Aleve

(naproxen)

ApprovedSmall molecule

Naproxen is used to reduce pain, fever, and inflammation from conditions like headaches, muscle aches, arthritis, and menstrual cramps. It works by reducing pain signals and swelling in the body.[2] Aleve is currently approved and in use across 45 indications[4].[1]

Aleve is one of 519 small molecule programs targeting Gout. It is currently in Approved.

Indications

157

Total Trials

Active Trials

518

Competitors

112

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GoutActive, not recruiting

ArthralgiaActive, not recruiting

MyalgiaActive, not recruiting

BursitisActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

TendinitisActive, not recruiting

Muscle CrampActive, not recruiting

Peptic Ulcer DiseaseActive, not recruiting

SpondylitisActive, not recruiting

Juvenile Idiopathic ArthritisActive, not recruiting

GoutApproved

Active, not recruiting

ArthralgiaApproved

Active, not recruiting

MyalgiaApproved

Active, not recruiting

BursitisApproved

Active, not recruiting

Rheumatoid ArthritisApproved

Active, not recruiting

TendinitisApproved

Active, not recruiting

Muscle CrampApproved

Active, not recruiting

Peptic Ulcer DiseaseApproved

Active, not recruiting

SpondylitisApproved

Active, not recruiting

Juvenile Idiopathic ArthritisApproved

Active, not recruiting

Showing 10 of 41 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Aleve

Jazz Pharmaceuticals

Approved

157 2

Biological Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 3

Antihypertensive Agents

NNational Heart, Lung, and Blood Institute (NHLBI)

Preclinical

1 4

Pfizer-COVID-19 Vaccine

Moderna

Preclinical

1 5

Interferon-Gamma

SSPP Pharmaclon Ltd.

Preclinical

1 6

Proventil

Mylan Pharmaceuticals Inc

Preclinical

1 7

Serology

UUniversity Hospital Center of Martinique

Preclinical

3 8

T89

TTasly Pharmaceuticals, Inc.

Preclinical

2 9

Pfizer-Biontech COVID-19 MRNA Vaccine

Pfizer

Preclinical

1 10

Administration of Almitrine

CCentre Hospitalier Universitaire de Nice

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Adult

NCT07277712

Q4 2026

Phase 2Recruiting

Lynch Syndrome

NCT05411718

Q2 2027

Post-ApprovalRecruiting

Study completion

NCT05851976

Q3 2027

Post-ApprovalActive, not recruiting

Osteoarthritis

NCT05430230

Clinical

Trials by Indication[1]

Osteoarthritis28 trials

Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis

Active, not recruiting·NNorthwestern University·Phase 4·NCT05430230·20 enrolled

A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

Terminated· Pfizer logo

Pfizer·Phase 2·NCT01147458·190 enrolled

Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients

Completed· Pfizer logo

Pfizer·Phase 1·NCT00830050·24 enrolled

Show 25 more trials

Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

Completed·NNicOx·Phase 3·NCT00542555·918 enrolled

Tanezumab In Osteoarthritis Of The Knee (2)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00830063·832 enrolled

To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

Completed· Novartis logo

Novartis·Phase 2·NCT01160822·169 enrolled

Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee

Completed·PPrimus Pharmaceuticals·N/A·NCT00790985·223 enrolled

A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 3·NCT00240773·581 enrolled

A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain

Completed·NNeomed Institute·Phase 2·NCT02712957·54 enrolled

Tanezumab in Osteoarthritis of the Hip or Knee (2)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00863304·849 enrolled

A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

Completed· Pfizer logo

Pfizer·Phase 3·NCT00648258·130 enrolled

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01343303·43 enrolled

A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb

Completed· Pfizer logo

Pfizer·Phase 1·NCT00743587·36 enrolled

A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

Completed· Pfizer logo

Pfizer·Phase 2·NCT00981357·76 enrolled

Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00643799·586 enrolled

Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

Completed·NNicOx·Phase 3·NCT00541489·800 enrolled

Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip

Terminated· Regeneron logo

Regeneron·Phase 2·NCT03949673·23 enrolled

Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Completed· Pfizer logo

Pfizer·Phase 3·NCT00652808·265 enrolled

Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee

Unknown status·AAnalgesic Solutions·N/A·NCT01557816·70 enrolled

A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee

Completed·PPurdue Pharma LP·Phase 2·NCT03028870·291 enrolled

Acute Osteoarthritis Experimental Model Study.

