Ibuprofen lysine
Ibuprofen, Neoprofen, Pedea (ibuprofen lysine) is a small molecule pharmaceutical. Ibuprofen lysine was first approved as Pedea on 2004-07-28. It is used to treat ankylosing spondylitis, bursitis, dysmenorrhea, fever, and gout amongst others in the USA. It has been approved in Europe to treat patent ductus arteriosus. The pharmaceutical is active against prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1. In addition, it is known to target acid-sensing ion channel 1, peroxisome proliferator-activated receptor gamma, and sodium-coupled monocarboxylate transporter 1.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 10 person ansi | OTC monograph final | 2010-06-07 |
| 24/7 life ibuprofen | ANDA | 2023-07-19 |
| 25 person ansi | OTC monograph final | 2010-06-07 |
| 365 everday value ibuprofen | ANDA | 2023-07-27 |
| 365 everyday value ibuprofen | ANDA | 2019-01-08 |
| 50 person ansi | OTC monograph final | 2010-06-07 |
| acetaminophen 250 mg and ibuprofen 125 mg | ANDA | 2023-07-11 |
| acetaminophen and ibuprofen | ANDA | 2024-08-04 |
| acetaminophen and ibuprofen (nsaid) | ANDA | 2024-01-02 |
| acetaminophen and ibuprofen back pain | ANDA | 2024-04-04 |
Show 275 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ibuprofen Lysine, Neoprofen, Recordati Rare | |||
| 8415337 | 2032-03-02 | DS, DP | |
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01E: Other cardiac preparations in atc
— C01EB: Other plain cardiac preparations in atc
— C01EB16: Ibuprofen
G: Genito urinary system and sex hormones
— G02: Other gynecologicals in atc
— G02C: Other gynecologicals in atc
— G02CC: Antiinflammatory products for vaginal administration
— G02CC01: Ibuprofen
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AE: Propionic acid derivatives, antiinflammatory and antirheumatic products
— M01AE01: Ibuprofen
— M01AE51: Ibuprofen, combinations
— M02: Topical products for joint and muscular pain
— M02A: Topical products for joint and muscular pain
— M02AA: Antiinflammatory preparations, non-steroids for topical use
— M02AA13: Ibuprofen
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AJ: Opioids in combination with non-opioid analgesics
— N02AJ08: Codeine and ibuprofen
— N02AJ19: Oxycodone and ibuprofen
R: Respiratory system drugs
— R02: Throat preparations
— R02A: Throat preparations
— R02AX: Other throat preparations in atc
— R02AX02: Ibuprofen
HCPCS
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Clinical
Clinical Trials
975 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 9 | 17 | 25 | 46 | 57 | 150 |
| Pain | D010146 | EFO_0003843 | R52 | 14 | 16 | 25 | 35 | 26 | 115 |
| Patent ductus arteriosus | D004374 | HP_0001643 | Q25.0 | 2 | 15 | 13 | 9 | 19 | 54 |
| Healthy volunteers/patients | — | — | — | 44 | — | — | 3 | 3 | 50 |
| Acute pain | D059787 | — | R52 | 5 | 6 | 7 | 14 | 12 | 42 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 6 | 6 | 7 | 14 | 10 | 42 |
| Back pain | D001416 | HP_0003418 | M54 | 2 | 3 | 4 | 16 | 11 | 35 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | 3 | 5 | 14 | 8 | 29 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 4 | 3 | 2 | 8 | 10 | 26 |
| Toothache | D014098 | — | K08.89 | 1 | 8 | 12 | 3 | 2 | 25 |
Show 188 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | 1 | — | 6 | 8 |
| Neoplasms | D009369 | — | C80 | 1 | 3 | 2 | — | 2 | 8 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | 1 | — | 5 | 6 |
| Ulcer | D014456 | MPATH_579 | — | — | — | 2 | — | 3 | 5 |
| Breast diseases | D001941 | — | N60-N65 | — | — | 1 | — | 3 | 4 |
| Local anesthesia | D000772 | — | — | — | 2 | 1 | — | 2 | 4 |
| Anesthesia and analgesia | D000760 | — | — | 2 | 3 | 1 | — | — | 4 |
| Adenoidectomy | D000233 | — | — | 2 | 3 | 1 | — | — | 4 |
| Musculoskeletal diseases | D009140 | — | — | — | 1 | 1 | — | 2 | 4 |
| Temporomandibular joint disorders | D013705 | — | M26.6 | 1 | 2 | 1 | — | 2 | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Foot and mouth disease hand | D006232 | EFO_0007294 | B08.4 | — | 1 | — | — | 4 | 5 |
| Mouth diseases | D009059 | EFO_1001047 | K13 | — | 1 | — | — | 4 | 5 |
| Foot-and-mouth disease | D005536 | EFO_0007277 | B08.8 | — | 1 | — | — | 4 | 5 |
| Colorectal neoplasms | D015179 | — | — | — | 2 | — | — | 2 | 4 |
| Pancreatitis | D010195 | HP_0001733 | K85 | — | 2 | — | — | 1 | 3 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 3 | — | — | — | 3 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | 2 | — | — | — | 3 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 1 | — | — | — | 2 |
| Phimosis | D010688 | EFO_1001104 | N47.1 | 1 | 1 | — | — | — | 2 |
| Paraphimosis | D010263 | EFO_1001086 | N47.2 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 5 | — | — | — | — | 5 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 4 | — | — | — | — | 4 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | 1 | 2 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | — | — | — | 1 | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | 1 | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholecystitis | D002764 | HP_0001082 | K81 | — | — | — | — | 4 | 4 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 3 | 3 |
| Trismus | D014313 | — | — | — | — | — | — | 3 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 3 | 3 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 3 | 3 |
| Acalculous cholecystitis | D042101 | EFO_1000790 | — | — | — | — | — | 3 | 3 |
| Spondylarthritis | D025241 | — | — | — | — | — | — | 2 | 2 |
| Spondylitis | D013166 | — | M46.9 | — | — | — | — | 2 | 2 |
| Male breast neoplasms | D018567 | — | — | — | — | — | — | 2 | 2 |
| Urinary calculi | D014545 | — | — | — | — | — | — | 2 | 2 |
Show 142 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ibuprofen lysine |
| INN | ibuprofen |
| Description | Ibuprofen is a monocarboxylic acid that is propionic acid in which one of the hydrogens at position 2 is substituted by a 4-(2-methylpropyl)phenyl group. It has a role as a non-steroidal anti-inflammatory drug, a non-narcotic analgesic, a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, an antipyretic, a xenobiotic, an environmental contaminant, a radical scavenger, a drug allergen and a geroprotector. It is functionally related to a propionic acid. It is a conjugate acid of an ibuprofen(1-). |
| Classification | Small molecule |
| Drug class | anti-inflammatory/analgesic agents (ibuprofen type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)Cc1ccc(C(C)C(=O)O)cc1.NCCCC[C@H](N)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 1010396-31-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201141 |
| ChEBI ID | — |
| PubChem CID | 3672 |
| DrugBank | DB01050 |
| UNII ID | WK2XYI10QM (ChemIDplus, GSRS) |
Target
Agency Approved
PTGS2
PTGS2
PTGS1
PTGS1
Organism
Homo sapiens
Gene name
PTGS2
Gene synonyms
COX2
NCBI Gene ID
Protein name
prostaglandin G/H synthase 2
Protein synonyms
COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)
Uniprot ID
Mouse ortholog
Ptgs2 (19225)
prostaglandin G/H synthase 2 (Q543K3)
Alternate
ASIC1
ASIC1
PPARG
PPARG
SLC5A8
SLC5A8
Organism
Homo sapiens
Gene name
ASIC1
Gene synonyms
ACCN2, BNAC2
NCBI Gene ID
Protein name
acid-sensing ion channel 1
Protein synonyms
acid sensing (proton gated) ion channel 1, acid-sensing ion channel 1a protein, Amiloride-sensitive cation channel 2, neuronal, BNaC2, Brain sodium channel 2, Cation channel, amiloride-sensitive, neuronal, 2
Uniprot ID
Mouse ortholog
Asic1 (11419)
acid-sensing ion channel 1 (Q6NXK8)
Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Alivio, Caldolor, Combogesic, Combogesic iv, Counteract, Duexis, Hydrocodone bitartrate and ibuprofen, Ibu, Ibupak, Ibuprofen, Ibuprofen and famotidine, Ibuprofentablets, Prastera, Prastera - ibuprofen, Theraprofen-60, Theraprofen-800, Toxicology saliva collection kit
Adverse Events
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110,000 adverse events reported
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