Drugs / Sodium Oxybate
Sodium Oxybate
also known as
Xyrem · JZP-258 · SXB · low-sodium oxybate · XYWAV · LXB · SMO · Brand name: Xyrem · +4 more
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LUMRYZ | — | 2024-10-16 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | XYREM | — | 2005-11-18 – 2020-09-25 | fda.gov ↗ |
| Approved | EU (EMA) | Xyrem | — | 2005-10-13 | europa.eu ↗ |
| Approved | US (FDA) | XYREM | — | 2002-07-17 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03626727 | Sep 2020 | hypersomnia, narcolepsy, traumatic brain injury | Brigham and Women's Hospital | Withdrawn | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT07041203 | Oct 2026 → Sep 2027 expected | spasmodic dystonia | Kristina Simonyan | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT00345800 | Apr 2006 → Jan 2008 | narcolepsy-cataplexy syndrome | UCB Pharma | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00931164 | Aug 2009 → Jan 2011 | alternating hemiplegia of childhood | University of Utah | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06950281 | Jan 2026 → Dec 2027 expected | cluster headache syndrome | Leiden University Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06809803 | Oct 2025 → Jun 2027 expected | narcolepsy 1 | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT02111122 | Apr 2014 → Apr 2016 | sleep-wake disorder | Christian Baumann | Completed | No outcome recorded |
| Phase 2 | NCT01961297 | Jul 2012 → Jun 2017 | spasmodic dystonia | Kristina Simonyan | Completed | No outcome recorded |
| Phase 2 | NCT00594256 | May 2008 → Apr 2009 | insomnia, schizophrenia | Nathan Kline Institute for Psychiatric Research | Completed | No outcome recorded |
| Phase 2 | NCT00598078 | Dec 2007 → Aug 2008 | essential tremor | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00330291 | Aug 2005 → Aug 2006 | post-traumatic stress disorder | State University of New York - Upstate Medical University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00641186 | Sep 2004 → Jul 2008 | Parkinson disease | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT00087555 | Jul 2004 → Apr 2005 | fibromyalgia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT03597555 | Oct 2018 → Apr 2023 | idiopathic hypersomnia | University Hospital, Montpellier | Completed | No outcome recorded |
| Phase 2/3 | NCT03292458 | Jan 2018 → Dec 2021 | spasmodic dystonia | Kristina Simonyan | Completed | No outcome recorded |
| Phase 2/3 | NCT00514995 | Aug 2007 → Apr 2011 | binge eating disorder | Lindner Center of HOPE | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT03533114 | Nov 2018 → Jun 2020 | idiopathic hypersomnia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03030599 | Mar 2017 → Jan 2019 | narcolepsy-cataplexy syndrome | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02720744 | Nov 2016 → Mar 2020 | hypersomnia, narcolepsy-cataplexy syndrome | Avadel | Completed | No outcome recorded |
| Phase 3 | NCT02637648 | Dec 2015 → Sep 2016 | cluster headache syndrome | Ramin Khatami | Unknown | No outcome recorded |
| Phase 3 | NCT02221869 | Oct 2014 → Feb 2017 | narcolepsy-cataplexy syndrome | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00803023 | Mar → Jul 2010 | fibromyalgia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00423605 | Dec 2006 → Jan 2010 | fibromyalgia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00423813 | Dec 2006 → Apr 2009 | fibromyalgia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00371137 | Aug 2006 → Sep 2008 | fibromyalgia | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00132873 | Oct 2004 → Sep 2007 | narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00066170 | Apr 2003 → Jul 2004 | narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00049803 | Dec 2000 → Apr 2004 | narcolepsy | Orphan Medical | Completed | No outcome recorded |
| Phase 414 trials | ||||||
| Phase 4 | NCT07077278 | Oct 2025 → Sep 2027 expected | idiopathic hypersomnia, postural orthostatic tachycardia syndrome | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05837091 | Feb 2024 → Jan 2027 expected | idiopathic hypersomnia | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 4 | NCT05875974 | Jul 2023 → Mar 2025 | idiopathic hypersomnia, narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT05869773 | Jun 2023 → Feb 2025 | narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT05085873 | Oct 2021 → Oct 2023 | — | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Completed | No outcome recorded |
| Phase 4 | NCT04794491 | Mar 2021 → Nov 2022 | narcolepsy | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02637076 | Jan 2016 → Jan 2020 | narcolepsy-cataplexy syndrome | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 4 | NCT02055898 | Apr 2014 → Aug 2015 | myalgic encephalomeyelitis/chronic fatigue syndrome | Imperial College London | Completed | No outcome recorded |
| Phase 4 | NCT01584934 | Jun 2013 → Jun 2015 | myalgic encephalomeyelitis/chronic fatigue syndrome | University Hospital, Ghent | Withdrawn | No outcome recorded |