Completed· GSK logo

GSK·Phase 2·NCT01231490·53 enrolled

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

Completed· Regeneron logo

Regeneron·Phase 3·NCT03161093·3,307 enrolled

Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

Completed·PPrimus Pharmaceuticals·N/A·NCT00928837·350 enrolled

A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

Completed· AbbVie logo

AbbVie·Phase 2·NCT01207115·322 enrolled

Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

Completed· Pfizer logo

Pfizer·Phase 2·NCT01102660·172 enrolled

A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee

Completed· Astellas logo

Astellas·Phase 2·NCT02611466·215 enrolled

Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee

Completed·PPrimus Pharmaceuticals·N/A·NCT00435292·350 enrolled

A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00418782·212 enrolled

Low back pain5 trials

Diazepam Use With Standard Management for Acute Low Back Pain

Completed·MMontefiore Medical Center·Phase 2/3·NCT02646124·114 enrolled

RN624 In Adult Patients With Chronic Low Back Pain

Completed· Pfizer logo

Pfizer·Phase 2·NCT00584870·220 enrolled

A Study of Tanezumab in Adults With Chronic Low Back Pain

Completed· Pfizer logo

Pfizer·Phase 2·NCT00876187·1,359 enrolled

Show 2 more trials

A Randomized Study of Three Medication Regimens for Acute Low Back Pain

Completed·MMontefiore Medical Center·Phase 4·NCT01587274·323 enrolled

PF-06372865 In Subjects With Chronic Low Back Pain

Completed· Pfizer logo

Pfizer·Phase 2·NCT02262754·302 enrolled

Back pain5 trials

Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial

Completed·NNorthwestern University·Phase 4·NCT02013427·82 enrolled

Placebo In Chronic Back Pain (Phase 2)

Completed·AApkar Apkarian·Phase 4·NCT02986334·94 enrolled

Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

Completed·EEMS·Phase 3·NCT01471899·78 enrolled

Show 2 more trials

Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

Completed·EEMS·Phase 3·NCT01471886·83 enrolled

Effect of L-dopa In Subacute Back Pain Population

Completed·NNorthwestern University·Phase 4·NCT01951105·72 enrolled

Gastrointestinal4 trials

Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo

Completed·BBiolab Sanus Farmaceutica·Phase 1·NCT02632812·24 enrolled

Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

Completed·PPLx Pharma·Phase 2·NCT01139190·77 enrolled

A Study to Assess the Safety and Tolerability, Including Gastrointestinal Safety, Pharmacokinetics and Pharmacodynamics of ASP7657 in Caucasian Healthy Male and Female Subjects

Terminated· Astellas logo

Astellas·Phase 1·NCT02108548·89 enrolled

Show 1 more trial

Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen

Completed· Pfizer logo

Pfizer·Phase 1·NCT00366262

Arthritis4 trials

Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients

Completed·—·Phase 3·NCT00153660·514 enrolled

Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00844805·158 enrolled

Symptomatic Management of Lyme Arthritis

Terminated·—·Phase 3·NCT04038346·3 enrolled

Show 1 more trial

Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT04115098·42 enrolled

79 more indications

Pain Control3 trials

Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion

Completed·WWalter Reed National Military Medical Center·N/A·NCT02769247·160 enrolled

Pain Control After Lumbar Spine Fusion

Enrolling by invitation·RRothman Institute Orthopaedics·Phase 4·NCT06484192·428 enrolled

Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control

Completed·UUniversity of Saskatchewan·Phase 4·NCT00222976·60 enrolled

Gastric Ulcer3 trials

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

Completed·PPOZEN·Phase 3·NCT00367211·400 enrolled

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

Completed·PPOZEN·Phase 3·NCT01129011·420 enrolled

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

Completed·PPOZEN·Phase 3·NCT00527787·434 enrolled

Rheumatoid Arthritis3 trials

Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00034853·180 enrolled

Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

Completed· Pfizer logo

Pfizer·Phase 4·NCT00650455·489 enrolled

Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00626275·46 enrolled

Interaction3 trials

NSAID Drug Interaction Study

Completed·AArdea Biosciences, Inc.·Phase 1·NCT01884272·24 enrolled

Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs

Unknown status· Daewoong Pharmaceutical Co. LTD. logo

Daewoong Pharmaceutical Co. LTD.·Phase 1·NCT04490434·110 enrolled

Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04639804·60 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment

Completed· Takeda logo

Takeda·Phase 2·NCT02128490·189 enrolled

A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

Completed· Pfizer logo

Pfizer·Phase 3·NCT00652925·225 enrolled

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Completed· Takeda logo

Takeda·Phase 3·NCT02139046·1,790 enrolled

Adult3 trials

A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers

Not yet recruiting·HHK inno.N Corporation·Phase 1·NCT07277712·74 enrolled

Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01358383·28 enrolled

Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Completed·PPLx Pharma·Phase 1/2·NCT00966641·34 enrolled

Migraine3 trials

Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine.

Withdrawn·AAche Laboratorios Farmaceuticos S.A.·Phase 3·NCT01726920

Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine

Withdrawn·AAche Laboratorios Farmaceuticos S.A.·Phase 3·NCT01390324

Trial of Comprehensive Migraine Intervention

Completed·MMontefiore Medical Center·Phase 4·NCT01071317·50 enrolled

Analgesic3 trials

Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?

Unknown status·—·N/A·NCT02522130·200 enrolled

Effect of Oral Analgesics on Post-op Pain

Completed·—·Phase 1·NCT07204379·100 enrolled

MAST Trial: Multi-modal Analgesic Strategies in Trauma

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03472469·1,561 enrolled

Bone pain2 trials

Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy

Not yet recruiting·—·Phase 2·NCT06903585·385 enrolled

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Completed·GGary Morrow·Phase 3·NCT00602420·510 enrolled

MPA2 trials

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00761501·38 enrolled

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00907400·48 enrolled

Lateral Epicondylitis2 trials

Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?

Completed·—·N/A·NCT03794219·80 enrolled

Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis

Completed·UUniversity of Oslo·Phase 4·NCT00826462·177 enrolled

Oral2 trials

Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions

Completed·PPerrigo Company·Phase 1·NCT00803764·34 enrolled

Phase I Study on Multiple Oral Dosing of CG100649

Completed·CCrystalGenomics, Inc.·Phase 1·NCT01154790·120 enrolled

Tics2 trials

Pharmacogenetic and Pharmacokinetics of Naproxen and Associated Naproxen-esomeprazole

Completed·UUniversity of Sao Paulo·Phase 4·NCT03092193·8 enrolled

Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001

Unknown status·SSen-Jam Pharmaceutical·Phase 1·NCT03183297·48 enrolled

Dysmenorrhea2 trials

Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain

Completed·EEndeavor Health·Phase 4·NCT03697720·26 enrolled

The Effect of Turmeric on New Onset Primary Dysmenorrhea

Completed·—·N/A·NCT04183556·90 enrolled

Analgesic Efficacy2 trials

Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00672646·103 enrolled

Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00659490·151 enrolled

CAR2 trials

Effects of Dual Cyclooxygenase-2 and Carbonic Anhydrase Inhibition

Terminated·UUniversity of Pennsylvania·Phase 1·NCT00780325·26 enrolled

Orphenadrine and Methocarbamol for LBP

Completed·MMontefiore Medical Center·Phase 4·NCT02665286·240 enrolled

ESS2 trials

Changes in mRNA Expression Following Exposure to Naproxen

Completed·RResearch Associates of New York, LLP·N/A·NCT01090596·48 enrolled

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT02451748·32 enrolled

Tendinopathy1 trial

Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

Completed·—·N/A·NCT03401177·70 enrolled

Sciatica1 trial

NSAIDs in Sciatica NSAIDS IN SCIATICA

Completed·OOstfold Hospital Trust·Phase 4·NCT03347929·123 enrolled

Clinical Trial1 trial

A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.

