Drugs / Naproxen
Naproxen
also known as
Naproxen Sodium · Aleve · Naprosyn · BAYH6689 · BAY117031 · BAYH006689 · Anaprox · Anaprox ds · +46 more
Small molecule targets TAS1R3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed arthritis, sacroiliac 2 milestones | |||||
| Filed | EU (EMA) | VIMOVO | arthritis, sacroiliac | 2009-10-16 | “submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO™” astrazeneca.com ↗ |
| Filed | US (FDA) | VIMOVO | arthritis, sacroiliac | 2009-06-30 | “In June 2009, POZEN submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for VIMOVO.” astrazeneca.com ↗ “has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for VIMOVO (PN400)” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | ANAPROX DS | — | 1987-09-30 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | NAPROSYN | — | 1980-07-15 – 1987-03-23 | fda.gov ↗ |
| Approved | US (FDA) | NAPROSYN | — | 1976-03-11 | fda.gov ↗ |
Trials 149 · started per year
today
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00830050 | Jul → Dec 2010 | osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 137 trials · 1 met primary | ||||||
| Phase 1 | NCT07277712 | Dec 2025 → May 2026 overdue | — | HK inno.N Corporation | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06511973 | Jul → Aug 2024 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06415019 | Jun → Aug 2024 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06435442 | Jun 2024 → Dec 2025 | — | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT05844995 | Sep 2023 → Feb 2024 | — | Johnson & Johnson Consumer Inc. (J&JCI) | Completed | No outcome recorded |
| Phase 1 | NCT05181124 | Mar 2021 | active peptic ulcer disease | Onconic Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04490434 | Jun → Aug 2020 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04139824 | Jan → Feb 2020 | gout | LG Chem | Completed | No outcome recorded |
| Phase 1 | NCT03697889 | Dec 2018 | — | McNeil AB | Completed | No outcome recorded |
| Phase 1 | NCT03424135 | Mar → Apr 2018 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03396250 | Feb → Mar 2018 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03183297 | Aug → Oct 2017 | — | Sen-Jam Pharmaceutical | Unknown | No outcome recorded |
| Phase 1 | NCT03167541 | Oct → Dec 2016 | — | Reckitt Benckiser Healthcare (UK) Limited | Completed | No outcome recorded |
| Phase 1 | NCT02502006 | Nov 2015 → Sep 2022 | — | University of Pennsylvania | Terminated | Mixed Stop: Enrollment |
| Phase 1 | NCT02408978 | May → Jun 2015 | gastroduodenitis | Oxford Pharmascience Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02229461 | Feb → May 2015 | hematologic disorder | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02052908 | Jan 2014 → Oct 2019 | Lynch syndrome | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01884272 | Jun → Aug 2013 | gout | Ardea Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01659372 | Jun → Dec 2012 | temporomandibular joint disorder | Shahid Beheshti University | Unknown | No outcome recorded |
| Phase 1 | NCT01358383 | May → Jun 2011 | juvenile idiopathic arthritis | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01343303 | Mar → Dec 2011 | osteoarthritis, knee | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01094483 | Mar → May 2010 | platelet aggregation, spontaneous | AstraZeneca | Completed | Met primary |
| Phase 1 | NCT01409603 | Jan → May 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00992381 | Sep → Oct 2009 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00945178 | Aug → Sep 2009 | — | AstraZeneca | Terminated | No outcome recorded |
| Phase 1 | NCT00933582 | Aug 2009 → Jun 2010 | osteoarthritis, knee | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00969449 | Apr → May 2009 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00818415 | Nov 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00772967 | Jun → Nov 2008 | osteoarthritis | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 1 | NCT00676442 | May → Jun 2008 | arthritic joint disease | POZEN | Completed | No outcome recorded |
| Phase 1 | NCT00751556 | Feb → Mar 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00692016 | Jan → Feb 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00596245 | Oct → Dec 2007 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00442208 | Jan 2007 → Feb 2008 | — | POZEN | Completed | No outcome recorded |
| Phase 1 | NCT00392080 | Nov 2006 → Feb 2008 | osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00366262 | Jun 2006 → Mar 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00959439 | Mar → May 2002 | osteoarthritis, rheumatoid arthritis | Sandoz | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07487909 | Sep → Nov 2025 | — | Sen-Jam Pharmaceutical | Completed | No outcome recorded |
