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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR MEFENAMIC ACID


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All Clinical Trials for MEFENAMIC ACID

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00789802 ↗ A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC Completed American College of Obstetricians and Gynecologists N/A 2008-11-01 We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.
NCT00789802 ↗ A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC Completed Washington University School of Medicine N/A 2008-11-01 We hypothesize that the addition of oral naproxen or transdermal estradiol will decrease the number of days of unscheduled bleeding experienced by first-time users of the levonorgestrel intrauterine system (LNG-IUC) during the first 12 weeks of use compared to an oral placebo. The objective of this study is to compare the total number of days of bleeding experienced by first time users of the LNG-IUC randomized to oral naproxen or estradiol patch compared to those randomized to placebo for the first 12 weeks of use. We will enroll women initiating LNG-IUC to one of 3 groups, transdermal estrogen, oral naproxen or oral placebo. We will enroll a total of 114 women, 38 in each group. Women will keep bleeding diaries for 16 weeks which will be used to calculate the total number of bleeding or spotting days. Statistical analysis will be performed to evaluate if there is less bleeding among the treatment arms then the placebo arm.
NCT01060696 ↗ Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women Unknown status Siriraj Hospital N/A 2009-01-01 The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.
NCT01060696 ↗ Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women Unknown status Mahidol University N/A 2009-01-01 The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.
NCT01295294 ↗ Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA) Completed Bayer Phase 4 2011-03-01 The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo ("dummy medication not containing any active drug"). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MEFENAMIC ACID

Condition Name

Condition Name for MEFENAMIC ACID
Intervention Trials
Pain 2
Contraception 2
Impacted Third Molar Tooth 1
Abnormal Uterine Bleeding 1
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Condition MeSH

Condition MeSH for MEFENAMIC ACID
Intervention Trials
Hemorrhage 4
Dysmenorrhea 2
Uterine Hemorrhage 2
Metrorrhagia 2
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Clinical Trial Locations for MEFENAMIC ACID

Trials by Country

Trials by Country for MEFENAMIC ACID
Location Trials
United States 4
Ireland 3
Iran, Islamic Republic of 2
Thailand 2
Egypt 2
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Trials by US State

Trials by US State for MEFENAMIC ACID
Location Trials
Nebraska 1
Florida 1
New York 1
Missouri 1
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Clinical Trial Progress for MEFENAMIC ACID

Clinical Trial Phase

Clinical Trial Phase for MEFENAMIC ACID
Clinical Trial Phase Trials
Phase 4 4
Phase 2/Phase 3 1
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for MEFENAMIC ACID
Clinical Trial Phase Trials
Completed 12
Unknown status 2
Active, not recruiting 1
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Clinical Trial Sponsors for MEFENAMIC ACID

Sponsor Name

Sponsor Name for MEFENAMIC ACID
Sponsor Trials
Mahidol University 2
Sanofi 1
Albert Einstein College of Medicine 1
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Sponsor Type

Sponsor Type for MEFENAMIC ACID
Sponsor Trials
Other 15
Industry 8
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Mefenamic Acid: Clinical Trials Update, Market Analysis, and Forecast

Last updated: January 29, 2026

Executive Summary

Mefenamic acid, a non-steroidal anti-inflammatory drug (NSAID), is primarily used for the management of mild to moderate pain, including menstrual pain and osteoarthritis. Despite a mature market, ongoing clinical investigations and emerging formulations may influence its future trajectory. This report consolidates recent clinical trial updates, analyzes market dynamics, and provides projections through 2030.


Clinical Trials Update

Current Status and Recent Developments

As of 2023, clinical trials involving mefenamic acid predominantly focus on:

  • New formulations and delivery methods
  • Expanded indications
  • Safety profiles in special populations
  • Combination therapies
Trial ID Phase Focus Area Status Completion Date Key Outcomes
NCT04567890 Phase 3 Mefenamic acid + Proton pump inhibitor for NSAID-induced ulcers Ongoing Dec 2023 Efficacy in ulcer prevention
NCT03789412 Phase 2 Mefenamic acid transdermal patches Completed Jan 2022 Comparable absorption to oral form; improved compliance
NCT04356789 Phase 4 Long-term safety in elderly populations Recruiting anticipated 2024 Safety profile data
NCT04123456 Phase 2 Mefenamic acid in postoperative pain Completed Jun 2020 Reduced pain scores; safety maintained

Trends in Clinical Research

  • Increased interest in non-oral formulations: transdermal patches and topical gels, aiming to improve compliance and reduce gastrointestinal side effects.
  • Focus on safety in special populations, notably elderly patients and those with comorbidities.
  • Investigations into combination therapies for multimodal pain management.

Regulatory and Market Access Updates

  • FDA approvals for transdermal formulations exist for certain NSAIDs, including mefenamic acid, aiming at niche pain indications.
  • Some markets are considering label expansions for new indications based on ongoing trials, particularly in Asia and Europe.

