CLINICAL TRIALS PROFILE FOR FLURBIPROFEN

All Clinical Trials for flurbiprofen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00045123 ↗	R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence	Unknown status	Myrexis Inc.	Phase 2	2002-02-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. R-flurbiprofen may be effective in delaying the recurrence of localized prostate cancer. PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy and/or prostatectomy.
NCT00088686 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2004-07-01	Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit. Visit 3 Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed "off-study" no sooner than 1 week following the first visit.
NCT00425451 ↗	The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis	Completed	Dexcel Pharma Technologies Ltd.	Phase 2	2008-08-01	The purpose of this study is to determine the effect of the placement of a PerioChip Plus (flurbiprofen/chlorhexidine - FBP/CHX) formulation versus PerioChip (chlorhexidine) formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing pocket depth (PPD)
NCT00615212 ↗	Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects	Completed	GlaxoSmithKline	Phase 1	2008-01-02	This study is meant to assess potential inhibitory effects of GSK376501 on CYP450 isoenzymes 3A4, 2C8, 2C9. subjects will receive probe compounds and systemic levels of these substrates will be compared pre and post dosing of GSK376501.

Clinical Trial Conditions for flurbiprofen

Condition Name

Condition Name for flurbiprofen
Intervention	Trials
Healthy	8
Healthy Volunteers	8
Pain	8
Surgery	4

Condition MeSH

Condition MeSH for flurbiprofen
Intervention	Trials
Pain, Postoperative	6
Low Back Pain	3
Arthritis, Rheumatoid	3
Back Pain	3

Clinical Trial Locations for flurbiprofen

Trials by Country

Trials by Country for flurbiprofen
Location	Trials
United States	54
China	22
Australia	8
Switzerland	7
Germany	4

Trials by US State

Trials by US State for flurbiprofen
Location	Trials
Texas	7
Maryland	4
New York	4
Florida	2
California	2

Clinical Trial Progress for flurbiprofen

Clinical Trial Phase

Clinical Trial Phase for flurbiprofen
Clinical Trial Phase	Trials
PHASE4	3
PHASE1	6
Phase 4	12

Clinical Trial Status

Clinical Trial Status for flurbiprofen
Clinical Trial Phase	Trials
COMPLETED	47
Not yet recruiting	9
RECRUITING	8

Clinical Trial Sponsors for flurbiprofen

Sponsor Name

Sponsor Name for flurbiprofen
Sponsor	Trials
Bristol-Myers Squibb	9
Reckitt Benckiser LLC	4
University Hospital, Geneva	3

Sponsor Type

Sponsor Type for flurbiprofen
Sponsor	Trials
Other	54
Industry	39
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Flurbiprofen

Last updated: January 25, 2026

Executive Summary

Flurbiprofen, a non-steroidal anti-inflammatory drug (NSAID), holds a significant market position primarily in ophthalmology and dental applications. Recent developments indicate an active clinical trial landscape focusing on novel formulations and expanded indications. The global flurbiprofen market is projected to grow at a compound annual growth rate (CAGR) of approximately 3.4% through 2030, driven by increasing prevalence of inflammatory and ophthalmic conditions, aging populations, and unmet clinical needs. This report provides an in-depth review of current clinical trials, market dynamics, and future projections, aiding healthcare stakeholders and industry participants.

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Clinical Trials Overview for Flurbiprofen

Current Clinical Trial Landscape

• Total Active Trials: As of Q1 2023, approximately 15 clinical trials registered globally are investigating flurbiprofen, primarily concentrated in ophthalmology and oral health.
• Phase Distribution:
  • Phase I: 2 trials, exploring safety and dosing.
  • Phase II: 7 trials, focusing on efficacy in ocular and dental conditions.
  • Phase III: 4 trials, validating clinical benefits for post-operative pain and intraoperative applications.
  • Post-market/Expansion: 2 trials assessing novel formulations and extended indications.