Completed· Bayer logo

Bayer·Phase 2·NCT05026320·76 enrolled

Irritation1 trial

A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT06511973·42 enrolled

Injury1 trial

Optimal Treatment of Acute Skeletal Muscle Injury

Not yet recruiting·—·N/A·NCT06274151·20 enrolled

ART1 trial

A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT06415019·236 enrolled

Chronic pain1 trial

Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure

Active, not recruiting·NNorthwestern University·Phase 2·NCT05463367·60 enrolled

Local Anesthesia1 trial

Local Anesthesia and Analgesics in Endodontic Pain

Withdrawn·UUniversity of Minnesota·N/A·NCT01982799

Pain Management1 trial

Pain Management After Surgery

Unknown status·RRothman Institute Orthopaedics·Phase 3·NCT05154682·200 enrolled

Gout1 trial

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

Recruiting·MMassachusetts General Hospital·Phase 4·NCT04875702·650 enrolled

Fasting Conditions1 trial

Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions

Completed·PPerrigo Company·Phase 1·NCT00804401·34 enrolled

Colchicine1 trial

Colchicine Or Naproxen Treatment for ACute gouT

Completed·KKeele University·Phase 4·NCT01994226·399 enrolled

Adductor Canal Block1 trial

Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction

Unknown status·RRothman Institute Orthopaedics·Phase 3·NCT05161221·154 enrolled

Stomach Ulcer1 trial

A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

Completed· Pfizer logo

Pfizer·Phase 1·NCT00392080·340 enrolled

Prevention1 trial

Naproxen for the Prevention of HO After Complex Elbow Trauma

Withdrawn·MMassachusetts General Hospital·Phase 4·NCT00586365

Colorectal Cancer1 trial

Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02052908·81 enrolled

Endometriosis1 trial

A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03654326·187 enrolled

Low Level Laser Therapy1 trial

Low Level Laser Therapy Versus Pharmacotherapy in in Improving Masticatory Muscle Pain

Unknown status·SShahid Beheshti University·Phase 1·NCT01659372·40 enrolled

Arthroscopy1 trial

Influence of Naproxen on Heterotropic Bone Formation Following Hip Arthroscopy

Completed·UUniversity of Utah·Phase 1·NCT01539447·108 enrolled

Multimodal Pain Management1 trial

Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial

Not yet recruiting·UUniversity of Puerto Rico·N/A·NCT06917118·100 enrolled

Cardiovascular1 trial

Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT02500641·196 enrolled

Blood Pressure1 trial

A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00807846·201 enrolled

Tooth Sensitivity1 trial

Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Completed·UUniversidade Federal de Sergipe·N/A·NCT02463552·50 enrolled

Pain After Surgery1 trial

Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

Unknown status·HHamilton Health Sciences Corporation·Phase 4·NCT00615875·24 enrolled

Efficacy1 trial

Efficacy of Co-administration of an NSAID With a Dopamine Agonist In Healthy Subjects

Withdrawn·NNorthwestern University·Phase 2·NCT02116790

Dental Pain1 trial

Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

Completed· Pfizer logo

Pfizer·Phase 2·NCT00913627·196 enrolled

Inflammation1 trial

Inflammation and Daily Life Study

Completed·UUniversity of California, Los Angeles·Phase 1·NCT03771612·144 enrolled

Epicondylitis1 trial

Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

Completed·IInternational Clinical Research Institute·Phase 4·NCT01525043·78 enrolled

Drug Interactions1 trial

Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole

Completed·IIl-Yang Pharm. Co., Ltd.·Phase 1·NCT05237297·72 enrolled

Ankle Injuries1 trial

Correlation Between Acute Analgesia and Long-Term Function Following Ankle Injuries

Completed·CCanadian Department of National Defence·Phase 4·NCT02667730·168 enrolled

Alzheimer's Disease1 trial

A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)

Completed·NNational Institute on Aging (NIA)·Phase 2/3·NCT00004845

Double-blind1 trial

Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT00945178·11 enrolled

Post Operative Pain1 trial

Effect of Over-the-counter Analgesics on Postoperative Pain

Completed·ZZitelli & Brodland Skin Cancer Center·Phase 3·NCT06948513·200 enrolled

