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clorazepate

Trade name: tranxene

Small moleculeapproved

Approved

Jun 23, 1972

Clorazepate is a water-soluble benzodiazepine derivative effective in the treatment of anxiety. It has also muscle relaxant and anticonvulsant actions. Studies in healthy men have shown that clorazepate dipotassium has depressant effects on the central nervous system. clorazepate is a prodrug since orally administered it is rapidly decarboxylated to form nordiazepam, there is essentially no circulating parent drug. Nordiazepam positively modulates GABAA receptors to produce anxiolytic and anticonvulsant effects. — NCATS

Clinical trial activity

2 trials · 2 clinical orgs · 25 marketing orgs

Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
0

Earliest trial started Aug 1, 2003 (NCT00775996)

Timeline

1970s

  1. Jun 23, 1972

    Recordati — Earliest FDA Approval

  2. Jun 23, 1972

    Recordati — NDA Secondary Org

  3. Jun 23, 1972

    Recordati — NDA Organization

  4. Jun 23, 1972

    KEY THERAP — Marketing Organization

  5. Jun 23, 1972

    KEY THERAP — NDA Secondary Org

  6. Jun 23, 1972

    AJENAT PHARMS — Marketing Organization

1980s

  1. Jun 26, 1987

    Able Laboratories — Marketing Organization

  2. Jul 17, 1987

    Mylan — Marketing Organization

  3. Oct 19, 1987

    Dash Pharms — Marketing Organization

  4. Dec 14, 1987

    DAVA Pharmaceuticals — Marketing Organization

  5. Dec 18, 1987

    G D Searle — Marketing Organization

  6. Dec 18, 1987

    Monsanto — Marketing Organization

  7. Feb 9, 1988

    Watson Pharmaceuticals — Marketing Organization

  8. Mar 3, 1988

    Warner Chilcott — Marketing Organization

  9. Apr 26, 1988

    Alta Pharma — Marketing Organization

  10. Aug 26, 1988

    Rising Pharmaceuticals — Marketing Organization

  11. Aug 26, 1988

    Aurobindo Pharma — Marketing Organization

2000s

  1. Apr 27, 2000

    Taro Pharmaceuticals — Marketing Organization

  2. Sep 29, 2004

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Jan 1, 2021

    Earliest Phase 3 Sponsor(trial)

  2. Jun 14, 2022

    Corepharma — Marketing Organization

  3. Jun 14, 2022

    Amneal Pharmaceuticals — Marketing Organization

  4. Jun 16, 2022

    Novitium Pharma — Marketing Organization

  5. Jun 16, 2022

    Ani Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 23, 1972

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)C1N=C(c2ccccc2)c2cc(Cl)ccc2NC1=O
Mol. weight
314.73 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 4306 cb
  • 4306 cb
  • 7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1h-1,4-benzodiazepine-3-carboxylic acid
  • 7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1h-1,4-benzodiazepine-3-carboxylic acid
  • abbott-35616
  • abbott-35616
  • bipotassium chlorazepate
  • chlorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate
  • clorazepate dipotassium
  • clorazepate dipotassium
  • clorazepate dipotassium
  • clorazepate dipotassium
  • clorazepate dipotassium
  • clorazepate monopotassium
  • clorazepate monopotassium
  • clorazepate monopotassium
  • clorazepate monopotassium
  • clorazepate monopotassium
  • clorazepate monopotassium
  • clorazepate potassium
  • clorazepic acid
  • clorazepic acid
  • clorazepic acid
  • clorazepic acid
  • dipotassium clorazepate
  • dipotassium clorazepate
  • dipotassium clorazepate
  • gen-xene
  • gen-xene
  • potassium clorazepate
  • potassium clorazepate
  • potassium clorazepate
  • tranxene
  • tranxene
  • tranxene
  • tranxene sd
  • tranxene sd

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04726592Phase 3Jul 8, 2021Assistance Publique - Hôpitaux de Paris
NCT00775996N/AAug 1, 2003Ranbaxy
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112021
RanbaxyFor profit1112003
2 organizations
Page 1 / 1

Marketing (29)

OrganizationOrg typeRelationshipDate
AJENAT PHARMSFor profitMKTGJun 23, 1972
Able LaboratoriesFor profitMKTGJun 26, 1987
Alta PharmaFor profitMKTGApr 26, 1988
Am TherapFor profitMKTG—
Amneal PharmaceuticalsFor profitMKTGJun 14, 2022
Ani PharmaceuticalsFor profitMKTGJun 16, 2022
Aurobindo PharmaFor profitMKTGAug 26, 1988
Aurobindo PharmaFor profitSYNJul 17, 1987
CorepharmaFor profitMKTGJun 14, 2022
DAVA PharmaceuticalsFor profitMKTGDec 14, 1987
Dash PharmsFor profitMKTGOct 19, 1987
G D SearleFor profitMKTGDec 18, 1987
KEY THERAPFor profitMKTGJun 23, 1972
KEY THERAPFor profitNDA2Jun 23, 1972
LederleFor profitMKTG—
MonsantoFor profitMKTGDec 18, 1987
MylanFor profitMKTGJul 17, 1987
Novitium PharmaFor profitMKTGJun 16, 2022
Puracap PharmaceuticalFor profitMKTG—
Quantum PharmaceuticalFor profitMKTG—
RecordatiFor profitNDA2Jun 23, 1972
RecordatiFor profitNDAJun 23, 1972
Rising PharmaceuticalsFor profitMKTGAug 26, 1988
Sun PharmaceuticalsFor profitMKTGSep 29, 2004
Taro PharmaceuticalsFor profitMKTGApr 27, 2000
Taro PharmaceuticalsFor profitSYNApr 27, 2000
Upsher-Smith LaboratoriesFor profitMKTG—
Warner ChilcottFor profitMKTGMar 3, 1988
Watson PharmaceuticalsFor profitMKTGFeb 9, 1988