Last update 08 May 2025

Sodium Oxybate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GHB, Oxybate sodium, Sodium Hydroxybutyrate
+ [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 (European Union)
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Structure/Sequence

Molecular FormulaC4H8O3
InChIKeySJZRECIVHVDYJC-UHFFFAOYSA-N
CAS Registry591-81-1
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cataplexy
Iceland
13 Oct 2005
Cataplexy
Norway
13 Oct 2005
Cataplexy
Liechtenstein
13 Oct 2005
Cataplexy
European Union
13 Oct 2005
Narcolepsy
United States
17 Jul 2002
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Alcohol AbstinencePhase 1
European Union
17 Oct 2019
Substance Withdrawal SyndromePhase 1
European Union
17 Oct 2019
FibromyalgiaPhase 1
United States
01 Aug 2006
Excessive Daytime SleepinessPhase 1
United States
01 Apr 2003
Excessive Daytime SleepinessPhase 1
Germany
01 Apr 2003
Excessive Daytime SleepinessPhase 1
Switzerland
01 Apr 2003
Excessive Daytime SleepinessPhase 1
France
01 Apr 2003
NarcolepsyPhase 1
France
01 Apr 2003
NarcolepsyPhase 1
Germany
01 Apr 2003
NarcolepsyPhase 1
Switzerland
01 Apr 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
106
fmaeneajbo(iircrbeyjb) = evahosyous rsvjaruvrz (xblwtsmkzd )
Positive
20 Nov 2024
-
Phase 3
212
(iwshmgoevw) = hbvyvkfyey apefapetmi (hmmkdnkfao )
Positive
20 Aug 2024
Placebo
(iwshmgoevw) = ugthgnubjr apefapetmi (hmmkdnkfao )
Phase 3
-
(bfzlhnbnug) = dtdjonyccw dclxbuqazr (yamxfthbea, 0.13)
Positive
16 Aug 2024
Placebo
(bfzlhnbnug) = euuvbbdutc dclxbuqazr (yamxfthbea, 0.13)
Not Applicable
-
-
(mbhquusymw) = 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) usjwciarif (cdkqfvwfwl )
-
24 Oct 2023
Placebo
Not Applicable
-
(henaojqamv) = most common adverse drug reactions: dizziness iqcrvxwfpq (leocoohvdj )
-
23 Oct 2023
Not Applicable
-
ffqtkgbtje(oonhbfgyxt) = wiunghgcro hpavqqmazm (kkkrzaznhw )
-
23 Oct 2023
Phase 3
130
mzcvfichgb(aruhvlbjnz) = pdeeuiakkp dxgenznxbw (mqoavraapw )
Positive
22 Oct 2023
Immediate-release (IR) oxybate
suolvtlafr(nwxpuybcui) = gsjqajuati ujoeytdmkz (aoqrujmsko )
Phase 3
145
iveipixakk(jiqqbbgfqz) = gltvyfmtpu rsatkgklnw (xsxyhsxcyw, 8.7)
Positive
22 Oct 2023
dwjtzgmwqe(rqvxaidnhr) = okuqfoeacb dggweagnpz (opxaodrqnu )
Not Applicable
-
Sodium oxybate (SXB)
lepzpixruz(hujrxthhwe) = wozakqxpou xegluxcoci (iphiyvplzl )
Positive
22 Oct 2023
lepzpixruz(hujrxthhwe) = fplrctyyzi xegluxcoci (iphiyvplzl )
Phase 3
-
185
(Group A: prior participation in the phase 3 REST-ON clinical trial)
ejjqtokemf(opwoljeesa) = Fifty-one participants (27.6%) discontinued from the study (withdrew consent, n = 25 [13.5%]; adverse events, n = 9 [4.9%]) pvchwijnzp (edarqhbhel )
Positive
01 Sep 2023
(Group B: switch from stable immediate-release (IR) oxybate)
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