Drugs / Vernakalant
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Brinavess | — | 2010-09-01 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT00526136 | Mar 2007 → Jul 2008 | atrial fibrillation | Advanz Pharma | Completed | Met primary |
| Phase 2 | NCT00267930 | Dec 2005 → Aug 2006 | atrial fibrillation | Advanz Pharma | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00476112 | Aug 2003 → Sep 2004 | atrial flutter | Advanz Pharma | Completed | No outcome recorded |
| Phase 38 trials · 3 met primary | ||||||
| Phase 3 | NCT04748991 | Sep 2026 → Jan 2028 expected | atrial fibrillation | University of Calgary | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT01174160 | Aug 2010 → Sep 2012 | atrial fibrillation | Advanz Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00989001 | Oct 2009 → Nov 2010 | atrial fibrillation | Advanz Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT00668759 | Apr 2008 → Oct 2009 | atrial fibrillation | Advanz Pharma | Completed | Met primary |
| Phase 3 | NCT00281554 | Oct 2005 → Jan 2007 | atrial fibrillation | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00115791 | Jun 2004 → Jun 2005 | atrial fibrillation, atrial flutter | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00125320 | Jun 2004 → Feb 2007 | atrial fibrillation, atrial flutter | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT00468767 | Aug 2003 → Nov 2004 | atrial fibrillation | Advanz Pharma | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT01627106 | Sep 2012 → Feb 2016 | atrial fibrillation | Advanz Pharma | Withdrawn | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 4 | NCT04485195 Comparator | Jun 2021 → Sep 2024 | atrial fibrillation | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT03005366 Comparator | Jan 2017 → Jun 2023 | paroxysmal atrial fibrillation | David Filgueiras-Rama | Completed | No outcome recorded |
| Phase 4 | NCT01646281 Comparator | Aug 2012 → Aug 2013 | atrial fibrillation | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01447862 Comparator | Oct 2011 → May 2015 | atrial fibrillation | Medical University of Vienna | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vernakalant | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00526136 ↗ |
| Known as | Brinavess | “Drug: Brinavess (Vernakalant)” NCT01447862 ↗ |
| Known as | Kynapid | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111112 ↗ |
| Known as | RSD1235 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00125320 ↗ |
| Known as | Vernakalant hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111112 ↗ |
| Known as | Vernakalant hydrochloride | “Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial.” PMID 18332267 ↗ Mar 2008 |
| Action | Inhibit | “Atria-preferential and atrial-specific blockade group using intravenous vernakalant.” NCT03005366 ↗4“Voltage-gated potassium channel subunit Kv1.5 blocker” CHEMBL2111112 ↗ “Voltage-gated potassium channel subunit Kv4.3 blocker” CHEMBL2111112 ↗ “Sodium channel protein type V alpha subunit blocker” CHEMBL2111112 ↗ “HERG blocker” CHEMBL2111112 ↗ |
| Modality | Other / unclassified | “Vernakalant is a novel, relatively atrial-selective antiarrhythmic agent” PMID 22291438 ↗ Jan 2012 |
| Route | Intravenous | “2 intravenous doses of RSD1235” NCT00125320 ↗ |
| Target | KCNA5 | “Voltage-gated potassium channel subunit Kv1.5 blocker” CHEMBL2111112 ↗ |
| Target | KCND3 | “Voltage-gated potassium channel subunit Kv4.3 blocker” CHEMBL2111112 ↗ |
| Target | KCNH2 | “HERG blocker” CHEMBL2111112 ↗ |
| Target | SCN5A | “Sodium channel protein type V alpha subunit blocker” CHEMBL2111112 ↗ |