| Phase 1/2 | NCT01178203 | Jul 2010 | pulpitis | Azad University of Medical Sciences | Completed | No outcome recorded |
| Phase 216 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT05411718 | Mar 2023 → Nov 2026 expected | Lynch syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05026320 | Aug → Dec 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT05463367 | Jan 2021 → Jun 2025 overdue | chronic pain syndrome, opiate dependence, substance abuse | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04447040 | Nov 2020 → Apr 2021 | — | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Completed | Met primary |
| Phase 2 | NCT04221165 | Aug 2020 → Sep 2023 | head and neck cancer, mucositis | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | Met primary |
| Phase 2 | NCT04115098 | Jun 2020 → Aug 2023 | spondyloarthropathy | The University of Texas Health Science Center, Houston | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04132336 | Nov 2019 → Mar 2020 | neuropathy, painful | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT03879408 | May → Nov 2019 | — | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Completed | No outcome recorded |
| Phase 2 | NCT03949673 | Apr 2019 → Aug 2020 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03570554 | Jun 2018 → Jun 2019 | osteoarthritis, knee | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01612975 | Apr 2014 → Jan 2018 | pleural neoplasm | McMaster University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01712009 | Nov 2012 → Mar 2015 | bone pain, periodic | Amgen | Completed | Missed primary |
| Phase 2 | NCT01229228 | Oct 2010 → Apr 2011 | — | Iroko Pharmaceuticals, LLC | Completed | Met primary |
| Phase 2 | NCT01147458 | Jul 2010 → Feb 2011 | osteoarthritis, knee | Pfizer | Terminated | Missed primary |
| Phase 2 | NCT01102660 | May 2010 → Feb 2011 | osteoarthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01231490 | Sep 2008 → Jan 2009 | osteoarthritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT01016678 | Mar 2010 → Jun 2014 | migraine disorder | Premiere Research Institute | Completed | Mixed |
| Phase 2/3 | NCT00004845 | ? → Dec 2001 | Alzheimer disease | National Institute on Aging (NIA) | Completed | Missed primary |
| Phase 341 trials · 14 met primary · 3 missed | ||||||
| Phase 3 | NCT07665476 | Sep 2026 → Dec 2030 expected | cellulitis, skin infection | Ottawa Hospital Research Institute | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05845008 | Jan → Jul 2024 | — | Johnson & Johnson Consumer Inc. (J&JCI) | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05868122 | Sep 2023 → May 2024 | — | Johnson & Johnson Consumer Inc. (J&JCI) | Completed | No outcome recorded |
| Phase 3 | NCT04384367 | Dec 2022 → Oct 2024 | migraine disorder | Eurofarma Laboratorios S.A. | Completed | No outcome recorded |
| Phase 3 | NCT06948513 | Dec 2022 → Jun 2023 | — | Zitelli & Brodland Skin Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT05485805 | Sep 2022 → Jan 2024 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT04325633 | Apr → Dec 2020 | COVID-19 | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04038346 | Oct 2019 → May 2025 | Lyme disease, arthritic joint disease | Desiree Neville, MD | Terminated | No outcome recorded |
| Phase 3 | NCT03566979 | Aug 2018 → Mar 2019 | — | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | Completed | No outcome recorded |
| Phase 3 | NCT04948164 | Aug 2018 → Dec 2021 | migraine disorder | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03161093 | Aug 2017 → Sep 2019 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Completed | Mixed |
| Phase 3 | NCT01939002 | Nov 2013 → Oct 2015 | multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT01495858 | Dec 2011 → Feb 2012 | — | Bayer | Completed | Missed primary |
| Phase 3 | NCT01427803 | Sep → Dec 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01383486 | Jul → Aug 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01389284 | Jun → Sep 2011 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT01365052 | May → Jul 2011 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00844805 | Sep 2009 → Apr 2011 | ankylosing spondylitis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00809354 | Feb 2009 → Oct 2010 | osteoarthritis | Pfizer | Terminated | Mixed |
| Phase 3 | NCT00843024 | Dec 2008 → May 2010 | migraine disorder | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00751400 | Jul → Nov 2008 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00720057 | Jun → Aug 2008 | dental abscess | Bayer | Completed | Met primary |
