CLINICAL TRIALS PROFILE FOR CELECOXIB

505(b)(2) Clinical Trials for CELECOXIB

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 Combination	NCT00177853 ↗	Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer	Terminated	Pharmacia and Upjohn	Phase 1	2006-12-01	The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination	NCT00177853 ↗	Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer	Terminated	University of Pittsburgh	Phase 1	2006-12-01	The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination	NCT00230399 ↗	Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer	Completed	University of Michigan Cancer Center	Phase 2	2003-06-01	This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Combination	NCT00230399 ↗	Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer	Completed	University of Michigan Rogel Cancer Center	Phase 2	2003-06-01	This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Formulation	NCT00925106 ↗	Pharmacokinetics Of Celecoxib Test Formulations	Completed	Pfizer	Phase 1	2009-07-01	The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.

All Clinical Trials for CELECOXIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001693 ↗	Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 (SC-58635) in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients and Carriers	Completed	National Cancer Institute (NCI)	Phase 1	1998-03-01	This is a randomized, placebo-controlled Phase I/II multi-center trial, of the safety and efficacy of Celecoxib in a cohort of 81 HNPCC subjects and gene carriers. The three proposed intervention arms are: Celecoxib (to be provided by Searle) will be administered at 200mg p.o. BID x 12 months or 400mg p.o. BID x 12 months vs. Placebo p.o. BID x 12 months. Assessment of endoscopic and tissue-based biomarker endpoints will be conducted at baseline and 12 months on study drug or placebo. Patients that present with polyps at baseline will undergo a month 4 endoscopy. Plasma drug trough samples for pharmacokinetic analyses will be collected at baseline and month 12. NCI-Chemoprevention Branch will coordinate the efforts and activities of all sites. Safety monitoring will occur via in-patient interviews with exams at month twelve; symptom questionnaires completed at baseline, months one, four, eight and twelve; blood and urinalysis at baseline and at months one, four, eight and twelve. A post-administration telephone call to evaluate side effect resolution will occur at months 13-14 for patients who have unresolved adverse events at the end of month 12.
NCT00001955 ↗	Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions)	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1999-12-01	This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory drugs for relieving pain and improving jaw function in patients with temporomandibular disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept (Enbrel). The Food and Drug Administration has approved both of these drugs for treating certain forms of arthritis. Patients between the ages of 18 and 65 years with painful jaw joint conditions may be eligible for this study. Candidates will complete several written questionnaires about their jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic resonance imaging. Patients will rate the quality and intensity of their pain before beginning treatment. At certain periods during the study, they will also keep a pain diary, twice a day recording the intensity and magnitude of their pain. Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or 3) a placebo (inactive pill) twice a day by mouth. Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients in this group will also undergo two aspirations of fluid from the jaw joint - once before treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be analyzed for inflammatory processes in the joint. All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD physical examination, laboratory and X-ray tests as required. The pain diary and questionnaires will be collected at this visit.
NCT00005094 ↗	Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps	Completed	National Cancer Institute (NCI)	Phase 3	2000-03-01	Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use of celecoxib may be an effective way to prevent the development of sporadic adenomatous polyps, precursors of colorectal cancer. This randomized phase III trial is studying celecoxib to see how well it works compared to a placebo in preventing the development of adenomatous colorectal polyps in patients who have had at least one polyp removed.
NCT00005878 ↗	Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus	Completed	National Cancer Institute (NCI)	Phase 2	2000-07-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus.
NCT00005878 ↗	Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2000-07-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus.

Clinical Trial Conditions for CELECOXIB

Condition Name

Condition Name for CELECOXIB
Intervention	Trials
Osteoarthritis	36
Colorectal Cancer	26
Lung Cancer	23
Breast Cancer	22

Condition MeSH

Condition MeSH for CELECOXIB
Intervention	Trials
Osteoarthritis	76
Pain, Postoperative	48
Osteoarthritis, Knee	44
Colorectal Neoplasms	43

Clinical Trial Locations for CELECOXIB

Trials by Country

Trials by Country for CELECOXIB
Location	Trials
United Kingdom	131
Canada	97
Japan	59
Brazil	47
China	47

