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...
Asenapine is a small molecule being developed for the treatment of schizophrenia. It is currently in Phase 2 clinical development, with a completed bioequivalence study in patients with schizophrenia. The drug is being developed by Amneal Pharmaceuticals, Inc.
Asenapine is being developed by Amneal Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker AMRX. The drug is intended for use in schizophrenia and is currently in Phase 2 clinical development.
Asenapine is in Phase 2 clinical development for schizophrenia. A Phase 2 bioequivalence study, NCT02072954, has been completed. The study enrolled 48 patients and was conducted in India. The drug remains investigational and is not yet approved.
Asenapine has one completed clinical trial, NCT02072954, titled 'Bioequivalence Fasting Study in Patients.' This Phase 2 study enrolled 48 patients with schizophrenia in India. The trial was active-controlled and randomized, though it was not double-blind.
Asenapine is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for schizophrenia. A completed bioequivalence study, NCT02072954, has been conducted, but the drug has not yet received regulatory approval.