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Gadoteric acid | CAS No: 72573-82-1 | GMP-certified suppliers

A medication that enhances MRI imaging of the brain and spine by detecting blood-brain barrier disruptions and abnormal vascularity in adult and pediatric patients.

Therapeutic categories

AlcoholsAmino SugarsCarbohydratesChelating AgentsCompounds used in a research, industrial, or household settingContrast Media

Generic name

Gadoteric acid

Molecule type

small molecule

CAS number

72573-82-1

DrugBank ID

DB09132

Approval status

Approved drug

ATC code

V08CA02

Primary indications

Gadoteric acid is indicated for intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine, and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity

Product Snapshot

Gadoteric acid is supplied as an injectable solution formulated for intravenous and other parenteral routes
It is primarily used as a contrast agent in magnetic resonance imaging (MRI) for detecting and visualizing disruptions in the blood-brain barrier and abnormal vascularity in the brain and spine
The product is approved for use in the US and Canadian markets

Clinical Overview

Gadoteric acid, commonly administered as its salt gadoterate meglumine, is a macrocyclic, ionic gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI). Its chemical composition includes the chelating organic acid DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) complexed with gadolinium ion (Gd3+). The macrocyclic structure confers high thermodynamic, apparent, and kinetic stability, reducing the likelihood of gadolinium ion release in vivo, a key factor in its safety profile.

Clinically, gadoteric acid is indicated for intravenous use to enhance MRI imaging of the brain, spine, and related tissues in pediatric (including term neonates) and adult patients. It is specifically used to detect and visualize regions with blood-brain barrier (BBB) disruption and abnormal vascularity, such as neoplasms, abscesses, and infarcts. The FDA approved gadoterate meglumine under the brand name DOTAREM in 2013 for these indications.

Pharmacodynamically, gadoteric acid acts by shortening the longitudinal (T1) and transverse (T2) relaxation times of nearby water protons when subjected to a magnetic field, thereby increasing signal intensity on T1-weighted MRI sequences. Its relaxivity values remain consistent across clinical MRI field strengths ranging from 0.2 to 1.5 Tesla. This paramagnetic effect facilitates improved contrast between normal and pathological tissues.

Following intravenous administration, gadoteric acid demonstrates predominantly renal excretion with minimal metabolism. Renal clearance efficiency is a critical factor affecting its elimination kinetics and safety.

Safety considerations focus on the reduced risk of gadolinium deposition and toxicity due to the strong chelation afforded by its macrocyclic ligand, distinguishing it from linear GBCAs. Nevertheless, caution is warranted in patients with impaired renal function to mitigate the rare risk of nephrogenic systemic fibrosis (NSF).

For API procurement, sourcing gadoteric acid requires attention to stringent quality standards relating to metal ion purity, chelate stability, and absence of free gadolinium. Compliance with pharmacopeial monographs and validated analytical methods is essential to ensure consistent performance and patient safety in contrast media formulations.

Identification & chemistry

Generic name	Gadoteric acid
Molecule type	Small molecule
CAS	72573-82-1
UNII	QVF9Y6955W
DrugBank ID	DB09132

Pharmacology

Summary	Gadoterate is a paramagnetic contrast agent used in magnetic resonance imaging (MRI) to enhance the visualization of tissues by shortening T1 and T2 relaxation times of nearby water protons. Its action increases signal intensity in T1-weighted MRI sequences, facilitating the detection of lesions with blood-brain barrier disruption or abnormal vascularity. Gadoterate’s relaxivity remains consistent across commonly used magnetic field strengths, supporting its use in imaging intracranial and spinal tissues.
Mechanism of action	Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occur with differences in proton density, spin-lattice or longitudinal relaxation times (T1), and differences in the spin-spin or transverse relaxation time (T2). When placed in a magnetic field, gadoterate shortens the T1 and T2 relaxation times in target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.
Pharmacodynamics	Gadoterate affects proton relaxation times and consequently the MR signal, and the contrast obtained is characterized by the relaxivity of the gadoterate molecule. The relaxivity values for gadoterate are similar across the spectrum of magnetic field strengths used in clinical MRI (0.2-1.5 T). Disruption of the blood-brain barrier or abnormal vascularity allows the distribution of gadoterate in lesions such as neoplasms, abscesses, and infarcts.

