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BAY2395840 · 3 trials · 6 indications
NRS is an one-item assessment of average neuropathic pain intensity which is presented as an 11-point Likert scale with 0 as "no pain" and 10 as "worst imaginable pain".
| Arm | Type | Description |
|---|---|---|
| Group 1 (BAY2395840 - placebo) | EXPERIMENTAL | Participants will be randomly assigned to treatment regimen of double-blind BAY2395840, and after an interim single blind period for washout will switch to double-blind placebo. |
| Group 2 (Placebo - BAY2395840) | EXPERIMENTAL | Participants will start with a treatment regimen of double-blind placebo, and after an interim single blind period for washout will switch to double-blind BAY2395840. |
| Dose step 1 | EXPERIMENTAL | Each participant will receive an single dose (SD) of dose 1 of BAY2395840 or matching placebo. |
| Dose step 2 | EXPERIMENTAL | Each participant will receive an single dose (SD) of dose 2 of BAY2395840 or matching placebo. |
| Dose step 3 | EXPERIMENTAL | Each participant will receive an single dose (SD) of dose 3 of BAY2395840 or matching placebo. |
| Dose step 4 | EXPERIMENTAL | Each participant will receive multiple doses (MDs) of dose 3 of BAY2395840 or matching placebo. |
| Group 1 | EXPERIMENTAL | Participants received BAY2395840 dose A as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with the same BAY2395840 dose A1 as oral solution under diet 1 conditions (Period 2) |
| Group 2 | EXPERIMENTAL | Participants received BAY2395840 dose C as tablets under diet 1 conditions. |
| Group 3 | EXPERIMENTAL | Participants received BAY2395840 dose E as tablets under diet 1 conditions. |
| Group 4 | EXPERIMENTAL | Participants received BAY2395840 dose H as tablets under diet 1 conditions |
| Group 5 | EXPERIMENTAL | Participants received BAY2395840 dose B as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Group 6 | EXPERIMENTAL | Participants received BAY2395840 dose C as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Group 7 | EXPERIMENTAL | Participants received BAY2395840 dose I as tablets under diet 1 conditions |
| Group 8 | EXPERIMENTAL | Participants received BAY2395840 dose G as tablets on Day 1, followed by 3 BAY395840 doses of dose F as tablets on Days 2 to 4 and subsequently 7 further BAY395840 doses of dose G as tablets on Days 5 to 11 under diet 1 conditions |
| Placebo matching Group 1 | PLACEBO_COMPARATOR | Participants received a dose of placebo as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with a single dose of placebo as oral solution under under diet 1 conditions (Period 2) |
| Placebo matching Group 2 to 4 and Group 7 | PLACEBO_COMPARATOR | Participants received a dose of Placebo as tablets under diet 1 conditions |
| Placebo matching Group 5 and 6 | PLACEBO_COMPARATOR | Participants received Placebo as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Placebo matching Group 8 | PLACEBO_COMPARATOR | Participants received a dose of Placebo as tablets on Day 1, followed by 3 doses of Placebo as tablets on Days 2 to 4 and subsequently 7 further doses of Placebo as tablets on Days 5 to 11 under diet 1 conditions. |
| Name | Type | Description |
|---|---|---|
| BAY2395840 | DRUG | Tablet, intake orally. |
| Placebo for BAY2395840 | DRUG | Tablet, intake orally. |
| BAY2395840 tablet | DRUG | tablets, oral administration |
| BAY2395840 oral solution | DRUG | solution, oral administration |
| Placebo oral solution | DRUG | Placebo matching BAY2395840, oral administration |
| Placebo tablet | DRUG | Placebo matching BAY2395840, oral administration |
Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent. * Have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM). * Have painful distal symmetrical sensorimotor diabetic neuropathy for at least 6 months prior to the screening and confirmed at screen...
BAY2395840 is an investigational small molecule being studied for neuropathic pain associated with diabetic peripheral neuropathy, diabetic neuropathic pain, and endometriosis. It is being developed by Bayer AG and is currently in clinical development, with trials having reached Phase 2.
BAY2395840 is a small molecule being developed by Bayer AG for pain-related conditions. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for neuropathic pain associated with diabetic peripheral neuropathy, diabetic neuropathic pain, and endometriosis.
BAY2395840 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is an investigational small molecule currently in clinical trials for pain-related indications.
BAY2395840 is in Phase 1 and Phase 2 clinical development. One Phase 2 trial has been completed, along with two Phase 1 trials. The drug is investigational and has not been approved by regulatory authorities. It is being studied for diabetic neuropathic pain and endometriosis.
BAY2395840 has been studied in three completed clinical trials. NCT05219812 was a Phase 2 study in participants with diabetic nerve pain. NCT05517746 was a Phase 1 study in healthy male participants. NCT05563454 was a Phase 1 study in Japanese healthy male participants.
BAY2395840 is the same drug as BAY 2395840, with the name written without spaces. It is an investigational small molecule being developed by Bayer AG for pain-related conditions, including diabetic neuropathic pain and endometriosis. The drug is currently in clinical development.