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 | 2023-10-11 |
| c-nate dha | unapproved drug other | 2024-01-22 |
| citranatal assure | unapproved drug other | 2024-01-08 |
| citranatal dha | unapproved drug other | 2020-07-28 |
| citranatal essence | unapproved drug other | 2020-07-07 |
| enbrace hr | unapproved drug other | 2023-12-15 |
| enlyte | unapproved drug other | 2022-07-01 |
| icosapent | ANDA | 2024-01-24 |
Show 8 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
595 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 | — | — | 8 | 6 | 4 | 26 | 42 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 4 | 3 | 11 | 5 | 8 | 30 |
| Depression | D003863 | — | F33.9 | 2 | 9 | 10 | 1 | 8 | 26 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 3 | 5 | 3 | 12 | 22 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 2 | 5 | 7 | 1 | 10 | 22 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 2 | 1 | 1 | 14 | 19 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 2 | 4 | 2 | 11 | 18 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | 2 | 2 | 10 | 16 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | 3 | 2 | 1 | 10 | 15 |
| Fatty liver | D005234 | EFO_0003934 | — | 2 | 6 | 4 | 1 | 3 | 14 |
Show 79 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | 1 | 2 | — | 18 | 26 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 4 | 1 | — | 7 | 16 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | 6 | — | 4 | 12 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | 4 | — | 6 | 11 |
| Syndrome | D013577 | — | — | — | 5 | 3 | — | 5 | 10 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | 2 | 2 | — | 7 | 10 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | 1 | — | 7 | 9 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 2 | 2 | 1 | — | 4 | 8 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | 1 | 1 | — | 5 | 8 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 1 | — | 1 | — | 6 | 8 |
Show 66 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | — | 1 | 1 | — | — | 3 | 5 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 3 | — | — | 2 | 5 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 1 | — | — | 3 | 5 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 3 | — | — | 2 | 5 |
| Sclerosis | D012598 | — | — | 2 | 2 | — | — | 1 | 4 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | — | — | 2 | 4 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | — | 2 | — | — | 2 | 4 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | 2 | 3 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 1 | — | — | 1 | 3 |
| Pregnancy rate | D018873 | — | — | — | 1 | — | — | 2 | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | HP_0000855 | — | 1 | — | — | — | 6 | 7 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | 5 | 6 |
| Lipid metabolism disorders | D052439 | — | — | 2 | — | — | — | 2 | 4 |
| Healthy diet | D000072001 | — | — | 1 | — | — | — | 3 | 4 |
| Infertility | D007246 | HP_0000789 | — | 2 | — | — | — | 1 | 3 |
| Pregnancy-induced hypertension | D046110 | — | O13 | 1 | — | — | — | 2 | 3 |
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | 1 | — | — | — | 2 | 3 |
| Brain concussion | D001924 | — | S06.0 | 1 | — | — | — | 2 | 3 |
| Male infertility | D007248 | EFO_0004248 | N46 | 1 | — | — | — | 1 | 2 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | 1 | 2 |
Show 14 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 | — | — | — | — | 6 | 6 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | — | — | — | 5 | 5 |
| Muscular atrophy | D009133 | HP_0003202 | — | — | — | — | — | 5 | 5 |
| Affect | D000339 | — | — | — | — | — | — | 4 | 4 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 4 | 4 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 3 | 3 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | — | — | 3 | 3 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | — | — | 3 | 3 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | — | 2 | 2 |
Show 115 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 | — |
| 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
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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 32,203 documents
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Safety
Black-box Warning
Black-box warning for: Citranatal assure, Citranatal dha, Citranatal essence, Enlyte, Nestabs dha, Pnv-omega, Pre-tabs dha, Prenate essential, Tristart dha
Adverse Events
Top Adverse Reactions
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4,389 adverse events reported
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