ALPRAZOLAM

Post-LOE

alprazolam

ANDAORALTABLET
Approved
Mar 1998
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

1,4 benzodiazepine. Alprazolam exerts its effect for the acute treatment of generalized anxiety disorder and panic disorder through binding to the benzodiazepine site of gamma-aminobutyric acid-A (GABA A ) receptors in the brain and enhances GABA-mediated synaptic inhibition.

Pharmacologic Class:

Benzodiazepine

Clinical Trials (5)

NCT07020988Phase 1Completed

A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants

Started Jun 2025
55 enrolled
Healthy Participants
NCT05626439Phase 1Completed

A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants

Started Dec 2022
21 enrolled
Healthy Participants
NCT05076617Phase 3Enrolling By Invitation

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Started Feb 2022
300 enrolled
Stereotypical Prolonged Seizures
NCT05077904Phase 3Recruiting

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Started Dec 2021
350 enrolled
Stereotypical Prolonged Seizures
NCT04857307Phase 1Completed

A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy

Started Apr 2021
14 enrolled
Epilepsy