NDAORALSOLUTIONPriority Review
Approved
Jul 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYWAV is an oral solution containing calcium, magnesium, potassium, and sodium oxybates approved by FDA in July 2020. It is indicated for narcolepsy and addresses the sodium content concerns of earlier oxybate formulations by distributing the active ingredient across multiple mineral salts. The drug works by enhancing GABAergic and GHB receptor-mediated neurotransmission to reduce excessive daytime sleepiness and cataplexy.
$169MPart D
Peak14.3 years to LOEProduct is in peak revenue stage with substantial Part D utilization, supporting a mature commercial infrastructure with stable brand management and field presence.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
Started Jul 2026
120 enrolled
NarcolepsyIdiopathic Hypersomnia
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
Started Jul 2023
199 enrolled
Idiopathic HypersomniaNarcolepsy
A Switch Study From High-Sodium Oxybate to Xywav to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Started Jun 2023
155 enrolled
Narcolepsy
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
Started Apr 2021
110 enrolled
Narcolepsy
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
Started Mar 2021
62 enrolled
Narcolepsy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.