Drugs / Ibutilide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CORVERT | — | 1999-05-13 | fda.gov ↗ |
| Approved | US (FDA) | CORVERT | — | 1995-12-28 | fda.gov ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT01929083 | Apr 2013 → Jun 2014 | long QT syndrome | Indiana University | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT04675788 | Sep 2021 → Apr 2025 | long QT syndrome | Indiana University | Completed | No outcome recorded |
| Phase 4 | NCT03834883 | Mar 2019 → May 2024 | long QT syndrome | Indiana University | Completed | Mixed |
| Phase not applicable3 trials · 1 missed | ||||||
| — | NCT03370536 | Nov 2017 → Jul 2018 | persistent atrial fibrillation | Vivek Reddy | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01014741 | Oct 2009 → Jan 2015 | persistent atrial fibrillation | Vivek Reddy | Completed | Missed primary |
| — | NCT00589992 | Oct 2007 → Dec 2015 | atrial fibrillation | Ball Memorial Hospital | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 4 | NCT02513940 Background | May 2016 → Oct 2017 | long QT syndrome | Indiana University | Completed | Mixed |
| Phase 4 | NCT01447862 Comparator | Oct 2011 → May 2015 | atrial fibrillation | Medical University of Vienna | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ibutilide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02513940 ↗ |
| Known as | Corvert | “Drug: Corvert (Ibutilide)” NCT01447862 ↗ |
| Known as | Ibutilida | ChEMBL registry synonym — accepted as the source's own label CHEMBL533 ↗ |
| Known as | IBUTILIDE FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL533 ↗ |
| Known as | U-70226E | ChEMBL registry synonym — accepted as the source's own label CHEMBL533 ↗ |
| Action | Inhibit | “HERG blocker” CHEMBL533 ↗ |
| Modality | Small molecule | — CHEMBL533 ↗ |
| Route | Intravenous | “ibutilide will be administered intravenously” NCT00589992 ↗ |
| Target | KCNH2 | “HERG blocker” CHEMBL533 ↗ |