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sodium oxybate

Trade name: xyrem

Small moleculeapprovedOrphan Drug FDA

Approved

Jul 17, 2002

Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous metabolite of gamma-aminobutyric acid (GABA) a major inhibitory neurotransmitter. Evidence suggests a role for GHB as a neuromodulator/neurotransmitter. Under endogenous conditions and concentrations, and depending on the cell group affected, GHB may increase or decrease neuronal activity by inhibiting the release of neurotransmitters that are co-localised with GHB. After exogenous administration, most of the observed behavioural effects appear to be mediated via the activity of GHB at GABA(B) receptors, as long as the concentration is sufficient to elicit binding, which does not happen at endogenous concentrations. Xyrem (sodium oxybate) oral solution is indicated for the treatment of cataplexy in narcolepsy and excessive daytime sleepiness (EDS) in narcolepsy. — NCATS

Clinical trial activity

58 trials · 56 clinical orgs · 9 marketing orgs

Phase 1
5
Phase 2
27
Phase 3
17
Phase 4
17

Earliest trial started Jan 1, 1993 (NCT00000193)

Timeline

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  2. Nov 7, 1994

    Orphan Drug Designation

2000s

  1. Jan 1, 2000

    Orphan Medical — Earliest Phase 3 Sponsor(trial)

  2. Jul 17, 2002

    Orphan Medical — Earliest FDA Approval

  3. Jul 17, 2002

    Orphan Medical — NDA Organization

  4. Jan 1, 2003

    Orphan Medical — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 17, 2017

    West-Ward Pharmaceutical — Marketing Organization

  2. Jan 17, 2017

    Hikma — Marketing Organization

  3. Jan 19, 2017

    Amneal Pharmaceuticals — Marketing Organization

  4. Jan 19, 2017

    Ohm Laboratories, Inc. — Marketing Organization

  5. Jan 19, 2017

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Jul 21, 2020

    Jazz Pharmaceuticals — NDA Secondary Org

  2. May 1, 2023

    Avadel Pharmaceuticals — Marketing Organization

  3. May 1, 2023

    Avadel Pharmaceuticals — NDA Secondary Org

  4. Nov 5, 2025

    Ascent Pharmahealth — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJul 17, 2002

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)CCCO
Mol. weight
104.11 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
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

