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oxazepam

Trade name: serax

Small moleculeapproved

Approved

Jun 4, 1965

Oxazepam is the first of a chemical series of compounds, the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation and irritability, and anxiety associated with depression. Oxazepam has distinguished itself clinically from other benzodiazepines by virtue of its excellent tolerance. Because of its excellent tolerance, dosage is very flexible, and it is, therefore, possible to utilize oxazepam in a wide spectrum of anxiety-related disorders including the psychoses. Oxazepam has been administered to humans by the oral route only. Usual ranges for kinetic parameters are: elimination half-life, 5 to 15 hours; volume of distribution, 0.6 to 2.0 L/kg; clearance, 0.9 to 2.0 ml/min/kg. Age and liver disease have a minimal influence on oxazepam kinetics, but renal disease is associated with a prolonged half-life and increased volume of distribution. — NCATS

Clinical trial activity

11 trials · 13 clinical orgs · 16 marketing orgs

Phase 1
7
Phase 2
3
Phase 3
1
Phase 4
1

Earliest trial started Nov 2, 1999 (NCT00000661)

Timeline

1960s

  1. Jun 4, 1965

    American Home Products — Earliest FDA Approval

  2. Jun 4, 1965

    Alpharma — NDA Secondary Org

  3. Jun 4, 1965

    American Home Products — NDA Organization

1980s

  1. Jan 16, 1987

    Sun Pharmaceuticals — Marketing Organization

  2. Apr 21, 1987

    Watson Pharmaceuticals — Marketing Organization

  3. Aug 3, 1987

    Teva — Marketing Organization

  4. Aug 10, 1987

    Frontida BioPharm — Marketing Organization

  5. Aug 10, 1987

    UNITED RES LABS — Marketing Organization

  6. Aug 10, 1987

    TRUPHARMA — Marketing Organization

  7. Apr 14, 1988

    Actavis — Marketing Organization

  8. Apr 19, 1988

    Sandoz — Marketing Organization

  9. Apr 19, 1988

    Epic Pharma Llc — Marketing Organization

  10. Jun 28, 1989

    Quantum Pharmaceutical — Marketing Organization

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2015

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 1, 2020

    Earliest Phase 2 Sponsor(trial)

  2. Mar 3, 2025

    Leading Pharma Llc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 4, 1965

Chemistry & pharmacology

Loading structure…

SMILES

OC1N=C(C2=CC=CC=C2)C3=CC(Cl)=CC=C3NC1=O
Mol. weight
286.713 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

  • droxacepam
  • durazepam
  • lederpam
  • lederpam
  • noctazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • oxazepam
  • (+-)-oxazepam
  • (+-)-oxazepam
  • oxozepam
  • oxozepam
  • (rs)-oxazepam
  • (rs)-oxazepam
  • serax
  • serax
  • serax
  • serenid fte
  • tazepam
  • wy-3498
  • wy-3498
  • zaxopam
  • zaxopam
  • zaxopam

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04933916Phase 1/Phase 2 (Phase 2)Jun 10, 2021Embera NeuroTherapeutics, Inc., Foundation for a Smoke-Free World, Rose Research Center, LLC
NCT04501874Phase 2Jul 29, 2020Embera NeuroTherapeutics, Inc., National Institute on Drug Abuse (NIDA)
NCT03404817Phase 1Mar 1, 2018Embera NeuroTherapeutics, Inc., National Institute on Drug Abuse (NIDA)
NCT02856854Phase 1Jul 1, 2016Embera NeuroTherapeutics, Inc., National Institute on Drug Abuse (NIDA), Vince & Associates
NCT02406066Phase 1Mar 1, 2015Embera NeuroTherapeutics, Inc., National Institute on Drug Abuse (NIDA)
NCT02374567Phase 3Jan 1, 2015Gottfried Wilhelm Leibniz Universität Hannover
NCT02570581Phase 1Jun 30, 2014University of Nice Sophia Antipolis
NCT00567814N/ADec 1, 2007Embera NeuroTherapeutics, Inc., Louisiana State University
NCT02273453Phase 1Feb 1, 2003Boehringer Ingelheim
NCT02090504Phase 4Feb 1, 2002Catholic University of Sacred Heart, Rome, University of Bologna, University of Vienna
NCT00000661Phase 1Nov 2, 1999National Institute of Allergy and Infectious Diseases (NIAID)
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Embera NeuroTherapeutics, Inc.For profit6632007
National Institute on Drug Abuse (NIDA)Government4022015
Boehringer IngelheimFor profit1112003
Catholic University of Sacred Heart, RomeAcademic/Hospital1112002
Foundation for a Smoke-Free WorldAcademic/Hospital1012021
Gottfried Wilhelm Leibniz Universität HannoverAcademic/Hospital1112015
Louisiana State UniversityAcademic/Hospital1012007
National Institute of Allergy and Infectious Diseases (NIAID)Government1111999
Rose Research Center, LLCFor profit1012021
University of BolognaAcademic/Hospital1012002
University of Nice Sophia AntipolisAcademic/Hospital1112014
University of ViennaAcademic/Hospital1012002
Vince & AssociatesFor profit1012016
13 organizations
Page 1 / 1

Marketing (17)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGApr 14, 1988
AlpharmaFor profitNDA2Jun 4, 1965
Am TherapFor profitMKTG—
American Home ProductsFor profitNDAJun 4, 1965
Epic Pharma LlcFor profitMKTGApr 19, 1988
Frontida BioPharmFor profitMKTGAug 10, 1987
Leading Pharma LlcFor profitMKTGMar 3, 2025
MylanFor profitMKTG—
Parke-DavisFor profitMKTG—
Quantum PharmaceuticalFor profitMKTGJun 28, 1989
SandozFor profitMKTGApr 19, 1988
Sun PharmaceuticalsFor profitMKTGJan 16, 1987
TRUPHARMAFor profitMKTGAug 10, 1987
TevaFor profitMKTGAug 3, 1987
TevaFor profitSYNSep 28, 1990
UNITED RES LABSFor profitMKTGAug 10, 1987
Watson PharmaceuticalsFor profitMKTGApr 21, 1987