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Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery	Withdrawn	HaEmek Medical Center, Israel	N/A	2009-05-01	It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical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
End Stage Renal Failure on Dialysis	1
End-stage Kidney Disease	1
Endstage Kidney Disease	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

Phytonadione Market Analysis and Financial Projection

Last updated: April 27, 2026

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

What is the current clinical-trials landscape for phytonadione?

Phytonadione (vitamin K1) is a long-established therapy with constrained contemporary registration-oriented development. Across major trial registries, active entries are sparse and tend to be limited to narrow settings such as perioperative bleeding prophylaxis, reversal of anticoagulation, or supportive dosing protocols, often using phytonadione in standardized regimens rather than novel formulations.

Global trial volume (registry level, directional):

• ClinicalTrials.gov: Low activity relative to classic development-stage drugs; entries are typically small and use phytonadione as a background standard.
• EU CTR / ICTRP-linked sources: Similar pattern, with limited pipeline-driven expansion.

Observed common trial motifs (when trials appear):

• Vitamin K deficiency correction (neonatal or nutritional etiologies).
• Bleeding risk management in specific anticoagulant contexts where vitamin K1 dosing is clinically protocolized.
• Perioperative or procedural prophylaxis (dose timing comparisons; routes such as oral vs IV).
• Formulation comparisons (salt forms or administration schedules) rather than new mechanisms.

Implication for product strategy: New entrants typically compete on access (form factor, dosing convenience) and execution (hospital formulary fit, IV/oral interoperability) more than on differentiated clinical claims.

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What does phytonadione’s market look like today?

Phytonadione is marketed as Vitamin K1 for vitamin deficiency states and for reversing the anticoagulant effect of vitamin K antagonists (where applicable clinically). Its market profile is shaped by:

• Broad historic use in hospitals and controlled dispensing in specialty settings.
• Strong payer familiarity and mature procurement pathways.
• Low margin variability compared with high-cost biologics or oncology specialty drugs, with profitability driven by supply reliability and unit economics.

Market demand drivers

• Hospital bleeding-risk management: dosing tied to anticoagulation protocols and reversal pathways.
• Neonatal care: prophylactic use patterns in countries with routine newborn vitamin K programs.
• Liver disease and malabsorption: chronic and episodic use based on clinical indications.
• Anticoagulation management: vitamin K1 use when warfarin effect needs reversal or mitigation.

Supply and competition

Competition is largely among:

• Generic phytonadione products (multiple strengths and routes).
• Brand products historically associated with specific manufacturing lines or presentation formats.
• Hospital distribution channels that prefer consistent supply, stability data, and straightforward dosing.

Product differentiation that holds in practice

• Route and administration: IV readiness, oral dosing convenience, infusion compatibility.
• Packaging and handling: multi-dose convenience and nursing workflow fit.
• Regulatory standing: established pharmacopoeial compliance and pharmacovigilance history.
• Price discipline: tender-driven procurement dominates.

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Where is value likely to concentrate: indications, routes, and formulations?

A practical segmentation view for phytonadione centers on where hospitals build protocols:

Indications that tend to drive recurring utilization

• Vitamin K deficiency and associated bleeding risk
• Reversal/mitigation in vitamin K antagonist management (clinical protocols vary by country and institution)
• Neonatal prophylaxis programs (where standard of care includes vitamin K1)

Route share: typical procurement logic

• IV phytonadione: used in acute care, reversal protocols, severe deficiency or when oral route is impractical.
• Oral phytonadione: used in non-acute deficiency, outpatient management, or when oral is feasible.
• IM use: appears in specific neonatal and emergency workflows depending on local practice.

Formulation differentiation that sells

• Concentrated injection presentations that reduce volume and improve line handling.
• Stable, easy-to-dose units that reduce administration errors.
• Compatibility with common clinical pathways (hospital formularies, infusion policies).

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What is the realistic market outlook and growth profile?

Phytonadione demand grows primarily with:

• Population-level need (neonatal prophylaxis, chronic liver and malabsorption prevalence)
• Hospital volume and anticoagulation management cadence
• Protocol updates that standardize dosing and administration

Core growth pattern expected for phytonadione

• Value growth: modest, tends to track inflation and tender pricing shifts.
• Volume growth: steadier, tied to demographic and care-delivery throughput.
• Competitive intensity: remains high due to generics and established purchasing habits.

Ceiling on blockbuster behavior

• Phytonadione does not exhibit the typical “new molecule” demand curve; it is an established standard with mature market access. Growth tends to be incremental and procurement-led rather than breakthrough-driven.

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How should investors and R&D teams project revenue potential by product type?

Revenue projection for phytonadione should be built around procurement capture, not clinical-trial novelty.

Projection logic (workable for business modeling)

1. Base utilization (by route and indication)
2. Formulary penetration (national and regional tenders)
3. Tender pricing trajectory (generic price compression)
4. Treatment conversion (share of eligible patients captured under hospital protocols)

What drives upside vs downside

Upside

• Entry into high-volume hospital systems with consolidated tenders.
• Product formats that reduce administration time or reduce error rates.
• Reliability of supply and reduced stock-outs.

Downside

• Aggressive price competition from low-cost generics.
• Contract loss in hospital tenders.
• Manufacturing disruptions and recalls (operational risk matters more than clinical differentiation).

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Clinical development: what is actually investable in phytonadione?

Given the mature status, investable opportunities usually fall into:

• Formulation and presentation improvements (stability, ready-to-use formats, dosing convenience)
• Route optimization for protocol alignment (IV workflow suitability, pediatric/neonatal handling)
• Regulatory strategy for market entry in geographies where access is fragmented

When “clinical trials” exist, they often do not function as de novo evidence for new disease paradigms. They instead support:

• Dosing regimen adoption
• Non-inferiority and practical administration claims
• Regulatory approvals for specific strengths/routes

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Key Takeaways

• Phytonadione’s clinical-trials footprint is limited and typically protocolized, with trial activity skewing toward narrow, standard-of-care comparisons rather than breakthrough innovation.
• The market is mature and procurement-driven, with demand rooted in standard bleeding-risk management and vitamin K deficiency correction.
• Growth is expected to be steady but constrained, with value shaped more by tender pricing and supply execution than by clinical differentiation.
• Business upside is most realistic through formulary capture and product presentation fit (route, stability, ready-to-use handling), not new mechanism claims.

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FAQs

1) Is phytonadione considered a “pipeline” drug?

No. Phytonadione is a mature, protocol-based therapy. Current activity is generally constrained to dosing administration and standard-of-care optimization rather than mechanism-led pipeline expansion.

2) What indications dominate demand?

Vitamin K deficiency states, bleeding-risk management in clinical protocols, and neonatal vitamin K prophylaxis programs where implemented.

3) What matters most for commercial success?

Hospital formulary adoption and tender pricing, plus product presentation that improves IV/oral administration workflow and reduces handling friction.

4) Are new clinical trials likely to re-rate phytonadione’s market size materially?

Not in a typical blockbuster pattern. Trial outcomes usually affect protocol adoption and incremental share rather than generating a new category.

5) What is the main risk in projections?

Price compression and loss of procurement contracts, with operational supply reliability as a critical swing factor.

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References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] World Health Organization. (n.d.). WHO Model Formulary and vitamin K-related guidance (context for vitamin K deficiency management). https://www.who.int/
[3] European Medicines Agency. (n.d.). EPARs and assessment materials for vitamin K products (phytonadione/vitamin K1 context). https://www.ema.europa.eu/
[4] U.S. Food and Drug Administration. (n.d.). Drug safety and labeling resources for vitamin K products (phytonadione context). https://www.fda.gov/