ADME / PK

Absorption	Within the studied dose range (0.1 to 0.3 mmol/kg), the kinetics of total gadolinium appear to be linear. Following the administration of 0.1 mmol/kg of gadoterate meglumine in healthy volunteers, the C<sub>max</sub>, T<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> were measured to be 799.03 (192.63) µmol/L, 5.00 (0.10-10.00) min, 953.51 (76.22) µmolh/L, and 970.72 (73.34) µmolh/L for female and 836.85 (451.02) µmol/L, 5.00 (0.11-10.00) min, 1038.74 (240.46) µmolh/L, and 1061.16 (239.24) µmolh/L for male subjects respectively.
Half-life	Following an intravenously administered 0.1 mmol/kg, gadoterate demonstrates a mean elimination half-life of about 1.4 ± 0.2 hr and 2.0 ± 0.7 hr in female and male subjects, respectively.L49911]
Protein binding	Gadoterate does not undergo protein binding in vitro.
Metabolism	Gadoterate is not known to be metabolized.
Route of elimination	Following a 0.1 mmol/kg dose of gadoterate, total gadolinium is excreted primarily in the urine with 72.9 ± 17.0% and 85.4 ± 9.7% (mean ± SD) eliminated within 48 hours, in female and male subjects, respectively. Similar values were achieved after a cumulative dose of 0.3 mmol/kg (0.1 + 0.2 mmol/kg, 20 minutes later), with 85.5 ± 13.2% and 92.0 ± 12.0% recovered in urine within 48 hrs in female and male subjects respectively.
Volume of distribution	The volume of distribution at steady state of total gadolinium in healthy subjects is 179 ± 26 and 211 ± 35 mL/kg in female and male subjects respectively, roughly equivalent to that of extracellular water. The extent of blood cell partitioning of gadoterate is not known.
Clearance	In healthy subjects, the renal and total clearance rates of total gadolinium are comparable (1.27 ± 0.32 and 1.74 ± 0.12 mL/min/kg in females; and 1.40 ± 0.31 and 1.64 ± 0.35 mL/min/kg in males, respectively) indicating that the drug is primarily cleared through the kidneys.

Formulation & handling

Gadoteric acid is a small molecule administered exclusively via parenteral routes including intravenous, intramuscular, and intra-articular injections.
Due to its high water solubility and negative logP, the formulation requires aqueous solutions to maintain stability and bioavailability.
Handling should consider its stable liquid form and protect from contamination during preparation and administration for diagnostic or therapeutic use.

Regulatory status

Lifecycle	The active pharmaceutical ingredient (API) has reached patent expiration in both the US and Canada, leading to a mature market with established generic alternatives. Market competition is characterized by multiple authorized generic products and widespread availability.

Markets	US, Canada

Supply Chain

Supply chain summary	Gadoteric acid is supplied by a limited number of originator companies, with branded products primarily present in the US and Canadian markets. The repeated presence of a single brand across these markets suggests established global distribution. Patent expiries indicate the potential for existing or forthcoming generic competition in these regions.

Safety

Toxicity	GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses of 16 and 10 times, respectively, the recommended human dose. Because of the potential risks of gadolinium to the fetus, use gadoterate only if imaging is essential during pregnancy and cannot be delayed. Gadoterate administered to healthy volunteers and to adult patients at cumulative doses up to 0.3 mmol/kg was tolerated in a manner similar to lower doses. Adverse reactions to overdosage with gadoterate have not been reported. Gadoterate can be removed from the body by hemodialysis. Long-term animal studies have not been performed to evaluate the carcinogenic potential of gadoterate meglumine. Gadoterate meglumine did not demonstrate mutagenic potential in in vitro bacterial reverse mutation assays (Ames test) using Salmonella typhimurium, in an in vitro chromosome aberration assay in Chinese hamster ovary cells, in an in vitro gene mutation assay in Chinese hamster lung cells, nor in an in vivo mouse micronucleus assay. No impairment of male or female fertility and reproductive performance were observed in rats after intravenous administration of gadoterate meglumine at the maximum tested dose of 10 mmol/kg/day (16 times the maximum human dose based on surface area), given during more than 9 weeks in males and more than 4 weeks in females. Sperm counts and sperm motility were not adversely affected by treatment with the drug. Local intolerance reactions, including moderate irritation associated with infiltration of inflammatory cells were observed after perivenous injection in rabbits suggesting the possibility of local irritation if the contrast medium leaks around the veins in a clinical setting. Toxicity of gadoterate meglumine was evaluated in neonatal and juvenile (pre- and post-weaning) rats following a single or repeated intravenous administration at doses 1, 2, and 4 times the MHD based on BSA. Gadoterate meglumine was well tolerated at all dose levels tested and had no effect on growth, pre-weaning development, behavior, or sexual maturation.

