CLINICAL TRIALS PROFILE FOR MENADIONE

All Clinical Trials for MENADIONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00656786 ↗	Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash	Completed	Spectrum Pharmaceuticals, Inc	Phase 1	2008-04-03	This is a clinical research study of an experimental new medication, Menadione Topical Lotion (MTL). The study lotion is experimental and has not been approved for public use. Hana Biosciences, Inc., the company that is developing MTL, is the sponsor of this study. EGFR inhibitors are used to treat non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, breast cancer and head and neck cancer. One of the side effects of EFGR inhibitors is skin toxicities including an acneform skin rash. This study is a Phase 1 study. The main purposes of this study are: - Evaluate the safety and tolerability of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash - Evaluate the systemic absorption and bioavailability of Menadione Topical Lotion as an emergent and pre-emergent treatment for EGFR inhibitor-associated rash It is planned that up to 24 patients undergoing EGFR inhibitor therapy will take part in this study at multiple clinical centers.
NCT01393821 ↗	Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab	Active, not recruiting	Mayo Clinic	N/A	2012-01-01	This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab
NCT02880033 ↗	Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes	Completed	University Hospital, Lille	N/A	2011-02-01	Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). The platelets are pivotal in the healing system with large range of growth factors. A new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development. The action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of PBMC and platelets from patient having Parkinson's disease and Amyotrophic lateral sclerosis and healthy controls to study ex vivo. PBMC and platelets will be stored for future analyses.
NCT04705714 ↗	Antibacterial and Anti-biofilm Activity of Frankincense Extract Against Porphyromonas Gingivalis	Completed	Tanta University	Phase 1	2021-01-15	Boswellia sacra Flueck. oleoresin extract (frankincense) was traditionally used in the treatment of different diseases as respiratory, rheumatoid arthritis, and bacterial infections. Therefore, the antibacterial and antibiofilm activity of frankincense extract against Porphyromonas gingivalis periodontal pathogen clinical isolates were studied
NCT05417880 ↗	Vitamin D, K2 Plus Empagliflozin Combination in Type Two Diabetes Mellitus	Not yet recruiting	University of Health Sciences Lahore	Phase 3	2022-08-01	The main purpose of the VETA trial is to verify the potential beneficial effects of the combination of micronutrients namely Vitamin D3 and K2 in combination with oral antihyperglycemic Empagliflozin in Diabetes Mellitus
NCT05417880 ↗	Vitamin D, K2 Plus Empagliflozin Combination in Type Two Diabetes Mellitus	Not yet recruiting	Scotmann Pharmaceuticals	Phase 3	2022-08-01	The main purpose of the VETA trial is to verify the potential beneficial effects of the combination of micronutrients namely Vitamin D3 and K2 in combination with oral antihyperglycemic Empagliflozin in Diabetes Mellitus
NCT07206537 ↗	The Role of Vitamin K2 in Preventing Glucocorticoid-Induced Bone Loss in Children With Nephrotic Syndrome	RECRUITING	Ain Shams University	NA	2025-04-01	Long-term glucocorticoids therapy is associated with various complications, including decreased bone strength (Glucocorticoid-induced osteoporosis) and an increased risk of fracture. Vitamin K2 has been recently deemed appreciable as a topic of research as it plays a pivotal role in maintenance of the bone strength, and it has been proved to have a positive impact on the bone metabolism. This study examines the impact of oral vitamin K2 supplementation on bone metabolism in pediatric patients with nephrotic syndrome on long-term steroid therapy, offering valuable therapeutic insights

Clinical Trial Conditions for MENADIONE

Condition Name

Condition Name for MENADIONE
Intervention	Trials
Dermatologic Complications	1
Diabetes Mellitus	1
EGFR Inhibitor-associated Rash	1
Iron Overload	1

Condition MeSH

Condition MeSH for MENADIONE
Intervention	Trials
Motor Neuron Disease	1
Iron Overload	1
Nephrotic Syndrome	1
Amyotrophic Lateral Sclerosis	1

Clinical Trial Locations for MENADIONE

Trials by Country

Trials by Country for MENADIONE
Location	Trials
United States	8
Egypt	2
France	1
Canada	1
Pakistan	1