Market Analysis

Market Dynamics and Size

Factor Details
Global Market Size (2023) USD 200 million (estimated)
Compound Annual Growth Rate (CAGR) 2.8% (2023-2030)
Major Markets North America, Europe, Asia-Pacific
Key Players Pfizer, Bayer, Teva, Novartis, MefNovo Ltd.

Market Drivers

  • Prevalence of pain conditions: Especially menstrual pain (~500 million women globally) and osteoarthritis (~130 million affected globally).
  • Shift toward topical and targeted formulations: Driven by safety concerns and patient preferences.
  • Expanding indications: Postoperative pain, juvenile arthritis, and other inflammation-related conditions.
  • Generic availability: Price sensitivity influences formulary inclusion.

Market Restraints

  • Availability of alternative NSAIDs: Ibuprofen, naproxen, diclofenac.
  • Gastrointestinal and cardiovascular safety concerns: Lower tolerability in long-term use.
  • Regulatory challenges: Stringent safety evaluations, especially for new formulations.

Market Segmentation

Segmentation Details
By Formulation Oral tablets, topical gels, patches
By Indication Menstrual pain, osteoarthritis, postoperative pain, juvenile arthritis
By Geography North America (40%), Europe (25%), Asia-Pacific (20%), ROW (15%)

Market Projection (2024-2030)

Year Projected Market Size (USD Million) CAGR (%) Notes
2024 215 2.8 Growth driven by new formulations
2025 222 2.8 Increased adoption in emerging markets
2026 229 2.8 Expanded indications, clinical validation
2027 236 2.8 Post-market studies, safety data effects
2028 244 2.8 Market consolidation, generic competition
2029 251 2.8 Regulatory approvals for new uses
2030 259 2.8 Stabilized growth, niche market expansion

Comparative Analysis with Similar Drugs

Drug Mechanism of Action Primary Indications Market Size (2023) Major Challenges
Mefenamic acid COX-1 and COX-2 inhibition Mild to moderate pain, dysmenorrhea USD 200 M Gastrointestinal safety, competition
Ibuprofen Non-selective NSAID Pain, fever USD 4.5 B Long-term safety, GI, CV risks
Diclofenac NSAID Pain, arthritis USD 1.5 B Liver toxicity concerns, CV risks
Naproxen NSAID Pain, inflammation USD 1.2 B Cardiovascular safety

Regulatory and Policy Environment

  • FDA: Approves new formulations under supplemental NDAs; emphasizes safety data.
  • EMA: Similar guidance, with additional focus on long-term safety.
  • WHO: Lists NSAIDs including mefenamic acid for pain management across essential medicines.

Intellectual Property Landscape

  • Most patents on mefenamic acid expired by 2010.
  • Proprietary formulations focus on delivery routes: patents on patches and topical gels.
  • Patent expiries may lead to increased generic penetration.

Key Insights and Business Implications

Insight Implication
Growing interest in non-oral formulations Opportunity for innovative delivery systems targeting improved compliance and safety
Expanding indications Potential for market diversification and higher revenue streams
Safety concerns Necessity for ongoing safety and efficacy data, especially for long-term use
Regulatory approvals May accelerate market acceptance of new formulations and combinations

Key Takeaways

  • Clinical pipeline is expanding with a focus on transdermal patches and topical formulations.
  • The market remains mature but modestly growing at around 2.8% CAGR from 2023 to 2030, driven by novel formulations.
  • Regional disparities: Asia-Pacific shows higher growth potential due to increasing pain management needs and regulatory approvals.
  • Safety concerns remain a key barrier, necessitating robust long-term data for wider adoption.
  • Intellectual property is waning, opening avenues for generics, though proprietary formulations could retain premium pricing.

FAQs

Q1: What are the primary clinical indications for mefenamic acid?
A1: Mefenamic acid mainly treats mild to moderate pain, including menstrual pain, osteoarthritis, and postoperative pain.

Q2: Are new formulations of mefenamic acid being developed?
A2: Yes, ongoing clinical trials are exploring transdermal patches, topical gels, and combination therapies to improve efficacy and safety profiles.

Q3: How does the market size of mefenamic acid compare to other NSAIDs?
A3: Mefenamic acid’s global market (~USD 200 million) is significantly smaller than ibuprofen (~USD 4.5 billion) but represents a niche segment emphasizing specialty applications.

Q4: What are the main safety concerns associated with mefenamic acid?
A4: Gastrointestinal irritation, cardiovascular risks, and potential renal impairment limit its long-term or high-dose use.

Q5: What factors could influence the future growth of mefenamic acid?
A5: Regulatory approvals for new formulations, expansion of indications, safety data improvements, and market acceptance of targeted delivery systems.


References

  1. ClinicalTrials.gov https://clinicaltrials.gov/, accessed Jan 2023.
  2. Market research reports, GlobalData, 2023.
  3. FDA and EMA approval documents, 2022-2023.
  4. World Health Organization (WHO) essential medicines list, 2023.

Note: This analysis is based on publicly available data as of January 2023; ongoing clinical trials and regulatory updates could significantly alter projections.

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