Approval Probability
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ADASUVE · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ADASUVE® | EXPERIMENTAL | oral inhalation using a single-use, hand-held, inhaler; dosage determined by the investigator according the participants weight |
| Name | Type | Description |
|---|---|---|
| ADASUVE® | DRUG | ADASUVE® 2.5, 5, or 10 mg |
Inclusion 1. Written informed consent is obtained from each patient's parent or legal guardian and written assent is obtained from each patient. 2. The patient is a boy or girl 10 through 17 years of age. 3. The patient is within the 2.5 to 97.5 percentile for body mass index (BMI) on the basis of ...
ADASUVE is an investigational small molecule being studied for use in bipolar disorder. It is being evaluated in children and adolescents aged 10 through 17 years with any condition warranting chronic use of an antipsychotic medication, including bipolar disorder. The drug is in Phase 1 clinical development and is not yet approved.
ADASUVE is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of ADASUVE in pediatric patients with conditions such as bipolar disorder.
ADASUVE is in Phase 1 clinical development. A Phase 1 study has been completed to assess the safety and pharmacokinetics of ADASUVE at doses of 2.5, 5, or 10 mg in children and adolescents aged 10 through 17 years. The drug remains investigational and has not been approved.
ADASUVE has one completed clinical trial, NCT02184767, which assessed the safety and pharmacokinetics of ADASUVE at doses of 2.5, 5, or 10 mg in children and adolescents aged 10 through 17 years with conditions warranting chronic antipsychotic use, including bipolar disorder. The study enrolled 30 participants in the United States.
ADASUVE is a small molecule being developed for psychiatric conditions. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not described here. The drug is being studied for its safety and pharmacokinetics in pediatric patients.