DrugEvidence

Drugs / Ibuprofen

Ibuprofen

Drug

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) widely used for pain, inflammation, and fever. It acts primarily by inhibiting cyclooxygenase pathways and reducing prostaglandin synthesis. It was first sold in the United Kingdom in 1969 and in the United States in 1974.

Trials
670
Recruiting
36
Completed
446
With results
169

Last revised

Pipeline

Phase by status

PhaseRecruitingNot yetBy invitationActiveCompletedTerminatedWithdrawnSuspendedUnknownTotal
Early Phase 1 27111 12
Phase 1 167214 75
Phase 1/2 14313 12
Phase 2 5256769 85
Phase 2/3 114 15
Phase 3 327312313 106
Phase 4 1571512221629 206
Not applicable 7719583217 140
Unknown 21115 19

Trials started per year

2021
10
2022
40
2023
24
2024
27
2025
20
2026
25

Conditions studied, by phase

ConditionEarly Phase 1Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Not applicableUnknownTotal
Pain 19115273917 109
Pain, Postoperative 41292144122 95
Agnosia 282112381 55
Ductus Arteriosus, Patent 2625784 34
Fever 1171112 23
Acute Pain 1224831 21
Low Back Pain 1121131 19
Osteoarthritis 312622 16
Inflammation 2515 13
Premature Birth 111622 13

Most active sponsors

#SponsorTrialsPhase 3
1Pfizer219
2Cairo University110
3Cumberland Pharmaceuticals116
4Boehringer Ingelheim92
5Montefiore Medical Center81
6Heron Therapeutics72
7AFT Pharmaceuticals, Ltd.65
8Bayer62
9Dr. Reddy's Laboratories Limited60
10Organon and Co65

Most studied interventions

#InterventionTrials
1Ibuprofen670
2Acetaminophen250
3Oxycodone40
4Anti-Inflammatory Agents, Non-Steroidal26
5Ketorolac26
6oxycodone-acetaminophen24
7Morphine22
8Celecoxib19
9Diclofenac18
10Tablets15

Evidence

Results reported
37.9%169 of 446 completed
Published
8.3%37 of 446 completed
Primary endpoint met
38.5%90 of 234 analyses
Median months to report
15

Documents disclosed

Protocol available
93
Statistical analysis plan
89
PubMed citations
191

Trial profile

Median enrollment
84
Median duration
15.9months
Countries
74
Study sites
2621

Who is enrolled

Adults
558
Children
198
Older adults
362
Healthy volunteers
230

Median enrollment by phase

Early Phase 1
40
Phase 1
33
Phase 1/2
56
Phase 2
100
Phase 2/3
50
Phase 3
180
Phase 4
100
Not applicable
78
Unknown
79

Where trials run

United States
268
Turkey (Türkiye)
35
Canada
31
United Kingdom
25
Egypt
20
Germany
18
Spain
17
South Korea
16
Brazil
15
Israel
14

Busiest cities

#CityCountryTrials
1Salt Lake CityUnited States26
2PhiladelphiaUnited States18
3HoustonUnited States15
4New YorkUnited States14
5SeoulSouth Korea14
6AustinUnited States13
7ChicagoUnited States13
8ClevelandUnited States13
9MiamiUnited States13
10ColumbusUnited States12

Terminations

Terminated
54
Withdrawn
21
Suspended
2
Stopped for recruitment
3.9%26 of 670 trials

Stated reasons

Other / unclear
31
Recruitment
26
Funding
6
COVID-19
5
Lack of efficacy
4
Regulatory
4
Business decision
1

Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.

Recently stopped

TrialStatusStated reasonStopped
NCT07625267 Withdrawn Withdrawn Study was never approved by the institutional review board. 2028-06-30
NCT02703610 Withdrawn Withdrawn No participants were enrolled and the study will not be conducted. 2026-07-30
NCT06496854 Withdrawn Withdrawn Unable to coordinate logistics 2026-01-31
NCT05640674 Terminated Terminated After reviewing our enrollment numbers and feasibility, we have decided to close the study due to low enrollment. 2025-12-15
NCT04813991 Withdrawn Withdrawn Enrollment was never initiated and the PI is leaving the institution so the study is closing. 2025-09-01
NCT05834569 Terminated Terminated The study was terminated early owing to challenges in completing the research registration process. 2025-01-23
NCT05190341 Terminated Terminated IRB voted to terminate the protocol for noncompliance 2024-10-10
NCT05742763 Withdrawn Withdrawn The study format without a crossover option for study participants enrolled in the control arm wasn't attractive to patients and we were unable to enroll any patients since enrollment began earlier this year, so the study will be withdrawn. 2024-10-07
NCT03648437 Terminated Terminated The PDA patients have vanished. The last recruitment took place in 2022. In the joint discussion of the principal researchers, it was concluded that PDA patients no longer have to be treated in Finland and the study was terminated. 2024-10-04
NCT04874675 Suspended Suspended Covid 19 lockdown 2024-04-30

Trial records

Individual study records live on ClinicalTrials.gov. A sample of the trials counted above:

Search all Ibuprofen trials on ClinicalTrials.gov →