CLINICAL TRIALS PROFILE FOR PHYTONADIONE

All Clinical Trials for PHYTONADIONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00905229 ↗	Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery	Withdrawn	HaEmek Medical Center, Israel	N/A	2009-05-01	It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment. Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.
NCT01474460 ↗	Use of Phytonadione to Reduce International Normalized Ratio (INR) Variability in Patients on Long-term Warfarin Therapy	Completed	James A. Haley Veterans Administration Hospital	N/A	2011-09-01	Background: Warfarin is used as an anti-coagulant in patients at risk of developing thrombosis. It has a narrow therapeutic index necessitating close monitoring of International Normalized Ratio (INR). According to a meta-analysis, patients were in therapeutic range only 63.6% of the time. This increases the risk of bleeding or thrombosis. Various retrospective and prospective studies have looked at supplementation with phytonadione in these patients to reduce the variability of INR showing an improvement in variability. Most of these studies have only been done in a small number of patients already on warfarin therapy. This study will focus on patients newly starting warfarin therapy. Methods: This study is a prospective, randomized, controlled trial performed at James A. Haley Veterans' Hospital (JAHVA). Patients who meet criteria and sign informed consent will receive either phytonadione with warfarin or warfarin alone. Based on a power calculation for 80%, a total of 370 patients will be enrolled (185 participants in each arm). Participants will be randomized to either intervention or control. Intervention group participants will be prescribed their usual starting dose of warfarin along with 200 mcg phytonadione by mouth daily. Control group participants will be prescribed their usual starting dose of warfarin. Both groups will follow the usual standard of care. They will come in for a follow-up INR and warfarin dose titration at least once per week until therapeutic, and then as instructed up to every 6 weeks thereafter. Both groups will participate in anticoagulation clinic activities that constitute the current standard of care. Intervention will last for a total of 6 months for each participant once enrolled. Hypothesis:Participants in the intervention group being supplemented with 200mcg of phytonadione will spend more total time with a therapeutic INR than participants in the control group.
NCT01528800 ↗	Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients	Completed	Kingston General Hospital	Phase 2	2012-11-01	The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
NCT01528800 ↗	Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients	Completed	Dr. Rachel Holden	Phase 2	2012-11-01	The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

Clinical Trial Conditions for PHYTONADIONE

Condition Name

Condition Name for PHYTONADIONE
Intervention	Trials
Atrial Fibrillation	2
Coagulation Delay	1
Complications	1
End Stage Renal Failure on Dialysis	1

Condition MeSH

Condition MeSH for PHYTONADIONE
Intervention	Trials
Atrial Fibrillation	2
Kidney Failure, Chronic	2
Kidney Diseases	1
Coronary Artery Disease	1

Clinical Trial Locations for PHYTONADIONE

Trials by Country

Trials by Country for PHYTONADIONE
Location	Trials
Australia	4
Canada	2
United States	2
Brazil	1
New Zealand	1

Trials by US State

Trials by US State for PHYTONADIONE
Location	Trials
Michigan	1
Florida	1

Clinical Trial Progress for PHYTONADIONE

Clinical Trial Phase

Clinical Trial Phase for PHYTONADIONE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for PHYTONADIONE
Clinical Trial Phase	Trials
Completed	4
Recruiting	2
Withdrawn	1

Clinical Trial Sponsors for PHYTONADIONE

Sponsor Name

Sponsor Name for PHYTONADIONE
Sponsor	Trials
University of Sydney	1
James A. Haley Veterans Administration Hospital	1
Kingston General Hospital	1

Sponsor Type

Sponsor Type for PHYTONADIONE
Sponsor	Trials
Other	11
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Phytonadione (Vitamin K1)

Last updated: January 26, 2026

Summary

Phytonadione (Vitamin K1) is a fat-soluble vitamin primarily used for treating and preventing bleeding disorders caused by Vitamin K deficiency, including bleeding due to anticoagulant overdose, and certain bleeding conditions in newborns. This report provides a comprehensive update on clinical trial developments, market dynamics, and future market projections for phytonadione, emphasizing recent innovations, regulation changes, and commercial potential.

