VUEWAY®
(gadopiclenol)
injection
VUEWAY® injection is the new Bracco contrast agent, with the highest relaxivity per gadolinium ion of all GBCAs today combined with high stability,4 making effective MRI contrast enhancement possible at half the gadolinium dose.*1-3
*Half the gadolinium dose compared to gadobutrol at a standard recommended gadolinium dose of 0.1 mmol/kg in authorized indications.
Molecule and Physiochemical properties
The chemical structure of gadopiclenol allows for a high r1 relaxivity by influencing three main parameters: inner and outer sphere coordination sites and tumbling rate.1,4
The large molecule size leads to a lower tumbling rate, which is the reason for high relaxivity compared to previously approved GBCAs.
Relaxivity (r1 or r2) is the extent to which a contrast agent can increase the relaxation rate of tissue water (1/T1 or 1/T2).
Inner sphere coordination
The structure of gadopiclenol permits the coordination of two water molecules in the inner sphere (q=2) versus one water molecule for the other GBCAs (q=1).
The inner sphere relaxivity is directly proportional to the number of water molecules coordinated with the gadolinium ion. Thus, q=2 in gadopiclenol contributes to increase the relaxivity.
Tumbling rate
Gadopiclenol has a large molecule size due to 3 hydrophilic polyalcohol pendant arms, which reduce rotational diffusion and leads to a lower tumbling rate.
Outer sphere coordination
Gadopiclenol was designed with 3 hydrophilic polyalcohol side chains to increase the number of water molecules bound through the outer coordination sphere mechanism.
Indications
VUEWAY® injection is indicated in adults and children aged 2 years and older for contrast enhanced Magnetic Resonance Imaging (MRI) to detect and visualize lesions with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity in:
- the Central Nervous System (CNS), i.e., brain, spine and surrounding tissues,
- the Body (head and neck, thorax including breast, abdomen including liver and kidneys, pelvis including prostate, and musculoskeletal system).
It should be used only when diagnostic information is essential and not available with unenhanced MRI.1
VUEWAY® injection, developed with Bracco’s scientific expertise, reflects our commitment to advancing MRI by delivering innovative contrast agents designed to shape the future of prevention and improve patients’ lives. Watch this video to see how VUEWAY® injection is redefining the MRI contrast experience.
Important Safety Information and Indications
Indications/Clinical Use:
VUEWAY® (gadopiclenol) is indicated in:
- adults and children aged 2 years and older for contrast enhanced Magnetic Resonance Imaging (MRI) to detect and visualize lesions with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity in:
- the Central Nervous System (CNS), i.e., brain, spine and surrounding tissues;
- the Body (head and neck, thorax including breast, abdomen including liver and kidneys, pelvis including prostate, and musculoskeletal system).
Most serious warnings and precautions:
- Nephrogenic Systemic Fibrosis (NSF): Gadolinium-based contrast agents (GBCAs) increase the risk for NSF in patients with chronic severe renal impairment (glomerular filtration rate <30 mL/min/1.73m2), or acute renal failure/acute kidney injury. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs.
- Intrathecal administration of GBCAs can cause serious, life-threatening, and fatal reactions. VUEWAY is not approved for intrathecal use.
Other relevant warnings and precautions:
- Accumulation of Gadolinium in the Brain
- Extravasation and Injection Site Reactions
- Seizures: Patients should be monitored during and following administration
- Renal: VUEWAY should be used with caution in patients with renal impairment
- Acute kidney injury: The risk of acute kidney injury may increase with increasing dose of the contrast agent
- Sensitivity/Resistance
- Skin: The fibrosis associated with NSF can extend beyond dermis and involve subcutaneous tissues, striated muscles, diaphragm, pleura, pericardium, and myocardium
- Pregnancy: The safety of VUEWAY during pregnancy has not been established
- Breastfeeding: It is unknown whether VUEWAY is excreted in human breast milk
For more information:
Please consult the VUEWAY Product Monograph at https://www.bracco.com/en-ca-vueway-monograph for important information relating to patient selection, adverse reactions, drug interactions, and dosing/administration information, which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-465-5820.
References
1. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL. Product Monograph. BRACCO IMAGING Canada. Montreal, QC; April 2026.
