Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication REMERON/REMERONSolTab are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . REMERON/REMERONSolTab is indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 ) FDA label
Mirtazapine · 2 trials · 1 indication
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Mirtazapine 15 mg (Orally Disintegrating) Tablets | DRUG | 1 x 15 mg, single-dose non-fasting |
| REMERON SolTab® 15 mg Orally Disintegrating Tablets | DRUG | 1 x 15 mg, single-dose non-fasting |
Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30. * Screening Procedures: Each subject will complete the screening pr...
Mirtazapine is a small molecule drug developed by Teva Pharmaceutical Industries Limited (ticker TEVA). It is being studied as mirtazapine 15 mg orally disintegrating tablets. The clinical program is in Phase 1, and the specific therapeutic indication has not been disclosed. It is an investigational product in clinical development.
Mirtazapine targets HTR2A, HTR2C, ADRA2A, ADRA2C, and ADRA2B. It acts as an antagonist at these receptors. The target class is antagonist, covering serotonin 5-HT2 receptor subtypes and alpha-2 adrenergic receptor subtypes. This receptor binding profile defines its pharmacological activity in the studies conducted to date.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of mirtazapine 15 mg orally disintegrating tablets. Teva is the company sponsoring the clinical development program for this formulation. The drug is a small molecule candidate being advanced by Teva.
Mirtazapine is in Phase 1 clinical development. Both trials in the program are Phase 1 studies, and both have been completed. There are no active trials at this time. The program is investigational and has not been approved by the FDA for any indication based on the development stage reported.
Two completed Phase 1 trials have evaluated mirtazapine 15 mg orally disintegrating tablets. NCT00835575 studied the fasting condition, and NCT00834197 studied the non-fasting condition. Each trial enrolled 32 healthy volunteers in the United States, for a total enrollment of 64 participants. Both were randomized and active controlled.