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clobazam

Trade name: onfi

Small moleculeapprovedOrphan Drug FDA

Approved

Oct 21, 2011

Clobazam belongs to the 1,5-benzodiazepine class of drugs with antiepileptic properties. It has been used to treat anxiety and epilepsy since 1970s. In the US clobazam was approved for marketing in October of 2011 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. It is also approved for adjunctive therapy for epilepsy in patients who have not responded to first-line drugs and in children who are refractory to first-line drugs. The mechanism of action for clobazam is not fully understood but is thought to involve what is known as potentiation of GABAergic neurotransmission resulting from binding at a benzodiazepine site at the GABA(A) receptor. Possible side effects: constipation, fever, drowsiness, sedation, ataxia, aggressive behavior, lethargy, drooling, and irritability. Other side effects include: urinary tract infection, pneumonia, cough, dysphagia, dysarthria, bronchitis, insomnia, fatigue, decreased appetite, and increased appetite. — NCATS

Clinical trial activity

15 trials · 23 clinical orgs · 27 marketing orgs

Phase 1
1
Phase 2
10
Phase 3
8
Phase 4
5

Earliest trial started Oct 1, 2005 (NCT00162981)

Timeline

2000s

  1. Jan 1, 2005

    Lundbeck — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2005

    Lundbeck — Earliest Phase 3 Sponsor(trial)

  3. May 25, 2005

    Lundbeck — IND Organization

  4. May 25, 2005

    Lundbeck — IND Organization

  5. Dec 18, 2007

    Orphan Drug Designation

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Oct 21, 2011

    Lundbeck — Earliest FDA Approval

  3. Oct 21, 2011

    Lundbeck — NDA Organization

  4. Oct 22, 2018

    Hikma — Marketing Organization

  5. Oct 22, 2018

    Amneal Pharmaceuticals — Marketing Organization

  6. Oct 22, 2018

    Bionpharma Inc — Marketing Organization

  7. Oct 22, 2018

    Esteve Labs — Marketing Organization

  8. Oct 22, 2018

    Hetero Labs Ltd — Marketing Organization

  9. Oct 22, 2018

    Mylan — Marketing Organization

  10. Oct 22, 2018

    Piramal — Marketing Organization

  11. Oct 22, 2018

    Taro Pharmaceuticals — Marketing Organization

  12. Oct 22, 2018

    Upsher-Smith Laboratories — Marketing Organization

  13. Oct 22, 2018

    West-Ward Pharmaceutical — Marketing Organization

  14. Oct 22, 2018

    Zydus Discovery DMCC — Marketing Organization

  15. Oct 22, 2018

    Sun Pharmaceuticals — Marketing Organization

  16. Nov 1, 2018

    Aquestive Therapeutics — NDA Secondary Org

  17. Nov 1, 2018

    Aquestive Therapeutics — Marketing Organization

  18. Nov 1, 2018

    Assertio — Marketing Organization

  19. Nov 1, 2018

    Assertio — NDA Secondary Org

  20. Dec 14, 2018

    Lupin — Marketing Organization

  21. Jan 30, 2019

    Micro Labs Ltd India — Marketing Organization

  22. May 23, 2019

    Accord Research — Marketing Organization

  23. Jul 10, 2019

    VistaPharm, Inc. — Marketing Organization

  24. Sep 6, 2019

    Alkem Labs Ltd — Marketing Organization

  25. Oct 30, 2019

    Lannett Company, Inc. — Marketing Organization

2020s

  1. Feb 3, 2020

    Teva — Marketing Organization

  2. Apr 24, 2020

    Chartwell Pharmaceuticals — Marketing Organization

  3. Jun 9, 2020

    Apotex — Marketing Organization

  4. Dec 9, 2020

    Celltrion — Marketing Organization

  5. May 11, 2021

    MSN Laboratories — Marketing Organization

  6. Mar 24, 2022

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 21, 2011

Chemistry & pharmacology

Loading structure…

SMILES

CN1C2=CC=C(Cl)C=C2N(C3=CC=CC=C3)C(=O)CC1=O
Mol. weight
300.74 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-phenyl-5-methyl-8-chloro-1,2,4,5- tetrahydro-2,4-diketo-3h-1,5-benzodiazepine
  • 1-phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3h-1,5-benzodiazepine
  • 1-phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3h-1,5-benzodiazepine
  • 7-chloro-1-methyl-5-phenyl-1,5-dihydro-benzo[b][1,4]diazepine-2,4-dione
  • 7-chloro-1-methyl-5-phenyl-1,5-dihydro-benzo[b][1,4]diazepine-2,4-dione
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazam
  • clobazamum
  • clobazamum
  • clobazepam
  • frisium
  • frisium
  • frisium
  • frisium
  • frizium
  • h-4723
  • h-4723
  • hr 376
  • hr-376
  • hr-376
  • lm-2717
  • lm-2717
  • lm-2717
  • onfi
  • onfi
  • onfi
  • onfi
  • onfi
  • perizam
  • tapclob
  • urbadan
  • urbanyl
  • urbanyl
  • urbanyl

