FELDENE (piroxicam)
Feldene is a nonsteroidal anti-inflammatory drug used to help patients with the physical symptoms of chronic joint conditions. It specifically treats the pain and inflammation associated with both osteoarthritis and rheumatoid arthritis. By providing relief from these signs and symptoms, it helps individuals manage the daily discomfort caused by these arthritic diseases.
How FELDENE Works
This medication works by inhibiting the COX-1 and COX-2 enzymes, which results in a decrease in the production of prostaglandins. Because prostaglandins are key mediators of inflammation and sensitize nerves to pain, reducing their levels in peripheral tissues helps alleviate swelling and discomfort.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1982-04-06
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FELDENE Approval History
What FELDENE Treats
2 indicationsFELDENE is approved for 2 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
FELDENE 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 treatment and may increase with duration of use [see Warnings and Precautions (5.1) ] . • Piroxicam capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Co...
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 treatment and may increase with duration of use [see Warnings and Precautions (5.1) ] . • Piroxicam capsules are 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 treatment and may increase with duration of use ( 5.1 ) • Piroxicam capsules are 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 )
FELDENE 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 FELDENE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FELDENE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FELDENE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06727734 | UW 24-054 | Ph 3 | recruiting | Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception |
| NCT06404177 PiDex | Dexketoprofene-Piroxicam | Ph 3 | recruiting | Enantyum® IV Versus Piroxen® IM in Emergency Pain Management |
| NCT02304783 ONSAIP-RC | Oral NSAI in RC | Ph 3 | completed | Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics |
| NCT05722782 NAP-RC | NAP in RC | Ph 2 | recruiting | Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics |
| NCT05488925 | BDC/ERB/2021/016 | Ph 4 | completed | Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block. |
| NCT02450487 results posted | 20657913.7.0000.5417 CAAE | Ph 4 | completed | Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery |
| NCT02253446 | MDhayri2014 | Ph 4 | completed | A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea |
| NCT00670475 | 1/86010 | Ph 2 | completed | Comparative Study of Olive Oil With Piroxicam Gel in Osteoarthritis of the Knee |
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.
FELDENE FDA Label Details
Indications & Usage
FDA Label (PDF)FELDENE is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis.
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 occu...
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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