Acceptability1 trial

Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study

Completed·PPrimus Pharmaceuticals·N/A·NCT00303017·60 enrolled

Delirium1 trial

Delirium in Elderly Patients With Trauma of the Hip

Terminated·—·Phase 4·NCT02689024·239 enrolled

Acute Postoperative Pain1 trial

Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain

Completed·LLaboratorios Liomont·Phase 2·NCT05995912·58 enrolled

Duodenal Ulcer1 trial

Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00137033·605 enrolled

Pilot Study1 trial

Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Completed·OOxford Pharmascience Ltd·Phase 1·NCT02408978

Endodontic Treatment1 trial

The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment

Completed·—·Phase 1/2·NCT01178203

Dementia1 trial

Randomized Trial of Low-dose Naproxen in Cognitively Intact Persons at Risk of Alzheimer's Dementia

Completed·—·Phase 2·NCT02702817·200 enrolled

Non-steroidal Anti-inflammatory Drugs1 trial

Variability in Response to Non-steroidal Anti-inflammatory Drugs

Terminated·UUniversity of Pennsylvania·Phase 1·NCT02502006·16 enrolled

Post-surgical Pain1 trial

Novel Non-opioid Post-surgical Pain Treatment in Females

Withdrawn·NNorthwestern University·Phase 2·NCT05087914

Tuberculosis1 trial

Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial

Withdrawn·UUniversity of Minnesota·Phase 2/3·NCT01442428

Treatment1 trial

Copper IUD Treatment Observation Study

Completed·UUniversity of Washington·Phase 4·NCT02519231·34 enrolled

Knee Pain1 trial

A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00772967·22 enrolled

Immunotherapy1 trial

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03493945·59 enrolled

Function1 trial

Effect of Metamizole (Dipyrone) on Renal Function in Salt-depleted Healthy Subjects

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT01995006·15 enrolled

Headache1 trial

Comparing Naproxen to Sumatriptan for Emergency Headache Patients

Completed·MMontefiore Medical Center·Phase 4·NCT00449787·401 enrolled

Lynch syndrome1 trial

A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05411718·40 enrolled

TED1 trial

Effect of Repeated Doses of BI 1060469 and BI 1021958 on Glomerular Filtration Rate (GFR) in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02202512·53 enrolled

Dental Implant1 trial

OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients

Completed·HHersh, Elliot V., DMD, MS, PhD·Phase 4·NCT04694300·30 enrolled

Ankle Fracture1 trial

NSAIDs for Pain After Ankle Fracture Surgery

Withdrawn·NNorthwell Health·Phase 4·NCT02281968

Clopidogrel1 trial

Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers

Completed·RResearch Associates of New York, LLP·Phase 4·NCT00778193·125 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC

Completed·WWashington University School of Medicine·N/A·NCT00789802·129 enrolled

Multiple Sclerosis1 trial

Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)

Completed· Biogen logo

Biogen·Phase 3·NCT01939002·251 enrolled

Pleural effusion1 trial

The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

Terminated·MMcMaster University·Phase 2·NCT01612975·7 enrolled

Hemodynamic1 trial

Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide

Completed·NNicOx·Phase 1·NCT00909519·31 enrolled

Enrolling by invitation·AAdventHealth·Approved·NCT07750639·260 enrolled

NSAID (Non-Steroidal Anti-Inflammatory Drug)1 trial

Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion

Enrolling by invitation·RRothman Institute Orthopaedics·Phase 3·NCT07743606·428 enrolled

Unspecified8 trials

Naproxen Pharmacogenetic Study (Project 1, Aim 2)

Unknown status·UUniversity of Washington·Phase 4·NCT04449471·30 enrolled

To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their Effects

Completed· Astellas logo

Astellas·Phase 1·NCT01409603·26 enrolled

Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

Completed·PPOZEN·Phase 1·NCT00665743·30 enrolled

Show 5 more trials

Derris Scandens Benth Extract VS Naproxen in Knee OA

Completed·MMahidol University·Phase 3·NCT00503828·120 enrolled

Duloxetine for LBP

Recruiting·MMontefiore Medical Center·Phase 4·NCT05851976·120 enrolled

NOLAN: Naproxen or Loratadine and Neulasta

Completed· Amgen logo

Amgen·Phase 2·NCT01712009·600 enrolled

Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Completed·PPOZEN·Phase 1·NCT00692055·30 enrolled

