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Drug

Sodium oxybate

Approved · EMA
Emerging researchLate-stage development
Also known as Lumryz, Xyrem, Xywav, Gamma hydroxybutyrate sodium+4 more

Lumryz, Xyrem, Xywav, Gamma hydroxybutyrate sodium, Oxybate sodium, Sodium 4-hydroxybutyrate, Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb), Sodium oxybutyrate.

RxNorm9899ChEMBLCHEMBL1200682UNII7G33012534
1
Research papers
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Central Mechanisms and Treatment Response of Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor

Clinical trial2026-04-28Results expected Q3 2027 · ClinicalTrials.gov

Central Mechanisms and Treatment Response of Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor

Clinical trial2025-12-30Results posted · ClinicalTrials.gov

Sodium Oxybate Versus Midazolam for Comfort Sedation

Clinical trial2023-10-10Completed · ClinicalTrials.gov

Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial

Clinical trial2023-05-10Results posted · ClinicalTrials.gov

A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease

Clinical trial2022-10-06Results posted · ClinicalTrials.gov

Single Center, Therapeutic Exploratory Clinical Trial to Evaluate the Safety of Sodium Oxybate (Xyrem) 500 mg/mL Oral Solution on Potential Endocrine Changes at Currently Labeled Therapeutic Dose Regimens (4.5 - 9 g/Day Divided Into Two Equal Doses) During 12 Weeks of Treatment of Cataplexy in Adult Patients With Narcolepsy.

Clinical trial2022-04-08Results posted · ClinicalTrials.gov

Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate

Clinical trial2020-11-18Results posted · ClinicalTrials.gov

Open-label Clinical Trial to Evaluate the Efficacy of Sodium Oxybate (Xyrem®) in the Treatment of Two Under-recognized Clinical Conditions: Post-traumatic Narcolepsy and Post-traumatic Hypersomnia

Clinical trial2020-09-01Withdrawn · ClinicalTrials.gov

Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

Clinical trial2018-04-26Results posted · ClinicalTrials.gov

Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response

Clinical trial2017-11-22Results posted · ClinicalTrials.gov

An open-label study of sodium oxybate in Spasmodic dysphonia.

Research2016-11-03The Laryngoscope

Approval: Xyrem (EMA)

Regulatory2005-10-13EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Sodium oxybate
Aliases & brands
LumryzXyremXywavGamma hydroxybutyrate sodiumOxybate sodiumSodium 4-hydroxybutyrateSodium Oxybate (Gamma Hydroxybutyrate Or Ghb)Sodium oxybutyrate
RxNorm CUI
9899
ChEMBL ID
CHEMBL1200682
UNII
7G33012534
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2005-10-13
Latest approval
2005-10-13
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2005-10-13Approval
Approval: Xyrem (EMA)

Indication: Treatment of narcolepsy with cataplexy in adult patients.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

27 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
27
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
15
Late-stage (III+)
20
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 27
Early Phase 11Phase 13Phase 1 / 21Phase 27Phase 2 / 32Phase 33Phase 49Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Sodium Oxybate Versus Midazolam for Comfort Sedation

CompletedPH IVCentre Hospitalier Intercommunal de Toulon La Seyne sur Mern=222023

Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial

CompletedPH IVStanford Universityn=242022

The Effect of Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

WithdrawnPH IVUniversity Hospital, Ghent2015

Slow-wave Sleep and Daytime Functioning in Chronic Fatigue Syndrome: Effects of Sodium Oxybate

CompletedPH IVImperial College Londonn=132015

Multinational, Multicentre, Double-blind, Placebo-controlled Evaluation of the Efficacy of GHB in the Long-term Maintenance of Abstinence in Alcoholic Patients After the Initial Weaning Phase, Stratified by Lesch's Taxonomy (GATE 2)

CompletedPH IVLaboratorio Farmaceutico Ct S.r.l.n=3142012

Recent completions

Trials that read out recently, adding to the completed evidence base.

Central Mechanisms and Treatment Response of Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor

CompletedPH II/IIIKristina Simonyann=1172024

Sodium Oxybate Versus Midazolam for Comfort Sedation

CompletedPH IVCentre Hospitalier Intercommunal de Toulon La Seyne sur Mern=222023

Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial

CompletedPH IVStanford Universityn=242022

Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response

CompletedPH IIKristina Simonyann=532017

A Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease

CompletedPH IIChristian Baumannn=162016

Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

CompletedN/AWashington University School of Medicinen=362016

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

An open-label study of sodium oxybate in Spasmodic dysphonia.

The Laryngoscope · 2017 · 44 cites
Recent papers

An open-label study of sodium oxybate in Spasmodic dysphonia.

The Laryngoscope · 2017 · 44 cites
Journals, researchers & institutions
Top journals
  • The Laryngoscope1
Leading researchers
  • Blitzer A1
  • Frucht SJ1
  • Rumbach AF1
  • Simonyan K1
Leading institutions
free-text, unnormalised
  • Icahn School of Medicine at Mount Sinai1
  • School of Health and Rehabilitation Sciences1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.