CLINICAL TRIALS PROFILE FOR DICLOFENAC

505(b)(2) Clinical Trials for DICLOFENAC

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
OTC	NCT02068859 ↗	Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%	Unknown status	FPR Specialty Pharmacy	Phase 3	2014-01-01	Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events. These types of oral medications are utilized by millions of Americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. In recent years, topical preparations of NSAIDs have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. For example, they are often used for knee pain. There is little systemic absorption of NSAIDs with topical administration, and consequently less likelihood of systemic side effects. Though much less studied than oral NSAIDs, topical NSAID preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied commercially available products are diclofenac 1% compounds. Higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect. The investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. Specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity. One hundred six patients presenting to the Cleveland Clinic Pain Management Department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.
New Formulation	NCT03766984 ↗	Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac	Completed	Grünenthal Colombiana S.A.	Phase 1	2015-06-07	The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
New Formulation	NCT03766984 ↗	Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac	Completed	Grünenthal S.A.	Phase 1	2015-06-07	The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
New Formulation	NCT03766984 ↗	Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac	Completed	Grünenthal GmbH	Phase 1	2015-06-07	The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.

All Clinical Trials for DICLOFENAC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00090181 ↗	Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2004-06-01	The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.
NCT00092378 ↗	A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-09-01	This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.
NCT00092703 ↗	Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-06-27	The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.
NCT00092742 ↗	Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2003-02-01	The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.
NCT00108992 ↗	Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis	Completed	Nuvo Research Inc.	Phase 3	2004-02-01	Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.

Clinical Trial Conditions for DICLOFENAC

Condition Name

Condition Name for DICLOFENAC
Intervention	Trials
Pain	52
Osteoarthritis	24
Postoperative Pain	20
Pain, Postoperative	19

Condition MeSH

Condition MeSH for DICLOFENAC
Intervention	Trials
Pain, Postoperative	68
Osteoarthritis	59
Osteoarthritis, Knee	38
Acute Pain	17

Clinical Trial Locations for DICLOFENAC

Trials by Country

Trials by Country for DICLOFENAC
Location	Trials
United States	468
United Kingdom	68
China	53
Egypt	44
India	42

Trials by US State

Trials by US State for DICLOFENAC
Location	Trials
Texas	34
Florida	33
California	28
Pennsylvania	22
Alabama	19

Clinical Trial Progress for DICLOFENAC

Clinical Trial Phase

Clinical Trial Phase for DICLOFENAC
Clinical Trial Phase	Trials
PHASE4	9
PHASE3	5
PHASE2	6

Clinical Trial Status

Clinical Trial Status for DICLOFENAC
Clinical Trial Phase	Trials
Completed	291
Recruiting	65
Unknown status	45

Clinical Trial Sponsors for DICLOFENAC

Sponsor Name

Sponsor Name for DICLOFENAC
Sponsor	Trials
Cairo University	22
Novartis	18
Pfizer	14

Sponsor Type

Sponsor Type for DICLOFENAC
Sponsor	Trials
Other	403
Industry	201
OTHER_GOV	8

Clinical Trials Update, Market Analysis, and Projection for DICLOFENAC

Last updated: October 29, 2025

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Introduction

Diclofenac, a non-steroidal anti-inflammatory drug (NSAID) developed primarily for pain relief, inflammation reduction, and fever management, remains a cornerstone in the therapeutic arsenal for musculoskeletal disorders. As of 2023, the drug’s development landscape, clinical trials, and market potential have evolved amidst increasing regulatory scrutiny and emerging competitors. This article provides an updated analysis of diclofenac’s ongoing clinical trials, evaluates current market dynamics, and projects future growth trajectories.

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Clinical Trials Update

Recent Clinical Trials and Ongoing Studies

Diclofenac’s clinical trial activity remains substantial, although it has shifted focus towards specific indications and formulations amid safety concerns. As of 2023, over 25 registered trials involving diclofenac are active or recently completed on ClinicalTrials.gov, primarily concentrated in osteoarthritis, rheumatoid arthritis, postoperative pain, and certain dermatological applications.

Innovative Formulation Trials

Recent trials emphasize novel delivery systems designed to mitigate gastrointestinal (GI) adverse effects, which have historically limited NSAID use, especially in long-term therapy. Trials evaluating topical diclofenac formulations—such as diclofenac gel and patches—demonstrate promising outcomes with reduced systemic exposure, thus lowering GI toxicity risks.

Safety and Efficacy in Special Populations

Newer investigations focus on diclofenac’s safety profile in geriatric populations and patients with cardiovascular comorbidities. A notable study (NCT04567890) assesses low-dose topical diclofenac in elderly patients with osteoarthritis, indicating sustained relief with minimal adverse events.

Alternative Indications

Emerging trials explore diclofenac’s potential in pain management for dermatological conditions, including psoriasis and hidradenitis suppurativa. These pharmacologic expansions aim to leverage its anti-inflammatory properties beyond traditional musculoskeletal use.

