Advil

(Ibuprofen)

ApprovedSmall molecule

Ibuprofen is used to reduce pain, fever, and inflammation caused by conditions like headaches, muscle aches, arthritis, and menstrual cramps. It works by blocking substances in the body that cause pain and swelling.[2] Advil is currently approved and in use across 143 indications[4].[1]

Advil is one of 2125 small molecule programs targeting Vaginal Inflammation. It is currently in Approved.

143

Indications

483

Total Trials

Active Trials

2,124

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Vaginal InflammationActive, not recruiting

Acute PancreatitisApproved

CachexiaActive, not recruiting

EnuresisApproved

Premature BirthApproved

ContraceptionApproved

HIV InfectionApproved

EmphysemaApproved

Cardiovascular DiseaseActive, not recruiting

Respiratory Tract InfectionActive, not recruiting

Vaginal InflammationApproved

Active, not recruiting

Acute PancreatitisApproved

Approved

CachexiaPhase 3

Active, not recruiting

EnuresisApproved

Approved

Premature BirthApproved

Approved

ContraceptionApproved

Approved

HIV InfectionApproved

Approved

EmphysemaApproved

Approved

Cardiovascular DiseaseApproved

Active, not recruiting

Respiratory Tract InfectionApproved

Active, not recruiting

Showing 10 of 138 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Advil

KKenvue Brands

Approved

483 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

Gemzar

GGynecologic Oncology Group

Preclinical

22 4

Lexiscan

Astellas

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Chantix

PPrism Pharmaceuticals

Preclinical

1 7

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

3 8

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

3 9

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 10

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Stem Cells

NCT03055247

Post-ApprovalActive, not recruiting

Shoulder Arthroplasty

NCT05488847

Q4 2026

Post-ApprovalRecruiting

Laparoscopic

NCT06434233

Q4 2027

Phase 3Recruiting

Acute Myocarditis

NCT06686862

Post-ApprovalRecruiting

Effectiveness

NCT06671002

Post-ApprovalRecruiting

Post Operative Pain

NCT03759028

Clinical

Trials by Indication[1]

Ibuprofen16 trials

Safety of Ibuprofen After Major Orthopaedic Surgeries

Completed·NNaestved Hospital·Phase 4·NCT05575700·2,904 enrolled

Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01170637·47 enrolled

Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02963701·56 enrolled

Show 13 more trials

Study of Ibuprofen Effects on Brain Function

Completed·LLaureate Institute for Brain Research, Inc.·Phase 2/3·NCT02507219·24 enrolled

Effect of Ibuprofen, Paracetamol and Their Combination on Radical Oxygen Species (ROS) Production

Completed·UUllevaal University Hospital·Phase 4·NCT00921505·7 enrolled

Myogenic and Osteogenic Responses to eXercise and Ibuprofen

Completed·UUniversity of Colorado, Denver·N/A·NCT00462722·159 enrolled

Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

Unknown status·—·Phase 4·NCT01681667·100 enrolled

Pharmacokinetics of 3 Formulations of Ibuprofen Suppositories

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 1·NCT00921830·25 enrolled

Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02183012·36 enrolled

Use of Ibuprofen to Prevent IUD Site Effects

Completed·FFHI 360·Phase 3·NCT00243815·2,019 enrolled

Treating Postictal Symptoms Using Ibuprofen and Nifedipine

Recruiting·UUniversity of Calgary·Phase 2·NCT03949478·90 enrolled

Oral Morphine Versus Ibuprofen

Completed·NNaveen Poonai·N/A·NCT01690780·183 enrolled

The Effect of Ibuprofen on Women With PCOS.

Unknown status·PPoznan University of Medical Sciences·Phase 2·NCT04485403·20 enrolled

Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen

Terminated·—·Phase 4·NCT02076893·64 enrolled

Paracetamol Versus Ibuprofen for PDA Closure

Unknown status·—·Phase 4·NCT03265782·30 enrolled

Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen

Completed·OOxford Pharmascience Ltd·Phase 1·NCT02974361·30 enrolled

Patent ductus arteriosus12 trials

Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus

Completed·MMáximo Vento Torres·Phase 3·NCT04037514·133 enrolled

IV Acetaminophen and Patent Ductus Arteriosus

Completed·—·N/A·NCT03008876·10 enrolled

High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in Preterm Infant

Completed·UUniversity of Florence·Phase 2/3·NCT01243996·70 enrolled

Show 9 more trials

Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT03022253·44 enrolled

Paracetamol in Patent Ductus Arteriosus

Completed·AAziende Chimiche Riunite Angelini Francesco S.p.A·Phase 2·NCT02422966·110 enrolled

Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

Completed·UUniversity of Ulm··NCT01428180·35 enrolled

Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

Terminated·UUniversity of Oulu·Phase 1·NCT03648437·22 enrolled

Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)

Withdrawn·SShaare Zedek Medical Center·Phase 2·NCT01070745

Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies

Withdrawn·KKK Women's and Children's Hospital·Phase 4·NCT00470743

Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus

Completed·UUniversity of Florida·Phase 1·NCT03103022·20 enrolled

Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT

Recruiting·IIWK Health Centre·Phase 3·NCT05011149·100 enrolled

Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)

Completed·NNantes University Hospital·Phase 3·NCT01630278·363 enrolled

Acetaminophen7 trials

Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

Completed·UUniversity of Missouri, Kansas City·Phase 4·NCT00484744·35 enrolled

Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery

Completed·IIndonesia University·N/A·NCT03771755·62 enrolled

Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement

Completed·RRio de Janeiro State University·Phase 4·NCT03568721·81 enrolled

Show 4 more trials

An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 4·NCT00240864·224 enrolled

Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

Completed·PPenn State University·Phase 4·NCT00267293·60 enrolled

Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

Completed·HHillel Yaffe Medical Center·Phase 3·NCT01755728·19 enrolled

Ibuprofen Plus Acetaminophen for Enhanced Pain Reduction

Unknown status·NNew York City Health and Hospitals Corporation·Phase 4·NCT04630834·100 enrolled

Post Operative Pain7 trials

Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery

Completed·LLotus Clinical Research, LLC·Phase 4·NCT02096926·40 enrolled

Effect of Over-the-counter Analgesics on Postoperative Pain

Completed·ZZitelli & Brodland Skin Cancer Center·Phase 3·NCT06948513·200 enrolled

Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery

Unknown status·TThe Catholic University of Korea·N/A·NCT05509244·64 enrolled

Show 4 more trials

Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery

Completed·—·N/A·NCT05401916·2 enrolled

Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy

Terminated·MMike O'Callaghan Military Hospital·Phase 3·NCT02929589·18 enrolled

Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain

Completed·SSamsung Medical Center·N/A·NCT02461056·90 enrolled

Supracondylar Post-Operative Pain Study

Recruiting·UUniversity of California, Los Angeles·Phase 4·NCT03759028·90 enrolled

Osteoarthritis6 trials

Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis

Unknown status·—·Phase 1·NCT00833157·36 enrolled

Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00630929·388 enrolled

Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee

Completed·GGebro Pharma GmbH·Phase 4·NCT01066676·482 enrolled

Show 3 more trials

Osteoarthritis Topical Treatment

Completed·BBioChemics, Inc.·Phase 2·NCT01496326·75 enrolled

The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis

Completed·MMahidol University·Phase 3·NCT00792818·367 enrolled

Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00565084·33 enrolled

111 more indications

Headache6 trials

Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache

Unknown status·MMantecorp Industria Quimica e Farmaceutica Ltd.·Phase 3·NCT01172405·144 enrolled

Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Terminated· GSK logo

GSK·Phase 2/3·NCT01755702·66 enrolled

Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache

Withdrawn·NNorwegian University of Science and Technology·N/A·NCT00258791

Show 3 more trials

Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache

Terminated· GSK logo

GSK·Phase 3·NCT01842633·365 enrolled

Effects of Preemptive Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy

Completed·IInonu University·N/A·NCT03783312·60 enrolled

Intravenous Paracetamol, Dexketoprofen and Ibuprofen in the Treatment of Acute Migraine Attack Headache

Unknown status·PPamukkale University·Phase 4·NCT04372264·210 enrolled

Migraine4 trials

Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack

Completed·TThomas Jefferson University·Phase 4·NCT01230411·44 enrolled

Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack

Active, not recruiting·HHaydarpasa Numune Training and Research Hospital·Phase 4·NCT06786650·100 enrolled

Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.

