Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Asenapine · 1 trial · 1 indication
The area under plasma concentration versus time curve, over the steady state dosing interval, calculated using linear trapezoidal method.
Maximum measured plasma concentration over the steady state doing interval
| Arm | Type | Description |
|---|---|---|
| Asenapine Sublingual Tablets | EXPERIMENTAL | Asenapine Sublingual Tablets, 10 mg. Twice daily for a period of 7 days |
| Saphris Subligual Tablets | ACTIVE_COMPARATOR | Asenapine Sublingual Tablets, 10 mg. Twice daily for 2 periods of 7 days each. |
| Name | Type | Description |
|---|---|---|
| Asenapine Sublingual Tablets 10 mg | DRUG | White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side |
Inclusion Criteria: * Adult patients of either sex with age between 18 to 65 years (both inclusive) and have been taking a stable dose of asenapine maleate sublingual tablet, EQ 10 mg base twice daily therapy for at least three months. * Willing and able to comply with study visit schedule and othe...
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Asenapine is an investigational small molecule being studied for the treatment of schizophrenia. It is being developed by Amneal Pharmaceuticals, Inc. under the ticker AMRX. The program is in Phase 2 clinical development, and the single completed trial enrolled patients with schizophrenia.
Asenapine targets DRD2 and HTR2A, acting as an antagonist at both receptors. DRD2 is the dopamine D2 receptor and HTR2A is the serotonin 5-HT2A receptor. This dual antagonism is the basis for its investigation in schizophrenia.
Amneal Pharmaceuticals, Inc. is developing asenapine. The company trades under the ticker AMRX. Amneal is the sponsor of the asenapine program, which is currently in Phase 2 development for schizophrenia.
Asenapine is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for the studied indication. The program includes one completed Phase 2 trial, with no active trials currently listed.
Asenapine has been studied in one completed Phase 2 trial, NCT02072954, titled Bioequivalence Fasting Study in Patients. The trial enrolled 48 patients with schizophrenia in India, used an active-controlled, randomized design, and included adults 18 years and older of all sexes.