Gadoquatrane

CAS2048221-65-2MW2579.0 g/mol

FDA 2026, APPROVALS 2026, Ambelvist, OZG7J613HK, BAY-1747846, BAY 1747846

2-[4,10-bis(carboxylatomethyl)-7-[1-oxo-1-[[2-oxo-2-[[3-[[2-[2-[4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]propanoylamino]acetyl]amino]-2,2-bis[[[2-[2-[4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]propanoylamino]acetyl]amino]methyl]propyl]amino]ethyl]amino]propan-2-yl]-1,4,7,10-tetrazacyclododec-1-yl]acetate;tetrakis(gadolinium(3+))

TETRAGADOLINIUM (4,10-BIS(CARBOXYLATOMETHYL)-7-(3,6,12,15-TETRAOXO-16-(4,7,10-TRIS-(CARBOXYLATOMETHYL)-1,4,7,10-TETRAAZACYCLODODECAN-1-YL)-9,9-BIS(((((2-(4,7,10-TRIS-(CARBOXYLATOMETHYL)-1,4,7,10-TETRAAZACYCLODODECAN-1-YL)PROPANOYL)AMINO)ACETYL)-AMINO)METHYL)-4,7,11,14-TETRAAZAHEPTADECAN-2-YL)-1,4,7,10-TETRAAZACYCLODODECAN-1-YL)ACETATE

To detect and visualize lesions with abnormal vascularity, in conjunction with MRI

Gadoquatrane (marketed as AMBELVIST®) is a low-dose, macrocyclic gadolinium-based contrast agent (GBCA) developed by Bayer for use in magnetic resonance imaging (MRI). It is designed to enhance the visualization of lesions in the central nervous system (CNS) and other body regions in adult and pediatric patients.

Core Highlights:

• Lower Gadolinium Exposure: It requires a dose of 0.04 mmol/kg, which results in 60% less gadolinium exposure compared to standard macrocyclic GBCAs.
• Regulatory Approval: The FDA approved it in June 2026 for use in adults and pediatric patients, including term neonates. It was also approved in Japan in March 2026.
• Efficacy & Safety: Phase III clinical trials (the QUANTI studies) showed it effectively detects lesions with abnormal vascularity while maintaining an efficacy and safety profile comparable to other standard macrocyclic agents.
• Structure: Gadoquatrane features a tetrameric, macrocyclic structure that gives it high relaxivity and stability in the body

SYN

https://patents.google.com/patent/US20250114485A1

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PAT

• Gadolinium chelate compounds for use in magnetic resonance imagingPublication Number: US-11491245-B2Priority Date: 2015-06-04Grant Date: 2022-11-08
• Gadolinium chelate compounds for use in magnetic resonance imagingPublication Number: US-2025114485-A1Priority Date: 2015-06-04
• Formulation of contrast media and process of preparation thereofPublication Number: US-2024252690-A1Priority Date: 2018-11-23
• Formulation of contrast media and process of preparation thereofPublication Number: US-12303573-B2Priority Date: 2018-11-23Grant Date: 2025-05-20
• New gadolinium chelate compounds for use in magnetic resonance imagingPublication Number: EP-3611169-A1Priority Date: 2015-06-04
• New gadolinium chelate compounds for use in magnetic resonance imagingPublication Number: US-2023113481-A1Priority Date: 2015-06-04
• New gadolinium chelate compounds for use in magnetic resonance imagingPublication Number: EP-3303307-B1Priority Date: 2015-06-04Grant Date: 2019-09-04
• Generation of artificial contrast-enhanced computed tomography imagesPublication Number: US-2024346718-A1Priority Date: 2023-04-13
• Generation of artificial contrast-enhanced radiological imagesPublication Number: WO-2024100233-A1Priority Date: 2022-11-12
• Generation of artificial contrast-enhanced radiological imagesPublication Number: EP-4616420-A1Priority Date: 2022-11-12
• Automated analysis of radiological imagesPublication Number: WO-2024083466-A1Priority Date: 2022-10-17
• Formulation of contrast media and process of preparation thereofPublication Number: US-11944690-B2Priority Date: 2018-11-23Grant Date: 2024-04-02

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