Gadopiclenol is a gadolinium-based contrast agent (GBCA) used with contrasted magnetic resonance imaging (MRI) to detect and visualize lesions and abnormal vascularity.

Brand Names
Generic Name
DrugBank Accession Number

Gadopiclenol is a gadolinium-based contrast agent (GBCA) based on a pyclen macrocyclic structure. It is indicated for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and the body.4 In 2006, the use of GBCAs was associated with the development of nephrogenic systemic fibrosis (NSF), a rare disorder characterized by the thickening and hardening of skin and subcutaneous tissues. However, studies revealed that NSF was associated with linear GBCAs, not macrocyclic GBCAs, such as gadopiclenol.1 Gadopiclenol has high kinetic stability and a high r1 relaxivity, allowing it to be used at lower doses than classic extracellular GBCAs.1,3

In September 2022, the use of gadopiclenol was approved by the FDA. The product label includes a black box warning regarding the increased risk for NSF among patients with impaired elimination of the drugs.4

Small Molecule
Average: 970.1
Monoisotopic: 970.2919
Chemical Formula
  • (.alpha.3,.alpha.6,.alpha.9-tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-.kappa.n3,.kappa.n6,.kappa.n9,.kappa.n15,.kappa.o3,.kappa.o6,.kappa.o9)gadolinium
  • 2-[3,9-bis[1-carboxylato-4-(2,3-dihydroxypropylamino)-4-oxobutyl]-3,6,9,15-tetrazabicyclo[9.3.1]pentadeca-1(15),11,13-trien-6-yl]-5-(2,3-dihydroxypropylamino)-5-oxopentanoate;gadolinium(3+)
External IDs
  • P-03277
  • P03277



Gadopiclenol is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).4

Reduce drug development failure rates
Build, train, & validate machine-learning models
with evidence-based and structured datasets.
See how
Build, train, & validate predictive machine-learning models with structured datasets.
See how
Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Diagnostic agentCns abnormal vascularity•••••••••••••••••• ••••••••••••••••••
Diagnostic agentAbnormal vascularity•••••••••••••••••• ••••••••••••••••••
Contraindications & Blackbox Warnings
Prevent Adverse Drug Events Today
Tap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.
Learn more
Avoid life-threatening adverse drug events with our Clinical API
Learn more

Variations in radiofrequency signal intensity allow the visualization of normal and pathological tissues during magnetic resonance imaging (MRI). These variations occur due to differences in proton density, differences of the spin-lattice or longitudinal relaxation times (T1), or differences in the spin-spin or transverse relaxation time (T2). Gadopiclenol shortens the T1 and T2 relaxation times and allows the visualization of targeted tissues during an MRI. The extent to which a contrast agent can affect the relaxation rate of tissue water (1/T1 or 1/T2) is termed relaxivity (r1 or r2). Gadopiclenol has a high r1 relaxivity compared to other gadolinium-based contrast agents.3,4 The use of gadopiclenol is not associated with QT interval prolongation; however, it can increase the risk for nephrogenic systemic fibrosis in patients with impaired elimination of the drugs. The use of gadopiclenol may also cause hypersensitivity reactions and acute kidney injury.4

Mechanism of action

Gadopiclenol is a macrocyclic non-ionic complex of gadolinium and a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body.4 Its use in magnetic resonance imaging (MRI) allows to selectively increase contrast in tissues where gadopiclenol accumulates.4


At a dose range between 0.025 mmol/kg and 0.3 mmol/kg (0.5 times to 6 times the recommended dosage), the Cmax and AUCinf of gadopiclenol increases in a dose-proportional manner. At the recommended dose, gadopiclenol has a Cmax of 525 µg/mL and an AUCinf of 569 µg·h/mL.4 A study that evaluated the pharmacokinetic parameters of gadopiclenol in healthy subjects and patients with brain lesions did not detect significant differences between the two groups.2

Volume of distribution

At steady state, the mean volume of distribution of gadopiclenol is 13 L.4

Protein binding

At clinically relevant concentrations, the protein binding of gadopiclenol is ≤ 1.8%.4


Gadopiclenol is not metabolized and is eliminated unchanged.1,4

Route of elimination

Gadopiclenol is mainly excreted in urine by glomerular filtration. Within 48 hours after administration, approximately 98% of the gadopiclenol dose was recovered in urine.4


Gadopiclenol has a mean elimination half-life of is 1.5 hours.4


Gadopiclenol has a total body clearance of 100 mL/min and a renal clearance of 81 mL/min.4

Adverse Effects
Improve decision support & research outcomes
With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!
See the data
Improve decision support & research outcomes with our structured adverse effects data.
See a data sample

There are no available data on gadopiclenol use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The available human data on GBCA exposure during pregnancy and adverse fetal outcomes are limited and inconclusive.5

In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadopiclenol during organogenesis. Because of the potential risks of gadolinium to the fetus, use gadopiclenol only if imaging is essential during pregnancy and cannot be delayed.5

In subjects that received a single intravenous dose of gadopiclenol (0.3 mmol/kg) that corresponded to 6 times the recommended dose, headache and nausea were the most frequently reported adverse reactions. Gadopiclenol can be removed from the body by hemodialysis.4 Carcinogenicity studies of gadopiclenol have not been performed. Gadopiclenol showed no evidence of mutagenicity in in vitro and in vivo assays. An in vivo study performed in rats showed that up to 10 mmol/kg (62 times the recommended human dose), gadopiclenol did not affect fertility and general reproductive performance.4

Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
No interactions found.


