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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EMA
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 |
|---|---|---|
| ibuprofen lysine | NDA authorized generic | 2024-01-05 |
| neoprofen | New Drug Application | 2024-10-15 |
| sarene soothing skin | OTC monograph final | 2010-04-10 |
Indications
FDA
EMA
No data
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
No data
Clinical
Clinical Trials
1055 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 | 21 | 26 | 55 | 56 | 162 |
| Pain | D010146 | EFO_0003843 | R52 | 19 | 21 | 32 | 48 | 41 | 158 |
| Agnosia | D000377 | EFO_0007136 | F88 | 3 | 11 | 16 | 26 | 29 | 79 |
| Patent ductus arteriosus | D004374 | — | Q25.0 | 2 | 16 | 13 | 9 | 19 | 55 |
| Healthy volunteers/patients | — | — | — | 45 | — | — | 3 | 3 | 51 |
| Acute pain | D059787 | — | R52 | 4 | 6 | 7 | 14 | 16 | 46 |
| Low back pain | D017116 | — | M54.5 | — | 3 | 5 | 14 | 11 | 32 |
| Fever | D005334 | — | R50.9 | 2 | 1 | 7 | 14 | 7 | 31 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 4 | 4 | 9 | 6 | 6 | 28 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 3 | 4 | — | 8 | 10 | 24 |
Show 181 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 7 | 2 | — | 3 | 12 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | 1 | — | 5 | 7 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 1 | — | 5 | 6 |
| Anesthesia and analgesia | D000760 | — | — | 2 | 3 | 1 | — | 1 | 5 |
| Musculoskeletal diseases | D009140 | — | — | — | 1 | 2 | — | 2 | 5 |
| Temporomandibular joint disorders | D013705 | — | M26.6 | 1 | 2 | 1 | — | 3 | 5 |
| Breast diseases | D001941 | — | N60-N65 | — | — | 1 | — | 3 | 4 |
| Local anesthesia | D000772 | — | — | — | 2 | 1 | — | 2 | 4 |
| Complex regional pain syndromes | D020918 | EFO_1001998 | — | — | — | 4 | — | — | 4 |
| Ulcer | D014456 | MPATH_579 | — | — | — | 2 | — | 2 | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Motor activity | D009043 | EFO_0003940 | — | 1 | 1 | — | — | 3 | 5 |
| Foot and mouth disease hand | D006232 | EFO_0007294 | B08.4 | — | 1 | — | — | 4 | 5 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | — | 2 | — | — | 1 | 3 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | 2 | 3 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | 2 | — | — | — | 3 |
| Phimosis | D010688 | EFO_1001104 | N47.1 | 1 | 1 | — | — | — | 2 |
| Paraphimosis | D010263 | EFO_1001086 | N47.2 | 1 | 1 | — | — | — | 2 |
| Balanitis | D001446 | EFO_1000833 | N48.1 | 1 | 1 | — | — | — | 2 |
| Retinopathy of prematurity | D012178 | EFO_1001158 | H35.1 | — | 1 | — | — | 1 | 2 |
| Spondylosis | D055009 | — | M47 | — | 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 | — | — | 6 | — | — | — | — | 6 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 1 | — | — | — | 2 | 3 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | 1 | 2 |
| Thyroid diseases | D013959 | — | E00-E07 | 1 | — | — | — | 1 | 2 |
| Postoperative hemorrhage | D019106 | — | — | 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 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Laparoscopic cholecystectomy | D017081 | — | — | — | — | — | — | 5 | 5 |
| Trismus | D014313 | — | — | — | — | — | — | 5 | 5 |
| Cholecystitis | D002764 | — | K81 | — | — | — | — | 4 | 4 |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | — | — | — | — | 3 | 3 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 3 | 3 |
| Mouth diseases | D009059 | EFO_1001047 | K13 | — | — | — | — | 3 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 3 | 3 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 3 | 3 |
| Hip injuries | D025981 | — | — | — | — | — | — | 3 | 3 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 3 | 3 |
Show 162 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
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Safety
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910 adverse events reported
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