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BAY1747846 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Mild renal impairment | EXPERIMENTAL | Participants with mild renal impairment will receive a single dose of BAY1747846. |
| Moderate renal impairment | EXPERIMENTAL | Participants with moderate renal impairment will receive a single dose of BAY1747846. |
| Normal renal function | EXPERIMENTAL | Participants with normal renal function will receive a single dose of BAY1747846. |
| Dose escalation of BAY1747846 | EXPERIMENTAL | - |
| Matching Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BAY1747846 | DRUG | Solution for intravenous (IV) injection, single dose |
| Matching placebo | DRUG | Single dose; IV injection. |
Inclusion Criteria: * Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent * Renally Impaired Participants and Disease Characteristics * Mildly or moderately decreased renal function, as assessed by estimated glomerular filtration rate (eGFR). Mildly i...
BAY1747846 is an investigational small molecule being developed for contrast enhancement in magnetic resonance imaging (MRI). It is a gadolinium-based contrast agent (GBCA) given as an injection into the vein. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BAY1747846 is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers and participants with varying kidney function.
BAY1747846 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 49 participants enrolled. The drug is investigational and remains in early-stage clinical testing; it has not received FDA approval or any other regulatory approval.
BAY1747846 has two completed Phase 1 trials. NCT05061979 evaluated the drug's pharmacokinetics and safety in participants with normal and impaired renal function in the United States, enrolling 24 participants. NCT06125366 assessed safety and drug levels after increasing single doses in 25 healthy Japanese male participants.
BAY1747846 is a gadolinium-based contrast agent (GBCA) that enhances contrast in magnetic resonance imaging. Gadolinium-based agents work by altering the magnetic properties of water in tissues, improving the visibility of structures or abnormalities during an MRI scan. The drug is administered as an intravenous injection.
No, BAY1747846 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. Two Phase 1 studies have been completed to evaluate its safety, tolerability, and pharmacokinetics, but the drug has not yet progressed through the later stages of clinical development required for regulatory approval.