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.
NCT00020878 ↗	Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers	Completed	National Cancer Institute (NCI)	Phase 2	2001-03-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers. PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.

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

Last updated: July 28, 2026

Celebrex (celecoxib) Clinical Trials Update, Market Analysis, and Pricing/Exclusivity-Based Entry Projections

Celebrex (celecoxib, Pfizer) is a mature, off-patent prescription NSAID. The near-term clinical-trials signal is concentrated in label-adjacent population studies (GI and cardiovascular risk stratification, peri-procedural and pain settings), while the commercial outlook is driven by pricing pressure from generics, steady baseline demand in chronic pain and osteoarthritis, and periodic payer-driven formulary changes. Patent exclusivity is not a meaningful gating factor for generic entry in most major markets; competitive dynamics are mainly governed by remaining branded lifecycle patents (if any), ANDA litigation history, and payer contracting.

At-a-glance (business-use)

• Drug class: Selective COX-2 inhibitor (NSAID)
• Originator: Pfizer
• Core uses: Osteoarthritis, rheumatoid arthritis, acute pain (including dysmenorrhea), ankylosing spondylitis (label varies by jurisdiction)
• Competitive regime: Predominantly generic worldwide in major markets; brand share depends on contracting and channel mix
• Clinical-development posture: Predominantly label-expansion/real-world outcomes studies rather than large new Phase 3 programs leading to new indications with distinct exclusivities

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What is the latest Celebrex clinical trials update by phase and indication?

Most “active” activity in celecoxib over the past several years comes from investigator-initiated or sponsor-funded comparative effectiveness work, safety registries, and niche peri-procedural/pain studies, rather than late-stage de novo development. The operational implication is that trials typically do not reset exclusivity clocks in a way that materially delays generic competition, but they can influence guideline positioning, payer criteria, and risk-management rules.

Indication clusters showing ongoing study interest

1. Cardiovascular risk mitigation and comparative safety

   • Focus: event rates in older patients, comorbid populations, and comparative outcomes versus non-selective NSAIDs or alternative analgesics.
   • Typical design: randomized or pragmatic trials, often with endpoints tied to GI and cardiovascular safety.

2. Gastrointestinal safety and co-therapy strategies

   • Focus: rates of ulcer/bleeding, need for PPI co-therapy, and outcomes in at-risk subgroups.
   • Typical design: comparative studies versus naproxen/ibuprofen and observational cohorts.

3. Peri-operative analgesia and enhanced recovery protocols

   • Focus: opioid-sparing strategies, timing of dosing, and post-procedural pain outcomes.
   • Typical design: randomized trials in surgical specialties (dental, ortho, general surgery) with acute endpoints.

4. Musculoskeletal pain and functional outcomes

   • Focus: osteoarthritis symptom burden, adherence, and real-world effectiveness.
   • Typical design: pragmatic randomized trials or post-marketing studies.

What the update means

• Trials in this space rarely create a clean “blocking position” for generic competitors because they usually do not generate new, independent regulatory exclusivities comparable to initial approvals.
• The value to sponsors is typically payer and guideline influence through safety/risk-management evidence, plus conversion of patients from OTC-available analgesics and other NSAIDs.

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Which Celebrex clinical trials outcomes matter for prescribing and reimbursement?

The high-leverage endpoints for celecoxib in real-world utilization are those that map to payer adjudication and formulary management.

Endpoints that shift access

• Serious GI events: GI bleed, ulcer complications
• CV events: myocardial infarction and stroke in high-risk cohorts
• Renal safety: AKI incidence
• Pain and function metrics: WOMAC for OA, VAS/NRS pain, rescue analgesic use
• Opioid-sparing: reduction in opioid consumption post-procedure
• Treatment adherence and discontinuation: discontinuation due to adverse events

Decision impact

• Evidence that supports lower GI and acceptable CV risk in defined populations can improve formulary standing for a COX-2 selective NSAID versus non-selectives, especially under prior authorization or step-therapy frameworks.
• Evidence in peri-operative settings can also shift hospital contracting toward COX-2 inhibitors if they reduce opioid utilization.

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What patents protect Celebrex (celecoxib) today, and how strong is the patent estate?

Celebrex is an older molecule with extensive global filings. The practical takeaway is that brand exclusivity has long expired, and remaining value comes from incremental lifecycle IP only if it is still active in a jurisdiction and still listed in the relevant regulatory inventory (e.g., Orange Book in the U.S.).

U.S. IP reality check (business view)

• Core composition and method-of-use exclusivities for the original product are not a barrier for generic competition in most cases.
• Any remaining “protection” that affects market entry would typically be:
  • narrow formulation or dosing regimens,
  • device/delivery specific claims (if any),
  • or process improvements tied to later manufacturing changes,
  • and would need to be actively asserted or listed for the relevant dosage form.

Practical strength assessment

• For market projection, celecoxib should be treated as largely generic-exposed unless a jurisdiction-specific lifecycle claim is confirmed to still block ANDA/MAA approvals or has settlement constraints.

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When does Celebrex lose exclusivity and what is the Orange Book status of celecoxib?

Celebrex is not a current exclusivity-driven product in the U.S. market. The dominant access pathway is generic entry already completed, with brand share depending on contracting and patient-specific preference rather than patent timing.

Exclusivity and listings

• Orange Book status for celecoxib is generally characterized by a mature portfolio: some listings may remain on record, but they typically do not provide a material exclusivity barrier to generic supply in the near term.

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What generic entry risks exist for Celebrex, including Paragraph IV challenges?

For a mature, off-exclusivity NSAID, Paragraph IV risk is not the core “timing variable” anymore. Instead, entry risk is tied to:

• how quickly additional generic suppliers can scale,
• pricing compression and supply stability,
• and any residual lifecycle IP barriers tied to specific presentations (strengths, dosage forms).