Toxicity

GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses of 16 and 10 times, respectively, the recommended human dose. Because of the potential risks of gadolinium to the fetus, use gadoterate only if imaging is essential during pregnancy and cannot be delayed. Gadoterate administered to healthy volunteers and to adult patients at cumulative doses up to 0.3 mmol/kg was tolerated in a manner similar to lower doses. Adverse reactions to overdosage with gadoterate have not been reported. Gadoterate can be removed from the body by hemodialysis. Long-term animal studies have not been performed to evaluate the carcinogenic potential of gadoterate meglumine. Gadoterate meglumine did not demonstrate mutagenic potential in in vitro bacterial reverse mutation assays (Ames test) using Salmonella typhimurium, in an in vitro chromosome aberration assay in Chinese hamster ovary cells, in an in vitro gene mutation assay in Chinese hamster lung cells, nor in an in vivo mouse micronucleus assay. No impairment of male or female fertility and reproductive performance were observed in rats after intravenous administration of gadoterate meglumine at the maximum tested dose of 10 mmol/kg/day (16 times the maximum human dose based on surface area), given during more than 9 weeks in males and more than 4 weeks in females. Sperm counts and sperm motility were not adversely affected by treatment with the drug. Local intolerance reactions, including moderate irritation associated with infiltration of inflammatory cells were observed after perivenous injection in rabbits suggesting the possibility of local irritation if the contrast medium leaks around the veins in a clinical setting. Toxicity of gadoterate meglumine was evaluated in neonatal and juvenile (pre- and post-weaning) rats following a single or repeated intravenous administration at doses 1, 2, and 4 times the MHD based on BSA. Gadoterate meglumine was well tolerated at all dose levels tested and had no effect on growth, pre-weaning development, behavior, or sexual maturation.

High Level Warnings:

Gadoterate meglumine crosses the placenta, resulting in fetal exposure
Animal studies showed no developmental toxicity at high doses, but human data remain limited and inconclusive
No mutagenic effects were observed in multiple in vitro and in vivo assays

Gadoteric acid is a type of Diagnostic agents

Diagnostic agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the field of medical diagnostics. These agents play a vital role in diagnosing various diseases and conditions by aiding in the visualization and identification of specific biomarkers or structures within the body.

Diagnostic agents encompass a wide range of substances, including contrast agents, radiopharmaceuticals, and imaging agents. Contrast agents are commonly used in medical imaging techniques such as X-rays, magnetic resonance imaging (MRI), and computed tomography (CT) scans. They enhance the visibility of certain tissues or organs, allowing healthcare professionals to detect abnormalities more accurately.

Radiopharmaceuticals are another type of diagnostic agent that combines a radioactive component with a pharmaceutical compound. These agents emit radiation that can be detected by specialized imaging equipment, enabling the visualization of metabolic processes and the identification of abnormal cellular activity.

Imaging agents are designed to target specific molecular structures or biomarkers within the body. They can be used to detect and visualize specific proteins, enzymes, or receptors associated with certain diseases or conditions. By targeting these specific biomarkers, imaging agents provide valuable information about the presence, location, and extent of a disease, aiding in diagnosis and treatment planning.

Overall, diagnostic agents are essential tools in modern medicine, facilitating accurate and timely diagnoses. These pharmaceutical APIs enable healthcare professionals to identify and monitor diseases at an early stage, leading to better patient outcomes and improved treatment strategies.