CELEBREX (celecoxib)
Celebrex is a nonsteroidal anti-inflammatory drug that helps patients manage the signs and symptoms of various chronic joint conditions, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is also used to help adults with acute pain and primary dysmenorrhea. For younger patients, it treats juvenile rheumatoid arthritis in children aged two years and older.
How CELEBREX Works
This medication works by inhibiting the production of prostaglandins, primarily through the inhibition of the COX-2 enzyme. Because prostaglandins normally mediate inflammation and sensitize nerves to pain, reducing their levels in peripheral tissues helps provide relief from pain, fever, and swelling.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-12-31
- Routes
- ORAL
- Dosage Forms
- CAPSULE
CELEBREX Approval History
What CELEBREX Treats
6 indicationsCELEBREX is approved for 6 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
- Ankylosing Spondylitis
- Acute Pain
- Primary Dysmenorrhea
CELEBREX Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions (5.1) ] . • CELEBREX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contrain...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions (5.1) ] . • CELEBREX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1) ] . Gastrointestinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ] . WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. ( 5.1 ) • CELEBREX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. ( 5.2 )
CELEBREX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CELEBREX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CELEBREX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CELEBREX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
159 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06997068 | MC240701 24-009083 | Ph 2 | recruiting | Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population |
| NCT07559682 EOSCOX2 | SMDC/SMRC/289-23 | Ph 1 | active not recruiting | Efficacy of Selective COX-2 Inhibitors in Relieving Orthodontic Pain |
| NCT06245109 PREDICT | STU00219434 | Ph 4 | recruiting | Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis |
| NCT06699966 | 2024-00259 | Ph 4 | not yet recruiting | Stony Brook Medicine Anti-Inflammatory Trial |
| NCT04765644 ASCENT results posted | 18IC4757 | Ph 4 | completed | Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment |
| NCT03818932 results posted | 123192 | Ph 2, Ph 3 | completed | Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction |
| NCT02115074 FLUVABREX | FLUVABREX-1208 2013-000213-20 | Ph 1 | completed | Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas |
| NCT04488081 I-SPY_COVID | I-SPY-COVID | Ph 2 | active not recruiting | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
| NCT05731726 | ASTRUM-REC01 | Ph 2 | recruiting | Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer |
| NCT03974932 results posted | HTX-011-306 | Ph 3 | completed | Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen |
| NCT02574728 AflacST1502 | IRB00082488 | Ph 2 | active not recruiting | Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors |
| NCT04469530 AflacST1903 | STUDY00000113 | Ph 2 | recruiting | Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors |
| NCT04093323 results posted | I 82419 NCI-2019-05911, I 82419 | Ph 2 | terminated | Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma |
| NCT01356290 MEMMAT | MUV-MEMMAT-01 | Ph 2 | recruiting | Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors |
| NCT05488847 results posted | 15592 | Ph 4 | active not recruiting | Opioid-Free Pain Protocol After Shoulder Arthroplasty |
| NCT07174570 | STUDY00008622 P30CA138292, NCI-2025-06192 | Ph 2 | recruiting | Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer |
| NCT06076837 | HRI-2023 Magnificent 7 | Ph 1 | active not recruiting | The Seven Trial: Exploiting the Unfolded Protein Response |
| NCT05077332 | LDOS-21-001 | Ph 2 | completed | LEAP-CT for Treatment of COVID-19 Patients (Master Protocol) |
| NCT06505187 | 2023-1527 A539770, Protocol Version 7/5/24 | Ph 2 | recruiting | Celecoxib for ENT Pain Management |
| NCT04786548 | 8115 | Ph 2 | suspended | Neuroinflammation in Patients With OCD |
| NCT03912428 results posted | 190079 19-M-0079 | Ph 1 | terminated | Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions |
| NCT07154316 | SERRAC | Ph 2 | recruiting | Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer |
| NCT07150949 | FDRT-2025-254-4403 | Ph 2 | recruiting | Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC) |
| NCT04115098 results posted | HSC-MS-19-0677 KL2TR003168 | Ph 2 | terminated | Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials |
| NCT02885974 BLAST | H-36486 | Ph 1 | completed | Celecoxib With Chemotherapy in Localized, Muscle-Invasive Bladder Cancer |
| NCT05756166 | I-3010822 NCI-2023-01262, I-3010822 | Ph 1, Ph 2 | terminated | Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer |
| NCT05965492 | 20230423 | Ph 3 | withdrawn | Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery |
| NCT06379425 | 23-0050 | Ph 4 | recruiting | Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries |
| NCT06863636 PRECEDENT | SIL-30221-III-23(1) | Ph 3 | recruiting | Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation |
| NCT02030964 DFMO | N2012-01 P01CA081403 | Ph 1 | completed | N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan |
| NCT04041050 | M19-753 2020-002597-27 | Ph 1 | active not recruiting | A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm |
| NCT05974501 results posted | 20230147 | Ph 4 | completed | Pre vs Post Block in Total Knee Arthroplasty (TKA) |
| NCT04162873 results posted | HCI124211 NCI-2019-07104, HCI124211 | Ph 2 | terminated | Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer |
| NCT03084536 results posted | 201703053 | Ph 2 | completed | PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery |
| NCT05281276 | N202007026 | Ph 1 | terminated | Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC) |
| NCT04176419 | CASE6319 | Ph 3 | terminated | Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery |
| NCT04147013 | 114809 | Ph 4 | active not recruiting | Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients with CRS |
| NCT05644301 INSTA-MD | T001222N | Ph 3 | recruiting | INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder |
| NCT03859024 results posted | IRB-300002992 | Ph 4 | completed | Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty |
| NCT05077969 results posted | LDOS-21-001-02 | Ph 2 | terminated | Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients |
| NCT04015908 results posted | 121505 | Ph 4 | completed | A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery |
| NCT05062083 results posted | 10000483 000483-M | Ph 2 | terminated | PET Imaging of Cyclooxygenase in Multiple Sclerosis |
| NCT01479829 results posted | 203368 | Ph 4 | completed | Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression |
| NCT03818919 results posted | 123191 | Ph 2 | completed | Nonopioid Analgesia After Rotator Cuff Repair |
| NCT06336993 | liuxianguiji | Ph 4 | completed | Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP |
| NCT04790812 results posted | HSC-DB-20-0118 | Ph 4 | completed | Preemptive Analgesia With Celecoxib for Acute Dental Pain Management |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT02667730 CALF | 2013-12-126-004-0001 | Ph 4 | completed | Correlation Between Acute Analgesia and Long-Term Function Following Ankle Injuries |
| NCT01344200 | 09/09E | Ph 2 | recruiting | CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children |
| NCT02502006 results posted | 820715 5U54HL117798 | Ph 1 | terminated | Variability in Response to Non-steroidal Anti-inflammatory Drugs |
Showing 50 of 159 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CELEBREX FDA Label Details
Indications & Usage
FDA Label (PDF)CELEBREX is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis; Ankylosing Spondylitis; Acute Pain; Primary Dysmenorrhea.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment