Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AMBELVIST | — | 2026-06-12 | fda.gov ↗ |
| Filed | US (FDA) | — | — | 2025-12-03 | “Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world, including the U.S., the EU, and China” bayer.com ↗ “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, including Japan, the U.S., the EU, and China.” bayer.com ↗ “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, such as Japan, the U.S., the EU, and China” bayer.com ↗ |
| Filed | Japan (PMDA) | — | — | 2025-12-03 | “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, including Japan, the U.S., the EU, and China.” bayer.com ↗ “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, such as Japan, the U.S., the EU, and China” bayer.com ↗ |
| Filed | China (NMPA) | — | — | 2025-12-03 | “Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world, including the U.S., the EU, and China” bayer.com ↗ “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, including Japan, the U.S., the EU, and China.” bayer.com ↗ “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, such as Japan, the U.S., the EU, and China” bayer.com ↗ |
| Filed | EU (EMA) | — | — | 2025-12-03 | “Bayer has submitted applications for marketing authorization of gadoquatrane in additional markets around the world, including the U.S., the EU, and China” bayer.com ↗ “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, including Japan, the U.S., the EU, and China.” bayer.com ↗ “Bayer has submitted applications for marketing authorization of gadoquatrane in markets around the world, such as Japan, the U.S., the EU, and China” bayer.com ↗ |
| Filed | China (NMPA) | — | — | 2025-09-18 | “the Center of Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application for gadoquatrane.” bayer.com ↗ |
| Filed | EU (EMA) | — | — | 2025-07-10 | “submission of a marketing authorization application to the European Medicines Agency for its investigational contrast agent gadoquatrane” bayer.com ↗ |
| Filed | US (FDA) | — | — | 2025-06-17 | “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane” bayer.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05061979 | Oct 2021 → Mar 2022 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06135181 | Aug 2020 → Feb 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06125366 | Apr → Jun 2019 | — | Bayer | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04307186 | Nov 2020 → Sep 2022 | central nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT05915026 | Aug 2023 → Sep 2024 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT05915728 | Jul 2023 → May 2024 | nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT05915702 | Jul 2023 → May 2024 | central nervous system disorder | Bayer | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-06-15 | Bayer | Regulatory Bayer’s low-dose MRI contrast agent approved in U.S. bayer.com ↗ |
| 2026-03-23 | Bayer | Regulatory First approval for Bayer’s low-dose MRI contrast agent in Japan bayer.com ↗
Bayer today announced the world’s first approval of the MRI contrast agent gadoquatrane by the Ministry of Health, Labour, and Welfare in Japan. |
| 2025-12-03 | Bayer | Results Data from Pediatric Study for Bayer's Investigational MRI Contrast Agent presented at RSNA 2025 bayer.com ↗
Bayer, a global leader in radiology, today revealed results from the QUANTI Pediatric study, adding to the safety and efficacy data of the investigational low-dose MRI gadolinium-based contrast agent (GBCA) gadoquatrane. |
| 2025-09-18 | Bayer | Regulatory New drug application for gadoquatrane accepted for review in China bayer.com ↗
Bayer today announced that the Center of Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application for gadoquatrane. |
| 2025-08-27 | Bayer | Regulatory Gadoquatrane New Drug Application Accepted for Review by U.S. FDA bayer.com ↗
Bayer today announced that a New Drug Application (NDA) for its investigational contrast agent gadoquatrane has been accepted for review by the U.S. Food and Drug Administration (FDA). |
| 2025-07-10 | Bayer | Regulatory Bayer files for EU approval of gadoquatrane bayer.com ↗
Bayer today announced the submission of a marketing authorization application to the European Medicines Agency for its investigational contrast agent gadoquatrane for contrast enhancement in magnetic resonance imaging to detect and visualize known or suspected pathologies in all body regions and the central nervous system (CNS) in adults and pediatric patients including neonates. |
| 2025-06-17 | Bayer | Regulatory Bayer files for approval of gadoquatrane in the U.S. bayer.com ↗ |
| 2025-06-02 | Bayer | Regulatory Gadoquatrane submitted for marketing authorization in Japan bayer.com ↗
Bayer today announced the submission of a marketing authorization application to the Ministry of Health, Labour, and Welfare (MHLW) in Japan for its investigational contrast agent gadoquatrane for contrast enhancement in magnetic resonance imaging (MRI) to detect and visualize known or suspected pathologies in all body regions and the central nervous system (CNS) in adults and pediatric patients including neonates. |
| 2025-02-26 | Bayer | Results Positive results from Phase III study for Bayer's investigational contrast agent gadoquatrane bayer.com ↗
Bayer, a global leader in radiology, announced positive results from the Phase III study QUANTI CNS, which evaluated the investigational gadolinium-based contrast agent (GBCA) gadoquatrane in adults with known or suspected pathologies of the central nervous system undergoing contrast-enhanced magnetic resonance imaging (MRI). |
| 2025-01-14 | Bayer | Results Bayer’s Pharma Growth Strategy Progressing Well as Pipeline Advances bayer.com ↗
The first data from the program show that the investigational gadolinium-based MRI contrast agent gadoquatrane successfully met the primary and main secondary diagnostic efficacy and safety endpoints in patients using a 60% lower gadolinium dose compared to trial comparators. |
| 2025-01-10 | Bayer | Results Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies bayer.com ↗
Gadoquatrane successfully met the primary and main secondary endpoints of all QUANTI studies. |
| 2024-12-01 | Bayer | Results Bayer showcases innovations in radiology portfolio at RSNA 2024 bayer.com ↗
Based on imaging and pharmacokinetic data, a dose of 0.04 mmol Gd/kg body weight was identified and is now being evaluated in a broad Phase III program. |
| 2023-11-22 | Bayer | Results Bayer Championing Advancements in Radiology Pipeline and Accelerating AI Innovation bayer.com ↗
A Dose of 0.04 mmol Gd/ kg body weight (bw) of Gadoquatrane Has Similar Efficacy to 0.1 mmol Gd/kg bw of Gadobutrol |
All press releases naming this drug 14 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | gadoquatrane | “The aim of this report was to characterize the key physicochemical, pharmacokinetic (PK), and magnetic resonance imaging (MRI) properties of gadoquatrane (BAY 1747846), a newly...” PMID 35703267 ↗ Jun 2022 |
| Known as | BAY1747846 | “Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg” NCT06135181 ↗6“Drug: Gadoquatrane (BAY1747846)” NCT05915026 ↗ “Gadoquatrane (BAY1747846)” NCT05915702 ↗ “Gadoquatrane (BAY1747846)” NCT05915728 ↗ “Gadoquatrane (BAY1747846)” NCT04307186 ↗ |
| Modality | Diagnostic / imaging agent | “Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast agents (GBCA) which are used in MRI examinations to provide contrast enhancement and...” NCT04307186 ↗ |
| Route | Intravenous | “Solution for IV injection, single dose” NCT04307186 ↗ |