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midazolam

Trade name: versed

Small moleculeapproved

Approved

Dec 20, 1985

Midazolam, previously marketed under the trade name Versed, is a medication used for anesthesia, procedural sedation, trouble sleeping, and severe agitation. Midazolam is a short-acting benzodiazepine central nervous system (CNS) depressant. Pharmacodynamic properties of midazolam and its metabolites, which are similar to those of other benzodiazepines, include sedative, anxiolytic, amnesic and hypnotic activities. Benzodiazepine pharmacologic effects appear to result from reversible interactions with the γ-amino butyric acid (GABA) benzodiazepine receptor in the CNS, the major inhibitory neurotransmitter in the central nervous system. The action of midazolam is readily reversed by the benzodiazepine receptor antagonist, flumazenil. Data from published reports of studies in pediatric patients clearly demonstrate that oral midazolam provides safe and effective sedation and anxiolysis prior to surgical procedures that require anesthesia as well as before other procedures that require sedation but may not require anesthesia. The most commonly reported effective doses range from 0.25 to 1 mg/kg in children (6 months to <16 years). The single most commonly reported effective dose is 0.5 mg/kg. Time to onset of effect is most frequently reported as 10 to 20 minutes. The effects of midazolam on the CNS are dependent on the dose administered, the route of administration, and the presence or absence of other medications. — NCATS

Clinical trial activity

1,052 trials · 678 clinical orgs · 38 marketing orgs

Phase 1
418
Phase 2
173
Phase 3
109
Phase 4
248

Earliest trial started Jul 1, 1996 (NCT00004424)

