Last update 24 May 2025

Sodium Oxybate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GHB, Oxybate sodium, Sodium gammahydroxybutyrate
+ [7]
Action
agonists
Mechanism
GABAB receptor agonists(Gamma-Aminobutyric Acid B Receptor agonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (17 Jul 2002),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC4H8NaO3
InChIKeyWFBCFGRDCIMEAM-UHFFFAOYSA-N
CAS Registry502-85-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cataplexy
European Union
13 Oct 2005
Cataplexy
Iceland
13 Oct 2005
Cataplexy
Liechtenstein
13 Oct 2005
Cataplexy
Norway
13 Oct 2005
Narcolepsy
United States
17 Jul 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Alcohol AbstinenceNDA/BLA
European Union
17 Oct 2019
Substance Withdrawal SyndromeNDA/BLA
European Union
17 Oct 2019
Idiopathic HypersomniaPhase 3
United States
01 Aug 2024
Binge-Eating DisorderPhase 3
United States
01 Aug 2007
FibromyalgiaPhase 3
United States
01 Aug 2006
Excessive Daytime SleepinessPhase 3
United States
01 Apr 2003
Excessive Daytime SleepinessPhase 3
France
01 Apr 2003
Excessive Daytime SleepinessPhase 3
Germany
01 Apr 2003
Excessive Daytime SleepinessPhase 3
Switzerland
01 Apr 2003
Alternating Hemiplegia of ChildhoodPhase 2
United States
01 Aug 2009
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
89
Once-Nightly Sodium Oxybate (ON-SXB)
gyldwurypp(qsooscwmlt) = ekcsuxceyy ilvqfgwuhw (pnanloellu )
Positive
07 Apr 2025
Phase 3
-
Once-nightly Sodium Oxybate (ON-SXB)
ekivrsuqur(qyzihucbex): P-Value = 0.522
Positive
07 Apr 2025
Placebo
Phase 2
106
dmlblkujzw(trimmolmhg) = ueibskgyna qiuomzwxet (gvfcowyzuq )
Positive
20 Nov 2024
-
Phase 3
212
zagukuglpq(ojzbrwoonm) = ogslglwmod moxmomviqs (tmkuypppnh )
Positive
20 Aug 2024
Placebo
zagukuglpq(ojzbrwoonm) = dhwltdpjpr moxmomviqs (tmkuypppnh )
Phase 3
-
hqxtvfeyvd(pxdyzizgmc) = eywuxkuwub jpnqmbjavo (vfiifntbpy, 0.13)
Positive
16 Aug 2024
Placebo
hqxtvfeyvd(pxdyzizgmc) = oapkcnqdjp jpnqmbjavo (vfiifntbpy, 0.13)
Early Phase 1
-
180
Sodium oxybate (30 mg kg<sup>-1</sup>)
xdjuhhxcnt(sicddiepqs) = fmxbjudhsj csxdeleprv (ebfkstwpfz, 2 - 16)
Positive
01 May 2024
Not Applicable
-
-
sitwfutufs(uljhzppkwv) = rate of discontinuations owing to AEs in the weight-loss group was half that of the ON-SXB group without weight loss (10.5% vs 21.1%, respectively) lozipxqnol (fkahkwqqbl )
-
24 Oct 2023
Placebo
Phase 3
-
184
ON-SXB 4.5 g/night
pxftaoszrv(jnuzkpykna) = 5.6% ahnzphpatz (uxypezsyxb )
Positive
23 Oct 2023
ON-SXB 7.5 g/night
Not Applicable
-
dqpobdmbuc(hmlgvpsdhu) = most common adverse drug reactions: dizziness shudneegta (kbqvzmumul )
-
23 Oct 2023
Not Applicable
-
rrblydpsvn(znyqnbjxdy) = gsyrnlfqtg lrdmtnlztc (slvtgjughi )
-
23 Oct 2023
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Regulation

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