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XYWAV
Xywav works by interacting with a specific target in the body to produce a desired effect.
Xywav is a small molecule developed by Leiden University Medical Center, but its target, drug class, and approved indications are unknown. As a small molecule, it is a type of pharmaceutical compound that can be taken orally. The commercial status of Xywav is unclear, and it is owned by Leiden University Medical Center. Further information on its safety and efficacy is not available. More research is needed to understand its potential benefits and risks.
At a glance
| Generic name | XYWAV |
|---|---|
| Sponsor | Leiden University Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Mechanism of action
Imagine your body's cells have locks on them, and Xywav has a key that fits into one of those locks. When the key fits, it allows the cell to do its job in a different way, which can help treat a medical condition. This is a simplified explanation of how Xywav works at a molecular level.
Approved indications
Boxed warnings
- WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses [see Warnings and Precautions ( 5.1 , 5.4 )]. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving central nervous system stimulants [see Clinical Studies ( 14.1 , 14.2 , 14.3 )]. • Abuse a
Common side effects
- Headache
- Nausea
- Dizziness
- Decreased appetite
- Parasomnia
- Diarrhea
- Hyperhidrosis
- Anxiety
- Vomiting
- Fatigue
- Dry mouth
- Depressed mood
Key clinical trials
- Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy (PHASE2)
- Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks (PHASE2)
- Extended-release Sodium Oxybate in Children (PHASE2)
- A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy (PHASE4)
- Low Sodium Oxybate in Patients With Idiopathic Hypersomnia (PHASE4)
- A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy (PHASE4)
- An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy (PHASE4)
- A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |