CLINICAL TRIALS PROFILE FOR MEFENAMIC ACID

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.
NCT01429935 ↗	Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model	Unknown status	Qazvin University Of Medical Sciences	Phase 2	2010-06-01	Ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory components, its efficacy on acute inflammation was not assessed before. The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce postoperative swelling, pain and trismus in an acute pain model.
NCT01598012 ↗	The Efficacy of Ayurved Siriraj Prasaplai for Treatment Primary Dysmenorrhea	Completed	Mahidol University	Phase 4	2011-12-01	Ayurved Siriraj Prasaplai is a Thai traditional herbal drug for pain treatment. Mostly it was used for antipain during menstruation or dysmenorrhea. This drug has been described by alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and showed clinical satisfied response. From review about this agent, it does not have clinical trial to prove its efficacy. So the author produce this research to study in efficacy of Ayurved Siriraj Prasaplai.

Clinical Trial Conditions for MEFENAMIC ACID

Condition Name

Condition Name for MEFENAMIC ACID
Intervention	Trials
Pain	2
Contraception	2
Healthy Volunteers	1
Impacted Third Molar Tooth	1

Condition MeSH

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

Clinical Trial Locations for MEFENAMIC ACID

Trials by Country

Trials by Country for MEFENAMIC ACID
Location	Trials
United States	4
Ireland	3
Thailand	2
Egypt	2
Indonesia	2

Trials by US State

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

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

Clinical Trial Status

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

Clinical Trial Sponsors for MEFENAMIC ACID

Sponsor Name

Sponsor Name for MEFENAMIC ACID
Sponsor	Trials
Mahidol University	2
Dexa Medica Group	1
Nuventra	1

Sponsor Type

Sponsor Type for MEFENAMIC ACID
Sponsor	Trials
Other	15
Industry	8

Mefenamic Acid: Clinical Trial Readout, Market Map, and Forward Projection

Last updated: April 30, 2026

What is the current clinical trial landscape for mefenamic acid?

Mefenamic acid is an established NSAID (analgesic and anti-inflammatory). In regulatory and commercial practice, its clinical posture is dominated by:

• Older efficacy/safety evidence from prior approvals and post-marketing use
• Newer “me-too” programs focused on formulation changes (bioequivalence, new salts, fixed-dose combinations, or modified-release/controlled-release variants)
• Occasional studies addressing specific subpopulations or endpoints such as pain timing, GI tolerability proxies, or use in dental/orthopedic indications

No consistent, globally consolidated, currently active Phase 3 or Phase 4 late-stage development program is identifiable from standard public registries at a level that supports a high-confidence “current trial status” narrative for mefenamic acid as a drug substance. The practical implication for investment and R&D planning is that most observable clinical activity is incremental rather than paradigm-shifting, typically anchored to regulatory filing needs and local market requirements.

Where do new mefenamic acid studies typically cluster?

Observed patterns in the clinical record for mefenamic acid across jurisdictions are dominated by:

• Acute pain models (post-dental extraction, postoperative pain, musculoskeletal pain)
• Dysmenorrhea endpoints (pain intensity reduction, time to meaningful relief)
• Safety monitoring focused on GI and bleeding risk (often reported as adverse event rates and discontinuation rates)

Clinical readout translation (decision-grade)

For pipeline and competitive assessment, the key “clinical update” value is less about new Phase 3 outcomes and more about:

• Whether trials are establishing non-inferiority in analgesic effect under defined conditions
• Whether formulations are improving tolerability (especially GI adverse event burden) through pharmacokinetic shaping or dosing schedules
• Whether local regulators accept bioequivalence as the bridge for market expansion

Because mefenamic acid is mature, the biggest clinical risk for entrants is not efficacy failure; it is label positioning and tolerability differentiation.

What does the market look like for mefenamic acid today?

Market character

Mefenamic acid is primarily sold as a generic NSAID across multiple countries. Market dynamics typically reflect:

• Price competition driven by generic entry
• Indication-led demand in pain and dysmenorrhea segments
• Procurement via wholesalers and retail channels with frequent substitution
• Heavy dependence on local reimbursement and prescribing guidelines

Competitive structure

The competitive set is usually:

• Multi-source generics (same API, varied strengths and pack formats)
• Formulation variants (immediate release vs. modified release where used commercially)
• Combination products where national labeling permits

Demand drivers that actually matter

• Persisting incidence of dysmenorrhea and common acute pain conditions
• Large volume prescribing of OTC or low-prescription NSAIDs in many markets
• Ongoing clinician and patient preference for familiar NSAIDs, provided tolerability is acceptable

Key restraints

• NSAID class risks (GI ulceration/bleeding, renal impairment, cardiovascular risk in certain populations)
• Guideline restrictions on long-term use and higher-risk patients
• Substitution toward other NSAIDs with perceived safety or tolerability advantages in some markets

What regulatory and label mechanics shape commercialization?

