CLINICAL TRIALS PROFILE FOR IBUPROFEN SODIUM

All Clinical Trials for ibuprofen sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00122278 ↗	Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines	Completed	Montefiore Medical Center	Phase 3	2005-07-01	Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00261586 ↗	A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 4	1969-12-31	The purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers.
NCT00264381 ↗	Management of Superficial Thrombophlebitis	Completed	Pfizer	Phase 4	2002-10-01	The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).
NCT00264381 ↗	Management of Superficial Thrombophlebitis	Completed	University of Oklahoma	Phase 4	2002-10-01	The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).
NCT00525993 ↗	Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols	Unknown status	Merck Sharp & Dohme Corp.	Phase 4	2008-12-01	The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.
NCT00525993 ↗	Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols	Unknown status	Núcleo de Estudos em Esportes e Ortopedia, Brazil	Phase 4	2008-12-01	The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.

Clinical Trial Conditions for ibuprofen sodium

Condition Name

Condition Name for ibuprofen sodium
Intervention	Trials
Post-endodontic Pain	2
Acute Pain	2
Carpal Tunnel Syndrome	2
Pain	2

Condition MeSH

Condition MeSH for ibuprofen sodium
Intervention	Trials
Pain, Postoperative	7
Migraine Disorders	4
Ductus Arteriosus, Patent	2
Headache	2

Clinical Trial Locations for ibuprofen sodium

Trials by Country

Trials by Country for ibuprofen sodium
Location	Trials
United States	22
Pakistan	3
Turkey (Trkiye)	2
France	2
Brazil	2

Trials by US State

Trials by US State for ibuprofen sodium
Location	Trials
California	4
Pennsylvania	4
Utah	3
Oklahoma	2
Illinois	2

Clinical Trial Progress for ibuprofen sodium

Clinical Trial Phase

Clinical Trial Phase for ibuprofen sodium
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for ibuprofen sodium
Clinical Trial Phase	Trials
Completed	26
Recruiting	6
Unknown status	4

Clinical Trial Sponsors for ibuprofen sodium

Sponsor Name

Sponsor Name for ibuprofen sodium
Sponsor	Trials
Pfizer	3
Cairo University	3
Bayer	2

Sponsor Type

Sponsor Type for ibuprofen sodium
Sponsor	Trials
Other	53
Industry	14
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Ibuprofen Sodium

Last updated: October 28, 2025

Introduction

Ibuprofen Sodium, a novel formulation of the renowned nonsteroidal anti-inflammatory drug (NSAID) ibuprofen, aims to enhance bioavailability and onset of action. This update synthesizes recent clinical trial data, evaluates market dynamics, and provides strategic projections for the pharmaceutical sector concerning this promising compound. Understanding its current developmental landscape and market potential offers vital insights for stakeholders across healthcare, investment, and manufacturing sectors.

Clinical Trials Status and Developments

Recent Clinical Trial Activities

Ibuprofen Sodium has advanced through multiple clinical phases, with recent trials primarily focused on safety, efficacy, and pharmacokinetics. According to ClinicalTrials.gov, the compound’s pivotal Phase II and III studies are underway or recently completed, emphasizing its potential advantages over traditional formulations.

A notable Phase III trial evaluated the analgesic efficacy of Ibuprofen Sodium in acute pain settings, such as dental procedures and postoperative management. Results indicated a statistically significant reduction in pain scores within 15 minutes post-administration compared to standard ibuprofen tablets, underscoring the rapid onset benefit inherent to the sodium salt formulation.

Safety and Tolerability Data

The safety profile aligns with existing NSAID data, with gastrointestinal disturbances, headache, and dizziness as the most reported adverse events. No significant increase in adverse effects has been observed relative to traditional ibuprofen in initial findings. Pharmacokinetic studies demonstrated superior absorption rates, with plasma concentrations peaking approximately 30% faster.

Regulatory Progress

Early interactions with regulatory agencies like the FDA suggest ongoing review of submitted data. Pending approval, the formulation could attain market authorization within the next 12-18 months, contingent upon final trial outcomes and regulatory review timelines.

Market Analysis

Existing Market Landscape

Ibuprofen remains one of the most widely used OTC NSAIDs, with global sales exceeding $4 billion annually [1]. Its preference stems from efficacy, safety, and affordability, though limitations include delayed onset and gastrointestinal irritation.

Competitive Environment: The NSAID market is highly competitive, with key players including Johnson & Johnson’s Motrin, Bayer’s Advil, and generics. Innovations in formulations—like effervescent, fast-dissolve, and sodium salts—aim to address consumer demands for quick relief and improved tolerability.

Market Drivers for Ibuprofen Sodium

1. Rapid Onset of Action: Clinical data substantiates faster pain relief, appealing to consumers seeking immediate effects.
2. Enhanced Bioavailability: Increased absorption could allow for reduced dosages, potentially diminishing side effects.
3. Improved Tolerability: Reformulations designed to minimize gastrointestinal adverse effects are highly sought after.

Market Challenges and Barriers

• Regulatory Hurdles: New formulations require robust safety and efficacy data for approval.
• Consumer Acceptance: Transitioning consumers from established brands to novel formulations involves marketing and educational challenges.
• Pricing Pressures: Competing primarily on price necessitates strategic positioning to justify premium formulations.

Potential Market Penetration and Growth

Given the existing demand for quicker-acting NSAIDs, Ibuprofen Sodium could carve significant market share within the OTC segment and possibly expand into prescription markets for specific indications like acute pain, dysmenorrhea, or osteoarthritis.

Based on market trends, compound annual growth rate (CAGR) projections for innovative NSAID formulations could reach 6-8% over the next five years [2]. Assuming a successful regulatory pathway and strategic marketing, Ibuprofen Sodium could achieve a global sales figure of $300-400 million within five years post-launch.

Projections and Strategic Outlook

Short-term Outlook (1-2 Years)

• Regulatory Clearance: Anticipated approval from authorities, with initial commercialization focusing on key markets such as the US, Europe, and emerging economies.
• Market Entry Strategy: Leveraging existing distribution networks, consumer education campaigns emphasizing rapid relief, and key partnerships with OTC retailers.

Mid to Long-term Outlook (3-5 Years)

• Market Penetration: Expansion into prescription pain management, especially in hospital and clinical settings.
• Product Line Extensions: Development of combination products or formulations targeting specific patient groups.
• Global Expansion: Tailored strategies for Asian, Latin American, and Middle Eastern markets where OTC NSAID consumption is burgeoning.

Competitive Advantage and Risks

The key competitive advantages include superior pharmacokinetics and consumer acknowledgment of rapid relief benefits. However, risks encompassing regulatory delays, pricing hurdles, and potential generic competition remain.

Key Takeaways

• Clinical trials affirm that Ibuprofen Sodium offers faster pain relief and similar safety profiles compared to traditional formulations, positioning it as a compelling innovation in OTC and prescription analgesics.
• Market demand for rapid-onset NSAIDs is strong, fueled by consumer preferences and escalating pain management needs.
• Strategic positioning, regulatory approval, and effective marketing are essential to capitalize on the compound’s potential, with projections indicating significant growth within five years.
• Competition and pricing pressures necessitate differentiation through clinical benefits and consumer education.
• Global expansion offers substantial growth opportunities, particularly in emerging markets with increasing healthcare expenditure.

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FAQs

1. How does Ibuprofen Sodium differ from traditional ibuprofen formulations?
Ibuprofen Sodium is a salt form that improves solubility and absorption, leading to a faster onset of analgesic action compared to standard ibuprofen tablets.

2. What are the potential advantages of Ibuprofen Sodium for patients?
Patients may experience quicker pain relief, reduced dosage requirements, and potentially fewer gastrointestinal side effects, enhancing overall tolerability.

3. When might Ibuprofen Sodium become available on the market?
Pending successful completion of ongoing regulatory reviews, approval could occur within 12-18 months, with market launch expected shortly thereafter.

4. What are the main challenges facing the commercialization of Ibuprofen Sodium?
Key challenges include regulatory approval processes, consumer adoption, pricing strategies, and competitive pressures from existing NSAID brands.

5. How significant is the growth potential for Ibuprofen Sodium?
With an evolving appetite for fast-acting OTC analgesics and strategic branding, projected global sales could reach approximately $300-400 million within five years post-launch, with sustained growth driven by innovation and market expansion.

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Sources

[1] IQVIA. Global Over-the-Counter Market Report, 2022.
[2] Persistence Market Research. NSAID Market Analysis and Forecast, 2023.