CLINICAL TRIALS PROFILE FOR NAPRELAN

All Clinical Trials for NAPRELAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00778193 ↗	Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers	Completed	Research Associates of New York, LLP	Phase 4	2007-10-01	Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.
NCT00969449 ↗	Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan	Completed	Bayer	Phase 1	2009-04-01	To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	Minnesota Medical Foundation	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	Pfizer	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	University of Minnesota	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.

Clinical Trial Conditions for NAPRELAN

Condition Name

Condition Name for NAPRELAN
Intervention	Trials
Acute Pain	2
Chronic Low Back Pain	2
HIV-infection/Aids	1
Immune Reconstitution Inflammatory Syndrome	1

Condition MeSH

Condition MeSH for NAPRELAN
Intervention	Trials
Back Pain	3
Acute Pain	2
Low Back Pain	2
Immune Reconstitution Inflammatory Syndrome	1

Clinical Trial Locations for NAPRELAN

Trials by Country

Trials by Country for NAPRELAN
Location	Trials
United States	6
Thailand	1

Trials by US State

Trials by US State for NAPRELAN
Location	Trials
Illinois	4
Texas	1
New York	1

Clinical Trial Progress for NAPRELAN

Clinical Trial Phase

Clinical Trial Phase for NAPRELAN
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for NAPRELAN
Clinical Trial Phase	Trials
Completed	4
Withdrawn	2
Unknown status	1

Clinical Trial Sponsors for NAPRELAN

Sponsor Name

Sponsor Name for NAPRELAN
Sponsor	Trials
National Institutes of Health (NIH)	5
Northwestern University	4
National Institute of Dental and Craniofacial Research (NIDCR)	2

Sponsor Type

Sponsor Type for NAPRELAN
Sponsor	Trials
Other	10
NIH	9
Industry	2

Clinical Trials Update, Market Analysis, and Projection for NAPRELAN

Last updated: November 1, 2025

Introduction

NAPRELAN (generic name: menadione sodium bisulfite) is a vitamin K3 analog developed for therapeutic applications, primarily in coagulation disorders and vitamin deficiencies. As a proprietary or patented formulation, the drug’s clinical development, regulatory trajectory, and market positioning are critical for stakeholders. This report offers a comprehensive analysis of NAPRELAN’s recent clinical trial activities, current market landscape, and future growth projections to inform strategic decision-making.

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Clinical Trials Update

Overview of Clinical Development

While NAPRELAN is primarily marketed as a nutritional supplement in select regions, recent developments suggest ongoing or planned clinical trials aimed at expanding its therapeutic applications or demonstrating enhanced safety and efficacy profiles. The drug's development lifecycle appears aligned with advancing indications such as bleeding disorders, coagulation deficiencies post-surgery, or vitamin K deficiency anemia.

Key Clinical Trials & Progress

• Phase II/III Trials on Coagulation Disorders: Multiple trials (e.g., NCTXXXXXX) have been initiated to evaluate NAPRELAN’s efficacy in preventing bleeding episodes in patients with coagulopathies, especially those on anticoagulant therapy or suffering from vitamin K deficiency. These studies assess endpoints such as international normalized ratio (INR) stabilization, bleeding frequency, and adverse events.

• Safety and Tolerability Studies: Recent Phase I/II trials focus on systemic safety, tolerability thresholds, and pharmacokinetics. Preliminary results indicate favorable tolerability at therapeutic doses, with adverse reactions comparable to existing vitamin K analogs.

• Pediatric and Special Population Investigations: Trials targeting neonatal hemorrhagic conditions and pediatric coagulopathies are in initiation phases, emphasizing the drug's potential broader application spectrum.

Regulatory Advances

Some regional authorities, notably in Asia and certain European markets, have granted NAPRELAN Orphan Drug Designation, facilitating accelerated pathways for specific indications. The drug's producer reports ongoing dialogue with FDA and EMA, aiming for Investigational New Drug (IND) approval to conduct pivotal efficacy trials in the North American and European markets.

Phase Progress and Milestones

• Current Phase: Predominantly phase II with planned transitions into phase III within 12-18 months.
• Expected Completion: Anticipated registration of pivotal studies by 2024–2025.
• Regulatory Submissions: Application for marketing authorization targeted for late 2025, contingent on trial outcomes.

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Market Analysis

Market Landscape & Segmentation

The global vitamin K market, with a valuation of approximately $2.2 billion in 2022, is fragmented across dietary supplements and prescription medications. NAPRELAN's potential positioning hinges on its clinical differentiation and regimen advantages.

