Icosapent
Icosapent Ethyl, Vascepa, Vazkepa (icosapent) is a small molecule pharmaceutical. Icosapent was first approved as Vascepa on 2012-07-26. It has been approved in Europe to treat dyslipidemias.
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Events Timeline
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
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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)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| animi-3 | unapproved drug other | 2013-02-06 |
| animi-3 with vitamin d | unapproved drug other | 2011-05-23 |
| bp vit 3 | unapproved drug other | 2025-02-13 |
| c-nate dha | unapproved drug other | 2024-01-22 |
| citranatal assure | unapproved drug other | 2026-01-08 |
| citranatal essence | unapproved drug other | 2020-07-07 |
| enbrace hr | unapproved drug other | 2026-02-10 |
| enlyte | unapproved drug other | 2022-07-01 |
| epaned | New Drug Application | 2025-12-16 |
| icosapent | ANDA | 2024-01-15 |
Show 9 more
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ICOSAPENT ETHYL, ICOSAPENT ETHYL, TEVA PHARMS USA | |||
| 2023-03-08 | PC | ||
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
1064 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | 4 | 14 | 8 | 5 | 54 | 80 |
| Healthy volunteers/patients | — | — | — | 8 | 2 | 5 | 5 | 32 | 52 |
| Depression | D003863 | — | F33.9 | 4 | 13 | 14 | 1 | 22 | 48 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | 6 | 6 | 3 | 30 | 44 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 5 | 7 | 13 | 6 | 13 | 42 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 4 | 4 | 2 | 32 | 42 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | 1 | 3 | 6 | 20 | 32 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 7 | 2 | 1 | 11 | 26 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | 5 | 1 | 3 | 17 | 26 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 2 | 6 | 5 | 1 | 13 | 25 |
Show 112 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 4 | 8 | 10 | — | 16 | 33 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 3 | 3 | 3 | — | 19 | 26 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | 3 | 3 | — | 13 | 20 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | 2 | 3 | 4 | — | 12 | 20 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 2 | 6 | — | 9 | 18 |
| Syndrome | D013577 | — | — | 1 | 5 | 2 | — | 12 | 18 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 2 | — | 1 | — | 11 | 14 |
| Overweight | D050177 | — | E66.3 | 3 | 2 | 1 | — | 8 | 13 |
| Dry eye syndromes | D015352 | — | H04.12 | — | 1 | 3 | — | 7 | 10 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | 1 | — | 8 | 10 |
Show 79 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malaria | D008288 | EFO_0001068 | B54 | 7 | 1 | — | — | — | 8 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 3 | — | — | 4 | 7 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | 4 | 5 |
| Hypercholesterolemia | D006937 | — | — | 1 | 1 | — | — | 3 | 5 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 1 | — | — | 4 | 5 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 1 | — | — | 3 | 5 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | 1 | — | — | 3 | 4 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 3 | 2 | — | — | 1 | 4 |
| Alcoholic fatty liver | D005235 | — | K70.0 | — | 2 | — | — | 2 | 4 |
| Brain concussion | D001924 | — | S06.0 | 1 | 1 | — | — | 2 | 4 |
Show 99 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | 10 | 11 |
| Gestational diabetes | D016640 | — | O24.4 | 1 | — | — | — | 5 | 6 |
| Healthy diet | D000072001 | — | — | 2 | — | — | — | 4 | 6 |
| Lipid metabolism disorders | D052439 | — | — | 2 | — | — | — | 3 | 5 |
| Dermatitis | D003872 | — | L30.9 | 1 | — | — | — | 2 | 3 |
| Pregnancy-induced hypertension | D046110 | — | O13 | 1 | — | — | — | 2 | 3 |
| Diabetic foot | D017719 | EFO_1001459 | — | 1 | — | — | — | 2 | 3 |
| Ulcer | D014456 | MPATH_579 | — | 1 | — | — | — | 2 | 3 |
| Foot ulcer | D016523 | — | — | 1 | — | — | — | 2 | 3 |
| Thrombosis | D013927 | — | — | 1 | — | — | — | 2 | 3 |
Show 32 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phenylketonurias | D010661 | — | E70.0 | — | — | — | — | 8 | 8 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 7 | 7 |
| Muscular atrophy | D009133 | — | — | — | — | — | — | 7 | 7 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 5 | 5 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 5 | 5 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 4 | 4 |
| Affect | D000339 | — | — | — | — | — | — | 4 | 4 |
| Breast feeding | D001942 | — | — | — | — | — | — | 4 | 4 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | — | 3 | 3 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 3 | 3 |
Show 190 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Icosapent |
| INN | icosapent |
| Description | All-cis-5,8,11,14,17-icosapentaenoic acid is an icosapentaenoic acid having five cis-double bonds at positions 5, 8, 11, 14 and 17. It has a role as a nutraceutical, a micronutrient, an antineoplastic agent, an antidepressant, a Daphnia galeata metabolite, a mouse metabolite, an anticholesteremic drug and a fungal metabolite. It is an icosapentaenoic acid and an omega-3 fatty acid. It is a conjugate acid of an all-cis-5,8,11,14,17-icosapentaenoate. |
| 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)O |
Identifiers
| PDB | — |
| CAS-ID | 10417-94-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL460026 |
| ChEBI ID | 28364 |
| PubChem CID | 446284 |
| DrugBank | DB00159 |
| UNII ID | AAN7QOV9EA (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Icosapent
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,692 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal assure, Citranatal essence, Enlyte, Epaned, Nestabs dha, Pnv-omega, Pre-tabs dha, Prenate essential, Tristart dha
Adverse Events
Top Adverse Reactions
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528,796 adverse events reported
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