NDARECTALGEL3 Generics Approved
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
7
Data completeness
3/8 — Basic
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIASTAT (diazepam) is a benzodiazepine rectal gel approved in 1997 for the acute treatment of seizures and epilepsy management. It works by enhancing GABA's inhibitory effects on CNS neurons, reducing excessive depolarization that triggers seizure activity. The rectal route enables rapid, non-invasive administration in emergency settings where IV access is unavailable.
LOE Approaching
Product is in LOE phase with 60% competitive pressure, indicating team contraction and focus on managed decline rather than growth initiatives.
Mechanism of Action
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
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
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Started Jan 2018
149 enrolled
Epilepsy
Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán
Started Nov 2017
2 enrolled
Alcohol Withdrawal Delirium
Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy
Started Aug 2017
24 enrolled
Epilepsy
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Started Feb 2011
24 enrolled
Epilepsy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.