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naproxen

Trade name: naprosyn

Small moleculeapproved

Approved

Mar 11, 1976

Naproxen (naproxen sodium, NAPROSYN®) is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). It is an anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout. The mechanism of action of the naproxen (naproxen sodium, NAPROSYN®), like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). — NCATS

Clinical trial activity

316 trials · 233 clinical orgs · 59 marketing orgs

Phase 1
87
Phase 2
120
Phase 3
79
Phase 4
72

Earliest trial started Jul 1, 1998 (NCT02183038)

Timeline

1970s

  1. Mar 11, 1976

    Roche — Earliest FDA Approval

  2. Mar 11, 1976

    Atnahs Pharmaceuticals — NDA Secondary Org

  3. Mar 11, 1976

    Roche — NDA Organization

1990s

  1. Oct 30, 1992

    Hamilton Pharmaceuticals — Marketing Organization

  2. Dec 21, 1993

    DAVA Pharmaceuticals — Marketing Organization

  3. Dec 21, 1993

    Fosun — Marketing Organization

  4. Dec 21, 1993

    Mylan — Marketing Organization

  5. Dec 21, 1993

    Roxane Laboratories — Marketing Organization

  6. Dec 21, 1993

    Sandoz — Marketing Organization

  7. Dec 21, 1993

    Teva — Marketing Organization

  8. Dec 21, 1993

    Watson Pharmaceuticals — Marketing Organization

  9. Dec 21, 1993

    Boehringer Ingelheim — Marketing Organization

  10. Jan 11, 1994

    Bayer — NDA Secondary Org

  11. Mar 30, 1994

    West-Ward Pharmaceutical — Marketing Organization

  12. Apr 28, 1995

    Chartwell Pharmaceuticals — Marketing Organization

  13. Jan 5, 1996

    Alvogen — NDA Secondary Org

  14. Jan 5, 1996

    Alvogen — Marketing Organization

  15. Jan 5, 1996

    TWi Biotechnology, Inc. — Marketing Organization

  16. May 14, 1996

    Hikma — Marketing Organization

  17. Jun 20, 1996

    Pliva — Marketing Organization

  18. Jan 13, 1997

    Contract Pharmacal — Marketing Organization

  19. Jan 13, 1997

    Perrigo — Marketing Organization

  20. Jan 1, 1998

    Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)

  21. Feb 24, 1998

    Actavis — Marketing Organization

  22. Jul 28, 1998

    Dr. Reddy's Laboratories — Marketing Organization

2000s

  1. Jan 1, 2000

    Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2002

    Sandoz — Earliest Phase 1 Sponsor(trial)