Patent reality and entry incentives

Mefenamic acid is off patent in major markets, so new entrants compete via:

• Bioequivalence and formulation differentiation
• Local regulatory strategy (product lifecycle management, line extensions, and packaging)
• Pricing and channel execution rather than clinical differentiation

Typical label elements affecting uptake

Most approved labels for mefenamic acid include:

• Indications: pain and dysmenorrhea (exact wording varies by jurisdiction)
• Dosing intervals and duration limits
• NSAID warnings (GI and renal risks)
• Contraindications (active GI bleeding or high-risk profiles per local label)

How should investors and R&D teams project mefenamic acid unit and revenue growth?

Projection framework for an off-patent NSAID

For an established, generic NSAID, projections should be built from:

1. Market size base: number of treated patients and prescription volumes by indication
2. Price erosion: generic competition tends to reduce ASP over time
3. Share shifts: formulation and channel execution determine local share
4. Regulatory shocks: label tightening or class safety communications can compress demand

Baseline projection (generic NSAID profile)

A typical off-patent NSAID shows:

• Units: stable to modest growth in many markets due to ongoing demand
• Revenue: often flat to declining in mature markets due to price erosion
• Regional divergence: faster unit growth where generic penetration is still expanding or where reimbursement improves

Because mefenamic acid is widely marketed, the highest growth segments are usually:

• Emerging markets with improving healthcare access
• Regions with less intense generic competition at the product level
• Niche formulation lines that gain share via local pharmacy relationships

Market projection scenarios for the next 5 years

The following is a decision-oriented projection structure, using the generic NSAID pattern rather than a single point estimate:

Base-case scenario (most likely)

• Unit growth: low single digits annually
• Revenue growth: near-flat to low single digits in price-stable territories; negative where ASP compression accelerates
• Share outcome: entrants win share only with execution (distribution, pack sizes, local registrations) or modest tolerability perception

Bull-case scenario (share capture + price stabilization)

• Unit growth: mid single digits annually in specific geographies
• Revenue growth: low to mid single digits driven by share gains offsetting mild price erosion
• Catalyst profile: local guideline support, improved formulary inclusion, or successful differentiation via formulation/bioequivalence advantages

Bear-case scenario (class risk + tighter restrictions)

• Unit growth: flat to slight decline
• Revenue: mid single digit declines in high-competition markets due to steeper ASP erosion
• Catalyst profile: renewed GI safety scrutiny for NSAIDs, formulary narrowing, or aggressive price competition

What is the practical competitive outlook for mefenamic acid products?

Where competitive advantage comes from

For off-patent mefenamic acid, competitive advantage is typically:

• Lower landed cost and reliable supply
• Wider distribution coverage and stronger retail pharmacy penetration
• Clear dosing convenience (pack sizes matched to dosing schedules)
• Brand-to-generic trust transfer in markets where prescribers are reluctant to switch

Where differentiation is constrained

Clinical differentiation is difficult unless:

• A formulation has meaningful pharmacokinetic advantages that translate into faster relief
• A product demonstrates better tolerability in real-world use
• A combination product targets a specific prescribing workflow that improves adherence

Implications for clinical strategy

If an entrant considers mefenamic acid as an R&D target, the most “defensible” clinical approach is not discovering new efficacy. It is:

• Building a regulatory package that clears bioequivalence and labeling needs quickly
• Using endpoints that map to local formularies and prescribing decisions (pain intensity timing, tolerability discontinuation proxies)
• Preparing pharmacovigilance plans aligned to NSAID risk monitoring

Key Takeaways

• Clinical activity for mefenamic acid is dominated by incremental programs rather than new late-stage breakthroughs; most value comes from formulation and regulatory readiness.
• Market growth is constrained by generic price erosion, so revenue performance hinges on geography, channel execution, and product line management.
• Projection outlook is best framed with scenarios: base case is stable units with flat-to-negative revenue in mature markets; bull case depends on share gains and partial price stabilization; bear case follows NSAID class restriction pressure and aggressive generic competition.

FAQs

1) Is mefenamic acid in active Phase 3 development globally?
No broadly visible, late-stage, paradigm-shifting Phase 3 program dominates public records in a way that supports a high-confidence update narrative for the drug substance.

2) What indications drive most demand for mefenamic acid?
Pain states (including acute musculoskeletal and postoperative pain) and dysmenorrhea, with details varying by local label.

3) What is the biggest commercialization risk for a new mefenamic acid product?
Price compression from multi-source generics and limited space for clinical differentiation without formulation advantages.

4) How should an entrant justify differentiation?
By establishing bioequivalence and using dosing/packaging or formulation design that supports faster relief perception or tolerability improvements aligned to local prescribing needs.

5) Are safety warnings a major market factor?
Yes. NSAID class risk messaging can tighten use patterns, especially in higher-risk patients, impacting net demand.

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References

[1] U.S. Food and Drug Administration. (n.d.). Drug Trials Snapshots: Mefenamic Acid (if applicable). FDA.
[2] European Medicines Agency. (n.d.). EPAR search for mefenamic acid and related products. EMA.
[3] World Health Organization. (n.d.). WHO Model Formulary and NSAID-related safety information. WHO.
[4] National Library of Medicine. (n.d.). ClinicalTrials.gov results for mefenamic acid. ClinicalTrials.gov.
[5] PubMed. (n.d.). Search results for mefenamic acid clinical studies. NCBI.