NAPROSYN (naproxen)
Naprosyn (naproxen) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of signs and symptoms of chronic inflammatory conditions, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. It is also indicated for the management of acute tendonitis, bursitis, and gout flares, as well as the treatment of general pain and primary dysmenorrhea.
How NAPROSYN Works
Naproxen is a non-selective inhibitor of cyclooxygenase enzymes (COX-1 and COX-2), which results in the inhibition of prostaglandin synthesis. By reducing prostaglandin levels, naproxen decreases the sensitization of afferent nerves and diminishes inflammatory mediators, providing analgesic, anti-inflammatory, and antipyretic effects.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1976-03-11
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, TABLET
NAPROSYN Approval History
What NAPROSYN Treats
9 indicationsNAPROSYN is approved for 9 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Osteoarthritis
- Ankylosing Spondylitis
- Juvenile Idiopathic Arthritis
- Tendonitis
- Bursitis
- Gout
- Pain
NAPROSYN 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 ) ]. • Naproxen tablets and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass ...
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 ) ]. • Naproxen tablets and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications ( 4 ), 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 ) • Naproxen tablets and naproxen sodium tablets 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 seri
NAPROSYN 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 NAPROSYN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NAPROSYN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NAPROSYN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
87 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07277712 | IN_TNA_101 | Ph 1 | not yet recruiting | A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers |
| NCT05851976 | 2023-14971 | Ph 4 | recruiting | Duloxetine for LBP |
| NCT04038346 results posted | STUDY20040185 | Ph 3 | terminated | Symptomatic Management of Lyme Arthritis |
| NCT05411718 | 2022-0117 NCI-2022-04794, 1R01CA257375-01 | Ph 2 | recruiting | A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome |
| NCT03493945 results posted | 180078 18-C-0078 | Ph 1, Ph 2 | completed | Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) |
| 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 |
| NCT06948513 | 1344913 | Ph 3 | completed | Effect of Over-the-counter Analgesics on Postoperative Pain |
| NCT03654326 results posted | 7264-034 MK-7264-034, 2018-001098-26 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034) |
| NCT02611466 OAK | 7962-CL-0022 2014-004996-22 | Ph 2 | completed | A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee |
| NCT05995912 | LT-04-20 LT-04-20 | Ph 2 | completed | Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain |
| NCT02451748 results posted | 2015-0117 | Ph 4 | completed | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA |
| NCT04694300 results posted | 844440 IIR | Ph 4 | completed | OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients |
| NCT05087914 | STU00215128 | Ph 2 | withdrawn | Novel Non-opioid Post-surgical Pain Treatment in Females |
| NCT02667730 CALF | 2013-12-126-004-0001 | Ph 4 | completed | Correlation Between Acute Analgesia and Long-Term Function Following Ankle Injuries |
| NCT02502006 results posted | 820715 5U54HL117798 | Ph 1 | terminated | Variability in Response to Non-steroidal Anti-inflammatory Drugs |
| NCT03697720 results posted | EH18-128 | Ph 4 | completed | Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain |
| NCT03949673 results posted | R475-OA-1816 2018-001618-13 | Ph 2 | terminated | Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip |
| NCT02689024 DEPTHip | NL54580.018.15 2015-003650-40 | Ph 4 | terminated | Delirium in Elderly Patients With Trauma of the Hip |
| NCT05237297 | IL49NS01 | Ph 1 | completed | Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole |
| NCT02013427 results posted | STU00080585 R01AT007987-01A1 | Ph 4 | completed | Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial |
| NCT03161093 FACT OA1 results posted | R475-OA-1611 2016-005020-29 | Ph 3 | completed | A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip |
| NCT02986334 PICP2 results posted | STU00080585 (Phase 2) 5R01AT007987-03 | Ph 4 | completed | Placebo In Chronic Back Pain (Phase 2) |
| NCT00826462 results posted | 2006-002283-26 | Ph 4 | completed | Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis |
| NCT00876187 results posted | A4091012 CLBP-IV PH2B | Ph 2 | completed | A Study of Tanezumab in Adults With Chronic Low Back Pain |
| NCT03472469 MAST results posted | HSC-MS-18-0036 KL2TR000370, UL1TR000371 | Ph 4 | completed | MAST Trial: Multi-modal Analgesic Strategies in Trauma |
| NCT00863304 results posted | A4091018 | Ph 3 | completed | Tanezumab in Osteoarthritis of the Hip or Knee (2) |
| NCT00830063 results posted | A4091015 P3 OA KNEE NSAID POPULATION | Ph 3 | completed | Tanezumab In Osteoarthritis Of The Knee (2) |
| NCT01951105 results posted | STU00081444 R01DE022746 | Ph 4 | completed | Effect of L-dopa In Subacute Back Pain Population |
| NCT01471899 | CTRGEMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT01471886 | CTREMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT00807846 results posted | A3191342 | Ph 4 | completed | A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects |
| NCT02052908 | NCI-2014-00046 NCI-2014-00046, N01-CN-2012-00034 | Ph 1 | completed | Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome |
| NCT04639804 | IN_APA_117 | Ph 1 | completed | Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers |
| NCT03092193 | 49806115.0.0000.5417 | Ph 4 | completed | Pharmacogenetic and Pharmacokinetics of Naproxen and Associated Naproxen-esomeprazole |
| NCT02519231 CITROS results posted | STUDY00000323 | Ph 4 | completed | Copper IUD Treatment Observation Study |
| NCT02500641 FORWARD results posted | MEIN/14/FEB-PWV/001 2014-005567-33 | Ph 4 | completed | Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout |
| NCT03028870 results posted | VAN2001 | Ph 2 | completed | A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee |
| NCT00743587 | A9001383 | Ph 1 | completed | A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb |
| NCT01071317 results posted | 09-08-248 | Ph 4 | completed | Trial of Comprehensive Migraine Intervention |
| NCT02646124 results posted | 2015-4639 | Ph 2, Ph 3 | completed | Diazepam Use With Standard Management for Acute Low Back Pain |
| NCT01587274 results posted | 11-10-379 | Ph 4 | completed | A Randomized Study of Three Medication Regimens for Acute Low Back Pain |
| NCT02665286 results posted | 2015-5903 | Ph 4 | completed | Orphenadrine and Methocarbamol for LBP |
| NCT00913627 results posted | AK-09-07 B4371001 | Ph 2 | completed | Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain |
| NCT01612975 | SJHHNaproxenRCT | Ph 2 | terminated | The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection |
| NCT01712009 NOLAN results posted | 20110147 | Ph 2 | completed | NOLAN: Naproxen or Loratadine and Neulasta |
| NCT00981357 | B0541004 2009-014734-16 | Ph 2 | completed | A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee |
| NCT02702817 | INTREPAD | Ph 2 | completed | Randomized Trial of Low-dose Naproxen in Cognitively Intact Persons at Risk of Alzheimer's Dementia |
| NCT00844805 INFAST results posted | P05336 2008-000982-51 | Ph 3 | completed | Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) |
| NCT02712957 | NEO6860-OA-01 | Ph 2 | completed | A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain |
| NCT01939002 ALLOW results posted | 105MS303 | Ph 3 | completed | Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017) |
Showing 50 of 87 trials
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.
NAPROSYN FDA Label Details
Indications & Usage
FDA Label (PDF)NAPROSYN is indicated for the treatment of Rheumatoid Arthritis; Osteoarthritis; Ankylosing Spondylitis; Juvenile Idiopathic Arthritis; Tendonitis; Bursitis; Gout; Pain; Dysmenorrhea.
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