Quinidine Gluconate

(quinidine)

ApprovedSmall molecule

Quinidine Gluconate is a small molecule that works as a Sodium Channel Alpha Subunit Blocker; Sodium Channel Alpha Subunit Blocker.[2] It is being used across 10 indications, with its most advanced program in Approved.[1]

Quinidine Gluconate is one of 274 small molecule programs targeting Constipation. It is currently in Approved.

Indications

Total Trials

Active Trials

273

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiac ArrhythmiaActive, not recruiting

Hepatitis B Virus InfectionApproved

Depressive DisorderApproved

Migraine DisorderApproved

Amyotrophic Lateral SclerosisApproved

Non-Alcoholic SteatohepatitisApproved

Multiple SclerosisApproved

Major Depressive DisorderApproved

Diabetic NeuropathyApproved

Cardiac ArrhythmiaApproved

Active, not recruiting

Hepatitis B Virus InfectionApproved

Approved

Depressive DisorderApproved

Approved

Migraine DisorderApproved

Approved

Amyotrophic Lateral SclerosisApproved

Approved

Non-Alcoholic SteatohepatitisApproved

Approved

Multiple SclerosisApproved

Approved

Major Depressive DisorderApproved

Approved

Diabetic NeuropathyApproved

Approved

Competition

Competitive Landscape

138 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Quinidine Gluconate

WWyeth-Lederle Vaccines

Approved

21 2

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

2 3

Versed

CConrado Roberto Hoffmann Filho

Phase 3

2 4

Vumerity

Biogen

Phase 3

5 5

Clemastine Fumarate

Novartis

Phase 3

2 6

Mayzent

Novartis

Phase 3

2 7

Antihistamine

Arrowhead Pharmaceuticals

Phase 3

2 8

Frexalimab

Sanofi

Phase 3

2 9

Tolebrutinib

Sanofi

Phase 3

5 10

PBR06

UUniversity Hospital, Bordeaux

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Interaction6 trials

A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06704763·27 enrolled

Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT05594602·36 enrolled

Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT03755778·72 enrolled

Show 3 more trials

Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT03610945·48 enrolled

A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT06847464·48 enrolled

Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT04783753·72 enrolled

Tics3 trials

Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01533155·214 enrolled

A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06974565·16 enrolled

Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02171624·42 enrolled

Cardiac Arrest1 trial

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)

Completed·UUniversity of Washington·Phase 3·NCT00000464

Atrial Fibrillation1 trial

Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000556

Dapagliflozin1 trial

A Study to Investigate the Effect of Food on Balcinrenone/Dapagliflozin Pharmacokinetics in Fed and Fasted State and Pharmacokinetics of Balcinrenone When Dosed With a P-gp Inhibitor in Healthy Participants.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06979388·14 enrolled

6 more indications

Idiopathic Ventricular Fibrillation1 trial

Quinidine Versus Verapamil in Short-coupled Idiopathic Ventricular Fibrillation

Unknown status·—·Phase 2·NCT05593757·24 enrolled

Single Dose1 trial

A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06493409·32 enrolled

Lenalidomide1 trial

Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01712828·31 enrolled

CAR1 trial

Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)

Completed·UUniversity of Utah·Phase 3·NCT00000518

Female1 trial

A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05444556·113 enrolled

Unspecified4 trials

Empiric Quinidine for Asymptomatic Brugada Syndrome

Withdrawn·IInternational Registry of Asymptomatic Brugada Syndrome·Phase 2/3·NCT00789165

A Study to Evaluate the Effect of Genotype on LY2216684

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01460381·18 enrolled

A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Embibatinib, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of Embibatinib.

Completed·TTerns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·Phase 1·NCT07838987·196 enrolled

Show 1 more trial

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Tolerability of NX-5948 Tablets Following Single and Multiple Ascending Doses, the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, the Effect of NX-5948 on the QT Interval, the Effect of Food on the Pharmacokinetics of NX-5948, Drug-Drug Interactions With NX-5948, and the Intra-Subject Variability of the Bioavailability of NX-5948 Capsules

Completed·NNurix Therapeutics, Inc.·Phase 1·NCT06717269·223 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

DURAQUIN

NDA NDA017917

Jan 1, 1982

QUINAGLUTE

NDA NDA016647

Jan 1, 1982

QUINIDEX

NDA NDA012796

Feb 10, 1989

QUINIDINE GLUCONATE

NDA NDA007529

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for quinidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — quinidine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for quinidine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA007529). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Wyeth-Lederle Vaccines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker; Sodium Channel Alpha Subunit Blocker[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWyeth-Lederle Vaccines

Quinidine Gluconate

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Interaction6 trials

Tics3 trials

Cardiac Arrest1 trial

Atrial Fibrillation1 trial

Dapagliflozin1 trial

Idiopathic Ventricular Fibrillation1 trial

Single Dose1 trial

Lenalidomide1 trial

CAR1 trial

Female1 trial

Unspecified4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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