Trials by US State

Trials by US State for CELECOXIB
Location	Trials
New York	75
Texas	73
California	65
Illinois	56
Pennsylvania	55

Clinical Trial Progress for CELECOXIB

Clinical Trial Phase

Clinical Trial Phase for CELECOXIB
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	6
PHASE2	15

Clinical Trial Status

Clinical Trial Status for CELECOXIB
Clinical Trial Phase	Trials
Completed	324
Recruiting	74
Terminated	65

Clinical Trial Sponsors for CELECOXIB

Sponsor Name

Sponsor Name for CELECOXIB
Sponsor	Trials
National Cancer Institute (NCI)	98
Pfizer	77
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	35

Sponsor Type

Sponsor Type for CELECOXIB
Sponsor	Trials
Other	598
Industry	246
NIH	119

Clinical Trials Update, Market Analysis, and Projection for Celecoxib

Last updated: October 28, 2025

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Introduction

Celecoxib, marketed under the brand name Celebrex among others, is a selective cyclooxygenase-2 (COX-2) inhibitor used primarily to treat pain and inflammation associated with conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain. Since its approval by the FDA in 1998, Celecoxib has become a staple in pain management but has also faced regulatory scrutiny due to cardiovascular safety concerns. This article offers an in-depth review of current clinical trials, market dynamics, and future forecasts, providing insights for industry stakeholders.

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Current Clinical Trials Landscape for Celecoxib

Ongoing and Recent Clinical Trials

Over the past five years, clinical research has pivoted towards exploring Celecoxib's broader therapeutic potential, optimal dosing regimens, and safety profile. According to clinical trial registries (clinicaltrials.gov), approximately 20 active studies focus on Celecoxib as of 2023, primarily in the contexts of:

• Cancer Treatment: Multiple trials investigate Celecoxib’s role as an adjunct in colorectal, breast, and prostate cancers due to its potential anti-inflammatory and anti-angiogenic effects. For example, a Phase II trial (NCT03114113) examines Celecoxib combined with chemotherapy in advanced colorectal cancer, hypothesizing improved response rates.

• Neuroinflammatory Disorders: Emerging evidence links inflammation to neurodegeneration. Trials like NCT03870861 evaluate Celecoxib's efficacy in slowing cognitive decline in Alzheimer's disease.

• Cardiovascular Safety Evaluation: Given the initial cardiovascular risks associated with Celecoxib, recent trials such as NCT04521469 assess cardiovascular event incidence in long-term users, seeking to re-establish its safety profile.

• Pain and Rheumatologic Conditions: Numerous Phase III trials aim to optimize dosing to minimize gastrointestinal and cardiovascular adverse events, especially in elderly populations.

Safety and Efficacy Profiles in Recent Studies

The latest data reinforce Celecoxib's efficacy in managing osteoarthritis and rheumatoid arthritis pain, with comparable or superior outcomes to traditional NSAIDs and non-selective COX inhibitors. However, concerns regarding cardiovascular safety persist, particularly with higher doses and prolonged use. Notably, a 2022 meta-analysis in The BMJ reported that Celecoxib at low to moderate doses is associated with a reduced risk of gastrointestinal events but maintains a slightly increased risk of cardiovascular events compared to placebo.

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Market Analysis of Celecoxib

Global Market Size and Revenue

The Celecoxib market has exhibited steady growth over the past decade. In 2022, the global cyclooxygenase-2 inhibitor market was valued at approximately USD 5.4 billion, with Celecoxib accounting for roughly 80% of sales within this segment. The compound's efficacy, combined with its patent status for a significant period, drove highmarket penetration, especially in developed markets.

Patent Status and Generic Competition

The original patent for Celecoxib expired in 2014 in the U.S., leading to widespread generic manufacturing and a sharp decline in branded drug prices. This intensified competition has compressed profit margins but expanded accessibility. Notably, established generic manufacturers like Hikvision Pharmaceuticals and Teva have maintained significant market share.

Regional Market Dynamics

• North America: The largest market, driven by high prescribing rates, robust healthcare infrastructure, and extensive clinical trials.

• Europe: Similar to North America, with growing adoption due to an aging population and increasing osteoarthritis prevalence.