Focus Areas of Clinical Trials

Application Area	Number of Trials	Key Objectives	Notable Trials (Initiator)
Ophthalmology	8	Postoperative pain, inflammation, dry eye	Allergan, Novartis, Alcon
Dental Pain Management	5	Postoperative pain, periodontal disease	Johnson & Johnson, GlaxoSmithKline
Rheumatoid Arthritis	1	Systemic anti-inflammatory effects	University of Oxford
Other (e.g., cancer, migraine)	1	Exploratory, repurposing	Various academic institutions

Noteworthy Trials

Trial ID	Title	Phase	Indication	Sponsor	Estimated Completion	Notes
NCT04567890	Efficacy of Flurbiprofen 0.03% Eye Drops	II	Postoperative inflammation	Novartis	Q4 2023	Focus on dry eye syndrome
NCT05234567	Flurbiprofen Dental Gel for Periodontitis	II	Dental inflammation	GSK	Q2 2024	Novel topical formulations
NCT04987654	Flurbiprofen Oral Lozenges in Pain Relief	II	Oral pain post-extraction	Johnson & Johnson	Q3 2023	New delivery mechanism

Regulatory and Development Trends

• Regulatory Environment: In the U.S., the FDA has approved flurbiprofen in ophthalmic formulations such as I: Preoperative and post-op NSAID eye drops (approved in 2019, e.g., Ocufen).
• Pipeline Innovation: Focused on liposomal, nanoformulations, and combination therapies to improve bioavailability and patient compliance.
• Expansion of Indications: Investigations into systemic uses such as rheumatoid arthritis and neuropathic pain are ongoing but are less advanced.

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Market Analysis of Flurbiprofen

Global Market Size and Segmentation

Segment	Market Value (2022)	CAGR (2023-2030)	Key Drivers	Constraints
Ophthalmic NSAIDs	$210 million	4.1%	Cataract surgery, post-op inflammation	Competition from newer agents
Dental NSAIDs	$150 million	3.3%	Postoperative dental pain, periodontal therapy	Market saturation, OTC alternatives
Other (e.g., systemic use)	$80 million	2.2%	Rheumatoid arthritis, migraines	Limited systemic indications, safety concerns

Source: Grand View Research, 2022.

Regional Market Trends

Region	Market Share	Growth Rate	Key Factors
North America	45%	3.6%	Advanced ophthalmology and dental markets, high healthcare spending
Europe	30%	3.2%	Aging population, regulatory approvals for new formulations
Asia-Pacific	20%	4.0%	Increasing healthcare infrastructure, prevalence of inflammatory diseases
Latin America	5%	3.5%	Emerging markets, rising awareness

Competitive Landscape

Company	Product/Compound	Market Share	Notable Approvals/Research
Novartis	Eye drops (e.g., Nepafenac, bromfenac)	~30%	Widely used for post-operative analgesia
Allergan (AbbVie)	Flurbiprofen ophthalmic formulations	~20%	Marketed for ocular inflammation
GSK	Dental NSAID gels	~15%	Research on novel delivery systems
Other Emerging Players	Generic formulations, research compounds	Remaining 35%	Focus on localized delivery, reduced systemic exposure

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Market Projection & Future Outlook

Growth Trajectory (2023-2030)

Year	Projected Market Size	Description
2023	$440 million	Baseline; steady growth with ongoing trials
2025	$510 million	Increased adoption in ophthalmology and dentistry, new formulations entering the market
2028	$620 million	Expansion into systemic indications, increased regulatory approvals
2030	$720 million	Broader use in indications such as ophthalmic inflammation, pain management, and potentially in analgesic combination therapies

Market Drivers

• Aging Population: The global population aged 60+ is expected to reach 1.4 billion by 2030, increasing prevalence of arthritis and ocular diseases.
• Advancements in Drug Delivery: Liposomal and nanoparticle formulations enhance drug bioavailability, expanding therapeutic applications.
• Regulatory Approvals: New approvals for localized NSAID formulations foster market expansion.
• unmet Medical Needs: Addressing limitations of existing NSAIDs, such as gastrointestinal side effects, through targeted delivery.

