Ibutilide

Overview

Ibutilide is a Class III antiarrhythmic agent available in intravenous formulations. It is indicated for the conversion of acute atrial flutter and recent onset atrial fibrillation to normal sinus rhythm (NSR).

Indication

Indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm.

Associated Conditions

Atrial Fibrillation
Atrial Flutter

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening	2020/12/19	NCT04675788	Phase 4	Completed	Indiana University
Reducing the Risk of Drug-Induced QT Interval Lengthening in Women	2019/02/08	NCT03834883	Phase 4	Completed	Indiana University
ECGi Ibutilide: Effect of Ibutilide on AF Source Location and Organization	2017/12/12	NCT03370536	Not Applicable	Terminated	Vivek Reddy
Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes	2015/08/03	NCT02513940	Phase 4	Completed	Indiana University
Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening	2013/08/27	NCT01929083	Phase 2	Completed	Indiana University
Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation	2011/10/06	NCT01447862	Phase 4	Completed	Medical University of Vienna
Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation	2009/11/17	NCT01014741	Not Applicable	Completed	Vivek Reddy
Ibutilide Administration During Pulmonary Vein Ablation	2008/01/10	NCT00589992	Not Applicable	UNKNOWN	Ball Memorial Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Corvert	Pharmacia & Upjohn Company LLC	0009-3794	INTRAVENOUS	0.1 mg in 1 mL	9/25/2023
Ibutilide Fumarate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-326	INTRAVENOUS	1 mg in 10 mL	4/2/2024
Corvert	Pharmacia & Upjohn Company LLC	0009-3794	INTRAVENOUS	0.1 mg in 1 mL	9/13/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CORVERT	Pfizer Canada Ulc	02242470	Solution - Intravenous	0.1 MG / ML	11/28/2000

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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