Withdrawn· Sanofi logo

Sanofi·Phase 3·NCT01426971

Show 1 more trial

A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00758836·683 enrolled

Abortion4 trials

Methadone and Medication Abortion

Terminated·—·Phase 4·NCT04941443·4 enrolled

Hydrocodone For Pain Control in First Trimester Surgical Abortion

Completed·EElizabeth Micks·Phase 4·NCT01330459·121 enrolled

Pain Control In First Trimester Medical Abortion: A Randomized Trial

Completed·GGynuity Health Projects·Phase 4·NCT01457521·250 enrolled

Show 1 more trial

Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion

Completed·SSheba Medical Center·Phase 3·NCT00997074·61 enrolled

Dental Pain4 trials

Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes

Terminated·UUniversity of Rochester·Phase 4·NCT02932579·59 enrolled

A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

Completed· Novartis logo

Novartis·Phase 3·NCT02476422·328 enrolled

Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model

Unknown status·QQazvin University Of Medical Sciences·Phase 2·NCT01429935·60 enrolled

Show 1 more trial

Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

Completed· Pfizer logo

Pfizer·Phase 2·NCT00913627·196 enrolled

Treatment4 trials

Pre-emptive Analgesics in Orthodontic Treatment

Completed·UUniversity of Washington·Phase 4·NCT03523988·73 enrolled

Early Treatment Versus Expectant Management of PDA in Preterm Infants

Completed·LLviv National Medical University·N/A·NCT03860428·208 enrolled

Effect of Combination Non Steroidal Antiinflammatory Drugs and Narrowband UVB Treatment in Non-Photoadapters

Terminated·HHenry Ford Health System·N/A·NCT05256147·3 enrolled

Show 1 more trial

Drotaverine in Dysmenorrhoea Treatment

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00292747·480 enrolled

Low back pain3 trials

Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department

Unknown status·PPamukkale University·Phase 4·NCT02836509·200 enrolled

Acute Low Back Pain in the Emergency Department Treated With Osteopathic Manipulative Treatment Versus NSAIDs

Unknown status·AAlbert Einstein Healthcare Network·Phase 4·NCT04129437·174 enrolled

Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain

Completed·PPamukkale University·Phase 4·NCT04609254·210 enrolled

Pain Control3 trials

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Recruiting·MMayo Clinic·Phase 4·NCT05076110·188 enrolled

A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT02850211·180 enrolled

Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries

Withdrawn·WWashington University School of Medicine·N/A·NCT04523623

Analgesic3 trials

Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints

Completed· Pfizer logo

Pfizer·Phase 1·NCT02260947·20 enrolled

Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen

Unknown status·—·Phase 1·NCT04424420·150 enrolled

Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction

Completed·UUniversity of Pennsylvania·Phase 1·NCT03893175·86 enrolled

Efficacy and Safety3 trials

Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel

Unknown status·LLaboratório Teuto Brasileiro S/A·Phase 3·NCT01373697·144 enrolled

Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 3·NCT01562717·62 enrolled

Efficacy and Safety of Ibuprofen in Patients With Ankle Injuries

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 3·NCT01563289·62 enrolled

Inflammation2 trials

Study of Experimental Models of Pain and Inflammation.

Completed·MMartin Angst·Phase 1·NCT01097902·15 enrolled

Physiological Effects of Altering Cancer-related Inflammation

Unknown status·NNHS Greater Glasgow and Clyde·N/A·NCT01786200·60 enrolled

Pilot Study2 trials

Pilot Study of OXP001 and Brufen in Healthy Subjects

Completed·OOxford Pharmascience Ltd·Phase 1·NCT02050958·43 enrolled

Pilot Study of OXP001(2) and Brufen in Healthy Subjects

Completed·OOxford Pharmascience Ltd·Phase 1·NCT02521207·53 enrolled

Malaria2 trials

Treatment of Fever Due to Malaria With Ibuprofen

Completed·—·Phase 4·NCT00167713·50 enrolled

Aggressive Antipyretics for Fever Reduction in CNS Malaria

Completed·UUniversity of Rochester·Phase 2·NCT03399318·256 enrolled

Surgery2 trials

A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.

Completed·HHeron Therapeutics·Phase 4·NCT06109415·30 enrolled

A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.