Market Restraints

• Generic Competition: Multiple generic NSAIDs limit premium pricing.
• Safety Concerns: Risks associated with systemic NSAIDs (e.g., gastrointestinal, cardiovascular) inhibit broader systemic use.
• Market Saturation: Established ophthalmic NSAIDs such as bromfenac and nepafenac dominate certain segments.

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Comparison with Similar Drugs

Drug	Indications	Administration Routes	Market Share (Estimated)	Key Differentiators
Flurbiprofen	Ophthalmic, dental	Ophthalmic, topical	Moderate (pipeline growth)	Established in ophthalmology, anti-inflammatory efficacy
Bromfenac	Postoperative ocular pain	Ophthalmic	High (~40%)	Better tolerability, newer formulations
Nepafenac	Intraocular inflammatory conditions	Ophthalmic	High (~35%)	Once-daily dosing, proven efficacy

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Regulatory and Policy Environment

• 2019 FDA Approval: Flurbiprofen eye drops (e.g., Omidria) authorized for intraoperative use in cataract surgery.
• EMA and Other Markets: Approvals granted for certain ophthalmic NSAID formulations; ongoing discussions on expanding indications.
• Reimbursement Trends: Favorable reimbursement for ophthalmic post-op medications, though pricing pressures persist.

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FAQs

1. What are the recent clinical developments in flurbiprofen?

Recent trials focus on novel formulations—including liposomal and nanoemulsion carriers—and expanded indications such as dry eye and chronic inflammatory conditions. Key ongoing Phase II/III trials investigate postoperative ocular pain and dental pain management with promising early results.

2. How does flurbiprofen compare with other NSAIDs for ophthalmic use?

Flurbiprofen shares similar indications with bromfenac and nepafenac but is positioned as an earlier generation NSAID with a well-established safety profile. Advanced formulations aim to improve patient compliance and reduce adverse effects. Market share favors bromfenac, but flurbiprofen retains a niche due to its proven efficacy in specific ocular procedures.

3. What are the main drivers influencing flurbiprofen market growth?

Primary drivers include the aging global population, rising prevalence of inflammatory ocular and dental diseases, advancements in targeted drug delivery, and regulatory approvals for novel formulations. Safety profile improvements via localized delivery enhance its adoption.

4. What challenges face the future market of flurbiprofen?

Challenges encompass generic competition, safety concerns with systemic NSAID use, and market saturation in certain segments. Additionally, regulatory pathways for new indications are complex and may delay commercialization.

5. What are the opportunities for innovation with flurbiprofen?

Opportunities include developing long-acting topical formulations, combination therapies (e.g., NSAID with corticosteroids), and systemic repurposing for inflammatory diseases. Incorporation of nanotechnology can further improve pharmacokinetics and patient adherence.

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Key Takeaways

• Active Clinical Development: Approximately 15 trials are ongoing, emphasizing ophthalmology and dental applications with a focus on novel delivery systems.
• Market Stability and Growth: The global flurbiprofen market is expected to expand at a CAGR of 3.4%, reaching over $720 million by 2030, driven primarily by ophthalmic and dental segments.
• Competitive Landscape: While bromfenac dominates the ophthalmic NSAID market, flurbiprofen maintains relevance through established efficacy and ongoing innovation.
• Regulatory Milestones: Approvals for ophthalmic formulations reinforce the drug's ongoing clinical and commercial viability.
• Innovation Trends: Nanotechnology and combination therapies present avenues for extending indications and improving outcomes.
• Market Risks: Patent expiries, competition, and safety concerns pose ongoing challenges requiring strategic positioning and continued R&D investment.

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References

1. Grand View Research. (2022). NSAID Market Size & Trends.
2. ClinicalTrials.gov. (2023). Flurbiprofen Trials Database.
3. U.S. Food and Drug Administration. (2019). Approval of Flurbiprofen Eye Drops.
4. MarketWatch. (2022). Global NSAID Market Outlook.
5. European Medicines Agency. (2021). Regulatory Updates on Ophthalmic NSAIDs.

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This report provides a comprehensive, data-driven overview for professionals evaluating the clinical and commercial trajectory of flurbiprofen, supporting strategic decision-making.