JANTOVEN (warfarin sodium)
Jantoven is an anticoagulant indicated for the prophylaxis and treatment of venous thrombosis, pulmonary embolism, and thromboembolic complications associated with atrial fibrillation or cardiac valve replacement. It is also indicated to reduce the risk of death, recurrent myocardial infarction (MI), and thromboembolic events (such as stroke or systemic embolization) following an MI. While Jantoven has no direct effect on established thrombi and does not reverse ischemic tissue damage, it is used to prevent further extension of formed clots and to mitigate secondary, potentially fatal thromboembolic complications.
How JANTOVEN Works
Warfarin acts as a vitamin K antagonist by inhibiting the C1 subunit of the vitamin K epoxide reductase (VKORC1) enzyme complex. This inhibition prevents the regeneration of vitamin K1 epoxide, thereby depleting the functional vitamin K required for the post-ribosomal synthesis of vitamin K-dependent clotting factors (Factors II, VII, IX, and X) and anticoagulant proteins (Proteins C and S). By interfering with the γ-carboxylation of glutamic acid residues on these proteins, the drug significantly reduces the body's procoagulant capacity.
Details
- Status
- Prescription
- First Approved
- 2003-10-02
- Routes
- ORAL
- Dosage Forms
- TABLET
JANTOVEN Approval History
What JANTOVEN Treats
6 indicationsJANTOVEN is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Venous Thrombosis
- Pulmonary Embolism
- Thromboembolism
- Atrial Fibrillation
- Myocardial Infarction
- Stroke
JANTOVEN Boxed Warning
BLEEDING RISK Warfarin Sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1) ]. Perform regular monitoring of INR in all treated patients [see Dosage and Administration (2.1) ]. Drugs, dietary changes, and other factors affect INR levels achieved with Warfarin Sodium therapy [see Drug Interactions (7) ]. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17) ]. WARNING: ...
WARNING: BLEEDING RISK Warfarin Sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1) ]. Perform regular monitoring of INR in all treated patients [see Dosage and Administration (2.1) ]. Drugs, dietary changes, and other factors affect INR levels achieved with Warfarin Sodium therapy [see Drug Interactions (7) ]. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17) ]. WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Warfarin Sodium can cause major or fatal bleeding. ( 5.1 ) Perform regular monitoring of INR in all treated patients. ( 2.1 ) Drugs, dietary changes, and other factors affect INR levels achieved with Warfarin Sodium therapy. ( 7 ) Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding. ( 17 )
JANTOVEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in JANTOVEN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JANTOVEN treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07404436 | 2023-P2-369-01 | Ph 4 | recruiting | Rivaroxaban in Idiopathic Membranous Nephropathy |
| NCT02982590 results posted | 304/PPSP/61313197 | Ph 3 | completed | Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus |
| NCT03926780 No-LVT | YIG01201903 | Ph 3 | completed | Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi |
| NCT01133366 | MIPO2900509 | Ph 1 | completed | A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin |
| NCT02182336 | 1220.32 | Ph 1 | completed | Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers |
| NCT00787150 results posted | B0661003 | Ph 2 | completed | A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JANTOVEN FDA Label Details
Indications & Usage
JANTOVEN is indicated for the treatment of Venous Thrombosis; Pulmonary Embolism; Thromboembolism; Atrial Fibrillation; Myocardial Infarction; Stroke.
WARNING: BLEEDING RISK Warfarin Sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1) ]. Perform regular monitoring of INR in all treated patients [see Dosage and Administration (2.1) ]. Drugs, dietary changes, and other factors affect INR levels achieved with Warfarin Sodium ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.