CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

clonazepam

Trade name: klonopin

Small moleculeapproved

Approved

Jun 4, 1975

Clonazepam, a benzodiazepine, is used primarily as an anticonvulsant in the treatment of absence seizures, petit mal variant seizures (Lennox-Gastaut syndrome), akinetic and myoclonic seizures, and nocturnal myoclonus. Klonopin is the brand name for Clonazepam, an anxiolytic and anticonvulsant. The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. Allosteric interactions between central benzodiazepine receptors and gamma-aminobutyric acid (GABA) receptors potentiate the effects of GABA. As GABA is an inhibitory neurotransmitter, this results in increased inhibition of the ascending reticular activating system. Benzodiazepines, in this way, block the cortical and limbic arousal that occurs following stimulation of the reticular pathways. — NCATS

Clinical trial activity

34 trials · 52 clinical orgs · 21 marketing orgs

Phase 1
6
Phase 2
11
Phase 3
6
Phase 4
12

Earliest trial started Mar 1, 1999 (NCT00118417)

Timeline

1970s

  1. Jun 4, 1975

    Roche — Earliest FDA Approval

  2. Jun 4, 1975

    CheplaPharm — Marketing Organization

  3. Jun 4, 1975

    Roche — NDA Organization

  4. Jun 4, 1975

    CheplaPharm — NDA Secondary Org

1990s

  1. Sep 10, 1996

    Teva — Marketing Organization

  2. Oct 31, 1996

    Actavis — Marketing Organization

  3. Aug 29, 1997

    Sandoz — Marketing Organization

  4. Aug 29, 1997

    Novartis — Marketing Organization

  5. Sep 30, 1997

    Chartwell Pharmaceuticals — Marketing Organization

  6. Oct 30, 1997

    PHARMOBEDIENT — Marketing Organization

  7. Oct 30, 1997

    Quagen Pharma — Marketing Organization

  8. Dec 30, 1997

    Watson Pharmaceuticals — Marketing Organization

  9. Oct 5, 1998

    Mylan — Marketing Organization

  10. Oct 5, 1998

    Aurobindo Pharma — Marketing Organization

  11. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Oct 6, 2000

    Apotex — Marketing Organization

  2. Oct 6, 2000

    Rubicon Research — Marketing Organization

  3. Apr 27, 2001

    Sun Pharmaceuticals — Marketing Organization

  4. Jan 1, 2004

    Par Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

  5. May 2, 2005

    Accord Research — Marketing Organization

  6. Aug 3, 2005

    Par Pharmaceuticals — Marketing Organization

  7. Aug 3, 2005

    PH HEALTH — Marketing Organization

  8. Aug 10, 2005

    Barr Laboratories — Marketing Organization

  9. Jun 28, 2006

    Prinston Inc — Marketing Organization

  10. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jun 28, 2019

    Alembic — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJun 4, 1975

Chemistry & pharmacology

Loading structure…

SMILES

[O-][N+](=O)C1=CC=C2NC(=O)CN=C(C3=CC=CC=C3Cl)C2=C1
Mol. weight
315.711 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 1,3-dihydro-7-nitro-5-(2-chlorophenyl)-2h-1,4.benzodiazepin-2-one
  • 1,3-dihydro-7-nitro-5-(2-chlorophenyl)-2h-1,4.benzodiazepin-2-one
  • 5-(2-chloro-phenyl)-7-nitro-1,3-dihydro-benzo[e][1,4]diazepin-2-one
  • 5-(2-chloro-phenyl)-7-nitro-1,3-dihydro-benzo[e][1,4]diazepin-2-one
  • 5-(2-chlorophenyl)-7-nitro-1h-benzo[e][1,4]diazepin-2(3h)-one
  • 5-(2-chlorophenyl)-7-nitro-1h-benzo[e][1,4]diazepin-2(3h)-one
  • 5-(o-chlorophenyl)-7-nitro-1,3-dihydro-2h-1,4-benzodiazepin-2-one
  • 5-(o-chlorophenyl)-7-nitro-1,3-dihydro-2h-1,4-benzodiazepin-2-one
  • cloazepam
  • cloazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepam
  • clonazepamum
  • clonazepamum
  • klonopin
  • klonopin
  • klonopin
  • klonopin
  • klonopin rapidly disintegrating
  • klonopin rapidly disintegrating
  • lonazep
  • rivotril
  • rivotril
  • rivotril
  • ro-54023
  • ro-54023
  • ro-5-4023
  • ro-5-4023

