MedPath

Icosapent

Generic Name
Icosapent
Brand Names
Animi-3 With Vitamin D
Drug Type
Small Molecule
Chemical Formula
C20H30O2
CAS Number
10417-94-4
Unique Ingredient Identifier
AAN7QOV9EA

Overview

Important polyunsaturated fatty acid found in fish oils. It serves as the precursor for the prostaglandin-3 and thromboxane-3 families. A diet rich in eicosapentaenoic acid lowers serum lipid concentration, reduces incidence of cardiovascular disorders, prevents platelet aggregation, and inhibits arachidonic acid conversion into the thromboxane-2 and prostaglandin-2 families.

Indication

EPA can be used for lowering elevated triglycerides in those who are hyperglyceridemic. In addition, EPA may play a therapeutic role in patients with cystic fibrosis by reducing disease severity and may play a similar role in type 2 diabetics in slowing the progression of diabetic nephropathy.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/29
Phase 3
Not yet recruiting
2024/07/10
Early Phase 1
Not yet recruiting
2020/12/24
N/A
Completed
2020/09/24
Phase 4
Completed
2020/07/07
Phase 3
Completed
Estudios Clínicos Latino América
2020/01/09
Phase 3
Completed
Mochida Pharmaceutical Company, Ltd.
2019/07/05
Phase 1
Terminated
2019/03/21
Phase 1
Completed
2018/10/02
Phase 3
Completed
Mochida Pharmaceutical Company, Ltd.
2018/09/05
Phase 4
UNKNOWN

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Avion Pharmaceuticals, LLC
75854-313
ORAL
40 mg in 1 1
1/7/2021
PBM Pharmaceuticals, Inc
66213-543
ORAL
35 mg in 1 1
2/6/2013
Acella Pharmaceuticals, LLC
42192-301
ORAL
35 mg in 1 1
10/11/2023
CarWin Pharmaceutical Associates, LLC
15370-250
ORAL
15 mg in 1 1
12/23/2019
Acella Pharmaceuticals, LLC
42192-332
ORAL
40 mg in 1 1
6/27/2019
PBM Pharmaceuticals, Inc
66213-542
ORAL
35 mg in 1 1
5/23/2011

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
DANES MAXEPA/EVENING PRIMROSE OIL capsule
50728
Danes Pty Ltd
Medicine
A
11/3/1994

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
HERBALIFELINE
herbalife international of luxembourg s à r l
02248423
Capsule - Oral
119 MG
7/19/2004

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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