CLINICAL TRIALS PROFILE FOR KETOPROFEN

505(b)(2) Clinical Trials for KETOPROFEN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT04678076 ↗	Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution	Completed	Cross Research S.A.	Phase 1	2018-07-23	This is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive periods to healthy voluteers under fed conditions.
New Formulation	NCT04678076 ↗	Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A	Phase 1	2018-07-23	This is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive periods to healthy voluteers under fed conditions.

All Clinical Trials for KETOPROFEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00265304 ↗	A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee	Completed	IDEA AG	Phase 2	2005-07-01	The purpose of this study is to evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees.
NCT00108810 ↗	Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee	Completed	ZARS Pharma Inc.	Phase 2	2005-04-01	The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.
NCT00188071 ↗	Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen	Completed	University Hospital, Angers	N/A	2002-09-01	- To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics - each treatment beeing allocated by randomization

Clinical Trial Conditions for KETOPROFEN

Condition Name

Condition Name for KETOPROFEN
Intervention	Trials
Pain, Postoperative	8
Postoperative Pain	7
Pain	7

Condition MeSH

Condition MeSH for KETOPROFEN
Intervention	Trials
Pain, Postoperative	18
Osteoarthritis	14
Osteoarthritis, Knee	12

Clinical Trial Locations for KETOPROFEN

Trials by Country

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Trials by Country for KETOPROFEN
Location	Trials
United States	137
Brazil	20
France	17
Italy	15
Egypt	5

Trials by US State

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Trials by US State for KETOPROFEN
Location	Trials
Texas	10
California	8
Florida	7
North Carolina	7
New York	6

Clinical Trial Progress for KETOPROFEN

Clinical Trial Phase

Clinical Trial Phase for KETOPROFEN
Clinical Trial Phase	Trials
Phase 4	34
Phase 3	36
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for KETOPROFEN
Clinical Trial Phase	Trials
Completed	67
Unknown status	11
Terminated	5

Clinical Trial Sponsors for KETOPROFEN

Sponsor Name

Sponsor Name for KETOPROFEN
Sponsor	Trials
Sanofi	5
IDEA AG	5
Pontificia Universidade Catolica de Sao Paulo	4

Sponsor Type

Sponsor Type for KETOPROFEN
Sponsor	Trials
Other	90
Industry	40

Ketoprofen: Clinical Trials, Market Analysis, and Projections

Introduction to Ketoprofen

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) widely used for its analgesic, anti-inflammatory, and antipyretic properties. It is employed in various formulations, including tablets, capsules, gels, and microspheres, to treat a range of conditions from chronic pain to inflammatory diseases.

Clinical Trials and Recent Developments

Lymphedema Treatment

One of the most significant recent developments involving ketoprofen is its potential use in treating lymphedema. A groundbreaking study published in Science Translational Medicine revealed that ketoprofen, along with another drug called bestatin (ubenimex), shows promise in alleviating lymphedema symptoms. Ketoprofen was found to relieve symptoms, although it had side effects and its molecular mechanism was unclear. The study led to the identification of bestatin as a more effective and safer alternative, which is now being tested in clinical trials for secondary lymphedema[1].

Sustained Release Formulations

Research has also focused on developing sustained-release formulations of ketoprofen to enhance its therapeutic efficacy and reduce side effects. For instance, a study on microspheres with sustained ketoprofen release demonstrated that these microspheres had no significant cytotoxic effects and provided a prolonged release of the drug over 20 days. This could be particularly beneficial for treating conditions like aseptic inflammation[4].

Market Analysis

Global Market Size and Growth

The global ketoprofen market is experiencing steady growth driven by the increasing prevalence of chronic pain conditions and the demand for effective analgesic treatments. As of 2022, the market was valued at approximately USD 500 million and is projected to reach around USD 650 million by 2027, with a compound annual growth rate (CAGR) of 5.1% during this period[3].

Market Segmentation

The ketoprofen market is segmented by type, application, and region. Key segments include:

• Types: Ketoprofen above 99.5% and below 99.5% purity levels.
• Applications: Ketoprofen tablets, capsules, gels, and other formulations.
• Regions: The market is dominated by China, which accounts for about 68% of the market share, followed by Europe with around 18%[2][3].

Key Players

Major players in the ketoprofen market include SANOFI-Aventis, Boehringer-Ingelheim, BEC, Zhejiang Jiuzhou, and Hubei Xunda. These companies are driving innovation and expansion in the market through advanced drug formulations and strategic collaborations[2][3].

Market Projections

Forecasted Market Size

By 2030, the global ketoprofen market is expected to grow from its current size. However, different reports provide varying projections:

• One report suggests the market will grow from USD 36 million in 2024 to USD 40 million by 2030, with a CAGR of 1.9%[2].
• Another report indicates a more substantial growth, projecting the market to reach around USD 650 million by 2027, with a CAGR of 5.1% from 2022 to 2027[3].

Technological Advancements

Technological advancements, such as the use of artificial intelligence (AI) and automation, are significantly influencing the ketoprofen market. AI-driven algorithms are accelerating drug discovery and improving the precision of clinical trials, while automation is enhancing manufacturing efficiencies and product quality. These advancements are expected to drive market growth and shape the future landscape of the industry[3].

Innovation and Product Development

The market is expected to benefit from innovations such as enhanced formulations that minimize side effects, combination therapies with complementary agents, and eco-friendly, bio-based packaging. Research into personalized medicine and strategic collaborations with healthcare providers are also anticipated to drive differentiation and growth[5].

Competitive Landscape

The ketoprofen market is competitive, with top companies occupying a significant market share. The competitive landscape is characterized by:

• Market Penetration: Detailed data from key industry players highlight the current market landscape.
• Market Development: Potential growth prospects in emerging markets and expansion opportunities in mature segments are being explored.
• Market Diversification: Recent product launches, untapped geographic regions, and strategic investments are key areas of focus[5].

Key Takeaways

• Clinical Trials: Ketoprofen is being explored for its potential in treating lymphedema, with bestatin emerging as a promising alternative.
• Market Growth: The global ketoprofen market is projected to grow, driven by increasing demand for analgesic treatments and technological advancements.
• Technological Advancements: AI and automation are enhancing drug discovery, clinical trials, and manufacturing efficiencies.
• Innovation: Enhanced formulations, combination therapies, and personalized medicine are expected to drive market differentiation and growth.

FAQs

What is the current market size of the ketoprofen market?

The global ketoprofen market was valued at approximately USD 500 million in 2022 and is projected to reach around USD 650 million by 2027[3].

Which regions dominate the ketoprofen market?

China dominates the market with about 68% market share, followed by Europe with around 18%[2].

What are the key applications of ketoprofen?

Key applications include inflammation reduction and pain relief, with formulations such as tablets, capsules, and gels[5].

How is AI influencing the ketoprofen market?

AI is accelerating drug discovery, improving clinical trial precision, and enhancing manufacturing efficiencies, contributing to more rapid and cost-effective product development[3].

What are the main players in the ketoprofen market?

Major players include SANOFI-Aventis, Boehringer-Ingelheim, BEC, Zhejiang Jiuzhou, and Hubei Xunda[2][3].

Sources

1. Groundbreaking Lymphedema Treatment Study - Georgia Tech.
2. Global Ketoprofen Market Insights, Forecast to 2030 - Valuates Reports.
3. Ketoprofen Market - GitHub.
4. Preparation of microspheres with sustained ketoprofen release by electrospray for the treatment of aseptic inflammation - Frontiers in Bioengineering and Biotechnology.
5. Ketoprofen Gel Market Size & Share 2025-2030 - 360iResearch.