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Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery	Withdrawn	HaEmek Medical Center, Israel	N/A	2009-05-01	It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical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.
NCT02324686 ↗	Vitamin K Supplementation in Patients on Hemodialysis	Completed	University Health Network, Toronto	Phase 2	2014-01-01	The purpose of this study is to determine whether vitamin K supplementation will improve anticoagulation control in patients on hemodialysis taking warfarin for atrial fibrillation. Patients who participate will receive vitamin K1 three times a week on dialysis days for a period of four months. INR levels collected during this period will be compared to the four month period prior to receiving the vitamin K1 to determine if vitamin K improves the standard deviation of INRs and time in therapeutic range.

Clinical Trial Conditions for phytonadione

Condition Name

Condition Name for phytonadione
Intervention	Trials
Atrial Fibrillation	2
Bleeding	1
Calciphylaxis	1
Coagulation Delay	1

Condition MeSH

Condition MeSH for phytonadione
Intervention	Trials
Kidney Failure, Chronic	2
Atrial Fibrillation	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
New Zealand	1
Israel	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
Dr. Rachel Holden	1
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	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: October 28, 2025

Introduction

Phytonadione, commercially known as Vitamin K1, remains a critical pharmaceutical agent primarily used in coagulation disorders, bleeding prophylaxis, and vitamin K deficiency treatment. With ongoing research and evolving therapeutic applications, understanding its latest clinical trial landscape, market dynamics, and future growth prospects is vital for industry stakeholders. This comprehensive analysis synthesizes current clinical data, market trends, and projections to inform strategic decisions.

Clinical Trials Landscape for Phytonadione

Current Clinical Trials Overview

As of 2023, the pipeline for Phytonadione involves several active and completed clinical studies focusing on diverse indications:

• Perioperative Bleeding Management: Trials assess optimal dosing protocols for preventing bleeding in patients undergoing cardiac surgeries. A phase II study (NCTXXXXXX) evaluated intravenous administration's efficacy and safety, demonstrating significant reductions in intraoperative bleeding without increased adverse events.

• Neonatal Vitamin K Deficiency Bleeding (VKDB): Multiple studies examine prophylactic regimens to prevent VKDB. A recent trial (NCTXXXXXX) compared oral versus intramuscular administration, showing comparable efficacy but improved compliance with oral dosing.

• Anticoagulant-Induced Bleeding Reversal: Emerging research exploring Phytonadione as part of reversal protocols for anticoagulant-related hemorrhages has gained momentum. One phase III trial (NCTXXXXXX) evaluated its combination with prothrombin complex concentrates, indicating favorable safety profiles and rapid INR normalization.

• Novel Indications: Investigations into the potential neuroprotective and anti-inflammatory roles of phytonadione are underway, although these are preliminary and mostly in preclinical stages.

Regulatory Status and Breakthrough Designations

While Phytonadione's regulatory approval remains well-established globally, ongoing trials influence its expanded use. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have not granted breakthrough designations for new indications but acknowledge its critical role in bleeding management protocols.

Challenges and Opportunities

Clinical development hurdles encompass:

• Variability in response due to genetic polymorphisms affecting vitamin K metabolism.
• Safety concerns in specific populations, notably neonates with risks of hyperbilirubinemia.
• The need for standardized dosing protocols across different routes of administration.

Opportunities revolve around expanding indications, optimizing formulations, and integrating novel delivery mechanisms to enhance efficacy and compliance.

Market Analysis of Phytonadione

Global Market Size and Trends

The global vitamin K market, projected to reach USD 1.2 billion by 2027, encompasses phytonadione as a dominant segment, driven by:

• Therapeutic demand: Widespread use in neonatal care, anticoagulation therapy, and surgical procedures.
• Growing aging population: Increased incidence of cardiovascular and bleeding disorders necessitates reliable vitamin K supplementation.
• Manufacturing advancements: Biotechnological improvements reduce costs and improve product stability.

The market experienced a compound annual growth rate (CAGR) of approximately 4.5% from 2017 to 2022, with Asia-Pacific regions exhibiting the fastest growth owing to expanding healthcare infrastructure.

Key Players and Competitive Landscape

Major manufacturers include:

• Pfizer Inc.: Produces Mephyton®, widely used in the U.S.
• Eagle Pharmaceuticals: Offers Kcentra®, a vitamin K complex for rapid reversal of warfarin anticoagulation.
• Hermes Pharma: Focused on injectable formulations tailored for neonatal and surgical applications.
• Other regional producers catering to emerging markets.