Timeline

1980s

  1. Dec 20, 1985

    Roche — Earliest FDA Approval

  2. Dec 20, 1985

    Roche — NDA Organization

1990s

  1. Nov 8, 1999

    Teligent Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jun 20, 2000

    Fresenius — Marketing Organization

  3. Jun 20, 2000

    Boehringer Ingelheim — Marketing Organization

  4. Jun 20, 2000

    Hospira — Marketing Organization

  5. Jun 20, 2000

    West-Ward Pharmaceutical — Marketing Organization

  6. Jun 23, 2000

    Bedford Pharmaceuticals — Marketing Organization

  7. Jun 30, 2000

    Akorn, Inc. — Marketing Organization

  8. Jun 30, 2000

    Rising Pharmaceuticals — Marketing Organization

  9. Jun 30, 2000

    Epic Pharma Llc — Marketing Organization

  10. Oct 19, 2000

    Apothecon — Marketing Organization

  11. Oct 31, 2000

    Baxalta — Marketing Organization

  12. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  13. Mar 15, 2002

    Sun Pharmaceuticals — Marketing Organization

  14. Apr 30, 2002

    Hikma — Marketing Organization

  15. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  16. Sep 4, 2003

    Hi Tech Pharmaceuticals — Marketing Organization

  17. Jul 16, 2004

    International Medication — Marketing Organization

  18. Jan 26, 2005

    International medicated systems ltd. — Marketing Organization

  19. May 2, 2005

    Paddock Laboratories — Marketing Organization

  20. May 2, 2005

    Padagis Us — Marketing Organization

  21. Sep 9, 2005

    Apotex — Marketing Organization

  22. Sep 9, 2005

    Pharmaceutical Associates — Marketing Organization

  23. May 30, 2008

    Atlantide Pharmaceuticals — Marketing Organization

  24. May 30, 2008

    Wockhardt — Marketing Organization

  25. May 30, 2008

    PH HEALTH — Marketing Organization

2010s

  1. Nov 29, 2010

    Mylan — Marketing Organization

  2. Nov 29, 2010

    STERISCIENCE — Marketing Organization

  3. Nov 29, 2010

    ONESOURCE SPECIALTY — Marketing Organization

  4. May 4, 2011

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  5. Jan 25, 2012

    Gland Pharma Ltd — Marketing Organization

  6. Sep 14, 2018

    Meridien Medical Technologies, Inc. — NDA Secondary Org

  7. Sep 14, 2018

    MMT — Marketing Organization

  8. Sep 14, 2018

    MMT — NDA Secondary Org

  9. May 17, 2019

    UCB — Marketing Organization

  10. May 17, 2019

    UCB — NDA Secondary Org

2020s

  1. Mar 22, 2021

    Inforlife — Marketing Organization

  2. Mar 22, 2021

    Inforlife — NDA Secondary Org

  3. Jul 20, 2022

    Exela Pharma Sciences, LLC. — Marketing Organization

  4. Jul 20, 2022

    Exela Pharma Sciences, LLC. — NDA Secondary Org

  5. Aug 8, 2022

    Rafa Laboratories — Marketing Organization

  6. Aug 8, 2022

    Rafa Laboratories — NDA Secondary Org

  7. Nov 1, 2022

    Cipla — Marketing Organization

  8. Aug 21, 2023

    Micro Labs Ltd India — Marketing Organization

  9. May 1, 2025

    B. Braun — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 20, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CC1=NC=C2CN=C(C3=CC=CC=C3F)C4=CC(Cl)=CC=C4N12
Mol. weight
325.767 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • buccolam
  • buccolam
  • buccolam
  • buccolam
  • buccolam
  • buccolam
  • dormicum
  • dormicum
  • dormicum
  • dormicum
  • fentanyl / midazolam
  • hypnovel
  • hypnovel
  • mezolam
  • midalzolam
  • midazolam
  • midazolam
  • midazolam
  • midazolam
  • midazolam
  • midazolam
  • midazolam
  • midazolam
  • midazolam
  • midazolam hcl
  • midazolam hcl
  • midazolam hcl
  • midazolam hydrochloride
  • midazolam hydrochloride
  • midazolam hydrochloride
  • midazolam hydrochloride
  • midazolam maleate
  • midazolam maleate
  • midazolamum
  • midazolamum
  • midozalam hcl
  • ro-213981001
  • ro-213981001
  • ro-213981003
  • ro-213981003
  • ro-213981-003
  • ro-213981-003
  • rocam
  • rocam
  • versed
  • versed
  • versed
  • versed

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07262008Phase 3Feb 1, 2026Canadian Institutes of Health Research (CIHR), Unity Health Toronto, University of Toronto
NCT07300826Phase 4Jan 31, 2026Assiut University
NCT07289776Phase 1Jan 14, 2026Grunenthal
NCT07190612Phase 4Dec 31, 2025Ain Shams University
NCT07265128Phase 4Dec 31, 2025Yonsei University
NCT07267221Phase 1Dec 1, 2025Daewoong Pharmaceutical Co. LTD.
NCT07177235Phase 4Nov 30, 2025Thomas Jefferson University
NCT07227454Phase 3Nov 20, 2025—
NCT07260851Phase 1Nov 5, 2025Daewoong Pharmaceutical Co. LTD.
NCT07235748Phase 1Oct 7, 2025Servier
NCT07190430Phase 1Oct 3, 2025Pfizer
NCT07226635Phase 1Oct 3, 2025Sparrow Pharmaceuticals
NCT07198412N/AOct 1, 2025Benha University
NCT07113483Phase 3Oct 1, 2025Romanian Society for Enteral and Parenteral Nutrition
NCT07155265Phase 3Oct 1, 2025Yancheng First People's Hospital
NCT07184801Phase 3Oct 1, 2025Postgraduate Institute of Medical Education and Research
NCT07118215Phase 1Sep 29, 2025Bristol-Myers Squibb, Karuna Pharmaceuticals
NCT07149545N/ASep 15, 2025Capital Medical University
NCT07099014Phase 3Sep 15, 2025Assistance Publique - Hôpitaux de Paris
NCT07161297Phase 4Sep 1, 2025Humanitas University
Showing 20 of 1,052 trials
Page 1 / 53