  3. Aug 22, 2003

    Able Laboratories — Marketing Organization

  4. Nov 14, 2003

    Takeda — Marketing Organization

  5. Nov 14, 2003

    Takeda — NDA Secondary Org

  6. Feb 17, 2006

    Bionpharma Inc — NDA Secondary Org

  7. Feb 17, 2006

    Bionpharma Inc — Marketing Organization

  8. Mar 28, 2007

    Glenmark Pharmaceuticals — Marketing Organization

  9. Jun 7, 2007

    Zydus Discovery DMCC — Marketing Organization

  10. Apr 15, 2008

    Currax Pharmaceuticals — NDA Secondary Org

  11. Apr 15, 2008

    Pernix — Marketing Organization

2010s

  1. Apr 30, 2010

    Horizon Pharma — Marketing Organization

  2. Apr 30, 2010

    Horizon Pharma — NDA Secondary Org

  3. Feb 14, 2011

    Marksans Pharma — Marketing Organization

  4. Aug 24, 2011

    Invagen Pharms — Marketing Organization

  5. Sep 19, 2011

    Sunrise Medical Research, Inc. — Marketing Organization

  6. Sep 19, 2011

    Nuvo Research Inc. — Marketing Organization

  7. Sep 20, 2011

    Granules India — Marketing Organization

  8. Oct 31, 2011

    Aurobindo Pharma — Marketing Organization

  9. Nov 29, 2013

    Par Pharmaceuticals — Marketing Organization

  10. Jan 17, 2014

    Bayer — Marketing Organization

  11. Jan 23, 2017

    LNK International — Marketing Organization

  12. Mar 15, 2018

    Puracap Pharmaceutical — Marketing Organization

  13. Jul 20, 2018

    Sun Pharmaceuticals — Marketing Organization

  14. Sep 4, 2018

    Rising Pharmaceuticals — Marketing Organization

  15. Oct 23, 2018

    Amneal Pharmaceuticals — Marketing Organization

  16. Nov 16, 2018

    Novelgenix Therapeutics — Marketing Organization

  17. Jan 4, 2019

    Catalent — Marketing Organization

  18. Jan 4, 2019

    Micron Technologies — Marketing Organization

  19. Jan 25, 2019

    P&L Development — Marketing Organization

  20. Aug 22, 2019

    Apotex — Marketing Organization

  21. Aug 22, 2019

    Corepharma — Marketing Organization

  22. Aug 30, 2019

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

  23. Oct 30, 2019

    Sciegen Pharmaceticals — Marketing Organization

2020s

  1. Mar 10, 2021

    Novitium Pharma — Marketing Organization

  2. Mar 10, 2021

    Ani Pharmaceuticals — Marketing Organization

  3. Jun 7, 2022

    Hetero Labs Ltd — Marketing Organization

  4. Aug 17, 2022

    Strides Pharma Science — Marketing Organization

  5. Aug 24, 2022

    AbbVie — Marketing Organization

  6. Oct 6, 2022

    Ajanta Pharma Ltd — Marketing Organization

  7. Jan 10, 2023

    Patheon — Marketing Organization

  8. Jan 10, 2023

    Thermo Fisher Scientific — Marketing Organization

  9. May 31, 2023

    Tulex Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMar 11, 1976

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Mol. weight
230.26 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Over the Counter

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • (+)-2-(6-methoxy-2-naphthyl)propionic acid
  • (+)-2-(6-methoxy-2-naphthyl)propionic acid
  • (+)-2-(methoxy-2-naphthyl)-propionic acid
  • (+)-2-(methoxy-2-naphthyl)-propionic acid
  • (+)-2-(methoxy-2-naphthyl)-propionsäure
  • (+)-2-(methoxy-2-naphthyl)-propionsäure
  • 4-(nitrooxy)butyl-(2s)-2-(6-methoxy-2-naphthyl)propanoate
  • aleve
  • aleve
  • aleve
  • aleve
  • anaprox
  • anaprox
  • anaprox ds
  • anaprox ds
  • aproxen
  • ar-p900758xx
  • ar-p900758xx
  • arthrosin 250
  • arthrosin 250 ec
  • arthrosin 500
  • arthrosin 500 ec
  • azd3582
  • azd3582
  • azd 3582
  • azd-3582
  • azd-3582
  • azd-3582
  • condrotec
  • ec-naprosyn
  • ec-naprosyn
  • equiproxen
  • equiproxen
  • feminax ultra
  • grenoxal
  • hct 3012
  • hct-3012
  • hct-3012
  • hct-3012
  • kenosyn
  • laraflex
  • laraflex
  • lt-ns001
  • lt-ns001
  • lt-ns001
  • methoxypropiocin
  • methoxypropiocin
  • methoxypropiocin
  • methoxypropiocin
  • methoxypropiocin
  • methoxypropiocin
  • mx-1094
  • mx-1094
  • napratec op
  • naprelan
  • naprelan
  • naprelan
  • naprolag
  • naprolag
  • naprosyn
  • naprosyn
  • naprosyn
  • naprosyn
  • naprosyn
  • naprosyn 375
  • naprosyn ec
  • naproxcinod
  • naproxcinod
  • naproxcinod
  • naproxcinod
  • naproxcinod
  • naproxcinod
  • naproxcinod
  • naproxen
  • naproxen
  • naproxen
  • naproxen
  • naproxen
  • naproxen
  • naproxen
  • naproxen
  • naproxen
  • (+)-naproxen
  • (+)-naproxen
  • naproxène
  • naproxène
  • naproxen etemesil
  • naproxen etemesil
  • naproxen etemesil
  • naproxen-n-butyl nitrate
  • naproxen-n-butyl nitrate
  • naproxen-n-butyl nitrate
  • naproxeno
  • naproxeno
  • naproxen sodium
  • naproxen sodium
  • naproxen sodium
  • naproxen sodium
  • naproxen sodium
  • naproxenum
  • naproxenum
  • nicox
  • nitric oxide naproxen
  • nitric oxide-releasing naproxen
  • nitronaproxen
  • no-naproxen
  • nycopren
  • nycopren
  • pranoxen continus
  • prosaid
  • rheuflex 250
  • rheuflex 500
  • rimoxyn
  • rs-3540
  • rs-3540
  • rs-3650
  • rs-3650
  • (s)-2-(6-methoxy-2-naphthyl)propanoic acid
  • (s)-2-(6-methoxy-2-naphthyl)propanoic acid
  • (s)-(+)-2-(6-methoxy-2-naphthyl)propionic acid
  • (s)-(+)-2-(6-methoxy-2-naphthyl)propionic acid
  • (s)-2-(6-methoxy-2-naphthyl)propionic acid
  • (s)-2-(6-methoxy-2-naphthyl)propionic acid
  • (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
  • (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
  • (+)-(s)-6-methoxy-α-methyl-2-naphthaleneacetic acid
  • (+)-(s)-6-methoxy-α-methyl-2-naphthaleneacetic acid
  • (+)-(s)-naproxen
  • (+)-(s)-naproxen
  • (s)-naproxen
  • (s)-naproxen
  • (s)-(+)-naproxen
  • (s)-(+)-naproxen
  • stirlescent
  • sumatriptan-naproxen
  • synflex
  • synflex
  • test
  • test
  • timpron
  • timpron 250 ec
  • timpron 500 ec
  • treximet
  • treximet
  • treximet
  • valrox
  • vimovo