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07313371Phase 4Dec 31, 2025University of Sao Paulo
NCT06040190Phase 4Nov 1, 2023Federal University of Minas Gerais
NCT06056349N/AMay 1, 2023El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
NCT05059418N/ANov 1, 2021Lund University, Malmö University
NCT04364321N/AMay 1, 2020Queen Sirikit National Institute of Child Health
NCT04189367N/ADec 31, 2019Chang Gung University, Government of Taiwan
NCT04313907Phase 4Aug 16, 2019National Autonomous University of Mexico
NCT04884503Phase 2Jan 12, 2019Wroclaw Medical University
NCT03255642N/ADec 1, 2017Kyung Hee University
NCT03375034Phase 1Mar 30, 2017University of Geneva
NCT03061136Phase 4Oct 1, 2016Palo Alto Veterans Institute for Research, Stanford University, University of California, Los Angeles
NCT02913924Phase 2Sep 1, 2016Columbia University, National Institute on Drug Abuse (NIDA)
NCT02789592Phase 2Jul 1, 2016Kuhnil Pharmaceutical Co., Ltd., Seoul National University
NCT02690844Phase 4Apr 1, 2016University of Alberta
NCT02312908Phase 2Mar 1, 2015Government of Korea, Seoul National University
NCT02205931Phase 4Jan 1, 2015Lancashire Teaching Hospitals NHS Foundation Trust, National Institute for Health Research, United Kingdom, Newcastle University, Sheffield Hallam University, University of Birmingham, University of Bristol, University of Cambridge, University of Leeds, University of Liverpool, University of London, University of Manchester
NCT02374567Phase 3Jan 1, 2015Gottfried Wilhelm Leibniz Universität Hannover
NCT02134366Phase 3Jul 1, 2014Lundbeck, Rowan University
NCT02382029Early Phase 1 (Phase 1)Mar 1, 2014University of Zagreb
NCT01870024Phase 3Jun 1, 2013University of Paris
Showing 20 of 34 trials
Page 1 / 2

Organizations

Research & Development (52)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Mental Health (NIMH)Government3121999
Harvard UniversityAcademic/Hospital2221999
LundbeckFor profit2022013
Par PharmaceuticalsFor profit2212004
PRACSFor profit2012004
Seoul National UniversityAcademic/Hospital2212015
University of GenevaAcademic/Hospital2222010
University of ParisAcademic/Hospital2212009
Chang Gung UniversityAcademic/Hospital1112019
Columbia UniversityAcademic/Hospital1112016
Conselho Nacional de Desenvolvimento Científico e TecnológicoGovernment1012000
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezAcademic/Hospital1112023
Federal University of Minas GeraisAcademic/Hospital1112023
Federal University of Rio de JaneiroAcademic/Hospital1112000
Gateway Medical ResearchFor profit1012004
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112015
Government of KoreaGovernment1012015
Government of TaiwanGovernment1012019
Jazz PharmaceuticalsFor profit1112007
Kuhnil Pharmaceutical Co., Ltd.For profit1012016
52 organizations
Page 1 / 3

Marketing (25)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGMay 2, 2005
ActavisFor profitMKTGOct 31, 1996
AlembicFor profitMKTGJun 28, 2019
AlembicFor profitSYNJun 28, 2019
ApotexFor profitMKTGOct 6, 2000
Aurobindo PharmaFor profitMKTGOct 5, 1998
Barr LaboratoriesFor profitMKTGAug 10, 2005
Chartwell PharmaceuticalsFor profitMKTGSep 30, 1997
CheplaPharmFor profitMKTGJun 4, 1975
CheplaPharmFor profitNDA2Jun 4, 1975
MylanFor profitMKTGOct 5, 1998
MylanFor profitSYNOct 30, 1997
NovartisFor profitMKTGAug 29, 1997
PH HEALTHFor profitMKTGAug 3, 2005
PHARMOBEDIENTFor profitMKTGOct 30, 1997
Par PharmaceuticalsFor profitMKTGAug 3, 2005
Prinston IncFor profitMKTGJun 28, 2006
Quagen PharmaFor profitMKTGOct 30, 1997
RocheFor profitNDAJun 4, 1975
Rubicon ResearchFor profitMKTGOct 6, 2000
Rubicon ResearchFor profitSYNOct 6, 2000
SandozFor profitMKTGAug 29, 1997
Sun PharmaceuticalsFor profitMKTGApr 27, 2001
TevaFor profitMKTGSep 10, 1996
Watson PharmaceuticalsFor profitMKTGDec 30, 1997