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04650204Phase 4Dec 15, 2020Mayo Clinic, National Cancer Institute (NCI)
NCT03371836Phase 4Oct 1, 2017Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
NCT02187809Phase 3Mar 1, 2015Lundbeck
NCT02174094Phase 3Mar 1, 2015Lundbeck
NCT02726919Phase 4Feb 1, 2015Lundbeck, Mid-Atlantic Epilepsy and Sleep Center
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
NCT01932502Phase 4Feb 1, 2013Lundbeck, University of Arizona
NCT01179828Phase 3Jul 1, 2010Aalborg University, University of Bern, University of Zurich
NCT01291316Phase 1/Phase 2 (Phase 2)Apr 1, 2010University of Geneva
NCT01011036Phase 3Dec 1, 2009University of Bern
NCT00518713Phase 3Aug 1, 2007Lundbeck
NCT01160770Phase 3Dec 1, 2005Lundbeck
NCT00162981Phase 2Oct 1, 2005Lundbeck
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
LundbeckFor profit8532005
University of BernAcademic/Hospital2212009
Aalborg UniversityAcademic/Hospital1012010
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112015
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Academic/Hospital1112017
Lancashire Teaching Hospitals NHS Foundation TrustAcademic/Hospital1012015
Mayo ClinicAcademic/Hospital1112020
Mid-Atlantic Epilepsy and Sleep CenterAcademic/Hospital1112015
National Cancer Institute (NCI)Government1012020
National Institute for Health Research, United KingdomGovernment1012015
Newcastle UniversityAcademic/Hospital1012015
Rowan UniversityAcademic/Hospital1112014
Sheffield Hallam UniversityAcademic/Hospital1012015
University of ArizonaAcademic/Hospital1112013
University of BirminghamAcademic/Hospital1012015
University of BristolAcademic/Hospital1012015
University of CambridgeAcademic/Hospital1012015
University of GenevaAcademic/Hospital1112010
University of LeedsAcademic/Hospital1012015
University of LiverpoolAcademic/Hospital1012015
23 organizations
Page 1 / 2

Marketing (38)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGMay 23, 2019
Alkem Labs LtdFor profitMKTGSep 6, 2019
Amneal PharmaceuticalsFor profitMKTGOct 22, 2018
Amneal PharmaceuticalsFor profitSYNOct 22, 2018
Amneal PharmaceuticalsFor profitSYNOct 22, 2018
ApotexFor profitMKTGJun 9, 2020
Aquestive TherapeuticsFor profitNDA2Nov 1, 2018
Aquestive TherapeuticsFor profitMKTGNov 1, 2018
AssertioFor profitMKTGNov 1, 2018
AssertioFor profitNDA2Nov 1, 2018
Aurobindo PharmaFor profitMKTGMar 24, 2022
Bionpharma IncFor profitMKTGOct 22, 2018
Bionpharma IncFor profitSYNOct 22, 2018
CelltrionFor profitMKTGDec 9, 2020
Chartwell PharmaceuticalsFor profitMKTGApr 24, 2020
Esteve LabsFor profitSYNOct 22, 2018
Esteve LabsFor profitMKTGOct 22, 2018
Hetero Labs LtdFor profitSYNFeb 24, 2020
Hetero Labs LtdFor profitMKTGOct 22, 2018
HikmaFor profitMKTGOct 22, 2018
HikmaFor profitSYNOct 22, 2018
Lannett Company, Inc.For profitMKTGOct 30, 2019
LundbeckFor profitNDAOct 21, 2011
LundbeckFor profitINDMay 25, 2005
LupinFor profitMKTGDec 14, 2018
MSN LaboratoriesFor profitMKTGMay 11, 2021
Micro Labs Ltd IndiaFor profitMKTGJan 30, 2019
MylanFor profitMKTGOct 22, 2018
MylanFor profitSYNOct 22, 2018
PiramalFor profitMKTGOct 22, 2018
Sun PharmaceuticalsFor profitMKTGOct 22, 2018
Taro PharmaceuticalsFor profitSYNOct 22, 2018
Taro PharmaceuticalsFor profitMKTGOct 22, 2018
TevaFor profitMKTGFeb 3, 2020
Upsher-Smith LaboratoriesFor profitMKTGOct 22, 2018
VistaPharm, Inc.For profitMKTGJul 10, 2019
West-Ward PharmaceuticalFor profitMKTGOct 22, 2018
Zydus Discovery DMCCFor profitMKTGOct 22, 2018