Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2940094 · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| LY2940094 | EXPERIMENTAL | 40 mg LY2940094 oral tablet, QD for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Identically matched placebo oral tablet, QD for 8 weeks |
| Cohort 1: 40 milligram (mg) LY2940094 | EXPERIMENTAL | 40 mg LY2940094 was administered orally, one time only (it was originally expected that 100 mg LY2940094 would be administered). If the receptor occupancy (RO) for a given dose is lower than 50%, (time to maximum concentration \[tmax\] or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. |
| Cohort 2: 10 mg LY2940094 | EXPERIMENTAL | The dose levels for subjects in Cohort 2 will be defined based on the results of the receptor occupancy (RO) data of previous cohort and the ongoing review of safety data. This dose was determined to be 10 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. |
| Cohort 3: 4 mg LY2940094 | EXPERIMENTAL | The dose levels for subjects in Cohort 3 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 4 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. |
| Cohort 4: 20 mg LY2940094 | EXPERIMENTAL | The dose levels for subjects in Cohort 4 will be defined based on the results of the receptor occupancy (RO) data of previous cohort(s) and the ongoing review of safety data. This dose was determined to be 20 mg, and was administered orally, one time only. If the RO for a given dose is lower than 50%, (tmax or an optimal time window) then a higher dose will be administered to the next cohort whereas if the RO for a given dose is higher than 50%, then a lower dose will be administered to the next cohorts. |
| LY2940094 - single dose | EXPERIMENTAL | Single oral dose of 2-800 milligram (mg) LY2940094 |
| LY2940094 - multiple dose | EXPERIMENTAL | Daily oral dose of 2-200 mg LY2940094 for 14 days |
| Name | Type | Description |
|---|---|---|
| LY2940094 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Present with alcohol dependence (AD) defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR 303.9) * Must have 3 to 6 heavy drinking days per week as assessed by the Timeline Follow Back (TLFB) scale at screening and base...
LY2940094 is an investigational small molecule developed by Neumora Therapeutics, Inc. (ticker NMRA) for psychiatric conditions. It has been studied in clinical trials for alcoholism, depression, and major depressive disorder. The drug is in Phase 2 development and has not been approved by the FDA.
LY2940094 has been studied for the treatment of alcoholism and major depressive disorder. Clinical trials have evaluated it in participants with alcohol dependency and in participants with major depressive disorder. It remains an investigational therapy and is not approved for any indication.
LY2940094 targets OPRL1, the nociceptin/orphanin FQ peptide receptor. It acts as an antagonist at this receptor, meaning it blocks receptor activity. This target class places it among compounds designed to modulate the nociceptin system in psychiatric research.
Neumora Therapeutics, Inc., which trades under the ticker NMRA, is developing LY2940094. The company is advancing the compound as an investigational small molecule in psychiatry, with completed Phase 2 trials in alcoholism and major depressive disorder.
LY2940094 is in Phase 2 development. Two completed Phase 2 trials have evaluated it in alcoholism and major depressive disorder, and two completed Phase 1 trials have also been conducted. The drug is investigational and has not received FDA approval.
Completed trials of LY2940094 include NCT01798303 in alcohol dependency, NCT01724112 in major depressive disorder, NCT01404091 in healthy subjects, and NCT01263236 in major depressive disorder. These studies were randomized, double-blind, and placebo-controlled where applicable, with total enrollment of 202 participants across the Phase 2 trials.