Xyrem
(sodium oxybate)ApprovedSmall molecule
Jazz PharmaceuticalsSodium oxybate is used to treat narcolepsy, a condition where people fall asleep suddenly and unexpectedly during the day, and it also helps reduce muscle weakness episodes that can occur with this condition.[2] Xyrem is currently approved and in use across 11 indications[4].[1]
Xyrem is one of 92 small molecule programs targeting Narcolepsy-Cataplexy Syndrome. It is currently in Approved.
11
Indications
30
Total Trials
3
Active Trials
91
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
58 competitors in Children
#DrugCompanyPhaseTrials
1Promacta
GSKApproved
Gleevec
NovartisApproved
Ozempic
Novo NordiskApproved
Oncaspar
SServier
Approved
Xyrem
Jazz PharmaceuticalsApproved
Velcade
SShilpa Grover, MD, MPH
Approved
Sprycel
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Approved
Byetta
AstraZenecaPhase 3
Neurontin
VViatris Specialty LLC
Phase 3
Somavaratan
Novo NordiskPhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Chronic Fatigue Syndrome3 trials
Tremor3 trials
Sleep2 trials
20 more indications
Single Dose1 trial
Alzheimer's Disease1 trial
Excessive Daytime Sleepiness1 trial
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
Completed·—·Phase 2·NCT00641186·30 enrolled
Alternating Hemiplegia of Childhood1 trial
Parkinson's Disease1 trial
REM sleep behavior disorder1 trial
Efficacy1 trial
Fibromyalgia1 trial
Essential Tremor1 trial
Insomnia1 trial
Sedation1 trial
Sodium Oxybate Versus Midazolam for Comfort Sedation
Completed·—·Phase 4·NCT05085873·22 enrolled
Alcohol Withdrawal1 trial
Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome
Completed·—·Phase 4·NCT02090504·127 enrolled
Hypersomnia1 trial
TIA1 trial
Safety and Efficacy1 trial
Regulatory
FDA Approval Timeline[5]
Jul 17, 2002
XYREM
NDA NDA021196
May 1, 2023
LUMRYZ
NDA NDA214755
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Xyrem drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for sodium oxybate. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- GABA-B Receptor Agonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company