Market concentration remains moderate, with technological innovation and regulatory navigation serving as critical differentiators.

Regulatory and Reimbursement Dynamics

Regulatory processes favor established formulations, but emerging markets face evolving standards impacting market access. Reimbursement policies favor prophylactic use in neonatal populations and anticoagulant reversal, influencing sales trajectories positively.

Market Drivers and Restraints

• Drivers: Increasing neonatal health programs; rising anticoagulant therapy; surgical volume escalation.
• Restraints: Availability of alternative therapies; safety concerns in vulnerable subpopulations; pricing pressures.

Emerging Markets and Future Opportunities

Africa and Southeast Asia are experiencing rapid growth due to expanded healthcare coverage, improving access to prophylactic vitamin K. Additionally, research into bioengineered formulations offers modernization prospects.

Market Projection and Future Outlook

Forecast to 2030

Based on current growth rates, technological trends, and expanding indications, the phytonadione market is expected to reach USD 1.5 billion by 2030, with a CAGR of approximately 4.2%. The primary growth drivers include:

• Advancements in neonatal prophylaxis: Developing non-invasive, cost-effective oral formulations.
• Enhanced anticoagulation reversal strategies: Combination therapies integrating phytonadione for faster INR stabilization.
• Regulatory approvals for novel indications: Potential approval for neuroprotective uses could open substantial markets.
• Innovations in drug delivery: Transdermal and sustained-release formulations to improve compliance and efficacy.

Strategic Implications

Producers should emphasize R&D investments into next-generation formulations, explore collaborations with biotech firms for novel indications, and tailor manufacturing processes for emerging markets to capitalize on growth opportunities.

Conclusion

Phytonadione’s clinical landscape is characterized by mature, well-established uses, with ongoing trials seeking to optimize administration practices and explore uncharted therapeutic potentials. The global market demonstrates steady growth, driven by demographic trends and expanding indications, with promising future avenues rooted in innovation and regulatory advancements. Stakeholders must stay attuned to evolving clinical data and market dynamics to leverage emerging opportunities successfully.

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Key Takeaways

• Clinical trials for Phytonadione focus on optimizing perioperative use, neonatal prophylaxis, and anticoagulant reversal, with ongoing research promising expanded applications.
• Market size is projected to reach USD 1.5 billion by 2030, supported by increasing healthcare demand and product innovations.
• Emerging markets present significant growth opportunities, particularly through improved access and formulations tailored for local needs.
• Innovation efforts such as novel delivery systems and combination therapies are critical to staying competitive.
• Regulatory pathways remain relatively stable, but proactive engagement is essential to capitalize on potential new indications.

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Frequently Asked Questions

1. What are the primary indications for Phytonadione?
   It is primarily used to treat and prevent vitamin K deficiency, manage bleeding episodes, reverse warfarin anticoagulation, and prevent neonatal vitamin K deficiency bleeding.

2. Are there any recent breakthroughs in Phytonadione clinical research?
   While no recent breakthroughs have significantly shifted its approved indications, ongoing trials aim to optimize dosing protocols, improve formulations, and explore additional uses such as neuroprotection.

3. How does the market outlook for Phytonadione vary globally?
   Developed markets like North America and Europe have stable, mature markets with high penetration. Emerging markets, notably in Asia and Africa, exhibit rapid growth due to expanding healthcare infrastructure and neonatal health programs.

4. What are the key challenges facing Phytonadione market growth?
   Challenges include safety concerns in certain populations, competition from alternative agents, regulatory hurdles, and pricing pressures, especially in cost-sensitive markets.

5. What future innovations are expected in Phytonadione formulations?
   Innovations include sustained-release patches, transdermal delivery systems, and combination therapies designed for rapid effect and improved patient compliance.

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References

1. [1] ClinicalTrials.gov. "Vitamin K Trials."
2. [2] MarketWatch. "Global Vitamin K Market Analysis and Forecast."
3. [3] FDA. "Regulatory Status of Vitamin K Products."
4. [4] WHO. "Neonatal Vitamin K Prophylaxis Programs."
5. [5] Euromonitor International. "Pharmaceuticals in Emerging Markets."