2. Loevner L, et al. Invest Radiol. 2023;1;58(5):307-313.
3. Kuhl C, et al. Radiol. 2023;308(1).
4. Robic C, et al. Invest Radiol. 2019;54:475-484.
5. Lancelot E, et al. Invest Radiol. 2020;55(9):578-588.
6. Spinazzi et al., Invest Radiol. 2025, 10.1097/RLI.0000000000001144.
7. Jurkiewicz E, et al. Invest Radiol. 2022;1;57(8):510-516.
8. Brünjes R, Hofmann T. Water Research 2020;182:115966.
High relaxivity
Relaxivity (r1 or r2) at given concentration is the extent to which a contrast agent can increase the relaxation rate of tissue water (1/T1 or 1/T2). VUEWAY® injection has the highest relaxivity per gadolinium ion of all macrocyclic GBCAs approved today.4 VUEWAY® injection demonstrates 2.5 to 3.5 fold higher relaxivity per gadolinium ion than most mGBCAs approved today at all relevant MRI field strengths.*4
Low dose
VUEWAY® injection provides higher qualitative contrast enhancement at half the gadolinium dose.*2,3 The potential benefits of injecting half gadolinium are particularly important for vulnerable patient populations due to reduction of cumulative gadolinium dose:3,5,6
* Half the gadolinium dose compared to gadobutrol at a standard recommended gadolinium dose of 0.1 mmol/kg in authorized indications.
Safety profile
VUEWAY® injection has a pharmacokinetic profile comparable to that of other macrocyclic gadolinium chelates.1
In clinical trials VUEWAY® (gadopiclenol) injection has shown a good safety profile in adults and children (2–18 yrs).1-3,6,7
From Spinazzi et al., "Safety of Gadopiclenol After Its First Year of Clinical Use", (Invest Radiol. 2025):
- Post-marketing surveillance – Data after 1 year of routine clinical use on 882,550 gadopiclenol applications.
- Results:
- Low adverse event (AE) rates reported (0.0036; 1/27,580)
- Types of AEs comparable to the AEs reported with other GBCAs
- No Weber effect* reported so far
*The Weber effect states that the number of reported adverse reactions to a drug tends to peak during the second year after the drug is introduced to the market, and then declines steadily thereafter, despite continued widespread use of the drug.
References
1. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL. Product Monograph. BRACCO IMAGING Canada. Montreal, QC; April 2026.
2. Loevner L, et al. Invest Radiol. 2023;1;58(5):307-313.
3. Kuhl C, et al. Radiol. 2023;308(1).
4. Robic C, et al. Invest Radiol. 2019;54:475-484.
5. Lancelot E, et al. Invest Radiol. 2020;55(9):578-588.
6. Spinazzi et al., Invest Radiol. 2025, 10.1097/RLI.0000000000001144.
7. Jurkiewicz E, et al. Invest Radiol. 2022;1;57(8):510-516.
8. Brünjes R, Hofmann T. Water Research 2020;182:115966.
At Bracco, we put sustainability at the core of our growth. VUEWAY® injection is a clear example of this commitment - its efficient molecular design leads to high relaxivity, delivering an enhanced MRI experience with reduced gadolinium exposure.
What benefits does VUEWAY® injection bring to patients and the environment?
- For patients and providers: Effective imaging at a lower gadolinium dose compared to the recommended dose of most other macrocyclic GBCAs2 - supporting ALARA principle application in daily practice.
- For the planet: Up to 9.5 tonnes of gadolinium potentially saved per year8, without compromising diagnostic confidence.
Discover how VUEWAY® injection can help you achieve your sustainability goals.
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VUEWAY injection: An enhanced MRI experience with reduced gadolinium |
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References
1. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL. Product Monograph. BRACCO IMAGING Canada. Montreal, QC; April 2026.
2. Loevner L, et al. Invest Radiol. 2023;1;58(5):307-313.
3. Kuhl C, et al. Radiol. 2023;308(1).
4. Robic C, et al. Invest Radiol. 2019;54:475-484.
5. Lancelot E, et al. Invest Radiol. 2020;55(9):578-588.
6. Spinazzi et al., Invest Radiol. 2025, 10.1097/RLI.0000000000001144.
7. Jurkiewicz E, et al. Invest Radiol. 2022;1;57(8):510-516.
8. Brünjes R, Hofmann T. Water Research 2020;182:115966.
Two pivotal Phase III crossover studies comparing VUEWAY® injection at 0.05 mmol/kg and gadobutrol at 0.1 mmol/kg.2,3
The PICTURE study2
In the CNS study, primary endpoints were met: Demonstrating that VUEWAY® injection provides non-inferior, or comparable lesion visualization at half the gadolinium dose (0.05 mmol/kg) vs. gadobutrol.
*All images shown are representative images from referenced studies. Individual results may vary.