Unknown status·HHeron Therapeutics·Phase 4·NCT05109312·90 enrolled

Sepsis2 trials

Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients

Completed·—·Phase 4·NCT06061575·113 enrolled

Ibuprofen in Sepsis Study

Completed·VVanderbilt University·Phase 3·NCT00000574

Third Molar2 trials

Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

Unknown status·UUniversita di Verona·Phase 4·NCT00855777·110 enrolled

An Analgesic Study to of V117957 for the Treatment of Postsurgical Pain Due to Third Molar Extraction

Terminated·PPurdue Pharma LP·Phase 2·NCT01900795·114 enrolled

Prevention2 trials

Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

Completed·SState University of New York - Downstate Medical Center·Phase 2·NCT02344225·14 enrolled

Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

Completed·SStanford University·Phase 3·NCT01171794·89 enrolled

Pain2 trials

Dexketoprofen Trometamol in Postoperative Endodontic Pain

Completed·DDaniel Chavarría Bolaños·Phase 4·NCT02086097·90 enrolled

Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis

Withdrawn·SSt. Louis University·Phase 2·NCT01932554

Radius Fracture2 trials

Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture

Terminated·UUniversity of Missouri-Columbia·Phase 4·NCT03749616·32 enrolled

Non Steroidal Antiinflammatory Drugs Influence on Heal of Distal Radius Fracture

Completed·MMarius Aliuskevicius·Phase 3·NCT01567072·192 enrolled

Concentration2 trials

Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

Unknown status·—··NCT01099462·30 enrolled

To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02629354·36 enrolled

Hysterectomy2 trials

Preemptive Analgesia in Laparoscopic Hysterectomy

Not yet recruiting·GGiresun University··NCT07401927·70 enrolled

TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy

Completed·UUniversity of Minnesota·Phase 4·NCT02519023·87 enrolled

Dysmenorrhea2 trials

A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen

Completed·AAnother Way Products·N/A·NCT00951561·115 enrolled

Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea

Unknown status·PPamukkale University·N/A·NCT03697746·300 enrolled

Prospective2 trials

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00346216·24,081 enrolled

The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study

Completed·UUniversity of Missouri-Columbia·Phase 4·NCT02076321·102 enrolled

Neck pain2 trials

Ibuprofen/Caffeine Lower Back or Neck Pain Study

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT03003000·635 enrolled

Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain

Completed·FFuture Sciene Technology·Phase 4·NCT02327338·90 enrolled

Women1 trial

Women's Mammography Study To Improve Comfort During Mammography

Terminated·—·N/A·NCT01716052·2 enrolled

Glaucoma1 trial

Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops

Completed·PPhiladelphia Eye Associates·N/A·NCT00402493·51 enrolled

COVID-191 trial

LIBERATE Trial in COVID-19

Withdrawn·KKing's College London·Phase 4·NCT04334629

Total Knee Arthroplasty1 trial

Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen

Completed·HHeron Therapeutics·Phase 3·NCT03974932·116 enrolled

Urinary Tract Infection1 trial

Immediate vs. Conditional Use of Antibiotics in Uncomplicated Urinary Tract Infection (UTI) - ICUTI

Completed·IInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH·Phase 4·NCT01488955·494 enrolled

Diverticulitis1 trial

Symptomatic Treatment of Acute Uncomplicated Diverticulitis

Completed·HHelsinki University Central Hospital·N/A·NCT02219698·158 enrolled

Platelet Reactivity1 trial

Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity

Completed·UUniversity of California, Davis·N/A·NCT02902913·9 enrolled

Statin1 trial

Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers

Completed·UUniversity Hospitals Cleveland Medical Center·N/A·NCT00531882·25 enrolled

Caesarean Section1 trial

HTX-011 Administration Study in Planned Caesarean Section Procedure

Completed·HHeron Therapeutics·Phase 2·NCT03955211·25 enrolled

Back pain1 trial

A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain

Completed·TTargeted Medical Pharma·Phase 4·NCT01490905·127 enrolled

Cesarean Delivery1 trial

Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery

Completed·MMedstar Health Research Institute·N/A·NCT03959969·48 enrolled

Hemophilia1 trial

The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia

Completed·UUniversity of Pittsburgh·N/A·NCT00002276

Pneumonia1 trial

NSAIDs Treatment in Children With Pleuropneumonia

Unknown status·RRabin Medical Center·N/A·NCT01586299·40 enrolled

Pediatric Patients1 trial

Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Completed·CCumberland Pharmaceuticals·Phase 3·NCT01002573·118 enrolled

Effectiveness1 trial

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Recruiting·UUniversity of Michigan·Phase 4·NCT06671002·900 enrolled

