Vascepa, Vazkepa(icosapent)
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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Vascepa (generic drugs available since 2020-05-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Icosapent ethyl
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VASCEPA | Amarin Corporation | N-202057 RX | 2012-07-26 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vascepa | New Drug Application | 2023-04-24 |
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 | |
| 8293727 | 2030-02-09 | U-1287 | |
| 8293728 | 2030-02-09 | U-1287 | |
| 8314086 | 2030-02-09 | U-1287 | |
| 8318715 | 2030-02-09 | U-1287 | |
| 8357677 | 2030-02-09 | U-1287 | |
| 8367652 | 2030-02-09 | U-1287 | |
| 8377920 | 2030-02-09 | U-1287 | |
| 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
356 clinical trials
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Mock data
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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 | 2 | 1 | 8 | 4 | 1 | 16 | |
| Inflammation | D007249 | — | 4 | 2 | 2 | 5 | 13 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 5 | 2 | 2 | 10 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 3 | 2 | 1 | 5 | 10 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 1 | 3 | 4 | 9 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 2 | 1 | 1 | 4 | 8 |
| Coronary artery disease | D003324 | I25.1 | — | 1 | 2 | 2 | 2 | 7 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 4 | — | 2 | 1 | 7 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 3 | 2 | 2 | 1 | 6 |
| Colorectal neoplasms | D015179 | 1 | 3 | — | 3 | — | 6 |
Show 41 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 8 | 1 | — | 8 | 20 |
| Healthy volunteers/patients | — | 2 | — | 2 | — | 12 | 16 | ||
| Depression | D003863 | F33.9 | — | 2 | 4 | — | 3 | 9 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 1 | 1 | 1 | — | 5 | 8 |
| Neoplasms | D009369 | C80 | 1 | 2 | 3 | — | 2 | 7 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | 2 | — | 3 | 6 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | 2 | — | 1 | 4 | |
| Dry eye syndromes | D015352 | H04.12 | — | — | 1 | — | 3 | 4 | |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 1 | — | 1 | — | 2 | 4 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | 1 | — | 1 | 3 |
Show 31 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | — | 2 | 3 | |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | 2 | 3 |
| Ductal carcinoma breast | D018270 | — | 3 | — | — | — | 3 | ||
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | 2 | — | — | — | 2 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | 1 | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 1 | — | — | — | 2 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 1 | — | — | 1 | 2 |
| Necrotizing enterocolitis | D020345 | EFO_0003928 | K55.3 | 1 | 1 | — | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | — | — | — | 2 |
| Myeloid leukemia chronic-phase | D015466 | 1 | 1 | — | — | — | 1 |
Show 33 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | 3 | 4 |
| Brain concussion | D001924 | S06.0 | 1 | — | — | — | 1 | 2 | |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
| Facial pain | D005157 | R51.9 | 1 | — | — | — | — | 1 | |
| Infertility | D007246 | EFO_0000545 | 1 | — | — | — | — | 1 | |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | — | — | — | — | 1 |
| Oligospermia | D009845 | N46.1 | 1 | — | — | — | — | 1 | |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | — | 1 |
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 3 | 3 |
| Prostatic neoplasms | D011471 | C61 | — | — | — | — | 3 | 3 | |
| Bone density | D015519 | EFO_0003923 | M85 | — | — | — | — | 2 | 2 |
| Body composition | D001823 | — | — | — | — | 2 | 2 | ||
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 2 | 2 | |
| Muscle weakness | D018908 | HP_0001324 | — | — | — | — | 2 | 2 | |
| Hot flashes | D019584 | — | — | — | — | 2 | 2 | ||
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 2 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 2 | 2 |
| Nasal polyps | D009298 | HP_0100582 | J33 | — | — | — | — | 1 | 1 |
Show 48 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 | 90 |
| ChEMBL ID | CHEMBL460026 |
| ChEBI ID | 28364 |
| PubChem CID | 446284 |
| DrugBank | DB00159 |
| UNII ID | AAN7QOV9EA (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,710 adverse events reported
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