  • 3-carboxypropoxy acid
  • 3-carboxypropoxy acid
  • 3-hydroxybutyrate
  • 3-hydroxybutyrate
  • 4-hydroxybutanoate
  • 4-hydroxybutanoate
  • 4-hydroxybutanoic acid
  • 4-hydroxybutanoic acid
  • 4-hydroxy-butyric acid
  • 4-hydroxy-butyric acid
  • 4-hydroxybutyric acid
  • 4-hydroxybutyric acid
  • 4-hydroxybutyric acid
  • gamma-hydroxybutyrate
  • gamma-hydroxybutyrate
  • gamma hydroxybutyric acid
  • gamma hydroxybutyric acid
  • gamma hydroxybutyric acid
  • gamma hydroxybutyric acid
  • gamma hydroxybutyric acid
  • gamma hydroxybutyric acid
  • gamma hydroxybutyric acid
  • gamma hydroxybutyric acid
  • gamma-hydroxybutyric acid
  • gamma-hydroxybutyric acid
  • gamma-hydroxybutyric acid
  • gammahydroxybutyric acid
  • ghb
  • ghb
  • hydroxybutyrate
  • hydroxybutyrate
  • jzp-258
  • oxybate
  • oxybate
  • oxybate
  • oxybate sodium
  • oxybate sodium
  • oxy-n-butyric acid
  • oxy-n-butyric acid
  • sodium hydroxybutyrate
  • sodium oxybate
  • sodium oxybate
  • sodium oxybate
  • sodium oxybate
  • sodium oxybate
  • sodium oxybate
  • sodium oxybate
  • sodium oxybate
  • sodium oxybate
  • wy-3478
  • wy-3478
  • xyrem
  • xyrem
  • xyrem
  • xyrem
  • xyrem
  • γ-hydroxybutyric acid
  • γ-hydroxybutyric acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07041203Phase 1Mar 1, 2026Harvard University
NCT06950281Phase 2Jan 31, 2026Leiden University
NCT07077278Phase 4Oct 1, 2025Stanford University
NCT06809803Phase 2Feb 28, 2025Avadel Pharmaceuticals, Stanford University
NCT06525077Phase 3Aug 1, 2024Avadel Pharmaceuticals
NCT05837091Phase 4Dec 31, 2023Mayo Clinic
NCT05875974Phase 4Jul 27, 2023Jazz Pharmaceuticals
NCT05869773Phase 4Jun 26, 2023Jazz Pharmaceuticals
NCT05085873Phase 4Oct 14, 2021Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Centre Hospitalier Princesse Grace
NCT04794491Phase 4Apr 9, 2021Jazz Pharmaceuticals
NCT04451668Phase 3Jun 12, 2020Avadel Pharmaceuticals
NCT04224246Phase 2Jan 31, 2020University of Poitiers
NCT04006925Phase 4Jul 31, 2019Jazz Pharmaceuticals, Stanford University
NCT03626727Early Phase 1 (Phase 1)Oct 1, 2018Harvard University
NCT03597555Phase 2/Phase 3 (Phase 3)Oct 1, 2018University of Montpellier
NCT03533114Phase 3Sep 30, 2018Jazz Pharmaceuticals
NCT03292458Phase 2/Phase 3 (Phase 3)Sep 1, 2017Harvard University, National Institute on Deafness and Other Communication Disorders (NIDCD)
NCT03073356Phase 2Mar 17, 2017Aarhus University
NCT03030599Phase 3Jan 1, 2017Jazz Pharmaceuticals
NCT02720744Phase 3Nov 1, 2016Flamel Technologies
Showing 20 of 58 trials
Page 1 / 3

Organizations

Research & Development (56)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Jazz PharmaceuticalsFor profit221542003
Stanford UniversityAcademic/Hospital4422006
Avadel PharmaceuticalsFor profit3222020
Harvard UniversityAcademic/Hospital3322017
Aarhus UniversityAcademic/Hospital2222011
Hoosier Cancer Research NetworkAcademic/Hospital2112006
National Institute on Deafness and Other Communication Disorders (NIDCD)Government2022012
National Institutes of Health (NIH)Government2012012
Orphan MedicalFor profit2222000
University of California, San DiegoAcademic/Hospital2212008
University of ViennaAcademic/Hospital2022002
University of ZurichAcademic/Hospital2222012
Alternating Hemiplegia of Childhood FoundationAcademic/Hospital1012009
Baylor UniversityAcademic/Hospital1112004
Catholic University of Sacred Heart, RomeAcademic/Hospital1112002
Centre Hospitalier Intercommunal de Toulon La Seyne sur MerAcademic/Hospital1112021
Centre Hospitalier Princesse GraceAcademic/Hospital1012021
Clayton Sleep InsitituteAcademic/Hospital1112008
Clinic Barmelweid AGAcademic/Hospital1012015
Concert PharmaceuticalsFor profit1112014
56 organizations
Page 1 / 3

Marketing (14)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGJan 19, 2017
Amneal PharmaceuticalsFor profitSYNSep 10, 2025
Ascent PharmahealthFor profitMKTGNov 5, 2025
Avadel PharmaceuticalsFor profitMKTGMay 1, 2023
Avadel PharmaceuticalsFor profitNDA2May 1, 2023
HikmaFor profitMKTGJan 17, 2017
HikmaFor profitSYNJan 17, 2017
Jazz PharmaceuticalsFor profitNDA2Jul 17, 2002
Jazz PharmaceuticalsFor profitSYNJul 21, 2020
Jazz PharmaceuticalsFor profitNDA2Jul 21, 2020
Ohm Laboratories, Inc.For profitMKTGJan 19, 2017
Orphan MedicalFor profitNDAJul 17, 2002
Sun PharmaceuticalsFor profitMKTGJan 19, 2017
West-Ward PharmaceuticalFor profitMKTGJan 17, 2017