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07277712Phase 1Dec 27, 2025Inno.N, Jeonbuk National University
NCT06861387N/AMay 1, 2025St. Antonius Hospital, Nieuwegein
NCT06917118N/AMay 1, 2025University of Puerto Rico
NCT06903585Phase 2Apr 30, 2025American University of Beirut
NCT06861920Phase 4Apr 30, 2025Endeavor Health, National Institutes of Health (NIH), University of Chicago, University of Oklahoma
NCT06932536Phase 1Apr 21, 2025Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
NCT06595004Phase 3Nov 20, 2024Hanmi Pharmaceutical
NCT06379685Phase 1Sep 30, 2024Laboratorios Sophia S.A de C.V.
NCT06571448Phase 2Aug 31, 2024Peking University, Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
NCT06562816Phase 4Aug 16, 2024Dow University of Health Sciences, Duke University
NCT06511973Phase 1Jul 23, 2024Bayer
NCT06484192Phase 4Jun 28, 2024Thomas Jefferson University
NCT06415019Phase 1Jun 5, 2024Bayer
NCT06435442Phase 1May 31, 2024JW Pharmaceutical, Seoul National University
NCT06344195Phase 4Mar 27, 2024Dow University of Health Sciences, Duke University
NCT06274151N/AFeb 15, 2024University of Copenhagen
NCT05845008Phase 3Jan 15, 2024JBR Clinical Research, Johnson and Johnson
NCT05900336Phase 4Jan 1, 2024Department of Defense, Mclean Hospital, University of Chicago
NCT05411718Phase 2Nov 25, 2023National Cancer Institute (NCI), National Institutes of Health (NIH), University of Texas at Houston
NCT05851976Phase 4Oct 4, 2023Yeshiva University
Showing 20 of 316 trials
Page 1 / 16

Organizations

Research & Development (233)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit282742007
GlaxoSmithKlineFor profit251752005
PfizerFor profit232242002
POZENFor profit191622004
Johnson and JohnsonFor profit121242005
AstraZenecaFor profit9922008
National Institutes of Health (NIH)Government9022014
NicOxFor profit9922005
Northwestern UniversityAcademic/Hospital8822014
MerckFor profit7742002
Yeshiva UniversityAcademic/Hospital6612007
Allergan PLC (2015)For profit5512009
ClinvestFor profit5012009
IQVIAFor profit5012008
University of Sao PauloAcademic/Hospital5222011
Xgene PharmaceuticalFor profit5522017
Boehringer IngelheimFor profit4431998
Dr. Reddy's LaboratoriesFor profit4412004
JBR Clinical ResearchFor profit4022018
Primus PharmaceuticalsFor profit4412006
233 organizations
Page 1 / 12

