NDAORALCAPSULEPriority Review
Approved
Dec 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
CELEBREX (celecoxib) by Pfizer is analgesic, anti-inflammatory, and antipyretic properties. First approved in 1999.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELEBREX (celecoxib) is an oral selective COX-2 inhibitor approved in 1999 for pain and inflammation management. It works by inhibiting prostaglandin synthesis, primarily through COX-2 inhibition, thereby reducing pain, inflammation, and fever in peripheral tissues. The drug is indicated for patients with osteoarthritis, rheumatoid arthritis, and acute pain conditions.
LOE Approaching
As LOE approaches, the brand team is likely consolidating and shifting focus to lifecycle management and generic transition strategies rather than growth initiatives.
Mechanism of Action
analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro . Celecoxib concentrations reached…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
Started Sep 2024
40 enrolled
Healthy Volunteer
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
Started Jun 2022
59 enrolled
Healthy Volunteers
TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Started Jun 2022
25 enrolled
Colorectal Cancer
Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma
Started Jan 2019
53 enrolled
Malignant Pleural Mesothelioma
Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.
Started Mar 2017
637 enrolled
Acute Post-surgical Pain
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.