVITATION
Subtle Medical
2023/06/23
Phase 3
Completed
2023/06/23
Phase 3
Completed
2023/04/13
Early Phase 1
Completed
Christopher J Chermansky, MD
2022/04/28
N/A
Completed
2022/01/31
Phase 4
Recruiting
2021/06/02
Phase 2
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Fresenius Kabi USA, LLC
65219-289
INTRAVENOUS
604.72 mg in 1 mL
9/14/2023
Bayer HealthCare Pharmaceuticals Inc.
50419-325
INTRAVENOUS
604.72 mg in 1 mL
8/13/2020
Bayer HealthCare Pharmaceuticals Inc.
50419-325
INTRAVENOUS
604.72 mg in 1 mL
7/12/2019
Slate Run Pharmaceuticals, LLC
70436-217
INTRAVENOUS
604.72 mg in 1 mL
4/17/2025
Fresenius Kabi USA, LLC
65219-281
INTRAVENOUS
604.72 mg in 1 mL
2/1/2023
Slate Run Pharmaceuticals, LLC
70436-214
INTRAVENOUS
604.72 mg in 1 mL
11/7/2023
Slate Run Pharmaceuticals, LLC
70436-216
INTRAVENOUS
604.72 mg in 1 mL
4/17/2025
Slate Run Pharmaceuticals, LLC
70436-217
INTRAVENOUS
604.72 mg in 1 mL
4/17/2025
Slate Run Pharmaceuticals, LLC
70436-213
INTRAVENOUS
604.72 mg in 1 mL
4/17/2025
Slate Run Pharmaceuticals, LLC
70436-212
INTRAVENOUS
604.72 mg in 1 mL
11/7/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
GADOVIST 1MMOL/ML PREFILLED SYRINGE 5.0 ML
SIN13807P
INJECTION
604.720 MG/ML(EQUIV. 1.0 MMOL)
5/21/2010
GADOVIST INJECTION 1.0 mmol/ml
SIN12399P
INJECTION
604.720 mg
8/22/2003

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Gadobutrol Injection
国药准字H20223154
化学药品
注射剂
3/22/2022
Gadobutrol Injection
国药准字H20247072
化学药品
注射剂
4/19/2024
Gadobutrol Injection
国药准字H20249394
化学药品
注射剂
11/15/2024
Gadobutrol Injection
国药准字HJ20140513
化学药品
注射剂
4/25/2023
Gadobutrol Injection
国药准字HJ20140515
化学药品
注射剂
4/25/2023
Gadobutrol Injection
国药准字H20234395
化学药品
注射剂
10/27/2023
Gadobutrol Injection
国药准字HJ20140516
化学药品
注射剂
4/25/2023
Gadobutrol Injection
国药准字H20233921
化学药品
注射剂
7/11/2023
Gadobutrol Injection
国药准字H20249663
化学药品
注射剂
12/1/2024
Gadobutrol Injection
国药准字HJ20140514
化学药品
注射剂
4/25/2023

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
© Copyright 2025. All Rights Reserved by MedPath