CLINICAL TRIALS PROFILE FOR CELEBREX

505(b)(2) Clinical Trials for CELEBREX

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	NCT02641314 ↗	Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma	Recruiting	University of Cologne	Phase 2	2016-12-22	Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients experience further progression. Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying vasculature and the interactions between Tumor and immune cells. The toxicity is expected to be low due to the low (but continuous) dosing of drugs. The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected.

All Clinical Trials for CELEBREX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00006124 ↗	Celecoxib in Treating Patients With Bladder Cancer	Completed	National Cancer Institute (NCI)	Phase 2/Phase 3	2000-06-01	This randomized phase IIb/III trial is studying celecoxib to see how well it works in preventing disease recurrence in patients who have bladder cancer. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of bladder cancer
NCT00006299 ↗	Celebrex for Pain Relief After Oral Surgery	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1999-12-01	This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs. Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.

Clinical Trial Conditions for CELEBREX

Condition Name

Condition Name for CELEBREX
Intervention	Trials
Osteoarthritis	15
Lung Cancer	11
Colorectal Cancer	11
Pain	10

Condition MeSH

Condition MeSH for CELEBREX
Intervention	Trials
Osteoarthritis	34
Osteoarthritis, Knee	21
Breast Neoplasms	18
Colorectal Neoplasms	18

Clinical Trial Locations for CELEBREX

Trials by Country

Trials by Country for CELEBREX
Location	Trials
United States	565
United Kingdom	79
Canada	29
Korea, Republic of	14
Spain	9

Trials by US State

Trials by US State for CELEBREX
Location	Trials
Texas	36
New York	35
Pennsylvania	29
California	28
Illinois	27

Clinical Trial Progress for CELEBREX

Clinical Trial Phase

Clinical Trial Phase for CELEBREX
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	56
Phase 3	32

Clinical Trial Status

Clinical Trial Status for CELEBREX
Clinical Trial Phase	Trials
Completed	122
Terminated	35
Unknown status	27

Clinical Trial Sponsors for CELEBREX

Sponsor Name

Sponsor Name for CELEBREX
Sponsor	Trials
National Cancer Institute (NCI)	45
Pfizer	32
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	15

Sponsor Type

Sponsor Type for CELEBREX
Sponsor	Trials
Other	245
Industry	95
NIH	55

CELEBREX Market Analysis and Financial Projection

Last updated: April 28, 2026

Celebrex (celecoxib): Clinical-Stage Readout, Market Status, and Forward Projections

What does the current clinical-development picture show for celecoxib?

Celebrex (celecoxib) is an established NSAID. Public clinical-trial activity since the 2010s has largely shifted from foundational efficacy and safety programs to (1) label-support studies across defined populations, (2) comparative effectiveness work, and (3) studies in combination regimens and dosing strategies. Trial activity is still visible in registries, but it is not positioned like a late-stage “new entrant” pipeline with near-term pivotal readouts that would reset the commercial trajectory of the legacy product.

Clinical trial activity pattern (high level)

• Phase: Predominantly late-phase and post-authorization studies (registry records continue, but no widely documented Phase 3 “new registration” outcome is driving a near-term reinvention narrative).
• Endpoints: Standard NSAID outcomes (pain, inflammation, function), and safety endpoints tied to cardiovascular (CV) and gastrointestinal (GI) risk management, often in population subsets.
• Use-case focus: Chronic musculoskeletal indications remain the commercial core (osteoarthritis, rheumatoid arthritis, acute pain settings depending on label geography), with ongoing research into risk stratification and real-world effectiveness.

Because your request is specifically for a “clinical trials update,” the only actionable way to meet it at Bloomberg-grade specificity is to anchor the update to the latest publicly registered or posted pivotal outcomes. No such pivotal Phase 3 readout for a distinct celecoxib reformulation or new indication is present in the available knowledge context for this run.

What is the commercial and regulatory market reality for Celebrex now?

Celebrex is sold globally and competes in the “traditional branded NSAID to generic NSAID” landscape. The market is shaped by:

1. Class substitution: Other NSAIDs, including generics, keep price pressure on the segment.
2. COX-2 selectivity: Celecoxib’s differentiation is still its GI profile relative to nonselective NSAIDs, but CV risk management limits broad expansion.
3. Formulation maturity: The product is not a new chemical entity; payers and formularies treat it as a commodity unless a localized label or contracting advantage exists.

How does the NSAID market structure affect celecoxib’s pricing power?

Celecoxib competes in a crowded therapeutic class where formularies often implement step therapy. That shifts growth to:

• Continuations and line extensions (where contracting favors celecoxib),
• Switches from other NSAIDs due to tolerability,
• Special-population prescribing where clinicians prefer COX-2 selectivity.

Competitive benchmarks within NSAIDs

• Generic erosion: Generic NSAID use suppresses sustained brand premiums.
• Therapy overlap: COX-2 and nonselective NSAIDs share overlapping patient cohorts in osteoarthritis and chronic pain.
• Safety-driven selection: CV and GI risk profiles determine choice; this is where celecoxib can still win, but it does not create unlimited addressable demand.

What is the most investable lens for market analysis and projection?

For a mature drug like celecoxib, projections depend on three drivers more than clinical novelty:

1. Share retention vs generics (formulary position and switching patterns).
2. Net price trends (rebates, discounts, and payer pressure).
3. Volume stability (prevalence of chronic pain indications and guideline-based use).

With no new pivotal clinical event in the available context, the correct projection stance is: baseline-to-moderate decline from mature erosion, with episodic stabilization in markets with favorable contracting.

Market Projection: Base Case, Downside, Upside

What are the working forecasts for celecoxib demand and revenue trajectory?

Below are strategic projections expressed as directional ranges rather than precise global revenue figures. For an established product with ongoing generic substitution, this is the decision-grade way to model risk without pretending a single “headline” estimate can capture all regional payer dynamics.

Projection framework (directional)

• Base case: Low-single-digit annual declines in branded revenue, with volume largely stable and pricing pressure continuing.
• Downside: Mid-single-digit branded revenue erosion if formulary access worsens or price compression accelerates.
• Upside: Near-flat to low-single-digit growth in select geographies where contracting, safety positioning, or substitution patterns favor COX-2 inhibitors.

Key assumption list

• No new indication approval that would materially expand indication coverage.
• Ongoing generic penetration remains the dominant demand-shaping force.
• Clinical usage stays concentrated in chronic musculoskeletal pain and maintenance settings.

Where can growth still come from?

Even without a new pivotal outcome, celecoxib can see upside from:

• Switching from nonselective NSAIDs in patients with GI tolerability concerns.
• Formulary reinstatement in certain health systems when clinicians document tolerability outcomes.
• Protocol-driven continuity where celecoxib is used as a default COX-2 option for specific risk profiles.

Clinical Trials Update: What would change the trajectory

What would count as a “trajectory-changing” clinical update for celecoxib?

For celecoxib, the threshold for a market reset is high. Trajectory-changing events would typically be:

• A new indication approval (not just ongoing supportive studies),
• A new formulation with meaningful differentiation that alters prescribing behavior,
• A new Phase 3 outcome that shifts safety or efficacy perception at scale,
• A guideline or evidence breakthrough that explicitly upgrades celecoxib’s positioning relative to alternatives.

No such outcome is anchored in the available knowledge context for this run.

Strategic Takeaways for R&D and Investment

Key Takeaways

• Celebrex (celecoxib) is a mature NSAID with ongoing post-authorization and registry activity, but no trajectory-reset pivotal development is identified in the available context.
• The commercial outlook is driven primarily by generic erosion, formulary access, and price compression, not by new late-stage clinical breakthroughs.
• Market projection should be modeled as baseline erosion with potential stabilization pockets, not as a growth story tied to new indications.
• The investable lever is market access and contracting: where celecoxib retains a preferred COX-2 position, revenue decline can slow.

FAQs

1. Is celecoxib still being studied in clinical trials?
   Yes. Post-authorization and registry studies continue, but the available context does not identify a late-stage pivotal outcome that would rebase the commercial trajectory.

2. What keeps celecoxib on formularies?
   Safety positioning relative to nonselective NSAIDs, clinician familiarity, and payer contracting that may favor COX-2 selection for certain GI-risk patients.

3. What is the biggest risk to celecoxib revenue?
   Continued generic substitution and escalating payer price pressure.

4. What is the biggest opportunity?
   Variations in formulary access and switching patterns that favor COX-2 inhibitors in specific patient subsets.

5. Would a new indication approval materially change the outlook?
   Yes. A new label that expands addressable patient populations would be the most direct lever to offset mature-market decline.

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] U.S. FDA. Drug labeling and prescribing information for Celebrex (celecoxib). https://www.accessdata.fda.gov/