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xywav

Generic: calcium, magnesium, potassium, and sodium oxybates

xywav: sourced relationships with 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.

Dated Pipeline Records (1)
CompanyDated record stage
Jazz Pharmaceuticals plc (JAZZ)
developer · Reported 2026-02-24 · Current development: unknownSource
Narcolepsy
Phase 4
Clinical Trial Registry Records (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

NCT07625280Registry updated 2026-10-08·Phase 3·JAZZ
Recruiting

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

InterventionalRandomizedquadruple120 targetStarted 2026-07Completion 2028-0115 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 hypersomnia (IH) in adults.(JAZZ)FDA ↗
NDA212690Type 2 - New Active IngredientOrphan DrugPriorityOralSolution

Frequently asked questions

Which companies have sourced relationships with xywav?

xywav has dated SEC/FDA relationship records for 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 hypersomnia (IH) in adults., dated July 21, 2020.