Commercial risk pattern

• Brand erosion continues when pricing benchmarks drop and payer formularies list multiple A-rated generics.
• If supply constraints arise, brand may temporarily regain share, but this is a market mechanics factor rather than IP.

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How many competitors sell generic celecoxib and what is the competitive landscape?

Generic competition is the base case globally. The market structure typically shows:

• multiple abbreviated new drug applicants (in the U.S.),
• robust procurement and pharmacy switching,
• price competition across strengths (100 mg, 200 mg, 400 mg depending on jurisdiction and product lines).

Commercial behavior

• Payers often steer to the lowest net cost generic.
• Pharmacists switch based on formulary and brand/generic price gaps.
• Brand value persists primarily where:
  • prescribers have preference,
  • patients show tolerability issues with a specific generic,
  • or benefit design supports brand copays.

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How does celecoxib pricing evolve under generic pressure, and what does that do to revenue?

Revenue projection hinges on two variables: (1) net price trajectory and (2) volume resilience.

Net price drivers

• Wholesale acquisition cost benchmark compression over time
• Competitive rebates and contracting
• Pharmacy reimbursement practices (U.S. specifics vary by payer and channel)

Volume resilience drivers

• Chronic OA and inflammatory arthralgia recurrence and long-lived use patterns
• Peri-procedural prescriptions in hospital formularies
• Patient retention after a successful tolerability window

Projection logic for market model

• With generic saturation, expected market behavior is:
  • continued erosion in brand net price,
  • slower volume decline than price (brand often holds a residual share),
  • and a gradual shift from brand to generics unless a payer or guideline tilt supports COX-2 selectivity.

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What is the market outlook for celecoxib (Celebrex) by region, and how will it scale through 2030?

Base case (global)

• The mature NSAID market is slow-growth. Celecoxib will track population aging and chronic pain prevalence but will not outgrow generic substitution.
• Share movement depends more on reimbursement policy than on incremental clinical evidence.

Region patterns

• U.S.: continued brand share compression; generic share dominant; peri-operative and guideline-based prescribing may stabilize COX-2 selectivity within formularies.
• EU/UK: similar maturity with national procurement systems; variation by country formularies and pricing regulations.
• Emerging markets: growth can occur longer due to delayed generic uptake timing, but now largely mature in major markets.

2030 trajectory (directional)

• Brand revenue: likely downtrend or flat-to-declining depending on contracting.
• Total celecoxib category revenue: steady-to-slow growth driven by volume, partially offset by price compression.

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What do clinical trial updates imply for future FDA label changes or new exclusivities?

Given the maturity of celecoxib, the most plausible regulatory outcomes are:

• refinement of safety communications,
• expanded risk mitigation language,
• or label updates supporting dosing in specific pain settings.

These do not generally recreate a large exclusivity moat unless new regulatory exclusivity is created by a formal new indication pathway with qualifying pediatric or New Clinical Investigation triggers, which is typically not the pattern for a long-established NSAID.

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What formulation patents or delivery methods protect Celebrex, and what are the workarounds for generics?

For generics, workarounds are typically straightforward once composition and basic dosing are not blocked:

• generic tablets/capsules in the same strengths,
• alternative excipient systems where permitted,
• manufacturing process equivalency under ANDA frameworks.

If any lifecycle patents exist on formulation, they usually narrow the design space but rarely eliminate entry unless they cover core bioavailability-determining features.

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How does Celebrex compare with ibuprofen, naproxen, and other COX-2 inhibitors on safety and market positioning?

Clinical positioning

• Celecoxib is COX-2 selective relative to non-selective NSAIDs, which can support GI safety narratives.
• CV risk remains a key risk lens across COX-2 inhibitors and higher-dose NSAIDs.

Market positioning

• COX-2 selectivity can matter for payer controls, especially where GI risk and step therapy rules favor COX-2 options.
• In practice, prescriber behavior is influenced by:
  • patient CV/GI risk profile,
  • availability of co-therapy (PPI coverage),
  • formulary tier status.

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What Celebrex litigation, settlements, or consent decrees affect generic entry?

For a widely used product, litigation history can include ANDA disputes over listed patents. The business implication is that older settlements could have constrained timing in the past, but they generally do not keep a mature product branded today.

Impact on current market

• Most current generic competition timing is already realized.
• Remaining constraints, if any, would be dosage-form or strength-specific and would typically show as delayed approvals or limited authorized generic competition for a short window in the past.

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How will biosimilar-like dynamics apply to celecoxib?

Celecoxib is not a biologic, so biosimilar frameworks do not apply. Competition comes from chemical generics and authorized generics where relevant.

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Key Takeaways

• Celebrex is in a mature, generic-saturated market. Clinical updates are more likely to influence prescribing and payer risk-management than to re-create exclusivity.
• The commercial outlook through 2030 is driven mainly by net price erosion, contracting, and chronic pain volume resilience, not by patent timing.
• Generics remain the base case; entry risk is more about supply scale and channel contracting than Paragraph IV timing.

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FAQs

1. Are there any current Phase 3 trials for celecoxib that could change the competitive landscape?
2. Which payer criteria most often support COX-2 inhibitors like celecoxib over non-selective NSAIDs?
3. Do clinical trial results on cardiovascular or gastrointestinal safety materially shift celecoxib formulary status?
4. What drug forms and strengths of celecoxib typically have the lowest generic discounting and highest brand persistence?
5. How do hospital formularies and peri-operative protocols influence celecoxib demand versus outpatient arthritis use?

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References (APA)

1. FDA. (n.d.). Drugs@FDA: Celebrex (celecoxib). U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. EMA. (n.d.). EPAR for Celebrex (celecoxib). European Medicines Agency.