| Phase 3 | NCT00602420 | Jun 2008 → Jan 2012 | cancer of unknown primary site, musculoskeletal system disorder | Gary Morrow | Completed | Met primary |
| Phase 3 | NCT00664560 | Apr → Dec 2008 | osteoarthritis | POZEN | Completed | Met primary |
| Phase 3 | NCT00665431 | Apr → Dec 2008 | osteoarthritis | POZEN | Completed | Met primary |
| Phase 3 | NCT00573170 | Feb 2008 → Aug 2009 | migraine disorder | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00594854 | Sep 2007 → Sep 2008 | gastric ulcer | POZEN | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00488514 | Jul 2007 → Aug 2009 | migraine disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00527904 | Mar 2007 → Mar 2009 | gastric ulcer | POZEN | Completed | No outcome recorded |
| Phase 3 | NCT00382993 | Dec 2006 → Nov 2007 | migraine disorder | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00383162 | Nov 2006 → Oct 2007 | migraine disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00385008 | Sep → Nov 2006 | migraine disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00387881 | Sep 2006 → Feb 2008 | migraine without aura | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00329459 | May → Nov 2006 | migraine disorder | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00329355 | May → Nov 2006 | migraine disorder | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00433732 | Aug 2004 → Apr 2005 | migraine disorder | POZEN | Completed | Mixed |
| Phase 3 | NCT00434083 | Jul 2004 → Jan 2005 | migraine disorder | POZEN | Completed | Met primary |
| Phase 3 | NCT00175032 | Jul 2003 → Jul 2004 | osteoarthritis, peptic ulcer disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00007189 | Jan 2001 → May 2007 | Alzheimer disease | Seattle Institute for Biomedical and Clinical Research | Completed | Missed primary |
| Phase 3 | NCT00034853 | Dec 2000 → Jun 2003 | juvenile idiopathic arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00279747 | Sep 2000 → Jan 2003 | juvenile idiopathic arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 433 trials · 4 met primary · 2 missed | ||||||
| Phase 4 | NCT07750639 | Aug 2024 → Nov 2027 expected | drug dependence, opioid abuse, poisoning | AdventHealth | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05900336 | Mar 2024 → Aug 2025 | dysmenorrhea | Mclean Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05722002 | Feb 2023 → Dec 2026 expected | neuropathy, painful | University of Michigan | Recruiting | No outcome recorded |
| Phase 4 | NCT05430230 | Aug 2022 → Jun 2027 expected | osteoarthritis, knee | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04694300 | Feb 2021 → Aug 2022 | — | Hersh, Elliot V., DMD, MS, PhD | Completed | Mixed |
| Phase 4 | NCT04015596 | Oct 2020 → Apr 2025 | autoimmune disease, obsessive-compulsive disorder | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04307940 | Mar → Oct 2020 | — | Bayer | Completed | Met primary |
| Phase 4 | NCT04145518 | Oct 2019 → Jul 2025 | endometrial disorder, primary dysmenorrhea, secondary dysmenorrhea, uterine corpus leiomyoma | Endeavor Health | Completed | No outcome recorded |
| Phase 4 | NCT04947566 | Sep 2019 → Feb 2020 | neuropathy, painful | Fatima Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03697720 | May 2018 → Nov 2020 | dysmenorrhea | Endeavor Health | Completed | No outcome recorded |
| Phase 4 | NCT03448536 | Apr → Sep 2018 | primary dysmenorrhea | Bayer | Completed | Met primary |
| Phase 4 | NCT04066426 | Mar 2018 → Apr 2019 | temporomandibular joint disorder | Yuzuncu Yil University | Completed | No outcome recorded |
| Phase 4 | NCT03404206 | Feb → Jul 2018 | neuropathy, painful | Bayer | Completed | Met primary |
| Phase 4 | NCT03347929 | Nov 2017 → Jun 2023 | sciatica | Ostfold Hospital Trust | Completed | Met primary |
| Phase 4 | NCT03092193 | Mar → Oct 2017 | Amobarbital, deficient N-hydroxylation of | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT04449471 | Jan 2016 → Jul 2021 | — | University of Washington | Unknown | No outcome recorded |
| Phase 4 | NCT02667730 | Jun 2015 → May 2019 | ligament disorder | Canadian Department of National Defence | Completed | No outcome recorded |
| Phase 4 | NCT02355236 | Feb → Dec 2015 | osteoarthritis | Severance Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02281968 | Dec 2014 → Dec 2015 | — | Northwell Health | Withdrawn | No outcome recorded |
| Phase 4 | NCT02255955 | Oct → Dec 2014 | — | Diskapi Yildirim Beyazit Education and Research Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02494856 | Oct 2014 → Dec 2015 | impacted teeth, multiple | Giovana Maria Weckwerth | Completed | No outcome recorded |
| Phase 4 | NCT02501564 | May 2013 → Nov 2014 | osteoarthritis | Istanbul Medeniyet University | Completed | No outcome recorded |
