Wednesday, July 8, 2026

Drug profile · INN

diazepam

diazepam (ANTENEX 2) is a gaba-a receptor; anion channel positive allosteric modulator. Associated with Orion Laboratories Pty.. Route of administration: buccal. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 5
Pipeline programs 4
News articles 0
Drug details — diazepam
US status
approved
Class
Route
BUCCAL
Patents
5
Programs
4
Data quality
0.89

Quick answer

diazepam (ANTENEX 2) is a gaba-a receptor; anion channel positive allosteric modulator. Associated with Orion Laboratories Pty.. Route of administration: buccal. Current US regulatory status: approved.

Key facts

INN diazepam
Brand ANTENEX 2
Mechanism GABA-A receptor; anion channel positive allosteric modulator
Target GABA-A receptor; anion channel
Route BUCCAL
Formulation FILM

Mechanism of action

GABA-A receptor; anion channel positive allosteric modulator

Primary target: GABA-A receptor; anion channel

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. 42-1703 Phase 3 · Aquestive Therapeutics · Epilepsy
  2. diazepam Phase 3 · Ultragenyx UK · Status Epilepticus
  3. Diazepam Buccal Film Phase 2 · Aquestive Therapeutics · Epilepsy
  4. Diazepam Buccal Film 12.5 mg Phase 2 · Aquestive Therapeutics · Epilepsy

Related & competitor drugs

  1. acamprosate calcium GABA-A receptor; anion channel positive modulator
  2. alprazolam GABA-A receptor; anion channel positive allosteric modulator
  3. butabarbital sodium GABA-A receptor; anion channel positive allosteric modulator
  4. chlordiazepoxide hydrochloride GABA-A receptor; anion channel positive allosteric modulator
  5. clobazam GABA-A receptor; anion channel positive allosteric modulator
  6. clonazepam GABA-A receptor; anion channel positive allosteric modulator
  1. US 11273131

    Pharmaceutical compositions with enhanced permeation

    Expires Mon Mar 10 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11129799

    Dual lane coating

    Expires Mon Sep 23 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10947033

    Reduction in stress cracking of films

    Expires Mon Mar 11 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10464739

    Reduction in stress cracking of films

    Expires Mon Oct 31 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10034833

    Sublingual and buccal film compositions

    Expires Mon Jul 26 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is diazepam?

diazepam (ANTENEX 2) is a gaba-a receptor; anion channel positive allosteric modulator. Associated with Orion Laboratories Pty.. Route of administration: buccal. Current US regulatory status: approved.

What is the brand name for diazepam?

ANTENEX 2 is a marketed brand name for diazepam. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of diazepam?

diazepam has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.