Overview
Vernakalant was developed by Cardiome Pharma as as an antiarrhythmic drug intended for rapid conversion of atrial fibrillation to sinus rhythm. It acts as an atypical class III antiarrhythmic drug that potentiates its effect in higher heart rates. Intravenous formulation was approved in Europe in September 2010 as Brinavess and in Canada in April 2017. It is an investigational drug under regulatory review by FDA.
Indication
Indicated for the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults for non-surgery patients that lasts for less than 7 days of duration and post-cardiac surgery patients with atrial fibrillation lasting less than 3 days of duration.
Associated Conditions
- Atrial Fibrillation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/02/10 | Phase 3 | Not yet recruiting | |||
2020/07/24 | Phase 4 | Completed | |||
2016/12/29 | Phase 4 | Completed | David Filgueiras-Rama | ||
2012/07/20 | Phase 4 | UNKNOWN | |||
2012/06/25 | Phase 4 | Withdrawn | Advanz Pharma | ||
2011/10/06 | Phase 4 | Completed | |||
2011/06/10 | N/A | Completed | Correvio International Sarl | ||
2010/08/03 | Phase 3 | Completed | Advanz Pharma | ||
2009/10/02 | Phase 3 | Terminated | Advanz Pharma | ||
2008/04/29 | Phase 3 | Completed | Advanz Pharma |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/1/2010 | ||
Authorised | 9/1/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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