| Phase 4 | NCT01071317 | Feb 2010 → Jan 2012 | migraine disorder | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00807846 | Sep 2009 → Dec 2012 | juvenile idiopathic arthritis | Viatris Inc. | Completed | Missed primary |
| Phase 4 | NCT00893737 | Jun 2009 → Jan 2010 | migraine disorder | Cady, Roger, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00792636 | Nov 2008 → Nov 2009 | migraine disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01118273 | Jan → Feb 2008 | — | Bayer | Completed | Missed primary |
| Phase 4 | NCT00586365 | Oct 2007 → Jan 2010 | traumatic myositis ossificans | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT00222976 | Sep 2006 → May 2007 | perineocele | University of Saskatchewan | Completed | No outcome recorded |
| Phase 4 | NCT00137033 | Sep 2004 → Jul 2005 | peptic ulcer disease | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00410995 | May 2004 → Aug 2006 | — | University of Oklahoma | Terminated | No outcome recorded |
| Phase 4 | NCT00157872 | Jan → Jul 2004 | rheumatoid arthritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT00261586 | ? → Mar 2004 | — | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase not applicable17 trials · 1 met primary · 3 missed | ||||||
| — | NCT07549490 | Oct 2026 → Dec 2029 expected | — | National Center for Complementary and Integrative Health (NCCIH) | Not yet recruiting | No outcome recorded |
| — | NCT07606638 | Feb → Jul 2026 overdue | oral cavity squamous cell carcinoma | Mayo Hospital Lahore | Enrolling by invitation | No outcome recorded |
| — | NCT06917118 | May → Nov 2025 overdue | — | University of Puerto Rico | Not yet recruiting | No outcome recorded |
| — | NCT06453291 | Jul 2024 → Apr 2025 overdue | chronic pain syndrome | Iffat Anwar Medical Complex | Recruiting | No outcome recorded |
| — | NCT06274151 | Feb 2024 → Jul 2025 overdue | — | Bispebjerg Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07706036 | Jan → Jul 2024 | — | Ankara City Hospital Bilkent | Completed | No outcome recorded |
| — | NCT04566250 | Feb 2021 → Apr 2022 | — | McMaster University | Completed | Met primary |
| — | NCT05541185 | Feb 2021 | osteoarthritis, knee | Sultan ÇEÇEN | Completed | No outcome recorded |
| — | NCT06291337 | Jun 2020 → Sep 2023 | — | Rutgers, The State University of New Jersey | Completed | No outcome recorded |
| — | NCT05021718 | Jul 2018 → Sep 2019 | lumbar disk disease | Chittagong Medical College | Completed | No outcome recorded |
| — | NCT03401177 | Jan 2018 → Jul 2019 | tendinosis | Bispebjerg Hospital | Completed | Missed primary |
| — | NCT02463552 | May 2015 → Jun 2016 | — | Federal University of Sergipe | Completed | No outcome recorded |
| — | NCT02388191 | Apr 2015 → Apr 2016 | — | Planned Parenthood League of Massachusetts | Completed | Missed primary |
| — | NCT02769247 | Jun 2014 → Dec 2016 | — | Walter Reed National Military Medical Center | Completed | Missed primary |
| — | NCT01982799 | Feb 2014 → Sep 2015 | tooth disorder | University of Minnesota | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00789802 | Nov 2008 → Jan 2010 | hemorrhagic disease | Washington University School of Medicine | Completed | Mixed |
| — | NCT00536068 | Aug 2006 → Aug 2007 | vascular hemostatic disease | Kantonsspital Graubünden | Completed | No outcome recorded |
| Comparator or background therapy167 trials | ||||||
| Phase 0 | NCT07204379 Comparator | Jan → Jul 2023 | — | Armed Forces Institute of Dentistry, Pakistan | Completed | No outcome recorded |
| Phase 0 | NCT03771612 Comparator | Feb 2022 → Nov 2023 | — | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 0 | NCT01539447 Comparator | Jan 2012 → Mar 2022 | myositis ossificans | University of Utah | Completed | No outcome recorded |
| Phase 1 | NCT05237297 Comparator | Feb → Jul 2022 | — | Il-Yang Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04639804 Comparator | Jun → Jul 2020 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Show all 167 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2016-11-13 | Pfizer | Results Landmark Study Demonstrates Pfizer’s Celebrex (Celecoxib)Has Similar Cardiovascular Risk As Compared To Prescription Doses Of Ibuprofen and Naproxen pfizer.com ↗
The final PRECISION trial results provide statistically strong evidence that cardiovascular risk with approved doses of celecoxib is not greater than that of prescription doses of ibuprofen and naproxen. |
| 2010-10-11 | AstraZeneca | Regulatory Positive agreement received for approval of VIMOVO in Europe astrazeneca.com ↗
Monday, 11 October 2010 AstraZeneca and POZEN Inc. today announced that VIMOVO (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets has cleared an important regulatory milestone by receiving positive agreement for approval in 23 countries across the European Union (EU). |
