Celecoxib: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Celecoxib appears in the FDA drug-label database. Marketed as CELECOXIB.
- Drug class
- Nonsteroidal Anti-inflammatory Drug (FDA established pharmacologic class)
- Mechanism of action
- Cyclooxygenase Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Celecoxib carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
. INDICATIONS AND USAGE Celecoxib is indicated Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) ( 1.5 ) Primary Dysmenorrhea (PD) ( 1.6 ) 1.1 Osteoarthritis For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ]. 1.2 Rheumatoid Arthritis For the management of the signs and symptoms of RA [ see Clinical Studies (14.2) ]. 1.3 Juvenile Rheumatoid Arthritis For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ]. 1.4 Ankylosing Spondylitis For the management of the signs and symptoms of AS [ see Clinical Studies (14.4) ]. 1.5 Acute Pain For the management of acute pain in adults [ see Clinical Studies (14.5) ]. 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [ see Clinical Studies (14.5) ].
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule — Alembic Pharmaceuticals Limited | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-05-09 |
| Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules — AvKARE | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-05-13 |
Phase breakdown
Conditions being studied
Recruiting trials involving Celecoxib
- 99Tc-MDP Treatment for Knee Osteoarthritis
- Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
- Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation
- INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder
- Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer
- Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
Common questions
Is Celecoxib FDA-approved?
Yes, marketed as CELECOXIB. Its FDA label carries a boxed warning.
How many recruiting trials involve Celecoxib?
6 recruiting trials across 13 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.