VITAMIN K1 (phytonadione)
Vitamin K1 helps patients with bleeding disorders caused by a lack of specific clotting factors in the blood. It treats vitamin K deficiencies resulting from the use of certain medications, such as blood thinners or antibiotics, and addresses issues caused by medical conditions that interfere with how the body absorbs or produces the vitamin. Additionally, this medication is used to prevent and manage vitamin K-deficiency bleeding in newborn infants.
How VITAMIN K1 Works
This drug works by acting as an essential cofactor for a liver enzyme that modifies inactive precursors of clotting factors II, VII, IX, and X. It triggers a process called carboxylation, which converts these precursors into active coagulation factors that are then released into the bloodstream. In patients with a deficiency, this process promotes the necessary production of these factors to restore normal blood clotting.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1983-07-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VITAMIN K1 Approval History
What VITAMIN K1 Treats
10 indicationsVITAMIN K1 is approved for 10 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coagulation Disorder
- Hypoprothrombinemia
- Obstructive Jaundice
- Biliary Fistula
- Sprue
- Ulcerative Colitis
- Celiac Disease
- Cystic Fibrosis
VITAMIN K1 Boxed Warning
HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Warnings and Precaut...
WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Warnings and Precautions (5.1) ] . WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE See full prescribing information for complete boxed warning. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified. ( 5.1 )
VITAMIN K1 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 VITAMIN K1's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VITAMIN K1 treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to VITAMIN K1
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05018221 BEAT-Calci | BEAT-Calci | Ph 3 | recruiting | Better Evidence and Translation for Calciphylaxis |
| NCT06839352 | ZU-IRB#9092/16-11-2021 | Ph 4 | completed | Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding |
| NCT04477811 | vitamin k in dialysis patients | Ph 2, Ph 3 | completed | Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients |
| NCT01528800 iPACK-HD | iPACK-HD | Ph 2 | completed | Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients |
| NCT01742273 VitaVasK | VitaVasK 2010-021264-14 | Ph 3 | terminated | Vitamin K1 to Slow Progression of Vascular Calcification in HD Patients |
| NCT02324686 VISTA | 14-8200 | Ph 2 | completed | Vitamin K Supplementation in Patients on Hemodialysis |
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.
VITAMIN K1 FDA Label Details
Indications & Usage
VITAMIN K1 is indicated for the treatment of Coagulation Disorder; Hypoprothrombinemia; Obstructive Jaundice; Biliary Fistula; Sprue; Ulcerative Colitis; Celiac Disease; Cystic Fibrosis; Regional Enteritis; Vitamin K Deficiency Bleeding.
WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid int...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment