Lysine
Ibuprofen, LysaKare, Neoprofen (lysine) is a small molecule pharmaceutical. Lysine was first approved as Neoprofen on 2006-04-13. It is used to treat nutritional and metabolic diseases in the USA. It has been approved in Europe to treat radiation injuries. 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, G-protein coupled receptor family C group 6 member A, vasopressin V1b receptor, oxytocin receptor, sodium-coupled monocarboxylate transporter 1, nitric oxide synthase, inducible, peroxisome proliferator-activated receptor gamma, vasopressin V1a receptor, and vasopressin V2 receptor.
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Events Timeline
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2Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aminosyn ii | New Drug Application | 2025-11-02 |
| aminosyn-pf | New Drug Application | 2025-10-17 |
| clinimix | New Drug Application | 2021-04-13 |
| clinimix e | New Drug Application | 2021-04-13 |
| clinisol | ANDA | 2018-06-01 |
| ibuprofen lysine | NDA authorized generic | 2026-04-06 |
| kabiven | New Drug Application | 2025-09-11 |
| lip clear lysine plus | C200263 | 2025-10-20 |
| lip clear lysine plus coldstick | C200263 | 2025-10-20 |
| livdelzi | New Drug Application | 2026-02-03 |
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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
A: Alimentary tract and metabolism drugs
— A12: Mineral supplements
— A12A: Calcium supplements
— A12AA: Calcium
— A12AA09: Calcium citrate lysine complex
B: Blood and blood forming organ drugs
— B05: Blood substitutes and perfusion solutions
— B05X: I.v. solution additives
— B05XB: Amino acids, i.v. solution additive
— B05XB03: Lysine
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AF: Detoxifying agents for antineoplastic treatment
— V03AF11: Arginine and lysine
HCPCS
No data
Clinical
Clinical Trials
277 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 2 | 2 | — | — | 1 | 4 |
| Synovial sarcoma | D013584 | — | — | 2 | 2 | — | — | 1 | 4 |
| Rhabdoid tumor | D018335 | — | — | 1 | 1 | — | — | 1 | 3 |
| Brain stem neoplasms | D020295 | EFO_1001767 | — | 1 | 2 | — | — | 1 | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Malignant mesothelioma | D000086002 | — | — | — | 1 | — | — | 1 | 2 |
| Chordoma | D002817 | EFO_0000334 | — | — | 1 | — | — | 1 | 2 |
| Mesothelioma | D008654 | — | C45 | 1 | 2 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | — | — | 1 | 1 |
| Small cell carcinoma | D018288 | — | — | — | — | — | — | 1 | 1 |
| Thoracic neoplasms | D013899 | — | — | — | — | — | — | 1 | 1 |
| Chondrosarcoma | D002813 | — | — | — | — | — | — | 1 | 1 |
| Glandular and epithelial neoplasms | D009375 | — | — | — | — | — | — | 1 | 1 |
| Desmoplastic small round cell tumor | D058405 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lysine |
| INN | lysine |
| Description | Lysine is a diamino acid that is caproic (hexanoic) acid bearing two amino substituents at positions 2 and 6. It has a role as a Daphnia magna metabolite. It is an alpha-amino acid, a diamino acid and a polar amino acid. It contains a 4-aminobutyl group. It is functionally related to a hexanoic acid. It is a conjugate base of a lysinium(1+). It is a conjugate acid of a lysinate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NCCCC[C@H](N)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 56-87-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL8085 |
| ChEBI ID | 18019 |
| PubChem CID | 866 |
| DrugBank | DB00123 |
| UNII ID | K3Z4F929H6 (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
GPRC6A
GPRC6A
AVPR1B
AVPR1B
OXTR
OXTR
SLC5A8
SLC5A8
NOS2
NOS2
PPARG
PPARG
AVPR1A
AVPR1A
AVPR2
AVPR2
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
No data
Financial
Revenue by drug
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Estimated US medical usage
Lysine
Total medical expenditures per year (USD, in millions)
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Aminosyn ii
Adverse Events
Top Adverse Reactions
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23,138 adverse events reported
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