Naproxen sodium

ApprovedSmall molecule

Naproxen sodium is a small molecule that works as a Cyclooxygenase Inhibitor.[2] It is being used across 22 indications, with its most advanced program in Approved.[1]

Naproxen sodium is one of 432 small molecule programs targeting Contraception. It is currently in Approved.

Indications

Total Trials

Active Trials

431

Competitors

Pipeline

Status by Indication[3][1]

Indication

ContraceptionActive, not recruiting

AbscessActive, not recruiting

Migraine DisorderUnknown

Gastric UlcerActive, not recruiting

DysmenorrheaUnknown

Alzheimer DiseaseActive, not recruiting

BursitisUnknown

Frozen ShoulderUnknown

Juvenile Idiopathic ArthritisUnknown

Back PainUnknown

ContraceptionPreclinical

Active, not recruiting

AbscessApproved

Active, not recruiting

Migraine DisorderPreclinical

Unknown

Gastric UlcerPhase 1

Active, not recruiting

DysmenorrheaPreclinical

Unknown

Alzheimer DiseasePhase 3

Active, not recruiting

BursitisPreclinical

Unknown

Frozen ShoulderPreclinical

Unknown

Juvenile Idiopathic ArthritisPreclinical

Unknown

Back PainPreclinical

Unknown

Showing 10 of 20 indications

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Naproxen sodium

Bayer

Approved

39 2

Rituxan

Roche

Preclinical

61 3

Orencia

Bristol-Myers Squibb

Preclinical

47 4

Actemra

Cimzia

30 6

Simponi

Johnson & Johnson

Preclinical

19 7

Enbrel

IImmunex

Preclinical

64 8

Remicade

OOrganon and Co

Preclinical

43 9

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Ilaris

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2030

Post-ApprovalRecruiting

Dysmenorrhea

NCT06861920

Clinical

Trials by Indication[1]

Headache3 trials

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period

Completed· GSK logo

GSK·Phase 4·NCT00792636·407 enrolled

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches

Completed·PPOZEN·Phase 3·NCT00433732·1,400 enrolled

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

Completed·PPOZEN·Phase 3·NCT00434083·1,200 enrolled

Acetaminophen3 trials

Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

Completed·JJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·Phase 2·NCT03879408·290 enrolled

Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed

Completed· Bayer logo

Bayer·Phase 4·NCT04307940·221 enrolled

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

Completed·JJohnson & Johnson Consumer Inc. (J&JCI)·Phase 3·NCT05761574·447 enrolled

Pain Control2 trials

Naproxen for Pain Control With Intrauterine Device Insertion

Completed·PPlanned Parenthood League of Massachusetts·N/A·NCT02388191·119 enrolled

Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones

Completed·SShifa International Hospital·N/A·NCT02786446·135 enrolled

Efficacy and Safety2 trials

Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction

Completed·IIronwood Pharmaceuticals, Inc.·Phase 2·NCT01107236·90 enrolled

A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

Completed· Bayer logo

Bayer·Phase 4·NCT03404206·387 enrolled

Fed2 trials

Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions

Completed·—·Phase 1·NCT01052792·26 enrolled

Fast & Fed Pharmacokinetic (PK) Study

Completed· Bayer logo

Bayer·Phase 1·NCT00692016·32 enrolled

23 more indications

Migraine2 trials

Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

Completed·—·Phase 4·NCT01300546·40 enrolled

Treximet in the Treatment of Chronic Migraine

Completed·—·Phase 4·NCT01090050·56 enrolled

Dental Pain2 trials

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

Completed· Bayer logo

Bayer·Phase 3·NCT01280591·712 enrolled

Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

Completed· Bayer logo

Bayer·Phase 3·NCT01495858·267 enrolled

Dysmenorrhea2 trials

A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea

Completed· Bayer logo

Bayer·Phase 4·NCT03448536·201 enrolled

NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)

Recruiting·EEndeavor Health·Phase 4·NCT06861920·600 enrolled

Pain1 trial

Mechanistic Characterization of Uterine Pain

Completed·EEndeavor Health·Phase 4·NCT04145518·183 enrolled

Gastrointestinal1 trial

To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Completed·UUnknown Sponsor·Phase 1/2·NCT03291418·258 enrolled

Surgery1 trial

Naproxen Codeine in Arthroscopic Surgery

Completed·—·Phase 4·NCT01952652·61 enrolled

Trial1 trial

Single/Multiple Dose Bioavailability Trial

Completed· Bayer logo

Bayer·Phase 1·NCT00751556·32 enrolled

Alzheimer's Disease1 trial

Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)

Completed·SSeattle Institute for Biomedical and Clinical Research·Phase 3·NCT00007189·2,625 enrolled

Analgesic1 trial

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

Completed· Bayer logo

Bayer·Phase 4·NCT01118273·162 enrolled

Endodontic Treatment1 trial

Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain

Recruiting·—·Phase 4·NCT06562816·100 enrolled

MPA1 trial

Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination

Completed· Bayer logo

Bayer·Phase 1·NCT01666678·32 enrolled

Abscess1 trial

Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening

Recruiting·—·Phase 4·NCT06344195·82 enrolled

Adult1 trial

A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers

Completed·MMcNeil AB·Phase 1·NCT03697889·28 enrolled

Tics1 trial

Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan

Completed· Bayer logo

Bayer·Phase 1·NCT00969449·28 enrolled

Aspirin1 trial

NSAIDs vs. Coxibs in the Presence of Aspirin

Recruiting·IInova Health Care Services·Phase 4·NCT03699293·30 enrolled

Severe Pain1 trial

Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed

Completed· Bayer logo

Bayer·Phase 2·NCT04132336·193 enrolled

Osteoarthritis1 trial

A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale

Completed· Bayer logo

Bayer·Phase 2·NCT03570554·41 enrolled

Single Dose1 trial

A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo

Completed· Bayer logo

Bayer·Phase 3·NCT05485805·541 enrolled

Pharyngitis1 trial

Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02183038·390 enrolled

Treatment1 trial

Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS

Terminated·MMassachusetts General Hospital·Phase 4·NCT04015596·5 enrolled

Bunion1 trial

Bunionectomy Study (0000-063)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00601458·100 enrolled

Symptomatic Irreversible Pulpitis1 trial

Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis

Completed·DDow University of Health Sciences·Preclinical·NCT05982392·139 enrolled

Unspecified2 trials

Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition

Completed·—·Phase 1·NCT01052129·26 enrolled

Naproxen Sodium/ASA Platelet Study

Completed· Bayer logo

Bayer·Phase 1·NCT02229461·117 enrolled

Sources

References

[1]
ClinicalTrials.gov — 39 trial records for Naproxen sodium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naproxen sodium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Naproxen sodium. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Bayer

Naproxen sodium

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2030

Trials by Indication[1]

Headache3 trials

Acetaminophen3 trials

Pain Control2 trials

Efficacy and Safety2 trials

Fed2 trials

Migraine2 trials

Dental Pain2 trials

Dysmenorrhea2 trials

Pain1 trial

Gastrointestinal1 trial

Surgery1 trial

Trial1 trial

Alzheimer's Disease1 trial

Analgesic1 trial

Endodontic Treatment1 trial

MPA1 trial

Abscess1 trial

Adult1 trial

Tics1 trial

Aspirin1 trial

Severe Pain1 trial

Osteoarthritis1 trial

Single Dose1 trial

Pharyngitis1 trial

Treatment1 trial

Bunion1 trial

Symptomatic Irreversible Pulpitis1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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