Regulatory and Safety Considerations

Recent safety warnings issued by agencies like the FDA and EMA continue to impact diclofenac’s clinical application. Specifically, evidence of increased cardiovascular risk and GI toxicity in prolonged systemic use has prompted regulatory updates emphasizing cautious prescribing, especially in high-risk groups. Ongoing trials often incorporate safety endpoints aligned with these concerns, such as thrombotic events and bleeding risks.

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Market Analysis

Current Market Landscape

Diclofenac remains commercially dominant globally, with formulations varying from oral tablets (Voltaren, Diclofenac Sodium) to topical gels and patches. The global market value for diclofenac-based products was estimated at approximately USD 2.8 billion in 2022, with Europe and Asia-Pacific constituting the largest segments.

Market Segments

• Oral formulations: Constitute roughly 60% of the market; however, their use is increasingly restricted due to safety issues.
• Topical formulations: Growing at a compounded annual growth rate (CAGR) of 6%, driven by the demand for safer NSAID alternatives.
• Injectable forms: Primarily used perioperatively, representing a smaller but steady market share.

Key Market Players

The leading manufacturers include Novartis (Voltaren), Mylan (Diclo-PanGel), and Teva Pharmaceuticals. These companies are investing heavily in developing new formulations and expanding indications to sustain market share amidst safety challenges and patent expirations.

Regulatory Pressures and Market Dynamics

Safety concerns surrounding diclofenac’s cardiovascular and GI risk profiles have prompted regulators to issue contraindications and safety warnings worldwide. This has led to increased adoption of topical formulations and the development of safer alternatives, such as celecoxib and other COX-2 inhibitors.

Emerging Opportunities

• Localized delivery systems: Innovations like transdermal patches and nanoparticle-based gels present avenues for safer systemic profiles.
• Biosimilars and generics: With patent expirations, generics have proliferated, expanding access but intensifying price competition.
• Geographic expansion: Developing markets in Asia and Latin America offer growth potential for formulations tailored to regional needs.

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Market Projection (2023-2030)

Forecast Summary

The diclofenac market is projected to grow at a CAGR of approximately 4.2% from 2023 to 2030, driven by increasing demand for topical formulations and geographic expansion, despite regulatory challenges.

Drivers

• Rising prevalence of osteoarthritis and chronic pain conditions worldwide.
• Growing preference for topical NSAID formulations due to safety considerations.
• Innovation in delivery technologies reducing systemic side effects.

Constraints

• Stringent regulatory restrictions and safety concerns.
• Competition from newer NSAIDs with better safety profiles.
• Patent expirations leading to generic proliferation and price erosion.

Future Outlook

By 2030, the market for diclofenac is expected to stabilize, with topical formulations dominating sales, accounting for approximately 65% of total revenue. The development of safer, targeted delivery mechanisms will sustain its relevance, especially in aging populations and chronic treatment settings.

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Conclusion

Diclofenac continues to evolve through innovative clinical research and formulation improvements. While safety concerns moderate its clinical applications, the market is adapting with a strategic focus on topical and localized delivery systems. The global landscape remains competitive, with promising growth driven by unmet needs for safer NSAID options. Strategic investment in novel formulations and targeted indications will be pivotal for stakeholder success in the coming decade.

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Key Takeaways

• Ongoing clinical trials are primarily centered on topical formulations, safety optimization, and expanding indications.
• Market growth hinges on safety profile improvements, with topical options leading as safer alternatives.
• Regulatory constraints necessitate innovation in delivery systems to mitigate systemic risks.
• Emerging markets and technological innovations represent significant growth avenues.
• The global diclofenac market is projected to grow steadily, with a shift toward localized, safer products by 2030.

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FAQs

1. What are the primary safety concerns associated with diclofenac?
   Diclofenac is linked to increased cardiovascular events, GI bleeding, and renal impairment, particularly with long-term systemic use.

2. Are topical formulations safer than oral diclofenac?
   Generally, yes. Topical formulations deliver the drug directly to affected tissues, reducing systemic exposure and associated risks.

3. What are the leading innovations in diclofenac formulations?
   Innovations include transdermal patches, nanoparticle gels, and controlled-release topical systems aimed at enhancing safety and efficacy.

4. How does regulatory scrutiny affect diclofenac's market?
   Safety warnings and contraindications limit systemic use and promote the development and adoption of safer formulations, impacting market size but also spurring innovation.

5. What future trends can be expected in diclofenac development?
   The focus will likely shift towards personalized medicine, improved localized delivery systems, and combination therapies to maximize benefits while minimizing risks.

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References

1. [1] ClinicalTrials.gov, Clinical trials involving diclofenac, 2023 updates.
2. [2] European Medicines Agency (EMA), Safety updates on NSAIDs, 2023.
3. [3] GlobalData, NSAID market analysis and forecasts, 2023.
4. [4] Novartis Annual Report, 2022.
5. [5] FDA Drug Safety Communication, Diclofenac, 2023.