Drugs / KP415
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | attention deficit-hyperactivity disorder | — | “A New Drug Application (NDA) for KP415 is currently under review with the U.S. Food and Drug Administration (FDA)” zevra.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03460652 | Mar 2018 → Jun 2019 | attention deficit-hyperactivity disorder | Zevra Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-03-02 | ZevraDenmark | Regulatory KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD zevra.com ↗ |
All press releases naming this drug 2 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KP415 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03460652 ↗ |
| Route | Oral | “Once-daily oral dose” NCT03460652 ↗ |