Aleve
(naproxen)ApprovedSmall molecule
Alnylam PharmaceuticalsNaproxen 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 51 indications[4].[1]
Aleve is one of 751 small molecule programs targeting Vaginal Inflammation. It is currently in Approved.
51
Indications
155
Total Trials
11
Active Trials
750
Competitors
7
FDA Applications
NDA/BLA/ANDA regulatory filings
5
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 47 indications
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1Aleve
Alnylam PharmaceuticalsApproved
Stivarga
BayerPreclinical
Aimovig
AmgenPreclinical
Angiomax
BBaxter Healthcare Corporation
Preclinical
Tricor
JJagotec
Preclinical
SARS-COV-2 VACCINE
ModernaPreclinical
Biological Collection
AAssistance Publique - Hôpitaux de Paris
Preclinical
Antihypertensive Agents
NNational Heart, Lung, and Blood Institute (NHLBI)
Preclinical
Selenium
SSWOG Cancer Research Network
Preclinical
Blood Collection
AAssistance Publique - Hôpitaux de Paris
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Osteoarthritis28 trials
Show 25 more trials
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
Back pain5 trials
Low back pain5 trials
Arthritis4 trials
Symptomatic Management of Lyme Arthritis
Terminated·—·Phase 3·NCT04038346·3 enrolled
Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients
Completed·—·Phase 3·NCT00153660·514 enrolled
Gastrointestinal4 trials
77 more indications
Interaction3 trials
Rheumatoid Arthritis3 trials
Efficacy and Safety3 trials
Analgesic3 trials
MAST Trial: Multi-modal Analgesic Strategies in Trauma
Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03472469·1,561 enrolled
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
Pain Control3 trials
Adult3 trials
Gastric Ulcer3 trials
Analgesic Efficacy2 trials
Tics2 trials
CAR2 trials
Lateral Epicondylitis2 trials
MPA2 trials
Dysmenorrhea2 trials
The Effect of Turmeric on New Onset Primary Dysmenorrhea
Completed·—·N/A·NCT04183556·90 enrolled
ESS2 trials
Oral2 trials
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
Pain After Surgery1 trial
Efficacy1 trial
Cardiovascular1 trial
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
Epicondylitis1 trial
Drug Interactions1 trial
Ankle Injuries1 trial
Lynch syndrome1 trial
Dementia1 trial
Randomized Trial of Low-dose Naproxen in Cognitively Intact Persons at Risk of Alzheimer's Dementia
Completed·—·Phase 2·NCT02702817·200 enrolled
Tuberculosis1 trial
Immunotherapy1 trial
Randomized Controlled Trial1 trial
Multiple Sclerosis1 trial
Pleural effusion1 trial
Alzheimer's Disease1 trial
Double-blind1 trial
Delirium1 trial
Delirium in Elderly Patients With Trauma of the Hip
Terminated·—·Phase 4·NCT02689024·239 enrolled
Acute Postoperative Pain1 trial
TED1 trial
Dental Implant1 trial
Multimodal Pain Management1 trial
Tendinopathy1 trial
Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs
Completed·—·N/A·NCT03401177·70 enrolled
Adductor Canal Block1 trial
Clinical Trial1 trial
Irritation1 trial
Injury1 trial
Optimal Treatment of Acute Skeletal Muscle Injury
Not yet recruiting·—·N/A·NCT06274151·20 enrolled
Fasting Conditions1 trial
ART1 trial
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
Non-steroidal Anti-inflammatory Drugs1 trial
Endodontic Treatment1 trial
The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
Completed·—·Phase 1/2·NCT01178203
Knee Pain1 trial
Clopidogrel1 trial
Colorectal Cancer1 trial
Endometriosis1 trial
Hemodynamic1 trial
Prospective1 trial
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00346216·24,081 enrolled
Low Level Laser Therapy1 trial
Acute Pain1 trial
A Pilot Study for Developing a Comprehensive Signal Detection Approach for the Mechanisms of Action and Analgesic Efficacy of Two Analgesics Using Human Experimental Models of Pain (HEMP)
Not yet recruiting·NNational Center for Complementary and Integrative Health (NCCIH)·Preclinical·NCT07549490·25 enrolled
Unspecified8 trials
Show 5 more trials
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
Oct 14, 1994
EC-NAPROSYN
NDA NDA020067
Jan 5, 1996
NAPRELAN
NDA NDA020353
Feb 17, 2006
NAPROXEN SODIUM
NDA NDA021920
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Aleve drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for naproxen. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Aleve. U.S. Food & Drug Administration.
- [7]