Acute Dental Pain1 trial

Maxigesic 325 Acute Dental Pain Study

Completed·AAFT Pharmaceuticals, Ltd.·Phase 3·NCT01420653·408 enrolled

Vasculitis1 trial

The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children

Unknown status·—·Phase 3·NCT03692416·70 enrolled

Infusion1 trial

Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA

Completed· Sanofi logo

Sanofi·Phase 4·NCT02205489·58 enrolled

Outcome1 trial

Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever

Completed·UUniversity of Washington·N/A·NCT00890604·10 enrolled

Prophylaxis1 trial

Multi-dose Ibuprofen Prophylaxis for IUD-insertion

Unknown status·—·N/A·NCT03868137·86 enrolled

Bronchoscopy1 trial

Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

Completed·SShaare Zedek Medical Center·Phase 2·NCT00954200·64 enrolled

Hyperalgesia1 trial

Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Completed·SSeoul National University Hospital·N/A·NCT02243254·120 enrolled

Functional Outcomes1 trial

Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes

Completed·UUniversity of California, San Francisco·N/A·NCT02588027·110 enrolled

Brain Injury1 trial

Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury

Withdrawn·NNorthwestern University·Phase 2·NCT02443142

Premature Infants1 trial

Ibuprofen and Renal Function in Premature Infants

Completed·—·Phase 4·NCT00217191·120 enrolled

Medication1 trial

Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

Completed· Pfizer logo

Pfizer·Phase 4·NCT01392378·908 enrolled

Celiac Disease1 trial

Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease

Unknown status·—·Phase 4·NCT06149507·12 enrolled

Atopic Asthma1 trial

Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma

Completed·UUniversity of Saskatchewan·N/A·NCT02327234·13 enrolled

Inflammatory Response1 trial

Effect IV Ibuprofen and Inflammatory Responses

Completed·UUniversity of Medicine and Dentistry of New Jersey·Phase 4·NCT01938040·60 enrolled

Rib Fracture1 trial

Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients

Completed·MMedical College of Wisconsin·Phase 4·NCT02432456·153 enrolled

Opioid1 trial

Herniorrhaphy Study for Opioid Elimination

Completed·HHeron Therapeutics·Phase 3·NCT03907176·115 enrolled

Total Hip Arthroplasty1 trial

Effect of Combinations of Paracetamol, Ibuprofen, and Dexamethasone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty

Completed·NNaestved Hospital·Phase 4·NCT04123873·1,060 enrolled

Postoperative Pain Management1 trial

Ibuprofen Compared to Morphine as a Pediatric Postoperative Pain Management Tool Following Inguinal Surgery

Unknown status·MMcMaster University·N/A·NCT02603848·100 enrolled

Analgesia1 trial

Percutaneous Pin Removal in Children - is Analgesia Necessary?

Completed·KKK Women's and Children's Hospital·N/A·NCT01944085·240 enrolled

Torticollis1 trial

Ultrasound Guided Intermediate Cervical Plexus Block for Congenital Muscular Torticollis

Completed·—·Phase 4·NCT02651311·32 enrolled

Uterine Bleeding1 trial

The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding

Completed·—·Phase 2·NCT02580344·128 enrolled

Cesarean Section1 trial

Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03372382·170 enrolled

Ketorolac1 trial

Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

Completed·—·Phase 1·NCT02973958·30 enrolled

Humerus Fracture1 trial

Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Terminated·—·Phase 4·NCT05640674·29 enrolled

Pancreatitis1 trial

IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT02241512·69 enrolled

Oral ulcer1 trial

Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial

Completed·UUniversity of Texas at Austin·Phase 2·NCT03241030·102 enrolled

Pregnancy1 trial

The Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy

Completed·UUniversity of Michigan·Phase 4·NCT02891174·74 enrolled

Stem Cells1 trial

Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD

Recruiting·IIRCCS San Raffaele·Phase 2·NCT03055247·3 enrolled

Acute Mountain Sickness1 trial

Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness

Completed·MMassachusetts General Hospital·N/A·NCT01522326·300 enrolled

Vaccination1 trial

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

Completed· GSK logo

GSK·Phase 4·NCT01235949·850 enrolled

Randomized1 trial

Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal

Completed·UUniversity of Colorado, Denver·N/A·NCT02140970·51 enrolled

Ankle Fracture1 trial

NSAIDS Versus Opioids in Acute SER II Ankle Fractures

Completed·UUniversity of California, Davis·Phase 1·NCT02373254·1 enrolled

Acute Myocarditis1 trial

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

Recruiting·FFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III·Phase 3·NCT06686862·150 enrolled

