Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Gadoquatrane (BAY1747846)
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 was assessed by blinded independent central review (BICR) readers using separate blinded evaluations of unenhanced MRI image sets and combined pre- and post-contrast gadoquatrane MRI image sets. Contrast enhancement was rated on a 4-point scale (1 = not enhanced; 2 = weakly enhanced; 3 = clearly enhanced; 4 = clearly and brightly enhanced), and mean scores with standard deviation are reported.
Delineation was assessed by blinded independent central review (BICR) readers using separate blinded evaluations of unenhanced MRI image sets and combined pre- and post-contrast gadoquatrane MRI image sets. Delineation was rated on a 4-point scale (1 = no or unclear delineation; 2 = moderate delineation, with some aspects visible; 3 = good delineation, almost clear but not complete; 4 = excellent delineation, clear and complete), and mean scores with standard deviation are reported.
Morphology was assessed by blinded independent central review (BICR) readers using separate blinded evaluations of unenhanced MRI image sets and combined pre- and post-contrast gadoquatrane MRI image sets. Morphology was rated on a 3-point scale (1 = poor: no or poorly evaluable; 2 = moderate: partially evaluable; 3 = good: sufficiently evaluable), and mean scores with standard deviation are reported.
Contrast Enhancement was 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 was 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 was 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 being developed for contrast enhancement in magnetic resonance imaging (MRI). It is intended to help visualize known or suspected pathology in the central nervous system, such as brain or spinal cord conditions, as well as non-central nervous system pathology elsewhere in the body.
Gadoquatrane is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the agent as a contrast medium for magnetic resonance imaging.
Gadoquatrane is in Phase 2 development according to the drug's overall profile, though the clinical program includes completed Phase 3 trials. It is an investigational agent and has not been approved by the FDA. The completed studies enrolled a total of 836 participants across adult and pediatric populations.
Gadoquatrane has been studied in completed trials including NCT05915728, which evaluated contrast enhancement for non-central nervous system pathology in 410 adults, NCT05915702, which assessed brain or spinal cord-related pathology in 321 adults, NCT05915026, a pediatric study in 105 children from birth to under 18 years, and NCT04307186, a Phase 2 dose-finding study in 57 adults with central nervous system pathology.
Yes, Gadoquatrane is also known as BAY1747846. BAY1747846 is the internal Bayer development code for the same investigational gadolinium-based contrast agent. Both names refer to the identical molecule being studied for contrast enhancement in magnetic resonance imaging.