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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE


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All Clinical Trials for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00329355 ↗ Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA) Completed GlaxoSmithKline Phase 3 2006-05-01 This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
NCT00329459 ↗ Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea Completed GlaxoSmithKline Phase 3 2006-05-01 This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
NCT00382993 ↗ A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2) Completed GlaxoSmithKline Phase 3 2006-12-01 This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 2 of 2]
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Condition Name

Condition Name for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Intervention Trials
Migraine Disorders 7
Migraine With or Without Aura 2
Migraine 2
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Condition MeSH

Condition MeSH for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Intervention Trials
Migraine Disorders 11
Premenstrual Syndrome 2
Headache 1
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Clinical Trial Locations for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Trials by Country

Trials by Country for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Location Trials
United States 142
China 1
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Trials by US State

Trials by US State for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Location Trials
Tennessee 7
Florida 6
California 6
Missouri 6
Washington 6
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Clinical Trial Progress for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Clinical Trial Phase

Clinical Trial Phase for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Clinical Trial Phase Trials
Phase 4 1
Phase 3 8
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Clinical Trial Phase Trials
Completed 10
Recruiting 1
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Clinical Trial Sponsors for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Sponsor Name

Sponsor Name for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Sponsor Trials
GlaxoSmithKline 9
The Second Hospital of Nanjing Medical University 1
The Third Xiangya Hospital of Central South University 1
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Sponsor Type

Sponsor Type for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Sponsor Trials
Other 12
Industry 10
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Clinical Trials Update, Market Analysis, and Projection for Naproxen Sodium and Sumatriptan Succinate

Last updated: October 28, 2025


Introduction

Naproxen Sodium and Sumatriptan Succinate are widely prescribed pharmaceuticals, each addressing significant segments within the anti-inflammatory and migraine treatment markets, respectively. This detailed analysis examines recent clinical developments, evaluates current market dynamics, and projects future trends to inform strategic decision-making for stakeholders.


Clinical Trials Update

Naproxen Sodium

Naproxen Sodium, a nonsteroidal anti-inflammatory drug (NSAID), remains extensively studied owing to ongoing concerns about safety, efficacy, and expanding indications. Recent clinical trials emphasize its role in long-term management of osteoarthritis, rheumatoid arthritis, and acute pain.

  • Recent Developments:
    The latest phase III trials completed in 2022 evaluated extended-release formulations for better gastrointestinal tolerability. For example, a trial published in Arthritis & Rheumatology demonstrated that an optimized formulation reduced gastrointestinal adverse events without compromising anti-inflammatory efficacy [1].
    Additionally, studies exploring its use in juvenile idiopathic arthritis have shown promising results, potentially broadening its pediatric indication spectrum [2].

  • Safety Monitoring:
    Emerging data from real-world evidence captures adverse event profiles, including cardiovascular risk factors. The FDA continues to review surveillance data, underlining the importance of cautious use in at-risk populations [3].

Sumatriptan Succinate

Sumatriptan Succinate, a selective serotonin receptor agonist (triptan), addresses moderate to severe migraine attacks. Recent clinical trials focus on its pharmacokinetics, novel delivery systems, and expanded indications.

  • Innovations in Formulation:
    Novel formulations, including nasal sprays and autoinjectors, have improved onset of action and convenience. A 2021 trial demonstrated that a new nasal powder formulation provided faster relief compared to traditional nasal sprays [4].

  • Extended Indications & Efficacy:
    Trials exploring its efficacy as a prophylactic agent for cluster headaches or medication-overuse headaches are underway, with early results indicating possible broader therapeutic utility [5].

  • Safety and Tolerability:
    The most recent data reinforce its safety profile but highlight the need for caution in patients with cardiovascular comorbidities, consistent with existing guidelines [6].


Market Analysis

Naproxen Sodium Market

  • Market Size & Growth:
    The global NSAID market was valued at approximately $20 billion in 2022 and is anticipated to reach $31 billion by 2030 at a CAGR of 5.7% [7]. Naproxen Sodium accounts for a significant share, driven by its established efficacy and over-the-counter (OTC) availability.

  • Key Drivers:
    The rising prevalence of osteoarthritis and rheumatoid arthritis, coupled with an aging population, sustains demand. The expansion of OTC formulations in emerging markets like Asia-Pacific further fuels growth.

  • Challenges:
    Safety concerns, especially related to gastrointestinal and cardiovascular risks, prompt users and prescribers to seek safer alternatives. Strict regulatory scrutiny can influence market dynamics.

  • Competitive Landscape:
    Major players include Bayer, Johnson & Johnson, and Teva Pharmaceuticals. Patent expirations and generic proliferation have increased pricing pressure but also expanded access.