Drug product information from 10+ global regions
Our datasets provide approved product information including:
dosage, form, labeller, route of administration, and marketing period.
Access now
Access drug product information from over 10 global regions.
Access now
International/Other Brands
Elucirem (Guerbet)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
EluciremInjection485.1 mg/1mLIntravenousGuerbet LLC2022-09-21Not applicableUS flag
EluciremInjection485.1 mg/1mLIntravenousGuerbet LLC2022-09-21Not applicableUS flag
EluciremInjection485.1 mg/1mLIntravenousGuerbet LLC2022-09-21Not applicableUS flag
EluciremInjection485.1 mg/1mLIntravenousGuerbet LLC2022-09-21Not applicableUS flag
EluciremInjection485.1 mg/1mLIntravenousGuerbet LLC2022-09-21Not applicableUS flag


ATC Codes
V08CA12 — Gadopiclenol
Drug Categories
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

CAS number
InChI Key
gadolinium(3+) 2-[6,9-bis({1-carboxylato-3-[(2,3-dihydroxypropyl)carbamoyl]propyl})-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(14),11(15),12-trien-3-yl]-4-[(2,3-dihydroxypropyl)carbamoyl]butanoate


Synthesis Reference

Paratian, JM, et al. (2022) Method for synthesising 2-bromoglutaric acid diesters (French). World Intellectual Property Organization, patent WO 2022/013440 A1. Available at

General References
  1. Robic C, Port M, Rousseaux O, Louguet S, Fretellier N, Catoen S, Factor C, Le Greneur S, Medina C, Bourrinet P, Raynal I, Idee JM, Corot C: Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol. 2019 Aug;54(8):475-484. doi: 10.1097/RLI.0000000000000563. [Article]
  2. Hao J, Bourrinet P, Desche P: Assessment of Pharmacokinetic, Pharmacodynamic Profile, and Tolerance of Gadopiclenol, A New High Relaxivity GBCA, in Healthy Subjects and Patients With Brain Lesions (Phase I/IIa Study). Invest Radiol. 2019 Jul;54(7):396-402. doi: 10.1097/RLI.0000000000000556. [Article]
  3. Lancelot E, Raynaud JS, Desche P: Current and Future MR Contrast Agents: Seeking a Better Chemical Stability and Relaxivity for Optimal Safety and Efficacy. Invest Radiol. 2020 Sep;55(9):578-588. doi: 10.1097/RLI.0000000000000684. [Article]
  4. FDA Approved Drug Products: ELUCIREM (gadopiclenol) injection for intravenous use [Link]
  5. FDA Approved Drug Products: ELUCIREMTM (gadopiclenol) injection, for intravenous use (Jan 2024) [Link]

Clinical Trials

Clinical Trials
4Not Yet RecruitingDiagnosticProstate Cancer1
4Not Yet RecruitingOtherMyocardial Fibrosis1
3CompletedDiagnosticBlood Brain Barrier Defect / CNS Lesion1
3CompletedDiagnosticLesion in Body Region1
3RecruitingDiagnosticCNS Lesion / Lesion in Body Region1


Not Available
Not Available
Dosage Forms
InjectionIntravenous485.1 mg/1mL
Not Available
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US8114863No2012-02-142028-09-19US flag
US10973934No2021-04-132039-08-06US flag
US11590246No2020-01-172040-01-17US flag


Experimental Properties
Not Available
Predicted Properties
Water Solubility3.23 mg/mLALOGPS
pKa (Strongest Acidic)-2.5Chemaxon
pKa (Strongest Basic)7.51Chemaxon
Physiological Charge-2Chemaxon
Hydrogen Acceptor Count19Chemaxon
Hydrogen Donor Count9Chemaxon
Polar Surface Area351.68 Å2Chemaxon
Rotatable Bond Count24Chemaxon
Refractivity229.53 m3·mol-1Chemaxon
Polarizability79.94 Å3Chemaxon
Number of Rings2Chemaxon
Rule of FiveNoChemaxon
Ghose FilterNoChemaxon
Veber's RuleNoChemaxon
MDDR-like RuleNoChemaxon
Predicted ADMET Features
Not Available


Mass Spec (NIST)
Not Available
Not Available
Chromatographic Properties
Collision Cross Sections (CCS)
Not Available

Drug created at November 02, 2022 18:55 / Updated at February 05, 2024 00:28