Effects of Naproxen on Physical Performance

Terminated·UUniversity of Oklahoma·Phase 4·NCT00410995·40 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ANAPROX

NDA NDA018164

Jan 1, 1982

NAPROSYN

NDA NDA017581

Mar 23, 1987

NAPROSYN

NDA NDA018965

Jan 11, 1994

ALEVE

NDA NDA020204

Jan 11, 1994

ALEVE

NDA NDA020204

Oct 14, 1994

EC-NAPROSYN

NDA NDA020067

Feb 10, 1995

ALEVE

NDA NDA020204

Jan 5, 1996

NAPRELAN

NDA NDA020353

Aug 1, 1996

ALEVE

NDA NDA020204

Apr 16, 1998

ALEVE

NDA NDA020204

Nov 20, 1998

ALEVE

NDA NDA020204

May 11, 2000

ALEVE

NDA NDA020204

Jun 7, 2000

ALEVE

NDA NDA020204

Aug 23, 2000

ALEVE

NDA NDA020204

Jan 3, 2001

ALEVE

NDA NDA020204

Mar 6, 2001

ALEVE

NDA NDA020204

Mar 27, 2001

ALEVE

NDA NDA020204

Dec 21, 2001

ALEVE

NDA NDA020204

Mar 19, 2002

ALEVE

NDA NDA020204

Aug 30, 2002

ALEVE

NDA NDA020204

Mar 17, 2004

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NDA ANDA076518

Mar 22, 2004

ALEVE

NDA NDA020204

May 4, 2005

ALEVE

NDA NDA020204

Jan 6, 2006

ALEVE

NDA NDA020204

Feb 17, 2006

NAPROXEN SODIUM

NDA NDA021920

Feb 17, 2006

NAPROXEN SODIUM

NDA NDA021920

Mar 22, 2006

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NDA ANDA076518

Dec 19, 2006

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NDA ANDA076518

Sep 23, 2008

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NDA ANDA076518

Nov 24, 2008

ALEVE

NDA NDA020204

Apr 15, 2009

NAPROXEN SODIUM

NDA NDA021920

Apr 15, 2009

ALEVE

NDA NDA020204

Jul 14, 2009

NAPROXEN SODIUM

NDA NDA021920

Aug 12, 2010

NAPROXEN SODIUM

NDA NDA021920

Nov 3, 2010

ALEVE

NDA NDA020204

Feb 7, 2011

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NDA ANDA076518

Feb 7, 2011

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NDA ANDA076518

Feb 18, 2011

ALEVE

NDA NDA020204

Apr 8, 2011

ALEVE

NDA NDA020204

Mar 15, 2012

ALEVE

NDA NDA020204

Mar 16, 2012

ALEVE

NDA NDA020204

Jun 13, 2012

NAPROXEN SODIUM

NDA NDA021920

Nov 13, 2012

ALEVE

NDA NDA020204

Jan 3, 2013

ALEVE

NDA NDA020204

Jan 7, 2013

ALEVE

NDA NDA020204

Feb 7, 2013

ALEVE

NDA NDA020204

Apr 1, 2013

NAPROXEN SODIUM

NDA NDA021920

Apr 18, 2013

ALEVE

NDA NDA020204

Jan 17, 2014

ALEVE PM

NDA NDA205352

Nov 20, 2014

ALEVE PM

NDA NDA205352

Feb 4, 2015

ALEVE

NDA NDA020204

Feb 25, 2015

ALEVE PM

NDA NDA205352

Jul 15, 2015

ALEVE PM

NDA NDA205352

Aug 14, 2015

ALEVE PM

NDA NDA205352

Oct 28, 2015

ALEVE PM

NDA NDA205352

Dec 23, 2015

ALEVE PM

NDA NDA205352

Feb 25, 2016

ALEVE

NDA NDA020204

Jul 28, 2016

ALEVE

NDA NDA020204

Mar 16, 2017

NAPROXEN SODIUM

NDA NDA021920

