XIFYRM (meloxicam)
XIFYRM is a nonsteroidal anti-inflammatory drug used to help adults manage moderate-to-severe pain. It can be used as a standalone therapy or in combination with other non-NSAID pain medications. Because the medication has a delayed onset, it is not recommended for situations where patients require immediate relief.
How XIFYRM Works
This medication works by inhibiting the COX-1 and COX-2 enzymes, which in turn reduces the production of prostaglandins. Since prostaglandins are responsible for sensitizing nerves to pain and mediating inflammation, lowering their levels in peripheral tissues helps alleviate pain and fever.
Details
- Status
- Prescription
- First Approved
- 2025-06-05
- Patent Cliff
- 2041
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
XIFYRM Approval History
What XIFYRM Treats
1 indicationsXIFYRM is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
XIFYRM Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk • Non-steroidal 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 ) ]. • XIFYRM is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4 ) ...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk • Non-steroidal 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 ) ]. • XIFYRM is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Risk • 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. • Non-steroidal 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 ) • XIFYRM 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 )
XIFYRM 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.
Drugs Similar to XIFYRM
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.
XIFYRM FDA Label Details
Indications & Usage
FDA Label (PDF)XIFYRM is indicated for the treatment of Pain.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk • Non-steroidal 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 tr...
XIFYRM Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for XIFYRM
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.