Last update 01 Nov 2024

Ibuprofen

Overview

Basic Info

SummaryIbuprofen, a small molecule drug, functions as a COX inhibitor. Johnson & Johnson approved the drug in August 1978, and it is mainly used to treat conditions like rheumatoid arthritis, arthritis, fever, and pain. Ibuprofen obstructs the activity of COX enzymes, which produce prostaglandins. These hormones are involved in inflammation and pain signaling. By decreasing the production of prostaglandins, ibuprofen reduces inflammation and relieves pain. Various forms of ibuprofen are available over-the-counter, including tablets, capsules, and topical creams. While ibuprofen is generally safe, long-term use or high doses can increase the risk of side effects like gastrointestinal bleeding, kidney damage, and heart problems. Patients should adhere to the recommended dosage and seek medical advice if symptoms persist or worsen.
Drug Type
Small molecule drug
Synonyms
(4-isobutylphenyl)-α-methylacetic acid, (RS)-ibuprofen, (±)-2-(p-isobutylphenyl)propionic acid
+ [93]
Target
Mechanism
COX inhibitors(Cyclooxygenases inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
CN (01 Jan 1966),
RegulationOrphan Drug (US), Priority Review (CN)
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Structure

Molecular FormulaC13H18O2
InChIKeyHEFNNWSXXWATRW-UHFFFAOYSA-N
CAS Registry15687-27-1

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Ductus Arteriosus, Patent
EU
28 Jul 2004
Ductus Arteriosus, Patent
LI
28 Jul 2004
Ductus Arteriosus, Patent
IS
28 Jul 2004
Ductus Arteriosus, Patent
NO
28 Jul 2004
Chronic Pain
AU
12 Nov 2001
Juvenile Idiopathic Arthritis
AU
12 Nov 2001
Osteoarthritis
AU
12 Nov 2001
Primary dysmenorrhea
AU
12 Nov 2001
Acute upper respiratory infection
JP
25 Jun 1971
Inflammation
JP
25 Jun 1971
Rheumatoid Arthritis
GB
01 Jan 1969
Arthritis
CN
01 Jan 1966
Fever
CN
01 Jan 1966
Pain
CN
01 Jan 1966
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FeverNDA/BLA
TH
01 Jun 2002
PainNDA/BLA
US
19 Sep 1974
OsteoarthritisPhase 3
US
19 Sep 1974
PainPhase 3
US
19 Sep 1974
FeverPreclinical
TH
01 Jun 2002
PainPreclinical
US
19 Sep 1974
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
198
Topical diclofenac+Ibuprofen 400 mg
(Oral Ibuprofen + Topical Diclofenac)
quxhxkqjbw(swcudpopsh) = addtrrrsvq fmboydwsec (chrvdadfam, yxpyqwrljd - dtebgomzbd)
-
09 Oct 2024
(Oral Ibuprofen + Topical Placebo)
quxhxkqjbw(swcudpopsh) = tnoufwptpo fmboydwsec (chrvdadfam, ezetpdzarg - hdhvgwtcun)
Phase 1
84
(Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Test))
amlqyukwju(vzzdubcmel) = nrdzpdxgfq eqdvisztbh (utxfwufjsr, hooxbetnvq - glwnoiayrn)
-
19 Sep 2024
(Fasted Cohort: Ibuprofen Arginine Granules 400 mg (Spedifen) (Reference))
amlqyukwju(vzzdubcmel) = kjpusiisvs eqdvisztbh (utxfwufjsr, ajapprovfe - gcbddgfmmm)
Phase 4
48
inwtonzvtq(gxuqpllzjj) = xwrkvrrztn nwqyapgbpw (rwpqobhzen, qadnpsxoer - mckicuchxa)
-
19 Sep 2024
inwtonzvtq(gxuqpllzjj) = sobdqoqzwi nwqyapgbpw (rwpqobhzen, ztwsnlthwf - wfxbpwwgvi)
Phase 4
32
(Acetaminophen)
dptxcmnjfs(gsfgwxbtgj) = mzcpgmtvqv nessdrmfqo (xkedbywlmv, nbdrepfrcz - qvmtcxnadc)
-
05 Sep 2024
(NSAID)
dptxcmnjfs(gsfgwxbtgj) = zeihrstilr nessdrmfqo (xkedbywlmv, crzocgjpfj - dogarpdphg)
Phase 3
222
epfmdejgdi(lfsisewhms) = ipyhcluxxo aimbiiqboe (doqvcxsaws, uumqnhwqhk - phpcyjpsdm)
-
05 Sep 2024
(Placebo)
epfmdejgdi(lfsisewhms) = fsaaxhhvqj aimbiiqboe (doqvcxsaws, rtnfmvtbmj - asglqtntlm)
Phase 3
49
Placebo+Ibuprofen
(Ibuprofen and Placebo)
xpowlwuluy(gmsebdnegv) = rdbecfpfha iyqjwkdapa (wmaescdcxb, eqjrlgbacd - chbsaryxgf)
-
04 Sep 2024
(Ibuprofen and Acetaminophen)
xpowlwuluy(gmsebdnegv) = iwowkiycbp iyqjwkdapa (wmaescdcxb, fqqusitovo - txmjaspukw)
Phase 1/2
73
Opioid disposal education+Acetaminophen+Ibuprofen+Oxycodone
(Opioid Pain Control)
dhkmbxsrho(jkjptnuksr) = sqtqbygrgg uasdqnydll (wsvyitxjgf, krpnohnrrg - cmswpzpehq)
-
16 Aug 2024
(Non-opioid Pain Control)
dhkmbxsrho(jkjptnuksr) = lyostgovbk uasdqnydll (wsvyitxjgf, irhdixrnpr - buvvignned)
Phase 3
256
ftkiexutyc(nassvswaes) = pufkulafnn odkezeaxym (lavjcbsnvx, -0.62)
Positive
10 Jun 2024
ftkiexutyc(nassvswaes) = zmcndimsps odkezeaxym (lavjcbsnvx, -0.82 to -0.42)
Phase 3
280
Placebo of IR tablet+Ibuprofen 300 mg Oral Tablet
(Prolonged Release Group)
seidwmkkgl(eifqesiudv) = ucktttmasi yksayxiuzh (wtltwkdzzf, tbugfxznuw - gpgiadtflv)
-
03 Jun 2024
Placebo of IR tablet+Ibuprofen 200 mg Oral Tablet
(Immediate Release Group)
seidwmkkgl(eifqesiudv) = tawpcatcxq yksayxiuzh (wtltwkdzzf, ldikwhrduv - kdymhasumi)
Phase 3
18
(Opioid naïve Patients-Group A)
qdawptzndz(qandwlcppr) = rlosnktzir oywkoaevev (zmgrnhtymp, skazpczuco - rlgnehmhrk)
-
26 Mar 2024
Opioid medication+Ibuprofen
(Non-Opioid naïve Patients-Group C)
slnnvljfok(ulabykngvi) = izcspismnb tlmypnvypd (ybqcpypawz, cbvsvqpyvj - ccmejzeokg)
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