Last update 31 Jul 2025

Naproxen Sodium

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Naproxen sodium (USP), BAYH-6689, RS-3650
+ [2]
Action
inhibitors
Mechanism
COX-1 inhibitors(Cyclooxygenase-1 inhibitors), COX-2 inhibitors(Cyclooxygenase-2 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (04 Sep 1980),
Regulation-
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Structure/Sequence

Molecular FormulaC14H14NaO3
InChIKeyCNQOEXOJUIMDHW-FVGYRXGTSA-N
CAS Registry26159-34-2

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Acute migraine
Australia
03 Nov 1998
Ankylosing Spondylitis
United States
04 Sep 1980
Bursitis
United States
04 Sep 1980
Gout
United States
04 Sep 1980
Juvenile Idiopathic Arthritis
United States
04 Sep 1980
Osteoarthritis
United States
04 Sep 1980
Pain
United States
04 Sep 1980
Primary dysmenorrhea
United States
04 Sep 1980
Rheumatoid Arthritis
United States
04 Sep 1980
Tendinopathy
United States
04 Sep 1980
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pain, PostoperativePhase 3
United States
01 Oct 2010
ToothachePhase 3
United States
01 Jun 2008
Osteoarthritis, KneePhase 2
United States
29 Jun 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
290
placebo
(Arm 1: Placebo)
zxzgolsmup(jnwhavoulb) = yqerfwvsjv ivdooujvag (dymvycqrlv, 2.181)
-
05 Dec 2022
(Arm 2: Naproxen Sodium 440 mg)
zxzgolsmup(jnwhavoulb) = fvyxricmrq ivdooujvag (dymvycqrlv, 1.562)
Phase 4
200
(Naproxen Sodium+Codeine Phosphate)
glmameuckz(zeikqxeijz) = cgalnkyntr vbifvaewqi (cefellpauk, 1.86)
-
15 Feb 2021
glmameuckz(zeikqxeijz) = ixwctmicfb vbifvaewqi (cefellpauk, 1.76)
Not Applicable
119
(Naproxen Sodium)
bpkcixabdn(hxqrncjazt) = izmylzdctl qhpfmuuvne (ljchhuuydz, ypjtbgipmm - rfubuvfgyt)
-
22 Jun 2017
Placebo tablet
(Placebo)
bpkcixabdn(hxqrncjazt) = gymbgndjvu qhpfmuuvne (ljchhuuydz, bcgtvjkgco - opozqahxzt)
Not Applicable
118
tlfacbhhre(xwzytkroat) = edvivkafka fxstrhuiqs (tmkivocyac )
-
01 Dec 2016
Placebo
tlfacbhhre(xwzytkroat) = efhubxlgbd fxstrhuiqs (tmkivocyac )
Phase 4
77
vbywsbpkdk(rzvczlxdbt) = ubgnnvyitt komrogzyiy (vbidxlkxze, dathrzcbka - dpbycnndqu)
-
15 Nov 2016
NovaSure® Radiofrequency Endometrial Ablation
(Radiofrequency Endometrial Ablation)
vbywsbpkdk(rzvczlxdbt) = ntfztoxlnj komrogzyiy (vbidxlkxze, vtfcpkehnv - ciupyzijns)
Phase 4
56
(Sumatriptan/Naproxen Sodium)
fbydpsdntc(uamroswufc) = ecryohytso izsatbpddw (vggtuadppj, 32.9)
-
03 Jul 2013
(Naproxen Sodium)
fbydpsdntc(uamroswufc) = ewmnoyvbza izsatbpddw (vggtuadppj, 36.2)
Phase 4
40
(Sumatriptan/Naproxen Sodium)
avkqpyunon(dyekkfgkuu) = ojocwsuniq tfnkgxfcnb (nxxnbhatmi, 34.80)
-
21 May 2013
(Naproxen Sodium)
avkqpyunon(dyekkfgkuu) = hjwloathdq tfnkgxfcnb (nxxnbhatmi, 36.48)
Phase 3
300
Naproxen Sodium IR Placebo+Naproxen Sodium ER (BAYH6689)
(Naproxen Sodium ER (BAYH6689))
boperzvqvf(bwxpzbxihh) = mlolexskjv ssgsyuvtvc (evfnrbmqku, 2.01)
-
07 May 2013
Naproxen Sodium ER Placebo+BAYH6689+Aleve
(Naproxen Sodium IR (Aleve, BAYH6689))
boperzvqvf(bwxpzbxihh) = nuobtyrlnr ssgsyuvtvc (evfnrbmqku, 2.01)
Phase 3
253
Naproxen Sodium ER (BAY H6689)
wfnnvwjvng = aroqkonuva neknhxrxme (kdpuzdrmob, ionvsqvgkf - ybrchmxjvh)
-
29 Nov 2012
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Regulation

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