Approval Probability
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Fulacimstat · 3 trials · 3 indications
The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment
AUC(0-tlast) will be used if mean AUC(tlast ∞) \>20% of AUC)
AUC (0-tlast) u will be used if mean AUC (tlast ∞) \>20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.
An additional blood sample for fu will be collected at 2 hours after dosing.
| Arm | Type | Description |
|---|---|---|
| Fulacimstat (BAY1142524) | EXPERIMENTAL | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
| Placebo | PLACEBO_COMPARATOR | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
| Normal (healthy subjects) | EXPERIMENTAL | Healthy subjects matched for age, body weight and gender to the groups with renal impairment |
| Mildly renal impaired | EXPERIMENTAL | Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m\*2 |
| Moderately renal impaired | EXPERIMENTAL | Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m\*2 |
| Severely renal impaired | EXPERIMENTAL | Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m\*2 |
| Name | Type | Description |
|---|---|---|
| Fulacimstat (BAY1142524) | DRUG | 25 mg BAY1142524 are given twice daily over a treatment period of 6 months |
| Placebo | DRUG | Matching placebo tablets are given twice daily over a treatment period of 6 months |
Inclusion Criteria: * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximu...
Fulacimstat is an investigational small molecule being studied for diabetic kidney disease and for patients after acute myocardial infarction with left-ventricular dysfunction. It has also been evaluated in a renal impairment study. Fulacimstat is in clinical development and is not approved by the FDA.
Fulacimstat is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials of Fulacimstat in multiple countries including Germany, Israel, Italy, and Spain.
Fulacimstat has completed Phase 1 and Phase 2 clinical trials. The most advanced completed study was a Phase 2 trial in patients with diabetic kidney disease. Fulacimstat remains an investigational drug and has not received FDA approval.
Fulacimstat has been studied in three completed clinical trials. NCT02976467 was a Phase 2 study in myocardial infarction patients, NCT03402438 was a Phase 1 renal impairment study, and NCT03412006 was a Phase 2 study in diabetic kidney disease patients. All trials have been completed.
Yes, Fulacimstat is also known as BAY 1142524. Clinical trial records for Fulacimstat, including NCT02976467 and NCT03412006, refer to the drug as BAY 1142524. Both names refer to the same investigational compound being developed by Bayer.