Coumadin

(Warfarin sodium)

ApprovedSmall molecule

Coumadin is a small molecule that works as a Vitamin K Epoxide Reductase Complex Subunit 1 Isoform 1 Inhibitor.[2] It is being used across 12 indications, with its most advanced program in Approved.[1]

Coumadin is one of 268 small molecule programs targeting Oral Anticoagulation. It is currently in Approved.

Indications

Total Trials

Active Trials

267

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Oral AnticoagulationUnknown status

InteractionCompleted

StrokeUnknown

Atrial FibrillationUnknown

Pulmonary EmbolismUnknown

ThromboembolismUnknown

Venous ThrombosisUnknown

Myocardial InfarctionUnknown

CirrhosisActive, not recruiting

Membranous NephropathyActive, not recruiting

Oral AnticoagulationPreclinical

Unknown status

InteractionPhase 1

Completed

StrokePreclinical

Unknown

Atrial FibrillationPreclinical

Unknown

Pulmonary EmbolismPreclinical

Unknown

ThromboembolismPreclinical

Unknown

Venous ThrombosisPreclinical

Unknown

Myocardial InfarctionPreclinical

Unknown

CirrhosisPreclinical

Active, not recruiting

Membranous NephropathyApproved

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

150 competitors in Stroke

#DrugCompanyPhaseTrials

Coumadin

AAbbott

Approved

20 2

Recaticimab

SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Phase 3

1 3

Zometa

Pfizer

Preclinical

1 4

Savella

AbbVie

Preclinical

1 5

Proamatine

Repatha

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 8

Zantac 150

CChattem

Preclinical

1 9

Alka-Seltzer

AAbbott

Preclinical

1 10

Haldol

DDePuy Orthopaedics

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Study completion

NCT07785934

Post-ApprovalRecruiting

Membranous Nephropathy

NCT07404436

Clinical

Trials by Indication[1]

Atrial Fibrillation3 trials

Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction

Completed· Bayer logo

Bayer··NCT03359876·16,000 enrolled

D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

Completed·WWuhan Asia Heart Hospital··NCT03280641·1,194 enrolled

A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation

Completed· Pfizer logo

Pfizer·Phase 2·NCT00787150·222 enrolled

Interaction2 trials

A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT05273775·22 enrolled

A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT05392127·24 enrolled

Tics2 trials

Assessing the Clinical Benefits of a Pharmacogenetics-Guided Dosing Regiment for Calculating Warfarin Maintenance Dose

Unknown status·NNational University Hospital, Singapore·Phase 3·NCT00700895·320 enrolled

A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin

Completed·KKastle Therapeutics, LLC·Phase 1·NCT01133366·18 enrolled

Oral Anticoagulation2 trials

Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

Completed·TThe Young Investigator Group of Cardiovascular Research·Phase 3·NCT03926780·79 enrolled

Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy

Unknown status·WWuhan Asia Heart Hospital·N/A·NCT03885180·500 enrolled

Left Ventricular Thrombus1 trial

Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

Completed·UUniversiti Sains Malaysia·Phase 3·NCT02982590·27 enrolled

9 more indications

Atorvastatin1 trial

Drug-durg Interaction of RAY1225 With Warfarin, Atorvastatin, Metformin and Digoxin

Active, not recruiting·GGuangdong Raynovent Biotech Co., Ltd·Phase 1·NCT07362030·32 enrolled

Drug Interactions1 trial

A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects

Completed· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT05045313·28 enrolled

TIA1 trial

Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

Completed·SSarah Sabry Hashem·Phase 4·NCT04235569·50 enrolled

Membranous Nephropathy1 trial

Rivaroxaban in Idiopathic Membranous Nephropathy

Recruiting·—·Phase 4·NCT07404436·134 enrolled

Anticoagulation1 trial

Gene-guided Warfarin for Anticoagulation Therapy

Withdrawn·FFirst Affiliated Hospital Xi'an Jiaotong University·N/A·NCT04482842

Caffeine1 trial

Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02256813·20 enrolled

Drug1 trial

Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182336·23 enrolled

Cirrhosis1 trial

A Study to Compare How Different Substances (Caffeine, Warfarin, Omeprazole, Metoprolol, and Midazolam) Are Handled by the Body of Healthy People and People With Liver Cirrhosis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·N/A·NCT05741385·4 enrolled

Unspecified2 trials

Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02243553·34 enrolled

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of UBT251 on the Pharmacokinetics of Single Oral Doses of Metformin, Warfarin, Atorvastatin, and Digoxin in Overweight or Obese Participants.

Recruiting·TThe United Bio-Technology (Hengqin) Co., Ltd.·Phase 1·NCT07785934·48 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

ATHROMBIN

NDA NDA011771

Jan 1, 1982

PANWARFIN

NDA NDA017020

Feb 7, 1995

COUMADIN

NDA NDA009218

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Warfarin sodium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Warfarin sodium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Warfarin sodium. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA009218). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Abbott company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Vitamin K Epoxide Reductase Complex Subunit 1 Isoform 1 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAbbott

Coumadin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Atrial Fibrillation3 trials

Interaction2 trials

Tics2 trials

Oral Anticoagulation2 trials

Left Ventricular Thrombus1 trial

Atorvastatin1 trial

Drug Interactions1 trial

TIA1 trial

Membranous Nephropathy1 trial

Anticoagulation1 trial

Caffeine1 trial

Drug1 trial

Cirrhosis1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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