Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

midazolam

PFIZER AUSTRALIA PTY LTD

midazolam (PFIZER AUSTRALIA PTY LTD) is a gaba-a receptor; anion channel positive allosteric modulator. Associated with Pfizer Australia Pty Ltd. Route of administration: nasal. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Nervous system (N05) N05CD08
US status approved
Patents linked 20
Pipeline programs 37
News articles 0
Drug details — midazolam
US status
approved
Class
Nervous system (N05)
Route
NASAL
Patents
20
Programs
37
Data quality
0.84
← All drugs Manufacturer profile Related patents Pipeline programs Drug news hub Event calendar

Quick answer

midazolam (PFIZER AUSTRALIA PTY LTD) is a gaba-a receptor; anion channel positive allosteric modulator. Associated with Pfizer Australia Pty Ltd. Route of administration: nasal. Current US regulatory status: approved.

Key facts

INN midazolam
Brand PFIZER AUSTRALIA PTY LTD
Mechanism GABA-A receptor; anion channel positive allosteric modulator
Target GABA-A receptor; anion channel
Therapeutic class Nervous system (N05)
Route NASAL
Formulation SPRAY
ATC code N05CD08
Originator Pfizer Australia Pty Ltd

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 —
EMA approved —
TGA approved —
NMPA clinical trials —

Pipeline programs

Search pipeline Sponsor programs
  1. 54135419SUI3003 Phase 3 · Janssen-Cilag International N.V · Major Depressive Disorder
  2. APHP230813 Phase 3 · PARItec · Very preterm neonate (gestational age at birth < 32 WG) with
  3. APHP230844 Phase 3 · PARItec · Adult patients with severe cardiogenic shock on venoarterial
  4. HSK3486-309 Phase 3 · Anaxis Pharma · General anaesthesia
  5. PEDIADEX Phase 3 · Tour Hekla · Impact on delirium of the use of DEXmedetomidine as first-l
  6. 3124001 Phase 2 · Orion Laboratories Pty · Metastatic castration-resistant prostate cancer.
  7. 42756493BLC2001 Phase 2 · Janssen-Cilag International N.V · Urothelial cancer
  8. Midazolam Phase 2 · United Therapeutics Europe · Stress Disorders, Post-Traumatic

Related & competitor drugs

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  3. aripiprazole Nervous system (N05)
  4. brexpiprazole Nervous system (N05)
  5. brivaracetam Nervous system (N03)
  6. bupivacaine Nervous system (N01)

Related patents

Browse patents Pfizer Australia Pty Ltd patent hub

  1. WO 2026015039

    THÉRAPIE GÉNIQUE POUR LE TRAITEMENT DE L'ENCÉPHALOPATHIE ÉPILEPTIQUE ASSOCIÉE À LA SYNGAP1

    Expires Wed Jan 10 2046 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. WO 2025211975

    AGONISTES DU RÉCEPTEUR DE L'OREXINE

    Expires Wed Oct 04 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 12403137

    Compounds and methods of use

    Expires Mon Aug 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 12304907

    Compounds and methods of use

    Expires Mon May 15 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 12264154

    Compounds and methods of use

    Expires Mon Mar 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 11999727

    Compounds and methods of use

    Expires Mon May 30 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 11986471

    Compounds and methods of use

    Expires Mon May 16 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 11492350

    Compounds and methods of use

    Expires Mon Nov 03 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 11077101

    Compounds and methods of use

    Expires Mon Jul 29 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 10519191

    Bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Dec 26 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 10323061

    Heteroaryl containing bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Jun 13 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. US 10266560

    Bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Apr 18 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. US 10246483

    Bile acid analogs as FXR/TGR5 agonists and methods of use thereof

    Expires Mon Mar 28 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  14. US 9669095

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Jun 01 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  15. US 9616099

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Apr 06 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  16. US 9603895

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Mar 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  17. US 9221878

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Dec 24 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  18. US 9156886

    Cyclosporin analogues for preventing or treating hepatitis C infection

    Expires Mon Oct 08 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  19. CA 2919844

    COMPOSES D'UREE ET LEUR UTILISATION COMME INHIBITEURS DE L'ENZYME FAAH

    Expires Wed Jan 31 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  20. CA 2908706

    TRAITEMENTS UTILISANT L'ESLICARBAZEPINE ET L'ACETATE D'ESLICARBAZEPINE

    Expires Wed Oct 04 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is midazolam?

midazolam (PFIZER AUSTRALIA PTY LTD) is a gaba-a receptor; anion channel positive allosteric modulator. Associated with Pfizer Australia Pty Ltd. Route of administration: nasal. Current US regulatory status: approved.

What is the brand name for midazolam?

PFIZER AUSTRALIA PTY LTD is a marketed brand name for midazolam. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of midazolam?

midazolam 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.

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