Marketing (91)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGAug 24, 2022
Able LaboratoriesFor profitMKTGAug 22, 2003
ActavisFor profitMKTGFeb 24, 1998
ActavisFor profitSYNAug 27, 2002
Ajanta Pharma LtdFor profitMKTGOct 6, 2022
AlvogenFor profitNDA2Jan 5, 1996
AlvogenFor profitSYNJan 5, 1996
AlvogenFor profitMKTGJan 5, 1996
Amneal PharmaceuticalsFor profitMKTGOct 23, 2018
Amneal PharmaceuticalsFor profitSYNDec 18, 2001
Amneal PharmaceuticalsFor profitSYNJul 31, 2020
Amneal PharmaceuticalsFor profitSYNJul 31, 2020
Ani PharmaceuticalsFor profitMKTGMar 10, 2021
ApotexFor profitMKTGAug 22, 2019
ApotexFor profitSYNAug 22, 2019
Atnahs PharmaceuticalsFor profitNDA2Mar 11, 1976
Aurobindo PharmaFor profitSYNNov 8, 2011
Aurobindo PharmaFor profitMKTGOct 31, 2011
Aurobindo PharmaFor profitSYNApr 19, 2001
BayerFor profitNDA2Jan 11, 1994
BayerFor profitMKTGJan 17, 2014
Bionpharma IncFor profitNDA2Feb 17, 2006
Bionpharma IncFor profitMKTGFeb 17, 2006
Boehringer IngelheimFor profitMKTGDec 21, 1993
CatalentFor profitMKTGJan 4, 2019
Chartwell PharmaceuticalsFor profitMKTGApr 28, 1995
Contract PharmacalFor profitMKTGJan 13, 1997
CorepharmaFor profitMKTGAug 22, 2019
Currax PharmaceuticalsFor profitNDA2Apr 15, 2008
DAVA PharmaceuticalsFor profitMKTGDec 21, 1993
Dr. Reddy's LaboratoriesFor profitSYNFeb 18, 2020
Dr. Reddy's LaboratoriesFor profitMKTGJul 28, 1998
Dr. Reddy's LaboratoriesFor profitSYNJul 26, 2007
FosunFor profitMKTGDec 21, 1993
Glenmark PharmaceuticalsFor profitMKTGMar 28, 2007
Glenmark PharmaceuticalsFor profitSYNApr 27, 2007
Granules IndiaFor profitMKTGSep 20, 2011
Granules IndiaFor profitSYNSep 24, 2020
Granules IndiaFor profitSYNDec 21, 1993
Hamilton PharmaceuticalsFor profitMKTGOct 30, 1992
Hetero Labs LtdFor profitMKTGJun 7, 2022
Hetero Labs LtdFor profitSYNOct 28, 2022
HikmaFor profitSYNJan 14, 2004
HikmaFor profitMKTGMay 14, 1996
HikmaFor profitSYNMar 30, 1994
Horizon PharmaFor profitMKTGApr 30, 2010
Horizon PharmaFor profitNDA2Apr 30, 2010
Invagen PharmsFor profitMKTGAug 24, 2011
LNK InternationalFor profitMKTGJan 23, 2017
Marksans PharmaFor profitMKTGFeb 14, 2011
Micron TechnologiesFor profitMKTGJan 4, 2019
MylanFor profitMKTGDec 21, 1993
MylanFor profitSYNApr 19, 2001
Novelgenix TherapeuticsFor profitMKTGNov 16, 2018
Novitium PharmaFor profitMKTGMar 10, 2021
Nuvo Research Inc.For profitMKTGSep 19, 2011
P&L DevelopmentFor profitMKTGJan 25, 2019
Par PharmaceuticalsFor profitMKTGNov 29, 2013
PatheonFor profitMKTGJan 10, 2023
PernixFor profitMKTGApr 15, 2008
PerrigoFor profitSYNApr 27, 2005
PerrigoFor profitSYNJan 13, 1997
PerrigoFor profitSYNApr 27, 2005
PerrigoFor profitMKTGJan 13, 1997
PerrigoFor profitSYNApr 27, 2005
PlivaFor profitMKTGJun 20, 1996
Puracap PharmaceuticalFor profitMKTGMar 15, 2018
Puracap PharmaceuticalFor profitSYNSep 28, 1993
Rising PharmaceuticalsFor profitMKTGSep 4, 2018
RocheFor profitNDAMar 11, 1976
Roxane LaboratoriesFor profitMKTGDec 21, 1993
SandozFor profitMKTGDec 21, 1993
Sciegen PharmaceticalsFor profitMKTGOct 30, 2019
Strides Pharma ScienceFor profitMKTGAug 17, 2022
Sun PharmaceuticalsFor profitSYNJul 20, 2018
Sun PharmaceuticalsFor profitMKTGJul 20, 2018
Sun PharmaceuticalsFor profitSYNMay 20, 2011
Sunrise Medical Research, Inc.For profitMKTGSep 19, 2011
TWi Biotechnology, Inc.For profitMKTGJan 5, 1996
TakedaFor profitMKTGNov 14, 2003
TakedaFor profitNDA2Nov 14, 2003
TevaFor profitSYNFeb 28, 1995
TevaFor profitMKTGDec 21, 1993
TevaFor profitSYNDec 21, 1993
TevaFor profitSYNFeb 10, 1995
Thermo Fisher ScientificFor profitMKTGJan 10, 2023
Tulex PharmaceuticalsFor profitMKTGMay 31, 2023
Watson PharmaceuticalsFor profitMKTGDec 21, 1993
West-Ward PharmaceuticalFor profitMKTGMar 30, 1994
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGAug 30, 2019
Zydus Discovery DMCCFor profitMKTGJun 7, 2007