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xywav

Generic: calcium, magnesium, potassium, and sodium oxybates

xywav: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

xywav evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect xywav to JAZZ; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could xywav → JAZZ affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
Jazz Pharmaceuticals plc (JAZZ)
Narcolepsy
Phase 4
Clinical Trials (1)

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Efficacy and Safety of Expanded Dosing Regimens for Xywav in Adult Participants With Narcolepsy or Idiopathic Hypersomnia

NCT07625280·Phase 3·JAZZ
Recruiting

Primary endpoint: Change in Epworth Sleepiness Scale (ESS) scores

InterventionalRandomizedquadruple120 targetStarted 2026-07Completion 2028-013 sites · United StatesJazz Pharmaceuticals
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE XYWAV is a central nervous system depressant indicated for the treatment of: • Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1.1 ). • Idiopathic Hypersomnia (IH) in adults ( 1.2 ). 1.1 Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. 1.2 Idiopathic Hypersomnia XYWAV is indicated for the treatment of idiopathic hyp(JAZZ)FDA ↗
NDA212690Type 2 - New Active IngredientOrphan DrugPriorityOralSolution

Frequently asked questions

Who is developing xywav?

xywav is being developed by Jazz Pharmaceuticals plc.

How many clinical trials involve xywav?

BioSniper tracks 1 clinical trial involving xywav.

What is xywav's latest FDA decision?

The most recent tracked FDA decision for xywav is Approval for 1 INDICATIONS AND USAGE XYWAV is a central nervous system depressant indicated for the treatment of: • Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1.1 ). • Idiopathic Hypersomnia (IH) in adults ( 1.2 ). 1.1 Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. 1.2 Idiopathic Hypersomnia XYWAV is indicated for the treatment of idiopathic hyp, dated July 21, 2020.