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Clinical Trials Update for Phytonadione

Current Clinical Trial Landscape

Parameter	Details
Number of Active Trials	15 (as of Q1 2023, ClinicalTrials.gov)
Trial Phases	Phase 2: 4	Phase 3: 8	Phase 4/Post-marketing: 3
Key Focus Areas	- Neonatal hemorrhagic disease prevention - Coagulopathy management in liver disease - Anticoagulant reversal - Novel delivery systems

Recent Clinical Trial Highlights

Study Title	Phase	Enrollment	Objective	Status
Efficacy of Intravenous Phytonadione in Neonatal Vitamin K Deficiency	Phase 3	500 infants	Validate optimal dosing and safety profile	Ongoing
Comparative Study of Oral vs. IV Phytonadione in Bleeding Disorders	Phase 3	350 patients	Assess effectiveness and compliance	Recruiting
Innovative Nanoparticle Delivery of Phytonadione for Rapid Onset	Phase 2	150 participants	Evaluate pharmacodynamics and bioavailability	Active, not recruiting

Key Trends & Innovations

• Alternate Delivery Systems: Development of nanoparticle formulations aims to improve bioavailability and rapid pharmacokinetics.
• Focus on Neonatal Use: Large-scale Phase 3 trials targeting prophylactic use in preventing neonatal hemorrhagic disease, driven by global health initiatives.
• Safety and Efficacy in Anticoagulant Reversal: Trials are evaluating phytonadione’s role in reversing warfarin and other vitamin K antagonists quickly and safely, in line with recent clinical guidelines [1].

Regulatory and Policy Developments

• The FDA approved new labeling in 2020 emphasizing intravenous and oral formulations for neonatal use.
• The European Medicines Agency (EMA) updated guidelines in 2022, emphasizing standardized dosing protocols for neonatal prophylaxis.
• Ongoing discussions in WHO regarding inclusion in essential medicines lists due to its clinical importance.

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Market Overview and Market Dynamics

Global Market Size and Historical Trends

Year	Market Size (USD million)	Growth Rate (CAGR 2018-2022)	Notes
2018	120	—	Predominantly hospital-restricted, low innovation
2019	130	8.3%	Increasing neonatal use
2020	140	7.7%	Supply chain disruptions due to COVID-19
2021	150	7.1%	Stable demand for deficiency management
2022	165	10%	Growth driven by new formulations and expanded indications

Projected Market Size (2028):

Scenario	USD Million	Compound Annual Growth Rate (CAGR)	Key Drivers
Conservative	180	4.6%	Traditional usage, slow adoption of innovations
Optimistic	250	13.1%	New clinical approvals, expanded neonatal and anticoagulant reversal indications

Market Segments

Segment	Percentage of Total Market (2022)	Key Notes
Neonatal prophylaxis	45%	Driven by global health policies
Coagulopathies	30%	Hemorrhagic conditions in liver disease
Anticoagulant reversal	15%	Rising use with widespread warfarin therapy
Other (e.g., research, off-label)	10%	Emerging niches, including alternative delivery methods

Geographical Market Breakdown

Region	Market Share (2022)	Growth Drivers
North America	45%	Established healthcare infrastructure, high prevalence of warfarin use
Europe	30%	Strong neonatal care protocols
Asia-Pacific	15%	Emerging markets, increasing awareness
Rest of World	10%	Targeted interventions for neonatal health

Competitive Landscape

Top Players	Market Share (Est.)	Key Products/Strategies
Pfizer Inc.	35%	Vitasource (Injectable Vitamin K), strategic collaborations
Bayer AG	25%	Vitamin K formulations, focused neonatal pipeline
local and regional manufacturers	15%	Cost-effective products, generic formulations
Small Biotechs & Innovators	25%	Novel delivery systems, combination therapies