Trials by US State

Trials by US State for MENADIONE
Location	Trials
Minnesota	1
Arizona	1
Texas	1
Pennsylvania	1
Missouri	1

Clinical Trial Progress for MENADIONE

Clinical Trial Phase

Clinical Trial Phase for MENADIONE
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	2
NA	1

Clinical Trial Status

Clinical Trial Status for MENADIONE
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1
RECRUITING	1

Clinical Trial Sponsors for MENADIONE

Sponsor Name

Sponsor Name for MENADIONE
Sponsor	Trials
University of Health Sciences Lahore	1
Scotmann Pharmaceuticals	1
Ain Shams University	1

Sponsor Type

Sponsor Type for MENADIONE
Sponsor	Trials
Other	5
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Menadione

Last updated: November 3, 2025

Introduction

Menadione, also known as vitamin K3, is a synthetic compound within the vitamin K family primarily utilized as a dietary supplement, pharmaceutical agent, and animal feed additive. Its role in blood clotting and bone health has generated ongoing clinical interest. This article provides a comprehensive update on current clinical trials, market dynamics, and future market projections for menadione, aiming to support strategic decision-making for stakeholders in biotech, pharma, and related industries.

Clinical Trials Update

Existing and Ongoing Clinical Evaluations

While vitamin K compounds, including menadione, have a long-standing history of use, recent clinical trials focus on safety, efficacy, and novel applications, especially considering safety concerns associated with menadione’s toxicity profile. The most notable areas of ongoing research include:

• Bleeding Disorders and Hemophilia: Trials assess menadione’s efficacy in supporting coagulation in patients with deficiency or resistance to vitamin K. Historically, menadione was utilized to manage bleeding tendencies, but safety concerns over hepatotoxicity have curtailed widespread usage in favor of vitamin K1 (phylloquinone) and K2 (menaquinones).

• Bone Health and Osteoporosis: Emerging studies investigate menadione's potential role in bone mineralization, given vitamin K's critical role in activating osteocalcin. No recent large-scale trials are underway for menadione in this area, primarily due to safety concerns.

• Cancer Research: Preclinical data suggest potential anti-cancer properties through modulation of apoptosis pathways. Limited clinical trials are exploring menadione derivatives or analogs, rather than menadione itself.

Safety and Toxicity Concerns

The transition away from menadione in clinical applications stems from its narrow therapeutic window and hepatotoxic potential, especially at high doses. The FDA's classification of synthetic vitamin K3 (menadione) as unsafe for oral use in humans has led to reduced clinical exploration in major markets, though research continues in specific geographic contexts under strict monitoring.

Recent Regulatory and Research Milestones

• The FDA and EMA maintain restrictions against oral menadione due to safety issues, though topical and veterinary formulations continue.

• Recent preclinical studies, such as those published in Toxicological Sciences (2022), emphasize the importance of dosing thresholds to mitigate toxicity, encouraging cautious, targeted research avenues.

• Veterinary Clinical Trials: Menadione remains active as an additive in livestock, with ongoing trials assessing optimal dosing for coagulation support without toxicity.

Market Analysis

Historical Market Landscape

The global vitamin K market was valued at approximately USD 200 million in 2021, driven predominantly by dietary supplements and fortified foods. Menadione's contribution has been minor compared to natural vitamin K forms due to safety restrictions, yet it retains significance in veterinary applications and specific niche markets.

Current Market Dynamics

• Pharmaceutical Market: Strict regulatory bans have limited menadione’s presence in human pharmaceuticals. Nonetheless, its derivatives are explored in drug development pipelines for innovative applications.

• Veterinary Market: Menadione remains widely used as a feed additive in livestock and aquaculture, with an estimated market size of USD 70-80 million annually (2022 estimates). The demand is driven by the necessity for coagulation support in animals and regulatory requirements in feed formulations.

• Nutritional Supplements: The human supplement market favors natural vitamin K2 forms, thus minimizing menadione’s market share. However, some over-the-counter products, especially in regions with less regulatory stringency, continue to include menadione.

Regulatory Trends and Impact

• United States: FDA bans the oral use of menadione for humans; veterinary formulations are permitted under specific conditions.

• European Union: Similar restrictions are in place, leading to market shrinkage for human health applications.

