MedPath

Quinidine

Generic Name
Quinidine
Brand Names
Nuedexta
Drug Type
Small Molecule
Chemical Formula
C20H24N2O2
CAS Number
56-54-2
Unique Ingredient Identifier
ITX08688JL

Overview

Quinidine is a D-isomer of quinine present in the bark of the Cinchona tree and similar plant species. This alkaloid was first described in 1848 and has a long history as an antiarrhythmic medication. Quinidine is considered the first antiarrhythmic drug (class Ia) and is moderately efficacious in the acute conversion of atrial fibrillation to normal sinus rhythm. It prolongs cellular action potential by blocking sodium and potassium currents. A phenomenon known as “quinidine syncope” was first described in the 1950s, characterized by syncopal attacks and ventricular fibrillation in patients treated with this drug. Due to its side effects and increased risk of mortality, the use of quinidine was reduced over the next few decades. However, it continues to be used in the treatment of Brugada syndrome, short QT syndrome and idiopathic ventricular fibrillation.

Indication

Quinidine is indicated for the management and prophylactic therapy of atrial fibrillation/flutter, as well as the suppression of recurrent documented ventricular arrhythmias. It is also used in the treatment of Brugada syndrome, short QT syndrome and idiopathic ventricular fibrillation..

Associated Conditions

  • Atrial Fibrillation or Flutter
  • Malaria caused by Plasmodium falciparum
  • Pseudobulbar Affect (PBA)
  • Ventricular Arrhythmia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/05/19
Phase 1
Recruiting
2025/05/16
Phase 1
Active, not recruiting
2025/02/26
Phase 1
Completed
2024/11/26
Phase 1
Completed
2024/07/10
Phase 1
Recruiting
2022/10/26
Phase 1
Completed
2022/10/25
Phase 2
ENROLLING_BY_INVITATION
2022/07/06
Phase 1
Completed
2021/03/05
Phase 1
Completed
2018/11/28
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Eon Labs, Inc.
0185-1047
ORAL
300 mg in 1 1
9/13/2019
Sun Pharmaceutical Industries, Inc.
53489-141
ORAL
324 mg in 1 1
2/1/2018
Carilion Materials Management
68151-2701
ORAL
324 mg in 1 1
2/13/2015
Otsuka America Pharmaceutical, Inc
59148-053
ORAL
10 mg in 1 1
12/31/2022
Eon Labs, Inc.
0185-4346
ORAL
200 mg in 1 1
9/13/2019
Eywa Pharma Inc
71930-016
ORAL
324 mg in 1 1
12/29/2021
Carilion Materials Management
68151-1991
ORAL
200 mg in 1 1
10/4/2012
EPIC PHARMA, LLC
42806-513
ORAL
200 mg in 1 1
12/15/2021
Richmond Pharmaceuticals, Inc.
54738-901
ORAL
324 mg in 1 1
3/6/2019
EPIC PHARMA, LLC
42806-512
ORAL
300 mg in 1 1
12/15/2021

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
Quinidine Sulfate Tablets
国药准字H11020970
化学药品
片剂
11/27/2020

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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