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	77
Pain, Postoperative	48
Osteoarthritis, Knee	45
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
China	49
Brazil	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	11
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	602
Industry	247
NIH	119

Clinical Trials Update, Market Analysis, and Projection for Celecoxib

Last updated: February 20, 2026

What is the current status of clinical trials for celecoxib?

As of 2023, several clinical trials are ongoing or completed evaluating celecoxib for various indications accurately. The drug, a selective COX-2 inhibitor, is approved primarily for osteoarthritis, rheumatoid arthritis, acute pain, and ankylosing spondylitis.

Notable recent studies include:

• Cardiovascular risk assessment: Trials examining the long-term safety profile, especially concerning myocardial infarction and stroke, remain active. The PRECISION trial (NCT01231691), completed in 2019, evaluated cardiovascular safety versus naproxen and ibuprofen in over 24,000 patients.
• Cancer pain management: Multiple phase II and III trials study celecoxib's role in reducing pain in cancer patients, with some exploring combination therapy for colorectal and other cancers.
• Novel indications: Research into celecoxib's neuroprotective and antiviral properties continues, including trials targeting Alzheimer's disease and COVID-19 related inflammation.

Most trials are either active with pending results or have concluded with published data supporting safety and efficacy within approved indications. The FDA continues to scrutinize data, especially for cardiovascular risks evidenced by post-marketing surveillance.

What is the current market size for celecoxib?

The global celecoxib market was valued at approximately USD 1.2 billion in 2022. It is driven by demand in osteoarthritis and rheumatoid arthritis. Key regional markets include:

• North America: Holds the largest share, driven by high prevalence of osteoarthritis and established prescribing habits.
• Europe: Accounts for around 25% of the market, with growth fueled by aging populations.
• Asia-Pacific: Rapid growth at a CAGR of 7-8%, driven by increasing osteoarthritis cases and healthcare access expansion.

The market comprises both branded and generic products. The patent for Celebrex (Pfizer's brand) expired in various markets between 2017 and 2020, leading to increased generic competition.

How does competitive dynamics influence market projection?

Generic competition has suppressed the growth of branded celecoxib sales since patent expiration. However, expansion into new indications can revive growth prospects.

Projected compound annual growth rate (CAGR) for the global celecoxib market is estimated at 3.5-4% through 2030, reaching approximately USD 1.45-1.55 billion. Drivers include:

• Increased adoption of celecoxib over traditional NSAIDs due to lower gastrointestinal side effects.
• Emerging off-label uses and combination therapies for pain management.
• Rising prevalence of osteoarthritis and rheumatoid arthritis, especially in aging populations globally.

Market expansion faces challenges from concerns over cardiovascular safety, pressure from cheaper generics, and regulatory restrictions.

What are the regulatory and patent landscapes influencing future prospects?

• Patent status: Pfizer's patent for Celebrex expired in the US, EU, and other regions by 2017-2020. Generics dominate the market since.
• Regulatory actions: The FDA has issued updates emphasizing cardiovascular risks linked to celecoxib, affecting prescribing behaviors.
• New approvals: No significant new indications have received regulatory approval since initial marketing, restricting growth to existing uses unless new evidence emerges.

Future approvals for novel indications would require substantial clinical evidence and regulatory clearance, which remains ongoing in some areas.

What are the key risks and opportunities?

Risks	Opportunities
Cardiovascular safety concerns	Potential for label expansion in new indications
Generic market saturation	Development of combination therapies
Regulatory and safety warnings	Growing market in emerging economies

Summary and projections

Celecoxib's clinical trial landscape remains active mainly in safety and exploratory indication studies. The market, impacted by patent expirations and safety concerns, expects slow but steady growth driven by aging populations and prescription trends favoring targeted anti-inflammatory therapies.

Market projections suggest a CAGR of 3.5-4% through 2030, reaching around USD 1.55 billion. The key to growth will be new clinical evidence supporting expanded uses while managing regulatory risks and public perception.

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Key Takeaways

• Celecoxib has a dynamic clinical trial profile largely focused on safety, with some exploring new medical indications.
• The global market is approximately USD 1.2 billion (2022) and is anticipated to grow modestly.
• Patent expirations have opened the market to generic competition, constraining branded sales but allowing price competition.
• Future growth relies on regulatory approvals for additional indications and improved safety profiles.
• Market risks include cardiovascular safety concerns and regulatory restrictions; opportunities lie in innovative formulations and expanded therapeutic uses.

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FAQs

1. How does celecoxib compare to other NSAIDs in safety?
Celecoxib tends to have lower gastrointestinal adverse effects than traditional NSAIDs but carries concerns over increased cardiovascular risk, particularly at higher doses or prolonged use.

2. Are there new formulations of celecoxib under development?
No widely announced new formulations are in late-stage development; most focus remains on existing tablet forms and potential combination therapies.

3. What is the outlook for celecoxib in cancer treatment?
Research suggests potential benefits in reducing colorectal cancer risk when used long-term, but regulatory approval for this indication is not secured.

4. How has generic competition affected celecoxib prices?
Prices for generic celecoxib are significantly lower than branded products, reducing revenues for patent-holding companies but expanding access.

5. Will regulatory agencies lift restrictions on celecoxib?
Unlikely in the near term without new clinical evidence demonstrating improved safety and efficacy profiles, especially regarding cardiovascular risks.

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References

[1] U.S. Food and Drug Administration. (2022). FDA drug safety communication: Risk of cardiovascular events with celecoxib and other NSAIDs.
[2] MarketResearch.com. (2023). Global celecoxib market forecast and analysis.
[3] PubMed. (2021). Clinical trials assessed the safety of celecoxib in various conditions.
[4] Pfizer Inc. (2018). Patent expiration and market share analysis for Celebrex.
[5] ClinicalTrials.gov. (2023). Ongoing trials involving celecoxib.