• Emerging Markets: Countries like China and India exhibit higher acceptance of synthetic vitamins with lax regulatory frameworks, potentially creating localized markets for menadione in both human and veterinary sectors.

Market Challenges and Opportunities

Challenges:

• Safety concerns restrict broader human applications.

• Competition from safer natural vitamin K forms (K1 and K2).

• Regulatory scrutiny limits new formulation development.

Opportunities:

• Developing safer menadione analogs or derivatives with improved safety profiles.

• Expanding veterinary and livestock markets, where regulatory barriers are less restrictive.

• Investigating niche therapeutic applications with targeted, controlled use.

Future Market Projections

Market Growth Outlook (2023-2030)

Given current trends, the global market for menadione is expected to decline in human health applications, transitioning into specialized, niche segments. The projected compound annual growth rate (CAGR) for the veterinary segment remains stable at approximately 4-5%, driven by ongoing demand for coagulation agents in livestock farming.

In contrast, human pharmaceutical and supplement markets are anticipated to decline or plateau, with projections indicating a negative CAGR of -2% to -3% due to safety and regulatory constraints.

Strategic Opportunities

• Innovation in Derivatives: Investment in research to develop menadione analogs with reduced toxicity could revive interest.

• Regulatory Engagement: Engaging with authorities to establish safety profiles for controlled applications could open new markets.

• Emerging Markets Expansion: Capitalizing on less restrictive regulatory environments in developing countries could sustain revenues.

Long-term Outlook

Over the next decade, the focus for menadione-centered products will likely shift from direct human use to veterinary pharmaceutical applications, animal nutrition, and potentially niche research within academic settings.

Key Takeaways

• Clinical trials for menadione have largely diminished in human health due to safety concerns; ongoing research mainly explores derivatives, safety improvements, and veterinary uses.

• Market size is shrinking in the human segment but remains stable in veterinary applications, with veterinary feed additive markets being the primary revenue source.

• Regulatory restrictions significantly influence market dynamics, especially in North America and Europe, prompting a focus on developing safer analogs or alternative formulations.

• Future opportunities lie in innovation around derivatives, niche applications, and expanding into emerging markets with less regulatory oversight.

• Strategic focus should prioritize research into safety-enhanced formulations and fostering collaborations with veterinary sectors to sustain growth.

Conclusion

Menadione's trajectory illustrates the complex interplay between clinical safety, regulatory policies, and market dynamics. While its traditional use has declined in human medicine, ongoing veterinary applications ensure continued relevance in specific segments. Advances in safety profiling and derivative development present potential revival pathways, though the overall market will remain constrained by safety and regulatory challenges. Stakeholders must adopt a nuanced approach—balancing innovation, compliance, and market demands—to navigate the evolving landscape for menadione.

FAQs

1. Why has the use of menadione in human medicine declined?
Due to its narrow therapeutic window and hepatotoxicity risks, regulators, especially the FDA and EMA, restrict oral use of menadione for humans, favoring safer vitamin K1 and K2 forms.

2. Are there ongoing clinical trials exploring menadione for new therapeutic purposes?
Current clinical trials predominantly focus on safety assessments, derivative compounds, or veterinary applications. No significant human clinical trials are underway investigating menadione for new indications.

3. What are the primary markets for menadione today?
Veterinary medicine—specifically animal feed additives—constitutes the main commercial market, with minor roles in research and niche therapeutic applications.

4. Could menadione regain prominence in human health?
Only through the development of significantly safer derivatives or novel formulations that mitigate toxicity could menadione potentially re-enter human therapeutic markets—an ongoing research area.

5. How do regulatory agencies influence the market prospects for menadione?
Regulatory agencies' safety evaluations directly impact market access; restrictions have curtailed uses in human medicine, pushing development efforts toward veterinary and research applications.

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Sources:
[1] Global Market Insights. (2022). Vitamin K Market Size & Trends.
[2] U.S. Food and Drug Administration. (2021). Restrictions on Vitamin K3 use.
[3] Toxicological Sciences. (2022). Toxicity Profiles of Synthetic Vitamin K Compounds.
[4] MarketsandMarkets. (2023). Veterinary Drug Market Analysis.