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diazepam

Trade name: valium

Small moleculeapproved

Approved

Nov 15, 1963

Diazepam is a benzodiazepine first discovered at Hoffman-La Roche in the late 1950s. Diazepam was approved by FDA for the treatment of anxiety disorders as well as for such conditions as skeletal muscle spasm, alcohol withdrawal syndrom and convulsions (under the most known brand Valium). The drug acts by binding to GABA-A receptors and potentiating GABA evoked current. Chronic diazepam use is associated with tolerance, dependence, and withdrawal. — NCATS

Clinical trial activity

77 trials · 74 clinical orgs · 43 marketing orgs

Phase 1
13
Phase 2
24
Phase 3
12
Phase 4
19

Earliest trial started Nov 1, 1995 (NCT00004297)

Timeline

1960s

  1. Nov 15, 1963

    Roche — Earliest FDA Approval

  2. Nov 15, 1963

    Waylis Therap — Marketing Organization

  3. Nov 15, 1963

    Roche — NDA Organization

  4. Nov 15, 1963

    Waylis Therap — NDA Secondary Org

1980s

  1. Sep 4, 1985

    Mylan — Marketing Organization

  2. Sep 26, 1985

    DAVA Pharmaceuticals — Marketing Organization

  3. Sep 26, 1985

    Endo Pharmaceuticals — Marketing Organization

  4. Nov 1, 1985

    Barr Laboratories — Marketing Organization

  5. Nov 1, 1985

    Teva — Marketing Organization

  6. Dec 16, 1985

    West-Ward Pharmaceutical — Marketing Organization

  7. Dec 20, 1985

    Upsher-Smith Laboratories — Marketing Organization

  8. Feb 25, 1986

    Virtus Pharms — Marketing Organization

  9. Feb 25, 1986

    Nuvo Research Inc. — Marketing Organization

  10. Mar 19, 1986

    Actavis — Marketing Organization

  11. Aug 15, 1986

    Halsey — Marketing Organization

  12. Aug 27, 1986

    Duramed Research — Marketing Organization

  13. Feb 3, 1987

    Mayne Pharma — Marketing Organization

  14. Feb 3, 1987

    Dr. Reddy's Laboratories — Marketing Organization

  15. Apr 1, 1987

    Ferndale Laboratories, Inc. — Marketing Organization

  16. Apr 3, 1987

    Hikma — Marketing Organization

  17. Apr 16, 1987

    Quantum Pharmaceutical — Marketing Organization

  18. Oct 13, 1987

    Hospira — Marketing Organization

  19. Apr 1, 1988

    Abraxis — Marketing Organization

1990s

  1. Jan 16, 1990

    Roxane Laboratories — Marketing Organization

  2. Dec 5, 1990

    United States Army — NDA Secondary Org

  3. Jan 29, 1993

    Watson Pharmaceuticals — Marketing Organization

  4. Jan 29, 1993

    Marsam Pharmaceuticals — Marketing Organization

  5. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  6. Jul 29, 1997

    Bausch Health Companies — NDA Secondary Org

2000s

  1. Jan 3, 2000

    Boehringer Ingelheim — Marketing Organization

  2. Apr 15, 2004

    Parenta Pharmaceuticals — Marketing Organization

  3. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  4. Mar 31, 2006

    Vintage — Marketing Organization

  5. Mar 31, 2006

    Strides Pharma Science — Marketing Organization

  6. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 14, 2014

    Chartwell Pharmaceuticals — Marketing Organization

  2. Apr 14, 2014

    Lannett Company, Inc. — Marketing Organization

  3. Mar 18, 2019

    Beloteca Inc — Marketing Organization

2020s

  1. Jan 10, 2020

    Neurelis, Inc. — Marketing Organization

  2. Jan 10, 2020

    Neurelis, Inc. — NDA Secondary Org

  3. Aug 30, 2022

    Aquestive Therapeutics — Marketing Organization

  4. Aug 30, 2022

    Aquestive Therapeutics — NDA Secondary Org

  5. Nov 10, 2022

    Fresenius — Marketing Organization

  6. May 30, 2023

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  7. Dec 14, 2023

    Aurobindo Pharma — Marketing Organization

  8. Apr 25, 2024

    Alembic — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 15, 1963

Chemistry & pharmacology

Loading structure…

SMILES

CN1C2=CC=C(Cl)C=C2C(=NCC1=O)C3=CC=CC=C3
Mol. weight
284.74 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