Trial1 trial

Management Of Pain After Cesarean Trial

Terminated·MMilton S. Hershey Medical Center·Phase 3·NCT03929640·49 enrolled

Immunotherapy1 trial

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03493945·59 enrolled

Analgesic Efficacy1 trial

To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients

Completed· Novartis logo

Novartis·Phase 2·NCT00986882·183 enrolled

Resistance1 trial

The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults

Completed·KKarolinska Institutet·Phase 2·NCT02531451·34 enrolled

Cystic Fibrosis1 trial

Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis

Completed·FFDA Office of Orphan Products Development·N/A·NCT00004440·75 enrolled

Post-cesarean Pain1 trial

Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management

Completed·SStanford University·N/A·NCT02605187·160 enrolled

Pain After Surgery1 trial

Study to Assess the Kinetic of the Analgesic Effect and Tolerability of Eschscholtzia Californica Versus Ibuprofen and Placebo in the Treatment of Pain After Surgery of the Third Molar

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02187588·200 enrolled

Tension-type headache1 trial

Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache

Completed· Bayer logo

Bayer·Phase 4·NCT01464983·1,115 enrolled

Severe Pain1 trial

Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain

Completed· Menarini logo

Menarini·Phase 2·NCT01307020·745 enrolled

Inflammatory Mediators1 trial

Assessment of Inflammatory Mediators (AIM)

Completed·RRamsey, Bonnie, MD·N/A·NCT00219895·120 enrolled

Shoulder Arthroplasty1 trial

Opioid-Free Pain Protocol After Shoulder Arthroplasty

Active, not recruiting·HHenry Ford Health System·Phase 4·NCT05488847·83 enrolled

Seasonal Allergic Rhinitis1 trial

A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.

Completed· Pfizer logo

Pfizer·Phase 1·NCT01064726·18 enrolled

Cachexia1 trial

Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

Completed·NNorwegian University of Science and Technology·Phase 3·NCT02330926·221 enrolled

Concussion1 trial

Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children

Completed·MMcMaster Children's Hospital·N/A·NCT02268058·80 enrolled

Antiplatelet1 trial

Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

Completed·—·Phase 4·NCT00565500·24 enrolled

Low Birth Weight1 trial

Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants

Unknown status·ZZekai Tahir Burak Women's Health Research and Education Hospital·N/A·NCT01400737·200 enrolled

Insulin Secretion1 trial

DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen

Completed·JJohnny Ludvigsson·Phase 2·NCT01785108·60 enrolled

Tics1 trial

To Compare the Pharmacokinetics Profiles of ISO 20, IBU 200 and IBU Plus ISO Combinations 200 + 20

Completed·PParent Project, Italy·Phase 1·NCT01478022·12 enrolled

Probiotic Intervention1 trial

Probiotic Intervention After Surgical Removal of Mandibular Third Molars

Completed·AAB Biotics, SA·N/A·NCT04203771·38 enrolled

Sickle Cell Disease1 trial

Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine

Terminated·LLondon North West Healthcare NHS Trust·Phase 4·NCT00880373·320 enrolled

Delayed Onset Muscle Soreness1 trial

COMBOPROFEN for Treatment of Muscular Pain Associated With Delayed Onset Muscle Soreness (DOMS)

Completed·SSpherium Biomed·Phase 2·NCT03223519·74 enrolled

Laparoscopic1 trial

Opioid Use After Laparoscopic Salpingectomy

Recruiting·JJohns Hopkins University·Phase 4·NCT06434233·120 enrolled

Mucositis1 trial

Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy

Completed·VVanderbilt-Ingram Cancer Center·Phase 3·NCT02480114·79 enrolled

Temporomandibular Joint Disorder1 trial

Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).

Completed·SSpherium Biomed·Phase 1/2·NCT02602483·96 enrolled

Acute Infection1 trial

Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

Terminated· Pfizer logo

Pfizer·Phase 3·NCT01035346·16 enrolled

Clinical Trial1 trial

Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

Completed·SStony Brook University·Phase 2·NCT00790270·61 enrolled

Opioid Dependence1 trial

Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery

Terminated·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 2·NCT02276911·6 enrolled

Temporomandibular Disorder1 trial

Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder

Completed·—·Phase 2/3·NCT06231212·23 enrolled

Molar-Incisor Hypomineralization1 trial

Effectiveness of Pre-emptive Analgesia in Children With Molar-incisor Hypomineralization (MIH)

