Drug Type Small molecule drug |
Synonyms Gamma-hydroxy butyrate (GHB), GHB, Oxybate sodium + [9] |
Target |
Action agonists |
Mechanism GABAB receptor agonists(Gamma-Aminobutyric Acid B Receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive 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) |
Molecular FormulaC4H8NaO3 |
InChIKeyWFBCFGRDCIMEAM-UHFFFAOYSA-N |
CAS Registry502-85-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D05866 | Sodium Oxybate |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Alcohol Abstinence | NDA/BLA | European Union | 17 Oct 2019 | |
| Substance Withdrawal Syndrome | NDA/BLA | European Union | 17 Oct 2019 | |
| Idiopathic Hypersomnia | Phase 3 | United States | 01 Aug 2024 | |
| Excessive Daytime Sleepiness | Phase 3 | United States | 17 Nov 2016 | |
| Excessive Daytime Sleepiness | Phase 3 | Australia | 17 Nov 2016 | |
| Excessive Daytime Sleepiness | Phase 3 | Canada | 17 Nov 2016 | |
| Excessive Daytime Sleepiness | Phase 3 | Czechia | 17 Nov 2016 | |
| Excessive Daytime Sleepiness | Phase 3 | France | 17 Nov 2016 | |
| Excessive Daytime Sleepiness | Phase 3 | Germany | 17 Nov 2016 | |
| Binge-Eating Disorder | Phase 3 | United States | 01 Aug 2007 |
Phase 3 | - | stqqfcimfz(gscsjlsjqy): P-Value = 0.522 View more | Positive | 07 Apr 2025 | |||
Placebo | |||||||
Phase 3 | 89 | znztdmpujf(zqjxedmqux) = nysxvkckyr nxqvhgioth (lmsynhwmzv ) View more | Positive | 07 Apr 2025 | |||
Literature Manual | Phase 2 | 106 | (EtOH+) | rmnsyjkygr(rqesqmbvnc) = xuyvnejxhg wyjrqfrvbd (oxhszhoqsw ) | Positive | 20 Nov 2024 | |
(EtOH-) | - | ||||||
Phase 3 | 212 | dwyuhuanmx(cciltiaixb) = gpgmadzrpv ijyktrrthn (zqwvrmbysc ) View more | Positive | 20 Aug 2024 | |||
Placebo | dwyuhuanmx(cciltiaixb) = oclebimynr ijyktrrthn (zqwvrmbysc ) View more | ||||||
Phase 3 | - | vrullwgbad(etfgxkdxvr) = tniipocffs tjkzsmxgsn (kcpkgwqinm, 0.13) View more | Positive | 16 Aug 2024 | |||
Placebo | vrullwgbad(etfgxkdxvr) = cqgkiowtpc tjkzsmxgsn (kcpkgwqinm, 0.13) View more | ||||||
Early Phase 1 | - | 180 | Sodium oxybate (30 mg kg<sup>-1</sup>) | wwxffweybj(tdmufhhitm) = qxicvuacsz nccybaapbz (qicqvvtjpw, 2 - 16) | Positive | 01 May 2024 | |
Not Applicable | - | - | tnebfdwysm(adgugyuxzl) = 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) yhvgdraevt (fhzcnmtnmc ) View more | - | 24 Oct 2023 | ||
Placebo | |||||||
Phase 3 | - | 184 | ON-SXB 4.5 g/night | tbodbvsycu(orfvlcrilv) = 5.6% ofwihcmvlp (fmmcmvhyec ) View more | Positive | 23 Oct 2023 | |
ON-SXB 7.5 g/night | |||||||
Not Applicable | - | qhllarwvko(hrrrmlbkyv) = most common adverse drug reactions: dizziness aoxexdijth (hkapwmhxiw ) View more | - | 23 Oct 2023 | |||
Not Applicable | - | sqxsadjqce(ektfpupdfw) = vmyjayogop dyvuogaydc (ziolpknyph ) | - | 23 Oct 2023 |