†Presented studies in their primary outcomes proved non-inferiority of VUEWAY® injection (0.05 mmol/kg) in half gadolinium dose compared to gadobutrol (0.1 mmol/kg) in full gadolinium dose.
‡From Phase III PICTURE Clinical Trial of MRI in the CNS: Study GDX-44-010. Data on file.
The PROMISE study3
In the Body study (PROMISE), primary endpoints were met: Superiority of VUEWAY® injection at 0.05 mmol/kg to unenhanced MRI across lesion visualization criteria.
MRI of the Body - A 66-year-old male patient with hepatocellular cancer‡
Contrast-enhanced MRI of the liver after administration of gadopiclenol (0.05 mmol/kg) and gadobutrol (0.1 mmol/kg). Axial three-dimensional T1-weighted dynamic contrast-enhanced MRI scans during the (A, D) arterial, (B, E) portal venous, and (C, F) delayed phases
MRI of the Breast - 68-year-old female patient with left breast adenocarcinoma
*All images shown are representative images from referenced studies. Individual results may vary.
†Presented studies in their primary outcomes proved non-inferiority of VUEWAY® injection (0.05 mmol/kg) in half gadolinium dose compared to gadobutrol (0.1 mmol/kg) in full gadolinium dose.
‡From Phase III PROMISE Clinical Trial of MRI in the Body: Study GDX-44-011. Data on file.
Expert Insights
Watch expert insights from Daniela Bernardi and Francesco Sardanelli where they share their clinical perspectives on the role of VUEWAY® injection in breast MRI and the added value of using a safe GBCA with high relaxivity at half the gadolinium dose.*
*Half the gadolinium dose compared to gadobutrol at a standard recommended Gd dose of 0.1 mmol/kg in authorized indications.
References
1. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL. Product Monograph. BRACCO IMAGING Canada. Montreal, QC; April 2026.
2. Loevner L, et al. Invest Radiol. 2023;1;58(5):307-313.
3. Kuhl C, et al. Radiol. 2023;308(1).
4. Robic C, et al. Invest Radiol. 2019;54:475-484.
5. Lancelot E, et al. Invest Radiol. 2020;55(9):578-588.
6. Spinazzi et al., Invest Radiol. 2025, 10.1097/RLI.0000000000001144.
7. Jurkiewicz E, et al. Invest Radiol. 2022;1;57(8):510-516.
8. Brünjes R, Hofmann T. Water Research 2020;182:115966.
*from 10 to 140 kg
VUEWAY® injection
0.5 M
Volume (mL)
Quantity (mmol)
Macrocyclic
GBCA
1.0 M
Volume (mL)
Quantity (mmol)
Macrocyclic
GBCA
0.5 M
Volume (mL)
Quantity (mmol)
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VUEWAY® injection Product Monograph |
Download | |||
Important Safety Information and Indications
Indications/Clinical Use:
VUEWAY® (gadopiclenol) is indicated in:
- adults and children aged 2 years and older for contrast enhanced Magnetic Resonance Imaging (MRI) to detect and visualize lesions with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity in:
- the Central Nervous System (CNS), i.e., brain, spine and surrounding tissues;
- the Body (head and neck, thorax including breast, abdomen including liver and kidneys, pelvis including prostate, and musculoskeletal system).
Most serious warnings and precautions:
- Nephrogenic Systemic Fibrosis (NSF): Gadolinium-based contrast agents (GBCAs) increase the risk for NSF in patients with chronic severe renal impairment (glomerular filtration rate <30 mL/min/1.73m2), or acute renal failure/acute kidney injury. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs.
- Intrathecal administration of GBCAs can cause serious, life-threatening, and fatal reactions. VUEWAY is not approved for intrathecal use.
Other relevant warnings and precautions:
- Accumulation of Gadolinium in the Brain
- Extravasation and Injection Site Reactions
- Seizures: Patients should be monitored during and following administration
- Renal: VUEWAY should be used with caution in patients with renal impairment
- Acute kidney injury: The risk of acute kidney injury may increase with increasing dose of the contrast agent
- Sensitivity/Resistance
- Skin: The fibrosis associated with NSF can extend beyond dermis and involve subcutaneous tissues, striated muscles, diaphragm, pleura, pericardium, and myocardium
- Pregnancy: The safety of VUEWAY during pregnancy has not been established
- Breastfeeding: It is unknown whether VUEWAY is excreted in human breast milk
For more information:
Please consult the VUEWAY Product Monograph at https://www.bracco.com/en-ca-vueway-monograph for important information relating to patient selection, adverse reactions, drug interactions, and dosing/administration information, which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-465-5820.