Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gadoquatrane · 4 trials · 4 indications
Median values (5th and 95th percentile)
Median values (5th and 95th percentile)
Median values (5th and 95th percentile)
Median values (5th and 95th percentile)
Contrast Enhancement will be assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
Delineation will be assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
Morphology will be assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gadobutrol). If 2 or 3 readers reach the same conclusion on the recommended action (e.g. no dose adjustment needed), then this will be the recommended action taken.
| Arm | Type | Description |
|---|---|---|
| Gadoquatrane | EXPERIMENTAL | Participants will receive one intravenous injection of gadoquatrane during MRI. |
| Gadoquatrane - Approved Macrocyclic GBCA | EXPERIMENTAL | Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2. |
| Approved Macrocyclic GBCA - Gadoquatrane | EXPERIMENTAL | Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2. |
| Gadobutrol + Gadoquatrane | EXPERIMENTAL | Participants will receive one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) and one IV injection of Gadoquatrane (BAY1747846). |
| Name | Type | Description |
|---|---|---|
| Gadoquatrane (BAY1747846) | DRUG | 0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose |
| Gadobutrol | DRUG | Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose |
| Gadoterate meglumine | DRUG | Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose |
| Gadoteridol | DRUG | Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose |
| Gadobutrol (Gadovist/Gadavist) | DRUG | Solution for IV injection, single dose |
Inclusion Criteria: * Participants from birth to \<18 years of age at the time of signing the informed consent form. * Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement. * ...
Gadoquatrane is an investigational gadolinium-based contrast agent (GBCA) being developed for contrast enhancement in magnetic resonance imaging (MRI) of the central nervous system and other body regions. It is intended for use in adults and children undergoing contrast-enhanced MRI for known or suspected brain, spinal cord, or other body conditions.
Gadoquatrane is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials to evaluate the safety and efficacy of this contrast agent for MRI procedures.
Gadoquatrane is in Phase 3 clinical development. While one early dose-finding study was Phase 2, three later-stage trials are Phase 3 and have been completed. The drug is investigational and has not been approved by regulatory authorities.
Gadoquatrane has completed four clinical trials. NCT04307186 was a Phase 2 dose-finding study in adults with CNS pathology. NCT05915026 was a Phase 3 pediatric study. NCT05915702 and NCT05915728 were Phase 3 comparator trials in adults with CNS and non-CNS conditions, respectively.
Gadoquatrane is a gadolinium-based contrast agent. It contains gadolinium, a paramagnetic metal that enhances MRI signal by altering the relaxation times of nearby water protons, improving the visibility of lesions and vascular structures during magnetic resonance imaging.
Gadoquatrane is a distinct investigational contrast agent, not the same as already available GBCAs. Clinical trials compare it against an existing contrast agent to evaluate its efficacy and safety for MRI in various patient populations, including children and adults.