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Drug

Ibuprofen

Approved · FDA / EMA
Emerging researchLate-stage developmentSteady momentum
Also known as (±)-2-(p-isobutylphenyl)propionic acid, (±)-p-isobutylhydratropic acid, 2-(4-isobutylphenyl)propanoic acid, 4-isobutylhydratropic acid+50 more

(±)-2-(p-isobutylphenyl)propionic acid, (±)-p-isobutylhydratropic acid, 2-(4-isobutylphenyl)propanoic acid, 4-isobutylhydratropic acid, Addaprin, Advil, Caldolor, Combogesic, Combunox, Counteract IB, Dolgesic, Duexis, Haltran, IBU, Ibifon 600, Ibren, Ibu-Tab, Ibudone, Ibuprofen Lysine, Ibuprofen PMR, Ibuprofen-Pseudoephedrine, Ibuprohm, Menadol, Motrin, Motrin PM, Nuprin, Proprinal, Reprexain, Rufen, Saleto-200, Saleto-400, Saleto-600, Saleto-800, Samson 8, Sup Pain Med, Uni-Pro, p-Isobutylhydratropic acid, (RS)-ibuprofen, Acetaminophen-Ibuprofen, Cap-Profen, Famotidine-Ibuprofen, Genpril, Hydrocodone-Ibuprofen, Motrin IB, NeoProfen, Q-Profen, Tab-Profen, Vicoprofen, Wal-Profen, (±)-ibuprofen, Ibuprofene, Ibuprofeno, Ibuprophen, Ibuprofenum.

RxNorm5640ChEMBLCHEMBL521UNIIWK2XYI10QM
4
Research papers
9
Active clinical trials
90
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: IBUPROFEN (NDA020516)

Regulatory2026-07-22FDA

Label change: IBUPROFEN AND FAMOTIDINE (ANDA211890)

Regulatory2026-07-16FDA

Efficacy of Non-opioid Drugs in Addition to Opioid Therapy for Cancer Pain Management: a Double-blind, Randomized, Three Arm, Placebo Controlled Trial Assessing the Key Non-opioids Dipyrone (Metamizole) and Ibuprofen

Clinical trial2026-07-07Results expected Q4 2029 · ClinicalTrials.gov

Label change: IBUPROFEN (NDA020589)

Regulatory2026-06-26FDA

Supplemental approval: HYDROCODONE BITARTRATE AND IBUPROFEN (ANDA076642)

Regulatory2026-06-18FDA

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain of Initial Orthodontic Wire Insertion: a Randomized Controlled Trial

Clinical trial2026-05-14Results expected Q2 2028 · ClinicalTrials.gov

Regional Anesthesia in Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block

Clinical trial2026-05-12Results expected Q3 2026 · ClinicalTrials.gov

Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours After Injury in Orthopedic Trauma Patients.

Research2020-07-01Journal of orthopaedic trauma

Ibuprofen versus placebo effect on acute kidney injury in ultramarathons: a randomised controlled trial.

Research2017-07-05Emergency medicine journal : EMJ

Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

Research2017-03-03Journal of neurosurgery

Ibuprofen prevents altitude illness: a randomized controlled trial for prevention of altitude illness with nonsteroidal anti-inflammatories.

Research2012-03-21Lipman GS · Annals of emergency medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ibuprofen
Aliases & brands
(±)-2-(p-isobutylphenyl)propionic acid(±)-p-isobutylhydratropic acid2-(4-isobutylphenyl)propanoic acid4-isobutylhydratropic acidAddaprinAdvilCaldolorCombogesicCombunoxCounteract IBDolgesicDuexisHaltranIBUIbifon 600IbrenIbu-TabIbudoneIbuprofen LysineIbuprofen PMRIbuprofen-PseudoephedrineIbuprohmMenadolMotrinMotrin PMNuprinProprinalReprexainRufenSaleto-200Saleto-400Saleto-600Saleto-800Samson 8Sup Pain MedUni-Prop-Isobutylhydratropic acid(RS)-ibuprofenAcetaminophen-IbuprofenCap-ProfenFamotidine-IbuprofenGenprilHydrocodone-IbuprofenMotrin IBNeoProfenQ-ProfenTab-ProfenVicoprofenWal-Profen(±)-ibuprofenIbuprofeneIbuprofenoIbuprophenIbuprofenum
RxNorm CUI
5640
ChEMBL ID
CHEMBL521
UNII
WK2XYI10QM
Regulatory jurisdictions
fdaema

Regulatory timeline

90 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2004-03-18 → 2005-02-07)
Approval / market entry confirmed across FDA and EMA (2024-02-16 → 2024-10-31)
Earliest approval
1995-06-16
Latest approval
2026-06-18
Authorities
FDA · EMA
Total events
90
fdaU.S. Food and Drug Administration· 88 events
2026-07-22Label change
Label change: IBUPROFEN (NDA020516)
Evidence ↗
2026-07-16Label change
Label change: IBUPROFEN AND FAMOTIDINE (ANDA211890)
Evidence ↗
2026-06-26Label change
Label change: IBUPROFEN (NDA020589)
Evidence ↗
emaEuropean Medicines Agency· 2 events
2024-02-16ApprovalMulti-authority
Approval: Ibuprofen Gen.Orph (EMA)

Indication: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age

Evidence ↗
2004-07-28ApprovalMulti-authority
Approval: Pedea (EMA)

Indication: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

180 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
180
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
7
Recruiting
133
Late-stage (III+)
125
Completed
46
Discontinued
PHASE DISTRIBUTIONn = 180
Early Phase 13Phase 115Phase 1 / 21Phase 228Phase 2 / 35Phase 335Phase 460Phase N / A33

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

RecruitingPH IVMontefiore Medical Centern=1322027

Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy

Active, not recruitingPH IVSt Joseph University, Beirut, Lebanonn=672026

Comparison of the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy: a Randomized, Phase iv, Double-blind Trial

Not yet recruitingPH IVASST Fatebenefratelli Saccon=1902026

Comparative Evaluation of the Efficacy of Diclofenac Sodium and Ibuprofen in the Management of Post-Endodontic Pain Following Single-Visit Root Canal Treatment: A Randomized Controlled Trial

CompletedPH IVArmed Forces Institute of Dentistry, Pakistann=602026

Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute and Subacute Low Back Pain: A Randomized, Factorial Trial

Unknown statusPH IVInsel Gruppe AG, University Hospital Bernn=1202025

Recent completions

Trials that read out recently, adding to the completed evidence base.

Elevation of Effect of Common Analgesic on Pulp Sensibility Test .:A Cilinical Trial

CompletedN/APakistan Institute of Medical Sciencesn=1842026

Comparative Evaluation of the Efficacy of Diclofenac Sodium and Ibuprofen in the Management of Post-Endodontic Pain Following Single-Visit Root Canal Treatment: A Randomized Controlled Trial

CompletedPH IVArmed Forces Institute of Dentistry, Pakistann=602026

A Randomized, Open-label, Single-Center, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) to Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions

CompletedPH IHALEONn=502026

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

CompletedPH IVMayo Clinicn=862025

Efficacy of Connective Tissue Graft Wall Technique and Enamel Matrix Derivative in the Regenerative Treatment of Intrabony Periodontal Defects: A Prospective Clinical Study

CompletedN/APhạm Đình Thiên Khảin=172025

Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial

CompletedPH IIStanford Universityn=1592025

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20122020
Major research themes3
Analgesics, Non-Narcotic1Ibuprofen1Placebo Effect1
Journals, researchers & institutions
Top journals
  • Annals of emergency medicine1
  • Emergency medicine journal : EMJ1
  • Journal of neurosurgery1
  • Journal of orthopaedic trauma1
Leading researchers
  • Lipman GS2
  • Burns P1
  • Christensen M1
  • Constance BB1
  • Crawford M1
  • Eifling K1
  • Flynt A1
  • Fokin AA1
Leading institutions
free-text, unnormalised
  • Stanford University School of Medicine2
  • Delray Medical Center1
  • Harvard Medical School1
  • University of Colorado at Boulder1
  • University of Washington1
  • Washington University in St. Louis Emergency Medicine Residency1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.