Last reviewed 2026-04-20 · How we verify

PHYTONADIONE

Phytonadione is a marketed drug that acts as a cofactor in the synthesis of clotting factors, primarily indicated for anticoagulant-induced prothrombin deficiency. Its key strength lies in its well-established mechanism and efficacy, supported by a key composition patent expiring in 2028. The primary risk is competition from alternative forms of Vitamin K, including Menadiol, Phylloquinone, and Menaquinone, which offer natural and synthetic options.

At a glance

Approved indications

• Anticoagulant-induced prothrombin deficiency
• Hemorrhagic disease of the newborn
• Hypoprothrombinemia due to antibacterial therapy
• Hypoprothrombinemia due to absorption or synthesis limitations
• Drug-induced hypoprothrombinemia

Pipeline indications

• Glioblastoma — Phase 2
• Skin toxicity from EGFR inhibitors — Phase 2
• Coronary artery calcification in hemodialysis patients — Phase 2
• Metastatic colorectal cancer — Phase 2
• End-stage kidney disease — Phase 2

Boxed warnings

• BOXED WARNING WARNING — INTRAVENOUS AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.

Common side effects

• Flushing sensations
• Peculiar sensations of taste
• Dizziness
• Profuse sweating
• Brief hypotension
• Dyspnea
• Cyanosis
• Pain at injection site
• Swelling at injection site
• Tenderness at injection site
• Allergic sensitivity
• Anaphylactoid reaction

Drug interactions

• prothrombin-depressing anticoagulants

Key clinical trials

• A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) (PHASE2)
• The Role of Vitamin K on Knee Osteoarthritis Outcomes (PHASE1, PHASE2)
• Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis: (NA)
• Better Evidence and Translation for Calciphylaxis (PHASE3)
• Bioavailability of Different Vitamin K Vitamers Studied Using 13C-labelled Vitamin K Vitamers (NA)
• Predictive Value of Coronary Heart Disease (CHD) Biomarkers for CHD Death
• Vitamin K and Cognition in Coronary Heart Disease (NutriCog) (NA)
• Efficacy and Safety of Intravenous Vitamin K1 in Management of Acute Variceal Bleeding (PHASE4)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• PHYTONADIONE CI brief — competitive landscape report
• PHYTONADIONE updates RSS · CI watch RSS