  • 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2h-1,4-benzodiazepin-2-one
  • 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2h-1,4-benzodiazepin-2-one
  • alupram 10
  • alupram 2
  • alupram 5
  • apozepam
  • apozepam
  • atensine
  • atensine
  • dialar
  • dialar
  • dialar fte
  • diastat
  • diastat
  • diastat acudial
  • diastat acudial
  • diazemuls
  • diazemuls
  • diazepam
  • diazepam
  • diazepam
  • diazepam
  • diazepam
  • diazepam
  • diazepam
  • diazepam
  • diazepam
  • diazepam intensol
  • diazepam intensol
  • dizac
  • dizac
  • e-pam
  • e-pam
  • la-iii
  • la-iii
  • methyl diazepinone
  • methyl diazepinone
  • paxel
  • paxel
  • q-pam
  • q-pam
  • relanium
  • relanium
  • ro-52807
  • ro-52807
  • ro-5-2807
  • ro-5-2807
  • ro-5-2807
  • ro-5-2807
  • ro-5-2807
  • ro-5-2807
  • scriptopam
  • serenack
  • serenack
  • solis
  • solis
  • stesolid
  • stesolid
  • tensium
  • tensium
  • tranimul
  • tranimul
  • valclair
  • valium
  • valium
  • valium
  • valium
  • valium
  • valrelease
  • valrelease
  • vivol
  • vivol
  • wy-3467
  • wy-3467

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07020988Phase 1Jun 12, 2025UCB
NCT06293989Phase 3May 1, 2024University of Monastir
NCT06103188Phase 3Oct 2, 2023University of Jordan
NCT05860153N/AJun 1, 2023Assiut University
NCT05361447Phase 1/Phase 2 (Phase 2)Jan 31, 2023Mayo Clinic
NCT05076838Phase 1/Phase 2 (Phase 2)Nov 8, 2021Neurelis, Inc.
NCT04858490N/ASep 30, 2021Canadian Institutes of Health Research (CIHR), Government of Ontario, University of Toronto
NCT04885075Phase 4May 30, 2021Shaheed Zulfiqar Ali Bhutto Medical University
NCT04570436Phase 4Oct 30, 2020Pfizer
NCT05872789N/AMay 2, 2020University of Catania
NCT04364321N/AMay 1, 2020Queen Sirikit National Institute of Child Health
NCT04198233Phase 4Mar 31, 2020TriHealth
NCT04216797Phase 4Jan 13, 2020University of Washington
NCT05041985Phase 4Jan 1, 2020Cantonal Hospital Dr. Safet Mujic Mostar
NCT06271096Early Phase 1 (Phase 1)Nov 1, 2019Khyber Medical University Peshawer
NCT06190483N/AJul 24, 2019University of London, Wellcome Trust
NCT03953820Phase 1/Phase 2 (Phase 2)Apr 13, 2019Aquestive Therapeutics
NCT03818919Phase 2Jan 22, 2019Henry Ford Health System, University of Vermont
NCT03825809Phase 2/Phase 3 (Phase 3)Jan 22, 2019Henry Ford Health System
NCT03818932Phase 2/Phase 3 (Phase 3)Jan 22, 2019Henry Ford Health System, University of Vermont
Showing 20 of 77 trials
Page 1 / 4

Organizations

Research & Development (74)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Acorda TherapeuticsFor profit4422011
Aquestive TherapeuticsFor profit4422017
Henry Ford Health SystemAcademic/Hospital4432019
Neurelis, Inc.For profit4332011
Assiut UniversityAcademic/Hospital3332013
CovanceFor profit3022017
inVentivFor profit3022017
TriHealthAcademic/Hospital3322010
Johns Hopkins UniversityAcademic/Hospital2222009
Mayo ClinicAcademic/Hospital2222016
PfizerFor profit2222006
Radboud UniversityAcademic/Hospital2212011
The University of Hong KongAcademic/Hospital2112015
United States ArmyGovernment2122012
University of VermontAcademic/Hospital2022019
Avanti AnesthesiaAcademic/Hospital1112017
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012021
Cantonal Hospital Dr. Safet Mujic MostarAcademic/Hospital1112020
Centro Medico Nacional La Raza, IMSSAcademic/Hospital1112017
Changhai HospitalAcademic/Hospital1112016
74 organizations
Page 1 / 4

Marketing (53)

OrganizationOrg typeRelationshipDate
AbraxisFor profitMKTGApr 1, 1988
ActavisFor profitMKTGMar 19, 1986
AlembicFor profitMKTGApr 25, 2024
Aquestive TherapeuticsFor profitMKTGAug 30, 2022
Aquestive TherapeuticsFor profitNDA2Aug 30, 2022
Aurobindo PharmaFor profitMKTGDec 14, 2023
Barr LaboratoriesFor profitMKTGNov 1, 1985
Bausch Health CompaniesFor profitNDA2Jul 29, 1997
Beloteca IncFor profitMKTGMar 18, 2019
Beloteca IncFor profitSYNMar 18, 2019
Boehringer IngelheimFor profitMKTGJan 3, 2000
Chartwell PharmaceuticalsFor profitMKTGApr 14, 2014
Chartwell PharmaceuticalsFor profitSYNDec 20, 1985
DAVA PharmaceuticalsFor profitMKTGSep 26, 1985
Dow ChemicalFor profitMKTG—
Dr. Reddy's LaboratoriesFor profitMKTGFeb 3, 1987
Dr. Reddy's LaboratoriesFor profitSYNJul 18, 2024
Duramed ResearchFor profitMKTGAug 27, 1986
Endo PharmaceuticalsFor profitMKTGSep 26, 1985
Ferndale Laboratories, Inc.For profitMKTGApr 1, 1987
FreseniusFor profitMKTGNov 10, 2022
HalseyFor profitMKTGAug 15, 1986
HikmaFor profitMKTGApr 3, 1987
HikmaFor profitSYNApr 3, 1987
HospiraFor profitMKTGOct 13, 1987
Lannett Company, Inc.For profitMKTGApr 14, 2014
Marsam PharmaceuticalsFor profitMKTGJan 29, 1993
Mayne PharmaFor profitMKTGFeb 3, 1987
MylanFor profitMKTGSep 4, 1985
Neurelis, Inc.For profitMKTGJan 10, 2020
Neurelis, Inc.For profitNDA2Jan 10, 2020
Novel Anti-Infective Technologies, LLCFor profitMKTGMay 30, 2023
Nuvo Research Inc.For profitMKTGFeb 25, 1986
Parenta PharmaceuticalsFor profitMKTGApr 15, 2004
Pharmacia & UpjohnFor profitNDA2—
Quantum PharmaceuticalFor profitMKTGApr 16, 1987
RocheFor profitNDANov 15, 1963
Roxane LaboratoriesFor profitMKTGJan 16, 1990
Soremartec Italia S.r.l.For profitMKTG—
Strides Pharma ScienceFor profitMKTGMar 31, 2006
TevaFor profitSYNDec 10, 1986
TevaFor profitMKTGNov 1, 1985
United States ArmyGovernmentNDA2Dec 5, 1990
Upsher-Smith LaboratoriesFor profitMKTGDec 20, 1985
VintageFor profitMKTGMar 31, 2006
Virtus PharmsFor profitMKTGFeb 25, 1986
Virtus PharmsFor profitSYNFeb 25, 1986
Warner ChilcottFor profitMKTG—
Watson PharmaceuticalsFor profitSYNFeb 12, 1986
Watson PharmaceuticalsFor profitMKTGJan 29, 1993
Waylis TherapFor profitMKTGNov 15, 1963
Waylis TherapFor profitNDA2Nov 15, 1963
West-Ward PharmaceuticalFor profitMKTGDec 16, 1985