MELOXICAM
Meloxicam is a nonsteroidal anti-inflammatory drug used to manage pain and inflammation in adults with osteoarthritis and rheumatoid arthritis. It also helps patients weighing at least 60 kg who have juvenile rheumatoid arthritis, specifically the pauciarticular or polyarticular types. This medication is prescribed to provide relief from the physical signs and symptoms associated with these chronic joint conditions.
How MELOXICAM Works
Meloxicam works by inhibiting the cyclooxygenase enzymes, COX-1 and COX-2, which are responsible for producing prostaglandins. By decreasing the synthesis of these prostaglandins—which normally sensitize nerves and mediate inflammation—the drug helps reduce pain, fever, and swelling in peripheral tissues.
Details
- Status
- Prescription
- First Approved
- 2004-06-01
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, SUSPENSION
Companies
MELOXICAM Approval History
What MELOXICAM Treats
3 indicationsMELOXICAM is approved for 3 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis (pauciarticular and polyarticular)
MELOXICAM 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 ) Meloxicam tablet is contraindicated in the sett...
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 ) Meloxicam tablet 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 ) ]. Meloxicam tablet 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 ) ].
MELOXICAM 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 MELOXICAM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MELOXICAM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MELOXICAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04115098 results posted | HSC-MS-19-0677 KL2TR003168 | Ph 2 | terminated | Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials |
| NCT01147289 Dextra | EF 102 | Ph 3 | completed | Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain |
| NCT05974501 results posted | 20230147 | Ph 4 | completed | Pre vs Post Block in Total Knee Arthroplasty (TKA) |
| NCT03896009 MOMENTUM results posted | AXS-07-301 | Ph 3 | completed | Maximizing Outcomes in Treating Acute Migraine |
| NCT04766996 results posted | STUDY00002021 | Ph 4 | terminated | PROUD Study - Preventing Opioid Use Disorders |
| NCT02706054 | MELO-RCT | Ph 3 | completed | Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam |
| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |
| NCT02078102 results posted | IUCRO-0419 CA182947, 1312925163 | Ph 2 | completed | A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma |
| NCT03473665 results posted | AAAR3505 | Ph 4 | terminated | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis |
| NCT02003625 results posted | 13-195 | Ph 2 | completed | Meloxicam vs Placebo for Mobilization |
| NCT02255045 | AVM002 | Ph 2, Ph 3 | completed | Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea |
| NCT02298218 | 4-2008-0597 | Ph 4 | completed | Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia |
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.
MELOXICAM FDA Label Details
Indications & Usage
FDA Label (PDF)MELOXICAM is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis (pauciarticular and polyarticular).
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 thromb...
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Full clinical data, patents, trials, and competitive landscape for meloxicam.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.