Organizations

Research & Development (678)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit342952007
Boehringer IngelheimFor profit302922002
Eli LillyFor profit232312010
AstraZenecaFor profit191812007
Assiut UniversityAcademic/Hospital161652016
Cairo UniversityAcademic/Hospital151552017
Johnson and JohnsonFor profit151332004
GlaxoSmithKlineFor profit131122004
Yonsei UniversityAcademic/Hospital131322009
BayerFor profit111122011
Bristol-Myers SquibbFor profit11922008
Seoul National UniversityAcademic/Hospital111142008
Columbia UniversityAcademic/Hospital101042011
Jiao Tong UniversityAcademic/Hospital10832013
Icahn School of Medicine at Mount SinaiAcademic/Hospital9632008
Peking UniversityAcademic/Hospital9922014
RocheFor profit9712009
Yale UniversityAcademic/Hospital9842001
Capital Medical UniversityAcademic/Hospital8522014
NovartisFor profit8822006
678 organizations
Page 1 / 34

Marketing (50)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGJun 30, 2000
Akorn, Inc.For profitSYNSep 4, 2003
ApotexFor profitMKTGSep 9, 2005
ApotheconFor profitMKTGOct 19, 2000
Atlantide PharmaceuticalsFor profitMKTGMay 30, 2008
B. BraunFor profitMKTGMay 1, 2025
BaxaltaFor profitMKTGOct 31, 2000
Bedford PharmaceuticalsFor profitMKTGJun 23, 2000
Boehringer IngelheimFor profitMKTGJun 20, 2000
CiplaFor profitMKTGNov 1, 2022
Epic Pharma LlcFor profitMKTGJun 30, 2000
Exela Pharma Sciences, LLC.For profitMKTGJul 20, 2022
Exela Pharma Sciences, LLC.For profitNDA2Jul 20, 2022
FreseniusFor profitMKTGJun 20, 2000
Gland Pharma LtdFor profitMKTGJan 25, 2012
Gland Pharma LtdFor profitSYNAug 12, 2024
Hi Tech PharmaceuticalsFor profitMKTGSep 4, 2003
HikmaFor profitMKTGApr 30, 2002
HikmaFor profitMKTGApr 30, 2002
HospiraFor profitMKTGJun 20, 2000
HospiraFor profitSYNJun 20, 2000
InforlifeFor profitMKTGMar 22, 2021
InforlifeFor profitNDA2Mar 22, 2021
International MedicationFor profitMKTGJul 16, 2004
International medicated systems ltd.For profitMKTGJan 26, 2005
MMTFor profitMKTGSep 14, 2018
MMTFor profitNDA2Sep 14, 2018
Meridien Medical Technologies, Inc.For profitNDA2Sep 14, 2018
Micro Labs Ltd IndiaFor profitMKTGAug 21, 2023
MylanFor profitMKTGNov 29, 2010
ONESOURCE SPECIALTYFor profitMKTGNov 29, 2010
PH HEALTHFor profitMKTGMay 30, 2008
Padagis UsFor profitMKTGMay 2, 2005
Paddock LaboratoriesFor profitMKTGMay 2, 2005
Pharmaceutical AssociatesFor profitMKTGSep 9, 2005
Pharmaceutical AssociatesFor profitSYNSep 4, 2003
Rafa LaboratoriesFor profitMKTGAug 8, 2022
Rafa LaboratoriesFor profitNDA2Aug 8, 2022
Rising PharmaceuticalsFor profitMKTGJun 30, 2000
RocheFor profitSYNOct 15, 1998
RocheFor profitNDADec 20, 1985
STERISCIENCEFor profitMKTGNov 29, 2010
Sagent Pharmaceuticals, Inc.For profitMKTGMay 4, 2011
Sun PharmaceuticalsFor profitMKTGMar 15, 2002
Teligent PharmaceuticalsFor profitMKTGNov 8, 1999
UCBFor profitMKTGMay 17, 2019
UCBFor profitNDA2May 17, 2019
West-Ward PharmaceuticalFor profitMKTGJun 20, 2000
WockhardtFor profitMKTGMay 30, 2008
WockhardtFor profitSYNMay 30, 2008