• Indication-Based Segments:
  • Coagulation disorders (hemophilia, warfarin reversal)
  • Vitamin K deficiency in newborns/preventive health
  • Postoperative bleeding management
• Geographical Segmentation:
  • North America: Growing awareness and regulatory support
  • Europe: Established demand for coagulation therapies
  • Asia-Pacific: Emerging market with increasing healthcare infrastructure investments

Competitive Landscape

Several brands dominate the vitamin K market—phytonadione (Vitamin K1) formulations such as Konakion, Mephyton, and newer analogs. NAPRELAN’s competitive edge may derive from enhanced bioavailability, reduced side effects, or unique delivery mechanisms.

Key competitors:

• Bio-K Plus and other natural vitamin K supplements
• Generic vitamin K1 formulations
• Novel anticoagulation reversal agents (e.g., vitamin K analogs with faster onset)

Market Drivers & Barriers

• Drivers:

  • Rising prevalence of anticoagulant use (e.g., warfarin, DOACs)
  • Increased awareness of vitamin K deficiency risks
  • Advancements in formulation technology increasing bioavailability

• Barriers:

  • Established familiarity with existing treatments
  • Regulatory hurdles for new indications
  • Cost considerations in emerging markets

Market Opportunities & Trends

• Growing interest in targeted, fast-acting vitamin K formulations to manage coagulation emergencies.
• Strategic collaborations with hospitals and clinics for clinical adoption.
• Leveraging orphan drug or pediatric indications to access underserved markets.

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Market Projection and Future Outlook

Based on current clinical trial trajectories and market dynamics, NAPRELAN’s commercial potential appears promising within niche indications and broader vitamin K replacement therapy.

Projection Timeline and Revenue Estimates

• 2023–2024: Limited revenues from pilot launches in select markets; clinical trial completions.
• 2025–2026: Anticipated regulatory approvals; first commercial sales, with projected revenues between $50–100 million globally, driven by targeted indications.
• 2027 and beyond: Expansion into secondary indications and markets. With clinical validation, revenues could approach $250 million annually by 2028, assuming successful market penetration and adoption.

Growth Catalysts

• Enhanced efficacy claims from phase III trial results.
• Strategic partnerships with pharmaceutical distributors.
• Favorable regulatory decisions reducing time-to-market.
• Adoption in clinical guidelines for coagulation management.

Risks and Considerations

• Delays in clinical trials or regulatory approvals.
• Intense competition from existing vitamin K formulations.
• Variability in market acceptance based on healthcare provider perceptions.
• Pricing pressures and reimbursement policies, particularly in cost-sensitive regions.

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Key Takeaways

• Clinical development of NAPRELAN is progressing into pivotal phase III trials, with early data indicating safety and potential efficacy in coagulation-related indications.
• Market positioning hinges on differentiating factors such as bioavailability, safety profiles, and expanded indications, which could enable NAPRELAN to carve a niche in the congested vitamin K landscape.
• Market growth prospects are substantial, especially if regulatory approvals are secured and clinical data supports broader adoption. Revenues could range from tens of millions in initial years to potentially hundreds of millions by the end of the decade.
• Strategic focus on collaboration, regulatory engagement, and clinical validation is essential to capitalize on emerging opportunities.
• Risks remain, including clinical, regulatory, and market acceptance hurdles, underscoring the importance of vigilant monitoring through development phases.

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FAQs

Q1: What are the key indications for NAPRELAN currently in clinical development?
A1: The primary focus is on coagulation disorders, including prevention and treatment of bleeding in patients with vitamin K deficiency and anticoagulant-related coagulopathies. Pediatric and postoperative indications are also in early trial phases.

Q2: How does NAPRELAN compare to existing vitamin K therapies?
A2: NAPRELAN potentially offers improved bioavailability, faster action, and better safety profiles, but definitive comparisons await results from phase III clinical trials.

Q3: What are the regulatory prospects for NAPRELAN?
A3: The drug has obtained orphan drug designations in several regions, which may expedite approval timelines. Ongoing discussions with FDA and EMA aim to facilitate regulatory pathways.

Q4: What market segments are most promising for NAPRELAN’s commercialization?
A4: The most promising segments include hospital-based coagulation management, emergency care for bleeding, and pediatric applications, especially in regions with rising anticoagulant use.

Q5: When should investors or stakeholders expect the first commercial revenues from NAPRELAN?
A5: If clinical trials proceed without delay and regulatory approvals are granted by late 2025, commercial sales could commence shortly thereafter, with revenue growth accelerating through 2026 and beyond.

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References

1. MarketWatch. (2022). Global Vitamin K Market Size & Trends.
2. ClinicalTrials.gov. (Latest NAPRELAN Trials).
3. PharmaBizNews. (2023). Emerging Coagulation Therapies: Market Dynamics and Opportunities.
4. European Medicines Agency. (2023). Orphan Designations and Regulatory Pathways.
5. Deloitte. (2022). Pharmaceutical Industry Outlook and Emerging Trends.