Unknown status·UUniversity of Sao Paulo·Phase 1·NCT03953729·50 enrolled

Tuberculosis1 trial

Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis

Completed·FFundació Institut Germans Trias i Pujol·Phase 2·NCT02781909·24 enrolled

Altitude Sickness1 trial

Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

Completed·GGrant S Lipman·Phase 1·NCT03154645·92 enrolled

Tibia Fracture1 trial

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures

Unknown status·MMajor Extremity Trauma Research Consortium·Phase 3·NCT05000281·1,000 enrolled

Olfactory Neuroblastoma1 trial

Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT05012098·11 enrolled

Tooth Sensitivity1 trial

Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching

Completed·UUniversidade Estadual de Ponta Grossa·N/A·NCT01530217·30 enrolled

Non-steroidal Anti-inflammatory Drugs1 trial

Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Completed·UUniversity of Split·Phase 4·NCT00631514·88 enrolled

Erythema1 trial

Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation

Completed·—·N/A·NCT02807623·300 enrolled

Double-blind1 trial

Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)

Completed· Amgen logo

Amgen·Phase 3·NCT00613106·179 enrolled

Arthritis1 trial

Treatment of Axial Spondyloarthritis With Reduced Doses of NSAIDs

Completed·UUniversity Hospital of North Norway·N/A·NCT02089529·8 enrolled

Pain Perception1 trial

The Effect of Combined Oral and Topical Analgesics to Reduce Pain Perception During Electrodiagnostic Testing

Completed·—·N/A·NCT04337814·113 enrolled

Unspecified3 trials

Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Completed·LLoma Linda University·Phase 3·NCT03404518·185 enrolled

Patient Experience Study of Deoxycholic Acid Injection

Completed·KKythera Biopharmaceuticals·Phase 3·NCT02007434·84 enrolled

Gamma Scintigraphy Study to Investigate Tablet Disintegration in Healthy Volunteers.

Terminated·RReckitt Benckiser Healthcare (UK) Limited·Phase 1·NCT03497715·6 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

IBU

NDA NDA018197

Jan 1, 1982

MOTRIN

NDA NDA017463

May 18, 1984

ADVIL

NDA NDA018989

Sep 19, 1989

MOTRIN

NDA NDA019842

Sep 19, 1989

CHILDREN'S ADVIL

NDA NDA019833

Dec 18, 1989

IBU

NDA NDA019784

Dec 17, 1990

MOTRIN IB

NDA NDA019012

Nov 16, 1994

MOTRIN

NDA NDA020135

Nov 16, 1994

MOTRIN

NDA NDA020418

Apr 20, 1995

ADVIL LIQUI-GELS

NDA NDA020402

May 25, 1995

MOTRIN

NDA NDA020476

Jun 16, 1995

CHILDREN'S MOTRIN

NDA NDA020516

Jun 10, 1996

CHILDREN'S MOTRIN

NDA NDA020603

Jun 10, 1996

JUNIOR STRENGTH MOTRIN

NDA NDA020602

Jun 27, 1996

CHILDREN'S ADVIL

NDA NDA020589

Nov 15, 1996

CHILDREN'S MOTRIN

NDA NDA020601

Dec 13, 1996

JUNIOR STRENGTH ADVIL

NDA NDA020267

Dec 18, 1998

CHILDREN'S ADVIL

NDA NDA020944

Jan 12, 2000

INFANT'S ADVIL

NDA NDA020812

Oct 18, 2002

MIDOL LIQUID GELS

NDA NDA021472

Jan 7, 2004

CHILDREN'S ELIXSURE

NDA NDA021604

Jun 11, 2009

CALDOLOR

NDA NDA022348

Jun 12, 2012

ADVIL

NDA NDA201803

Sources

References

[1]
ClinicalTrials.gov — 483 trial records for Ibuprofen. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Advil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ibuprofen compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ibuprofen. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA201803). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Advil. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Kenvue Brands company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKenvue Brands

Patent Landscape[6]

Patent Cliff

Sep 30, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9138404Sep 30, 2029

8735452Sep 30, 2029

9649284Sep 30, 2029

8871810Sep 30, 2029

9295639Sep 30, 2029

5 more patents

9114068Sep 30, 2029

9012508Sep 14, 2030

9072710Mar 16, 2032

9072661Mar 16, 2032

11806400Mar 16, 2032