DAYPRO (oxaprozin)
Daypro (oxaprozin) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis in adults. It is also indicated for the management of juvenile rheumatoid arthritis in pediatric patients.
How DAYPRO Works
Oxaprozin functions by inhibiting the enzymes cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), leading to decreased prostaglandin synthesis. By reducing prostaglandin levels in peripheral tissues, the drug exerts anti-inflammatory effects and prevents the sensitization of afferent nerves to painful stimuli.
Details
- Status
- Prescription
- First Approved
- 1992-10-29
- Routes
- ORAL
- Dosage Forms
- TABLET
DAYPRO Approval History
What DAYPRO Treats
3 indicationsDAYPRO is approved for 3 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
DAYPRO Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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 ) • DAYPRO is contraindicated in the setting of ...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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 ) • DAYPRO is 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 ) 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) ]. • DAYPRO is 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) ].
DAYPRO 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 DAYPRO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DAYPRO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DAYPRO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03350386 | FYU-981-017 | Ph 1 | completed | Drug-drug Interaction Study of FYU-981 and Oxaprozin |
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.
DAYPRO FDA Label Details
Indications & Usage
FDA Label (PDF)DAYPRO is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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 throm...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.