Aug 22, 2017

ALEVE

NDA NDA020204

Sep 12, 2017

ALEVE PM

NDA NDA205352

Sep 14, 2017

ALEVE

NDA NDA020204

Jan 16, 2018

ALEVE PM

NDA NDA205352

Mar 27, 2018

ALEVE

NDA NDA020204

Mar 29, 2018

ALEVE

NDA NDA020204

Jun 8, 2018

ALEVE

NDA NDA020204

Jun 11, 2018

ALEVE

NDA NDA020204

Jul 25, 2018

ALEVE

NDA NDA020204

Aug 28, 2018

ALEVE PM

NDA NDA205352

Aug 28, 2018

ALEVE

NDA NDA020204

Sep 21, 2018

ALEVE

NDA NDA020204

Nov 29, 2018

NAPROXEN SODIUM

NDA NDA021920

Jan 3, 2019

ALEVE

NDA NDA020204

Jan 28, 2019

ALEVE

NDA NDA020204

Feb 20, 2019

NAPROXEN SODIUM

NDA NDA021920

Apr 10, 2019

ALEVE PM

NDA NDA205352

May 13, 2019

ALEVE

NDA NDA020204

May 13, 2019

ALEVE

NDA NDA020204

May 13, 2019

ALEVE

NDA NDA020204

May 16, 2019

DICLOFENAC SODIUM

NDA ANDA211253

Jul 2, 2019

ALEVE

NDA NDA020204

Jul 23, 2019

ALEVE

NDA NDA020204

Aug 7, 2019

ALEVE

NDA NDA020204

Oct 26, 2019

NAPROXEN SODIUM

NDA NDA021920

Dec 9, 2019

NAPROXEN SODIUM

NDA NDA021920

Feb 27, 2020

NAPROXEN SODIUM

NDA NDA021920

Mar 2, 2020

ALEVE

NDA NDA020204

Apr 1, 2020

DICLOFENAC SODIUM

NDA ANDA211253

Apr 6, 2020

ALEVE PM

NDA NDA205352

Apr 23, 2020

ALEVE

NDA NDA020204

Apr 30, 2020

NAPROXEN SODIUM

NDA NDA021920

May 8, 2020

ALEVE

NDA NDA020204

Oct 23, 2020

DICLOFENAC SODIUM

NDA ANDA211253

Oct 23, 2020

DICLOFENAC SODIUM

NDA ANDA211253

Oct 28, 2020

ALEVE

NDA NDA020204

Oct 30, 2020

ALEVE PM

NDA NDA205352

Dec 12, 2020

NAPROXEN SODIUM

NDA NDA021920

Dec 31, 2020

ALEVE

NDA NDA020204

Dec 31, 2020

ALEVE

NDA NDA020204

Dec 31, 2020

ALEVE

NDA NDA020204

Dec 31, 2020

ALEVE

NDA NDA020204

Apr 1, 2021

ALEVE

NDA NDA020204

Dec 13, 2021

NAPROXEN SODIUM

NDA NDA021920

Feb 8, 2022

ALEVE PM

NDA NDA205352

Mar 10, 2022

ALEVE

NDA NDA020204

Sep 28, 2022

DICLOFENAC SODIUM

NDA ANDA211253

Apr 4, 2023

ALEVE

NDA NDA020204

Aug 9, 2023

NAPROXEN SODIUM

NDA ANDA214463

Sep 11, 2024

ALEVE

NDA NDA020204

Apr 24, 2025

ALEVE

NDA NDA020204

Jan 15, 2026

NAPROXEN SODIUM

NDA NDA021920

Mar 10, 2026

ALEVE

NDA NDA020204

Sources

References

[1]
ClinicalTrials.gov — 157 trial records for naproxen. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aleve drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — naproxen compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for naproxen. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020204). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Aleve. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[6]

Patent #Expires

10028925Mar 3, 2026

10022344Mar 3, 2026

11090280Mar 3, 2026

9693979Mar 3, 2026

9693978Mar 3, 2026