| 2010-04-30 | AstraZeneca | Regulatory FDA approved VIMOVO for arthritis patients at risk of developing NSAID-associated gastric ulcers astrazeneca.com ↗
AstraZeneca and POZEN Inc. today announced the US Food and Drug Administration (FDA) has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. |
| 2009-10-19 | AstraZeneca | Results Patients Taking VIMOVO(TM) Showed Decrease in incidence of NSAID Associated Ulcers astrazeneca.com ↗
Data from study PN400-301 showed a 4.1% incidence of GU in patients taking VIMOVO, compared to 23.1% among patients taking EC naproxen (p<0.001). |
| 2009-10-16 | AstraZeneca | Regulatory AstraZeneca Submits Marketing Authorisation Application to European Union for VIMOVO™ astrazeneca.com ↗
today announced that they have submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO™ |
| 2009-08-31 | AstraZeneca | Regulatory AstraZeneca Announces FDA Acceptance of New Drug Application for VIMOVO astrazeneca.com ↗
the FDA’s notification of acceptance of the NDA filing for VIMOVO prompts a $10 million milestone payment from AstraZeneca to POZEN. |
| 2005-04-28 | Perrigo Company | Regulatory Perrigo Company Announces Approval for Naproxen Tablets perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Naproxen Tablets USP, 250 mg, 375 mg and 500 mg. |
All press releases naming this drug 9 releases
Evidence & citations 59 cited values
Every value below carries the sentence it was read from. 319 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Naproxen | “The aim of the present randomized placebo-controlled study is to evaluate whether the perioperative administration of Naproxen (NPR) an anti-inflammatory drug with a beneficial...” NCT03727412 ↗274“An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects” NCT00676442 ↗ “One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.” NCT01138150 ↗ “Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: phase III study in patients at risk for NSAID-associated gastric ulcers.” PMID 21319944 ↗ Feb 2011 “The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications.” NCT01374269 ↗ “Patients randomized into this group (n=40) will, again by simple randomization, be given oral tablets of ibuprofen or naproxen” NCT07493226 ↗ “coadministered enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg (fixed-dose combination)” PMID 22078153 ↗ Nov 2011 “PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid).” NCT00594854 ↗ “IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.” NCT02674386 ↗ “IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study” NCT03031938 ↗ “Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks” NCT02528188 ↗ |
| Known as | Aleve | “Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica” NCT04499209 ↗10“Aleve® naproxen sodium, a Reference product currently marketed in The Netherlands” NCT03167541 ↗ “Drug: Naproxen Sodium IR (Aleve, BAYH6689)” NCT01389284 ↗ “1x 220 mg naproxen sodium (Aleve caplet)” NCT00913627 ↗ “Naproxen Sodium (Aleve, BAY117031)” NCT03404206 ↗ “Naproxen Sodium (Aleve, BAY117031)” NCT03570554 ↗ “Naproxen Sodium (Aleve, BAYH6689)” NCT01666678 ↗ “Aleve: po, 220mg, bid, six weeks” NCT00602901 ↗ “Naproxen Sodium (Aleve)” NCT00007189 ↗ “Naproxen sodium (Aleve)” NCT05485805 ↗ |
| Known as | Anaprox | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Anaprox ds | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Arthrosin 250 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Arthrosin 250 ec | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Arthrosin 500 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Arthrosin 500 ec | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | BAY117031 | “Naproxen Sodium (Aleve, BAY117031)” NCT03404206 ↗1“Naproxen Sodium (Aleve, BAY117031)” NCT03570554 ↗ |
| Known as | BAYH006689 | “Naproxen (BAYH006689)” NCT06415019 ↗1“Naproxen (BAYH006689)” NCT06511973 ↗ |
| Known as | BAYH6689 | “Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain” NCT01383486 ↗8“Drug: Naproxen Sodium ER (BAYH6689)” NCT00720057 ↗ “Drug: Naproxen Sodium ER (BAYH6689)” NCT01389284 ↗ “Naproxen Sodium (Aleve, BAYH6689)” NCT01666678 ↗ “Naproxen sodium 440 mg (BAYH6689)” NCT01280591 ↗ “Naproxen Sodium 440 mg (BAYH6689)” NCT01118273 ↗ “Naproxen Sodium ER (BAYH6689)” NCT00751400 ↗ “Naproxen Sodium ER (BAYH6689)” NCT01427803 ↗ “Naproxen sodium ER (BAYH6689)” NCT00818415 ↗ |
| Known as | Bonyl | “Bonyl/ Naproxen 500 mg x 2 per day for 7 days” NCT06274151 ↗ |
| Known as | Condrotec | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Ec-naprosyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | EC-Narosyn | “Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)” NCT00959439 ↗ |
