Drugs / Xywav
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XYWAV | — | 2020-07-21 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06809803 | Oct 2025 → Jun 2027 expected | narcolepsy 1 | Stanford University | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07625280 Comparator | Jun 2026 → Dec 2027 expected | idiopathic hypersomnia, narcolepsy | Jazz Pharmaceuticals | Not yet recruiting | No outcome recorded |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Xywav | “Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and...” NCT06809803 ↗ |
| Route | Oral | “4.5-9 g orally per night” NCT06809803 ↗ |