Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1193397 · 1 trial · 1 indication
= resting CBV after study drug administration - resting CBV before study drug administration
= peak CBV after study drug administration - peak CBV before study drug administration
= time to peak CBV after study drug administration - time to peak CBV before study drug administration
= TcPO2 after study drug administration - TcPO2 before study drug administration
| Arm | Type | Description |
|---|---|---|
| BAY1193397/Placebo (sequence A-B-C) | EXPERIMENTAL | Subjects with type II diabetes who follow treatment sequence A-B-C. Single oral dose of a placebo tablet in the first intervention period (Treatment A); followed by single oral dose of 1 mg BAY1193397 (Treatment B); then single oral dose of 5 mg BAY1193397 IR tablet under fasted state in the third intervention period (Treatment C). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment. |
| BAY1193397/Placebo (sequence B-C-A) | EXPERIMENTAL | Subjects with type II diabetes who follow treatment sequence B-C-A. Single oral dose of 1 mg BAY1193397 in the first intervention period (Treatment B); followed by single oral dose of 5 mg BAY1193397 IR tablet under fasted state in the second intervention period (Treatment C), then single oral dose of a placebo tablet under fasted conditions in the third intervention period (Treatment A). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment. |
| BAY1193397/Placebo (sequence B-A-C) | EXPERIMENTAL | Subjects with type II diabetes who follow treatment sequence B-A-C. Single oral dose of 1 mg BAY1193397 in the first intervention period (Treatment B); followed by single oral dose of a placebo tablet in the second intervention period (Treatment A), then 5 mg BAY1193397 IR tablet under fasted conditions in the third intervention period (Treatment C). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment. |
| Name | Type | Description |
|---|---|---|
| BAY1193397 | DRUG | Single dose of 1 mg BAY1193397 given in the fasted state |
| Placebo | DRUG | Single dose of placebo given in the fasted state |
Inclusion Criteria: * The informed consent must be signed before any study specific tests or procedures are done (patient must be able to give informed consent, no legal representative allowed) * Patients with a diagnosis of type II diabetes mellitus and PAD (peripheral artery disease) and/or micro...
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BAY1193397 is an investigational small molecule being developed for diabetic foot. It is a Phase 2 drug candidate studied for its effects on skin capillary blood flow and transcutaneous oxygen pressure in patients with diabetic foot. The drug is not approved and remains in clinical development.
BAY1193397 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical research to evaluate the drug's potential in treating diabetic foot.
BAY1193397 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, controlled study. The drug is investigational and has not received regulatory approval for any indication.
BAY1193397 has one completed clinical trial registered as NCT03128320, titled "The Effects of BAY1193397 on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure." This Phase 2 study enrolled 23 participants with diabetic foot in the United Kingdom. The trial is completed, and no active trials are currently listed.
BAY1193397 is a small molecule being studied for its effects on skin capillary blood flow and transcutaneous oxygen pressure in patients with diabetic foot. The specific molecular target of BAY1193397 has not been disclosed, so its mechanism of action is not fully characterized in available information.