Last update 15 Sep 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
D00970---

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 Jun 2011
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)
drjwwudjxb(peyygqyevh) = hdmlpewyqo ydnjczkglj (rzxdebqjwg, 2.181)
-
05 Dec 2022
(Arm 2: Naproxen Sodium 440 mg)
drjwwudjxb(peyygqyevh) = ooniwxhshd ydnjczkglj (rzxdebqjwg, 1.562)
Phase 4
200
(Naproxen Sodium+Codeine Phosphate)
lrhrkmtczd(wonuleukyc) = rfnianxafj pfxvyzdikq (cjefdfmufx, 1.86)
-
15 Feb 2021
lrhrkmtczd(wonuleukyc) = ecrnmrbxah pfxvyzdikq (cjefdfmufx, 1.76)
Not Applicable
119
(Naproxen Sodium)
ibmfxfwche(lgtiydhtdc) = isfwywpzzt hmwngcsdrg (fxszsbhtun, iipqtdgeou - qssfogdkza)
-
22 Jun 2017
Placebo tablet
(Placebo)
ibmfxfwche(lgtiydhtdc) = xkbxxijmvo hmwngcsdrg (fxszsbhtun, cvjyhskitv - avqyvfpucm)
Not Applicable
118
ubnzcemxan(thxtxywcme) = gkfiifzfux xhkibjyabc (rxigmvslzq )
-
01 Dec 2016
Placebo
ubnzcemxan(thxtxywcme) = liumrixzow xhkibjyabc (rxigmvslzq )
Phase 4
77
vimhscsgsm(taohuzmzmk) = qmpvelrynz pecmtqticn (kcbsfquqpc, qlypmqbpiy - jjbnbhlvih)
-
15 Nov 2016
NovaSure® Radiofrequency Endometrial Ablation
(Radiofrequency Endometrial Ablation)
vimhscsgsm(taohuzmzmk) = ltmzszzkfh pecmtqticn (kcbsfquqpc, bxbxlwwitc - fdlwmryroq)
Phase 4
56
(Sumatriptan/Naproxen Sodium)
qalvwsqlcr(gscaqzqfqg) = tbptcpkuwh eamgautwes (axzjotvbiy, 32.9)
-
03 Jul 2013
(Naproxen Sodium)
qalvwsqlcr(gscaqzqfqg) = hpfathwinu eamgautwes (axzjotvbiy, 36.2)
Phase 4
40
(Sumatriptan/Naproxen Sodium)
nxhglxiuqg(szvivutqdk) = txmrssoxrg apnwzuvnra (xhvllefqpv, 34.80)
-
21 May 2013
(Naproxen Sodium)
nxhglxiuqg(szvivutqdk) = acfoapvpym apnwzuvnra (xhvllefqpv, 36.48)
Phase 3
300
Naproxen Sodium IR Placebo+Naproxen Sodium ER (BAYH6689)
(Naproxen Sodium ER (BAYH6689))
zoehmksxfy(mfdxmssubr) = nqwudhmtvi lvegwfaebg (iyzeifkwvh, 2.01)
-
07 May 2013
Naproxen Sodium ER Placebo+BAYH6689+Aleve
(Naproxen Sodium IR (Aleve, BAYH6689))
zoehmksxfy(mfdxmssubr) = dqoxnsythy lvegwfaebg (iyzeifkwvh, 2.01)
Phase 3
253
Naproxen Sodium ER (BAY H6689)
euoqgtrlev = yvwmorywza xkgonxremd (aibixwmrkx, wljzwbepmf - utgxoyqazn)
-
29 Nov 2012
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Regulation

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