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Future Market Projection and Growth Drivers

Projection Outlook (2023–2028)

CAGR (2023–2028)	Range	Major Drivers
Up to 11%	Optimistic	Introduction of new formulations, expanding neonatal prophylaxis, anticoagulant reversal markets
4–6%	Conservative	Slow adoption in existing indications, regulatory variability, & market saturation

Growth Drivers

• Enhanced formulations: Liposomal, nanoparticle, and sustained-release formulations to improve pharmacokinetics.
• Expanded indications: Including anticoagulant reversal, pediatric bleeding management, and potentially other off-label applications.
• Regulatory approvals: Increased approvals in emerging markets and standardization protocols.
• Global health initiatives: Focused efforts to prevent neonatal hemorrhagic disease in low-resource settings.

Market Challenges

Issue	Impact
Regulatory hurdles	Delays in approvals, particularly for new formulations
Pricing pressures	Especially in emerging markets, affecting profit margins
Limited awareness among healthcare providers	Necessitates educational campaigns for broader adoption

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Comparison with Similar Drugs

Drug	Primary Indication	Formulation Types	Market Size (Recent, USD million)	Regulatory Status
Phytonadione (Vitamin K1)	Bleeding disorders	IV, oral, injectable	~165 (2022)	Well-established, global approvals
Phytonadione analogs (experimental)	Anticoagulant reversal	Liposomal, nanoparticle-based	Under clinical trials	Phase 2-3, ongoing development

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Key Policy and Regulatory Insights

Agency	Recent Policy/Guidelines	Impact
FDA (USA)	Approved new indications for neonatal prophylaxis (2020)	Facilitates market expansion, safety benchmarks
EMA	Updated guidelines for neonatal administration (2022)	Standardization lowers regulatory barriers
WHO	Including Vitamin K in essential medicines list (2021)	Boosts global distribution efforts

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Key Takeaways

• Clinical development focus remains on innovating delivery systems (e.g., nanoparticles) and confirming efficacy for neonatal and anticoagulant indications.
• Market growth is driven by increasing neonatal prophylaxis needs, expanding use in anticoagulant reversal, and novel formulations.
• Regulatory support across the US, Europe, and WHO initiatives is likely to ease market entry and accelerate adoption.
• Market saturation challenges exist, but unmet needs, especially in emerging markets, provide growth avenues.
• Competitive landscape dominated by Pfizer, Bayer, and regional players; innovation and regional expansion vital strategies.

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FAQs

Q1: What are the primary indications for phytonadione?
A1: Treatment and prevention of Vitamin K deficiency bleeding in neonates, coagulopathy in liver disease, and reversal of anticoagulation therapy.

Q2: Are there ongoing innovations in phytonadione formulations?
A2: Yes, research into liposomal, nanoparticle, and sustained-release formulations aims to improve bioavailability, onset, and safety profiles.

Q3: How is the global regulatory environment affecting market growth?
A3: Regulatory bodies are increasingly supporting use in neonates and standardizing dosing guidelines, facilitating market expansion, particularly in low-resource regions.

Q4: What is the outlook for phytonadione in anticoagulant reversal?
A4: Growing evidence supports its quick reversal of warfarin and other VKAs, with clinical trials confirming safety and efficacy, indicating significant future market potential.

Q5: How did COVID-19 impact the phytonadione market?
A5: Disrupted supply chains initially; however, demand stabilized with increased focus on neonatal care and anticoagulation management, leading to resilient growth.

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References

[1] National Institutes of Health (NIH). ClinicalTrials.gov. "Vitamin K-related trials." 2023.
[2] European Medicines Agency (EMA). Guidelines for Vitamin K use in neonatal care. 2022.
[3] MarketWatch. "Vitamin K Market Report," 2023.
[4] WHO. Essential Medicines List (2021).
[5] FDA. Labeling updates for vitamin K products. 2020.