TheraRadar
Data updated: Nov 8, 2026

LIBERVANT (diazepam) · AQUESTIVE

CNS

LIBERVANT is FDA-approved to treat 7 conditions (same as DIASTAT ACUDIAL).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Details

Status
None (Tentative Approval)
First Approved
N/A
Routes
BUCCAL
Dosage Forms
FILM

Companies

AQUESTIVE
Active Ingredient: DIAZEPAM

LIBERVANT Approval History

No approval records found

What LIBERVANT Treats

7 indications

LIBERVANT is approved for 7 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anxiety Disorder
  • Alcohol Withdrawal
  • Muscle Spasm
  • Spasticity
  • Athetosis
  • Stiff-Man Syndrome
  • Seizures

Same approved indications as DIASTAT ACUDIAL (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

18 trials
Trial Sponsor ID Phase Status Title
NCT03818932 results posted 123192 Ph 2, Ph 3 completed Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
NCT07020988 UP0127 Ph 1 completed A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants
NCT05361447 21-007195 Ph 1, Ph 2 withdrawn Diazepam Trial in GAD65 Associated Epilepsy
NCT06103188 results posted M001 Ph 3 completed Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively
NCT01938092 results posted 1208827 Ph 2 completed Vaginal Diazepam for the Treatment of Female Pelvic Pain
NCT03818919 results posted 123191 Ph 2 completed Nonopioid Analgesia After Rotator Cuff Repair
NCT02904265 results posted 16-002442 Ph 2, Ph 3 terminated Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome
NCT01364558 results posted 1012M93599 Ph 1 completed A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
NCT02494180 results posted KW/FR-15-021(83-22) Ph 4 completed A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
NCT03825809 1231914 Ph 2, Ph 3 recruiting Nonopioid Analgesia After Labral Surgery
NCT02646124 results posted 2015-4639 Ph 2, Ph 3 completed Diazepam Use With Standard Management for Acute Low Back Pain
NCT02374567 GAP GAP-2014 Ph 3 terminated Pharmacovigilance in Gerontopsychiatric Patients
NCT01417078 results posted DZNS-ARS-103 Ph 2 completed A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
NCT02935972 Diazepam and TRUS Biopsy Ph 2, Ph 3 completed Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy
NCT01438749 BP25259 Ph 1 completed A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users
NCT01675648 Lofex00428 Ph 4 completed Lofexidine for Inpatient Opiate Detox in Singapore
NCT01939093 MAP NRCT-53069 Ph 4 completed Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
NCT01318369 Delta-pain HEEL-2011-01 Ph 2 completed Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LIBERVANT FDA Label Details

Indications & Usage

LIBERVANT is FDA-approved to treat 7 conditions — same approved indications as DIASTAT ACUDIAL.

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Data Sources

FDA Approval: NDA212641 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.