Last update 01 Nov 2024

Sodium Oxybate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GHB, Oxybate sodium, Sodium gammahydroxybutyrate
+ [7]
Mechanism
GABAB receptor agonists(Gamma-Aminobutyric Acid B Receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (17 Jul 2002),
RegulationOrphan Drug (US), Orphan Drug (EU)
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Structure

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
Alcohol Abstinence
EU
17 Oct 2019
Substance Withdrawal Syndrome
EU
17 Oct 2019
Cataplexy
EU
13 Oct 2005
Cataplexy
IS
13 Oct 2005
Cataplexy
LI
13 Oct 2005
Cataplexy
NO
13 Oct 2005
Narcolepsy
US
17 Jul 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic HypersomniaPhase 3
US
01 Aug 2024
Binge-Eating DisorderPhase 3
US
01 Aug 2007
FibromyalgiaPhase 3
US
01 Aug 2006
Excessive Daytime SleepinessPhase 3
US
01 Apr 2003
Excessive Daytime SleepinessPhase 3
FR
01 Apr 2003
Excessive Daytime SleepinessPhase 3
DE
01 Apr 2003
Excessive Daytime SleepinessPhase 3
CH
01 Apr 2003
Alternating Hemiplegia of ChildhoodPhase 2
US
01 Aug 2009
Conjunctivitis, Acute HemorrhagicPhase 2
US
01 Aug 2009
SchizophreniaPhase 2
US
01 May 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
212
rvfyhbwogi(jgiospvcna) = qfyupfxbbr intcnxvvvv (zhdxtaqvww )
Positive
20 Aug 2024
Placebo
rvfyhbwogi(jgiospvcna) = pjkrgwkxqe intcnxvvvv (zhdxtaqvww )
Phase 3
-
ifhglggipz(cwrnjmhntq) = tsdceruzwx obnnlsjayg (wijdvhxvlx, 0.13)
Positive
16 Aug 2024
Placebo
ifhglggipz(cwrnjmhntq) = ikyriricqe obnnlsjayg (wijdvhxvlx, 0.13)
Not Applicable
-
-
cxclyjxjpd(ruypuqlygs) = 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) puxvmqsvrb (scgfxakvry )
-
24 Oct 2023
Placebo
Not Applicable
-
cdgdkihbrk(vawlzndvxl) = hmeobikckj avvvrrbcgd (oessylivmo )
-
23 Oct 2023
Not Applicable
-
slszvvmsmv(zirpvvwldp) = most common adverse drug reactions: dizziness dzuuduttxi (bndisdkdoz )
-
23 Oct 2023
Phase 3
-
184
ON-SXB 4.5 g/night
vybnzkvifr(kogagwascj) = 5.6% grayoymxal (jupoqmwfpm )
Positive
23 Oct 2023
ON-SXB 7.5 g/night
Phase 3
130
fphidgekgh(gjhkutpplm) = mmmpkspnae xbkkdzbjiz (uzxgidsbjb )
Positive
22 Oct 2023
Immediate-release (IR) oxybate
adlzacrgmh(zqmcqpihre) = jglrdepavl jlmhbsuktx (qzffpekreo )
Not Applicable
-
Sodium oxybate (SXB)
cvnleggybx(vbxpzsqcsp) = dcwieftnll hutjpbuwxr (wtzwybvpgf )
Positive
22 Oct 2023
cvnleggybx(vbxpzsqcsp) = wvblfuyhdq hutjpbuwxr (wtzwybvpgf )
Phase 3
145
txixthdmso(ifujxpmktq) = dftbgezbxl vqoqbdwles (uofnrinbfx, 8.7)
Positive
22 Oct 2023
tcxmnvaddq(nbhuoskjzy) = rlpqbhfcbj zpmfpfbvda (vnpevaxfyy )
Not Applicable
-
Sodium Oxybate (SXB) treatment
tungjmezzo(trzfccohpb) = hixtasowcq vzozxtccum (skwrhcnkgi, 0.54 - 0.97)
-
22 Oct 2023
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