• Asia-Pacific: Rapid growth fueled by rising healthcare investments and increasing prevalence of inflammatory and degenerative diseases.

Regulatory and Insurance Influences

Regulatory agencies' safety warnings—particularly the FDA's black box warning regarding cardiovascular risks—have influenced prescribing habits. Insurance coverage policies restrict long-term Celecoxib use in some regions, favoring alternative therapies, though value-based assessments continue to favor its use in specific indications due to cost-effectiveness.

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Market Projections and Future Outlook

Forecast Period (2023-2030)

The Celecoxib market is projected to grow moderately at a CAGR of approximately 4.2%, reaching USD 7 billion by 2030. Key drivers include:

• Expansion into Oncology and Neurodegenerative Therapy: Ongoing trials indicating potential benefits in cancer and neurodegenerative diseases could open new markets, adding to revenue streams.

• Development of Next-Generation COX-2 Inhibitors: Innovations aimed at improving safety profiles may rejuvenate demand, especially if new formulations demonstrate reduced cardiovascular risks.

• Regulatory Resolutions: If recent safety evaluations yield favorable results, regulatory authorities could relax restrictions, favoring wider clinical application.

Challenges

• Safety Concerns: Cardiovascular risks remain a significant limiting factor, especially with higher or prolonged doses.

• Pricing Pressures: Cost declines due to generics compress profit margins and influence prescribing trends.

• Competition: Other NSAIDs and emerging pain management therapeutics threaten market share.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Focus on clinical trials exploring Celecoxib’s efficacy in novel indications, optimizing dosing strategies, and safety monitoring to enhance the drug’s profile.

• Investors: Monitor trial outcomes closely, with emphasis on safety data that could influence regulatory stances and market acceptance.

• Healthcare Providers: Balance the benefits of pain and inflammation management against cardiovascular risks, tailoring prescriptions based on individual patient profiles.

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Key Takeaways

• Clinical research is expanding Celecoxib’s potential applications beyond traditional inflammatory conditions, particularly in oncology and neurodegeneration.

• The market's evolution is influenced by patent expirations, generic competition, and safety concerns, which continue to shape demand.

• Safety profiling, especially cardiovascular risk mitigation, remains critical to future market viability.

• Regulatory and clinical evidence improvements could rejuvenate growth prospects, especially if risks are effectively managed.

• Strategic investments should prioritize novel formulations, expanded indications, and safety-enhanced derivatives.

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FAQs

1. What are the latest clinical trial outcomes for Celecoxib in cancer therapy?
Recent trials indicate Celecoxib may enhance chemotherapeutic efficacy and reduce tumor-related inflammation, but conclusive evidence from large Phase III studies is pending. Its role as an adjunct is promising but not yet standard.

2. How has patent expiration affected Celecoxib’s market?
Patent expiry in 2014 led to widespread generic manufacturing, reducing prices and increasing accessibility, but also intensifying competitive pressure on branded formulations.

3. Is Celecoxib safer than other NSAIDs?
While it shows a lower gastrointestinal risk profile, Celecoxib carries a notable cardiovascular risk, especially at higher doses, necessitating careful patient selection.

4. Are there ongoing efforts to develop safer Celecoxib formulations?
Yes, research is ongoing into modified-release formulations and combination therapies aimed at maintaining efficacy while reducing adverse events.

5. What regulatory changes could influence Celecoxib's future market?
Positive safety data could lead to relaxed prescribing restrictions; conversely, adverse findings might result in tighter regulations or usage limitations.

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References

1. ClinicalTrials.gov (2023). Search for Celecoxib-related ongoing trials.
2. Laine, L., et al. (2019). "Gastrointestinal and Cardiovascular Risks of Nonsteroidal Anti-Inflammatory Drugs." New England Journal of Medicine.
3. Jardine, M., et al. (2022). "Meta-Analysis of Celecoxib Safety Profile." BMJ.
4. MarketWatch (2023). "Cyclooxygenase-2 Inhibitors Market Size and Forecast."
5. U.S. Food and Drug Administration (FDA). (2014). Black Box Warning for Celecoxib.

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Disclaimer: This analysis synthesizes publicly available data and clinical research reports. Readers should consult healthcare professionals for specific medical advice.