NDAORALTABLET
Approved
Mar 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
2/8 — Basic
Drug data last refreshed 7h ago · AI intelligence enriched 10h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIOXX (rofecoxib) is an oral tablet COX-2 selective inhibitor developed by Merck & Co. for the treatment of pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and acute pain conditions. It was approved on March 26, 2004, as a nonsteroidal anti-inflammatory drug (NSAID) offering selective cyclooxygenase-2 (COX-2) inhibition.
LOE Approaching
As LOE approaches, the brand team is likely in efficiency and optimization mode with reduced headcount relative to peak commercialization phases.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy
Started Jun 2021
2 enrolled
Hemophilic Arthropathy
12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)
Started Aug 2004
49 enrolled
Arthritis, RheumatoidOsteoarthritis
A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)
Started May 2004
11 enrolled
Pain
A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)
Started Jan 2004
150 enrolled
Rheumatoid Arthritis
A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain
Started Jun 2003
45 enrolled
Acute 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.