| Phase 4 | NCT00506974 | May 2007 → Jun 2008 | — | St. Luke's Hospital, Chesterfield, Missouri | Completed | No outcome recorded |
| Phase 4 | NCT00086281 | Nov 2003 → Jun 2005 | obstructive sleep apnea syndrome | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT02090504 | Feb 2002 → Apr 2009 | alcohol dependence, alcohol withdrawal | Catholic University of the Sacred Heart | Completed | No outcome recorded |
| Phase 4 | NCT04648423 | Jul 2001 → Mar 2011 | alcohol dependence | Laboratorio Farmaceutico Ct S.r.l. | Completed | No outcome recorded |
| Phase 4 | NCT00706186 | — | Alzheimer disease | Clayton Sleep Insititute | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02063217 | Dec 2013 → Jul 2016 | — | Washington University School of Medicine | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02215499 Comparator | Jul → Nov 2014 | narcolepsy | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00744393 Comparator | Oct 2008 → Dec 2009 | — | Tufts Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT00383643 Comparator | May 2006 → Dec 2009 | sleep disorder, initiating and maintaining sleep | Stanford University | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07625280 Comparator | Jun 2026 → Dec 2027 expected | idiopathic hypersomnia, narcolepsy | Jazz Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04006925 Comparator | Sep 2019 → Feb 2022 | Parkinson disease, REM sleep behavior disorder | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT00498485 Comparator | May 2007 → Dec 2008 | myalgic encephalomeyelitis/chronic fatigue syndrome | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sodium oxybate | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 202536“This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM).” PMID 21397402 ↗ Mar 2011 “Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency.” NCT00330291 ↗ “Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.” NCT00423605 ↗ “Xyrem (sodium oxybate) oral solution” NCT00132873 ↗ “Xyrem (Sodium Oxybate) Oral Solution” NCT00086281 ↗ “Xyrem® (Sodium Oxybate)” NCT00423813 ↗ |
| Known as | Brand name: Xyrem | “Brand name: Xyrem” NCT02111122 ↗ |
| Known as | FT218 | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 2025 |
| Known as | JZP-258 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03533114 ↗ |
| Known as | low-sodium oxybate | “Using data from a phase 3 trial of low-sodium oxybate in adults with idiopathic hypersomnia (NCT03533114), IHSS scores were psychometrically evaluated at Baseline, Weeks 1 and...” PMID 42382222 ↗ Jun 2026 |
| Known as | lower-sodium oxybate | “Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study.” PMID 34942138 ↗ Jan 2022 |
| Known as | LUMRYZ | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 2025 |
| Known as | LXB | “Low sodium oxybate (LXB) will be administered as a twice nightly regimen.” NCT06950281 ↗1“Low sodium oxybate (LXB)” NCT07077278 ↗ |
| Known as | ON-SXB | “Once-nightly sodium oxybate (ON-SXB; LUMRYZ™; FT218) treatment significantly improved the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness Test...” PMID 40111739 ↗ Mar 2025 |
| Known as | SMO | “Sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results.” NCT02090504 ↗1“Sodium oxybate (SMO) has been shown to be effective in the maintenance of abstinence” PMID 35796481 ↗ Jul 2022 |
| Known as | SXB | “The long-term safety and therapeutic response of sodium oxybate (SXB) in fibromyalgia syndrome (FM) patients were assessed for a combined period of up to 1 year in a...” PMID 24286114 ↗ Nov 20134“STUDY OBJECTIVES: To determine the time course and duration of common, early-onset treatment-emergent adverse events (TEAEs) associated with sodium oxybate (SXB) use in adults...” PMID 32356515 ↗ Sep 2020 “This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM).” PMID 21397402 ↗ Mar 2011 “we aimed to evaluate efficacy and safety of sodium oxybate (SXB) in IH.” PMID 40359459 ↗ May 2025 “Sodium oxybate (SXB), a gamma-aminobutyric acid (GABA)-B agonist” PMID 37052688 ↗ Aug 2023 |
| Known as | Xyrem | “Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and...” NCT06809803 ↗14“We conducted an open-label study in 23 SD and 22 SD/VT patients to examine the effects of sodium oxybate (Xyrem), an oral agent with therapeutic effects similar to those of...” PMID 27808415 ↗ Nov 2016 “Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients” NCT00049803 ↗ “Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.” NCT00423605 ↗ “Xyrem (Sodium Oxybate), oral solution 500mg/mL” NCT03597555 ↗ “Xyrem (sodium oxybate) oral solution” NCT00087555 ↗ “Sodium Oxybate Oral Solution [Xyrem]” NCT03626727 ↗ “sodium oxybate (Xyrem®)” NCT03292458 ↗ |
| Known as | XYWAV | “Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and...” NCT06809803 ↗2“Participants will self-administer an oral dose of JZP258 (XYWAV) as per label and titrate to an optimal dosage for each participant.” NCT05875974 ↗ |
| Action | Activate | “a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist” NCT00594256 ↗ |
| Route | Oral | “Orally Administered Xyrem (Sodium Oxybate)” NCT00049803 ↗ |