Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zaleplon · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Zaleplon | EXPERIMENTAL | Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period |
| Sonata® | ACTIVE_COMPARATOR | Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Zaleplon 10 mg Capsules | DRUG | 1 x 10 mg |
| SONATA® 10 mg capsules | DRUG | 1 x 10 mg |
Inclusion Criteria: * non-smokers * at least 18 years of age * subjects will have a BMI (body mass index) of 30 or less Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption(past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or car...
Zaleplon is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this asset is undisclosed, and it falls within the broader therapeutic area classified as Other.
Zaleplon acts as a positive allosteric modulator targeting the GABRA1, GABRG2, and GABRB1 receptors. By binding to these sites, it modulates the activity of the GABA-A receptor complex. This mechanism is characteristic of compounds designed to influence inhibitory neurotransmission in the central nervous system.
Zaleplon is developed by Teva Pharmaceutical Industries Limited. The company is publicly traded under the ticker symbol TEVA. Teva is responsible for the clinical development of this small molecule asset, which is currently in Phase 1 testing.
Zaleplon is in Phase 1 clinical development. It has completed two Phase 1 trials with a total enrollment of 82 participants. The trials were randomized and active-controlled, though they were not double-blind. No active trials are currently listed for this drug.
Zaleplon has been evaluated in two completed Phase 1 trials. NCT00829998 studied Zaleplon 10 mg capsules under fasting conditions with 40 healthy volunteers. NCT00829868 studied the same capsules under non-fasting conditions with 42 healthy volunteers. Both trials were conducted in the United States.