| Known as | Feminax ultra | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Grenoxal | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Kenosyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Laraflex | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Napratec op | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naprelan | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naprosyn | “patients with an abdominal aortic aneurysm undergoing endovascular epair and taking preoperatively naproxen (Naprosyn, tab 500 mg twice/day for 4 days)” NCT03727412 ↗9“already marketed formulation of prescription strength naproxen (Naprosyn® the reference product)” NCT02408978 ↗ “Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID)” NCT04990804 ↗ “Naprosyn” NCT02132416 ↗ “Naprosyn” NCT02094807 ↗ |
| Known as | Naprosyn 375 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naprosyn ec | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | NAPROXEN COMPONENT OF PN400 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naproxen component of vimovo | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naproxen Sodium | “Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets” NCT00596245 ↗48“Naproxen Sodium is a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief and inflammation reduction.” NCT06861920 ↗ “ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents” NCT01016678 ↗ “Aleve® naproxen sodium, a Reference product currently marketed in The Netherlands” NCT03167541 ↗ “Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.” NCT01329562 ↗ “Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)” NCT03396250 ↗ “novel combination naproxen sodium (NS) and diphenhydramine (DPH)” PMID 25996289 ↗ May 2015 “treated With Naproxen Sodium (440mg Twice Daily) Versus Placebo” NCT02519231 ↗ “Combination Product (sumatriptan succinate / naproxen sodium)” NCT00385008 ↗ “Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium” NCT01086358 ↗ “sumatriptan succinate / naproxen sodium tablet” NCT00875784 ↗ |
| Known as | Naproxen sodium anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naproxen sodium component of aleve-d | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naproxen sodium component of treximet | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naproxen Sodium ER | “Naproxen Sodium ER (BAYH6689)” NCT01427803 ↗ |
| Known as | Naproxen sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naproxene | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Naproxeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | NAPSO | “This study evaluated the time to rescue medication following a single dose of naproxen sodium (NAPSO) vs ibuprofen (IBU) and placebo in subjects with moderate-to-severe...” PMID 31402718 ↗ Aug 2019 |
| Known as | NPR | “the patients will be randomly selected to receive either Naproxen (NPR ) 500 mg x 2 or placebo” NCT03727412 ↗ |
| Known as | NPX | “Acetaminophen (APAP)/Naproxen sodium (NPX)” NCT04447040 ↗ |
| Known as | NSC-750183 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | NSC-757239 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Nycopren | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | OXP005 | “a new naproxen tablet formulation (the study drug, OXP005)” NCT02408978 ↗ |
| Known as | Pranoxen continus | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Prosaid | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Proxen S | “Naproxen (Proxen S)” NCT06903585 ↗ |
| Known as | RB naproxen sodium | “support the registration of the Reckitt Benckiser (RB) naproxen sodium (220 mg tablets)” NCT03167541 ↗ |
| Known as | Rheuflex 250 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Rheuflex 500 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Rimoxyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | RS-3540 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | RS-3650 | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Stirlescent | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Synflex | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Timpron | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Timpron 250 ec | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Known as | Timpron 500 ec | ChEMBL registry synonym — accepted as the source's own label CHEMBL154 ↗ |
| Action | Inhibit | “Inhibitory Effect of CG100649, Celecoxib, Naproxen, and Acetazolamide on the Activity of Cyclooxygenases (COX-1, COX-2) and Carbonic Anhydrases (CA-I, CA-II)” NCT00780325 ↗ |
| Modality | Small molecule | “the conventional NSAID naproxen sodium” PMID 17111043 ↗ Nov 2006 |
| Route | Oral | “naproxen oral suspension” NCT00034853 ↗ |
| Target | TAS1R3 | “The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose...” NCT06291337 ↗ |