NDAORALTABLET
Approved
Nov 1963
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
VALIUM (diazepam) by Viatris is mechanism of action although the precise mechanism by which diazepam exerts its antiseizure effects is unknown, animal and in vitro studies suggest that diazepam acts to suppress seizures through an interaction with γ-aminobutyric acid (gaba) receptors of the a-type (gaba a ). First approved in 1963.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Valium (diazepam) is an oral benzodiazepine small molecule approved in 1963 that treats seizures, anxiety, and muscle spasms by enhancing GABA-A receptor activity in the CNS. It works by increasing chloride ion influx into neurons, which suppresses excessive depolarization and prevents seizure generation and spread. Diazepam is one of the most widely recognized and longest-standing benzodiazepines in clinical use.
$0.279MPart D
LOE ApproachingMinimal Medicare Part D activity suggests niche positioning or formulary restrictions; LOE-approaching status indicates defensive commercial strategy with smaller team footprint.
Mechanism of Action
Mechanism of Action Although the precise mechanism by which diazepam exerts its antiseizure effects is unknown, animal and in vitro studies suggest that diazepam acts to suppress seizures through an interaction with γ-aminobutyric acid (GABA) receptors of the A-type (GABA A ). GABA, the major…
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.