Sumatriptan Succinate Market

  • Market Size & Growth:
    The global migraine therapeutics market is valued at approximately $6 billion as of 2022, projected to grow at a CAGR of 4.5% to reach $8 billion by 2030 [8]. Sumatriptan remains a leading product given its efficacy and early formulation patents.

  • Key Drivers:
    Increasing migraine prevalence worldwide, especially in women and young adults, sustains demand. Advancements in delivery systems (e.g., nasal powders) enhance patient adherence and satisfaction.

  • Challenges:
    Contraindications in cardiovascular disease limit use in certain segments. Competitive emergence of gepants (e.g., ubrogepant) and ditans (e.g., lasmiditan) introduces alternatives that may affect market share.

  • Emerging Trends:
    The shift towards personalized medicine and increased use of combination therapies could reshape the landscape. The ongoing pipeline, featuring long-acting formulations, indicates future growth.


Market Projections and Strategic Outlook

Naproxen Sodium

  • Growth Trajectory:
    Steady demand is expected, with particular strength in OTC channels. Regulatory pressures emphasizing safety may lead to formulation improvements and better risk profiles, broadening its usage in chronic conditions.

  • Product Innovation:
    Focus on developing formulations with reduced gastrointestinal and cardiovascular risks can differentiate brands. Pharmacovigilance data may influence labeling and prescribing habits.

  • Geographic Trends:
    Strong growth anticipated in emerging markets, driven by increasing healthcare access and rising prevalence of chronic inflammatory conditions.

Sumatriptan Succinate

  • Market Expansion:
    The authorization of new delivery systems and expanded indications could stimulate growth beyond acute migraine treatment, possibly encompassing preventive strategies for related headache disorders.

  • Competitive Dynamics:
    The rise of oral gepants and lasmiditan, alongside innovative delivery methods, may challenge sumatriptan's market dominance but also create opportunities for combination regimens.

  • Regulatory & Innovation Outlook:
    A focus on improving safety in high-risk patients and developing longer-acting formulations can sustain competitive advantages.


Key Takeaways

  • Clinical developments for Naproxen Sodium hinge on improving safety, particularly gastrointestinal and cardiovascular profiles, with ongoing trials aimed at expanding indications and formulations.

  • Sumatriptan Succinate is benefiting from innovations in delivery systems and broader indications, though competition from newer classes requires strategic positioning.

  • Market growth for both drugs remains robust but is increasingly influenced by safety concerns, regulatory scrutiny, and technological innovations.

  • Emerging markets present substantial opportunities, especially for OTC NSAIDs and innovative migraine treatments.

  • Strategic implications involve investing in formulation improvements, safety profiling, and marketing tailored to geographic and demographic trends.


FAQs

1. How does the safety profile of Naproxen Sodium impact its market?
Safety concerns related to gastrointestinal and cardiovascular risks have led to stricter labeling and influence prescribing practices. However, formulation modifications and risk mitigation strategies help sustain its market presence.

2. Are new formulations of Sumatriptan Succinate expected to significantly alter its market share?
Yes. Faster-onset nasal powders and autoinjectors enhance patient adherence, making it competitive against emerging migraine therapies, potentially extending market dominance.

3. What emerging drug classes threaten traditional NSAIDs and triptans?
Gepants (e.g., ubrogepant) and ditans (e.g., lasmiditan) offer effective, safety-advantaged alternatives for migraine, while monoclonal antibodies provide new avenues for chronic pain management.

4. How are regulatory agencies influencing the future of these drugs?
Regulators emphasize safety, especially cardiovascular risks, which prompts formulation reforms and careful post-market surveillance, shaping product innovation and compliance strategies.

5. What geographic markets present the most growth opportunities?
Emerging markets in Asia-Pacific, Latin America, and Africa exhibit increasing demand driven by rising prevalence of inflammatory and headache disorders and expanding healthcare infrastructure.


References

[1] Arthritis & Rheumatology, 2022. "Extended-release Naproxen formulations: efficacy and gastrointestinal safety."
[2] Pediatric Rheumatology, 2021. "Naproxen use in juvenile idiopathic arthritis."
[3] FDA Post-market surveillance data, 2022. "NSAID safety updates."
[4] Journal of Headache & Pain, 2021. "Rapid relief with nasal powder sumatriptan: pharmacokinetic profile."
[5] Clinical trial registries, 2022. "Sumatriptan prophylactic application in cluster headaches."
[6] The Lancet Neurology, 2022. "Safety considerations with triptan use."
[7] Global Market Insights, 2023. "NSAID market forecast."
[8] MarketWatch, 2022. "Migraine therapeutics market analysis and projections."


In conclusion, recent clinical advances and evolving market dynamics position Naproxen Sodium and Sumatriptan Succinate as essential, yet increasingly competitive, pharmaceuticals within their respective domains. Continuous innovation and adherence to safety profiles will be key drivers shaping their future growth trajectories.

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