Product Description
Celecoxib is a cyclo-oxygenase (COX) inhibitor that exhibits relative in vitro and ex vivo selectivity for COX-2 over COX-1. Celecoxib also has efficacy in treating the signs and symptoms of osteoarthritis of the hip. Celecoxib is the first COX-2 specific inhibitor approved for use in osteoarthritis and rheumatoid arthritis. Celecoxib produces significant improvements in pain and inflammation and these effects are maintained during treatment for up 24 weeks in clinical trials. Studies indicate that celecoxib has similar efficacy to conventional NSAIDs in relieving pain and improving functional status, but is associated with a lower incidence of upper gastrointestinal ulceration and complications. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/10804043/)
Mechanisms of Action: COX2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Migraine Disorders | Migraine with Aura | Migraine without Aura | Myocardial Infarction | Hypertension | Stroke | Arthritis | Osteoarthritis | Acute Myeloid Leukemia
Known Adverse Events: Dysgeusia | Abdominal Pain | Dizziness | Pain Unspecified | Pharyngitis | Respiratory Tract Infections | Arthritis | Acute Myeloid Leukemia | Rhinitis | Sinusitis | Diarrhea | Dyspepsia | Edema | Flatulence
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, China, France, Germany, Italy, Mexico, Poland, Russia, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 12
Highest Development Phases
Phase 3: Chronic Pain|Depressive Disorder|Low Back Pain|Mesothelioma|Pain, Postoperative|Total Knee Arthroplasty
Phase 2: Arthritis|Colorectal Cancer|Hypertension|Obesity|Type 2 Diabetes
Phase 1: Acute Pain|Adenocarcinoma|Arthritis, Rheumatoid|Central Serous Chorioretinopathy|Epiretinal Membrane|Healthy Volunteers|Macular Edema|Male Breast Cancer|Osteoarthritis|Pancreatic Cancer|Retinal Vein Occlusion|Spondylitis, Ankylosing
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
RESILIENCE | P2 |
Not yet recruiting |
Arthritis|Hypertension|Obesity|Type 2 Diabetes |
2028-11-26 |
|
100-CIP03-P | P3 |
Suspended |
Pain, Postoperative|Total Knee Arthroplasty |
2026-09-01 |
|
ASTRUM-REC01 | P2 |
Recruiting |
Colorectal Cancer |
2025-12-20 |
|
The Seven Trial | P1 |
Not yet recruiting |
Pancreatic Cancer|Adenocarcinoma |
2025-06-01 |