Icosapent ethyl
Icosapent Ethyl, Vascepa, Vazkepa (icosapent ethyl) is a small molecule pharmaceutical. Icosapent ethyl was first approved as Vascepa on 2012-07-26. It has been approved in Europe to treat dyslipidemias.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
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)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| icosapent | ANDA | 2024-01-24 |
| icosapent ethyl | ANDA | 2024-09-25 |
| vascepa | New Drug Application | 2024-04-03 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Icosapent Ethyl, Vascepa, Amarin Pharms | |||
| 9603826 | 2033-06-28 | U-2696 | |
| 9610272 | 2033-06-28 | U-2697 | |
| 9623001 | 2033-06-28 | U-2698 | |
| 9693984 | 2033-06-28 | U-2697 | |
| 9693985 | 2033-06-28 | U-2696 | |
| 9693986 | 2033-06-28 | U-2698 | |
| 9918954 | 2033-06-28 | U-2699 | |
| 10278935 | 2033-06-28 | U-2701 | |
| 10278936 | 2033-06-28 | U-2702 | |
| 10278937 | 2033-06-28 | U-2703 | |
| 10383840 | 2033-06-28 | U-2704 | |
| 10555924 | 2033-06-28 | U-2743 | |
| 10555925 | 2033-06-28 | U-2744 | |
| 10568861 | 2033-06-28 | U-2756 | |
| 10576054 | 2033-06-28 | U-2762 | |
| 10668042 | 2033-06-28 | U-2841 | |
| 10786478 | 2033-06-28 | U-2959, U-2960 | |
| 10792270 | 2033-06-28 | U-2962 | |
| 10894028 | 2033-06-28 | U-3053 | |
| 11000499 | 2033-06-28 | U-3126 | |
| 11116742 | 2033-06-28 | U-3221 | |
| 11298333 | 2033-06-28 | U-3358 | |
| 11369582 | 2033-06-28 | U-2841 | |
| 8410086 | 2030-06-15 | U-2688 | |
| 8455472 | 2030-06-15 | U-2690 | |
| 8669245 | 2030-06-15 | U-2694 | |
| 8710041 | 2030-06-15 | U-2690 | |
| 10842768 | 2030-06-15 | U-2688 | |
| 8298554 | 2030-04-29 | DP | |
| 8445003 | 2030-04-29 | U-1287 | |
| 8445013 | 2030-04-29 | U-1287 | |
| 8454994 | 2030-04-29 | U-2689 | |
| 8501225 | 2030-04-29 | U-1287 | |
| 8551521 | 2030-04-29 | U-1287 | |
| 8563608 | 2030-04-29 | U-1287 | |
| 8617593 | 2030-04-29 | U-1287, U-1478, U-2691 | |
| 8617594 | 2030-04-29 | U-1287 | |
| 8618166 | 2030-04-29 | U-2689 | |
| 8623406 | 2030-04-29 | U-1287, U-1478, U-2692 | |
| 8642077 | 2030-04-29 | U-2693 | |
| 8691871 | 2030-04-29 | U-2689 | |
| 8703185 | 2030-04-29 | U-2691 | |
| 8709475 | 2030-04-29 | U-2689 | |
| 10010517 | 2030-04-29 | U-2690 | |
| 10265287 | 2030-04-29 | U-2700 | |
| 10792267 | 2030-04-29 | U-2961 | |
| 10842766 | 2030-04-29 | U-2997 | |
| 10881632 | 2030-04-29 | U-3052 | |
| 11103477 | 2030-04-29 | U-3209 | |
| 11154526 | 2030-04-29 | U-3240 | |
| 11213504 | 2030-04-29 | U-3292 | |
| 11717504 | 2030-04-29 | U-3669 | |
| 8399446 | 2030-02-09 | U-1287 | |
| 8415335 | 2030-02-09 | U-1287 | |
| 8426399 | 2030-02-09 | U-1287 | |
| 8431560 | 2030-02-09 | U-1287 | |
| 8440650 | 2030-02-09 | U-1287 | |
| 8518929 | 2030-02-09 | U-1287 | |
| 8524698 | 2030-02-09 | U-1287 | |
| 8546372 | 2030-02-09 | U-1287 | |
| 8680144 | 2030-02-09 | U-2695 | |
| 9198892 | 2027-09-25 | U-2706 | |
| 9700537 | 2027-05-31 | U-2707 | |
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
70 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 3 | 3 | 8 | 2 | 1 | 16 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | 3 | 3 | 7 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 3 | 2 | 5 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 2 | 1 | — | 4 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 1 | 2 | 1 | 4 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 3 | 1 | 4 |
| Covid-19 | D000086382 | — | — | — | 1 | 1 | 1 | — | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 2 | 1 | — | 3 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | 2 | 1 | 3 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 2 | 2 | 1 | — | 3 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | — | 2 | 1 | — | 2 | 5 |
| Colonic neoplasms | D003110 | — | C18 | — | 1 | 1 | — | 1 | 3 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | 1 | — | 2 | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | 1 | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | 1 | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 1 | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 1 | — | — | 1 |
| Hypoalbuminemia | D034141 | HP_0003073 | — | — | — | 1 | — | — | 1 |
| Psychotic disorders | D011618 | — | F20.81 | — | 1 | 1 | — | — | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 1 | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | — | — | — | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 3 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | 1 | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | 2 | 3 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 2 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | — | — | — | 2 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 2 | — | — | — | 2 |
| Drug resistance | D004351 | — | Z16.30 | 1 | 1 | — | — | — | 1 |
| Alcoholic fatty liver | D005235 | — | K70.0 | — | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | HP_0000789 | — | 1 | — | — | — | — | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | — | 1 |
| Dyslipidemias | D050171 | HP_0003119 | — | 1 | — | — | — | — | 1 |
| Lipid metabolism disorders | D052439 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | — | — | — | — | 3 | 3 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | — | 1 | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 1 | 1 |
| Lipidoses | D008064 | — | E75.6 | — | — | — | — | 1 | 1 |
| Disease susceptibility | D004198 | — | — | — | — | — | — | 1 | 1 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 1 | 1 |
| Hyperkinesis | D006948 | HP_0000752 | — | — | — | — | — | 1 | 1 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | — | — | — | 1 | 1 |
| Biological availability | D001682 | — | — | — | — | — | — | 1 | 1 |
Show 6 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Icosapent ethyl |
| INN | — |
| Description | Ethyl (5Z,8Z,11Z,14Z,17Z)-icosapentaenoate is a long-chain fatty acid ethyl ester resulting from the formal condensation of the carboxy group of (5Z,8Z,11Z,14Z,17Z)-icosapentaenoic acid with the hydroxy group of ethanol. It has a role as an anticholesteremic drug, a marine metabolite, an antipsychotic agent, an antidepressant and a prodrug. It is a long-chain fatty acid ethyl ester and a polyunsaturated fatty ester. It is functionally related to an all-cis-5,8,11,14,17-icosapentaenoic acid. |
| Classification | Small molecule |
| Drug class | Antilipemic Agents |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)OCC |
Identifiers
| PDB | — |
| CAS-ID | 86227-47-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2095209 |
| ChEBI ID | 80366 |
| PubChem CID | 9831415 |
| DrugBank | DB08887 |
| UNII ID | — |
Target
No data
Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,679 adverse events reported
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