Overview
A mixture of fish oil and primrose oil, doconexent is used as a high-docosahexaenoic acid (DHA) supplement. DHA is a 22 carbon chain with 6 cis double bonds with anti-inflammatory effects. It can be biosythesized from alpha-linolenic acid or commercially manufactured from microalgae. It is an omega-3 fatty acid and primary structural component of the human brain, cerebral cortex, skin, and retina thus plays an important role in their development and function. The amino-phospholipid DHA is found at a high concentration across several brain subcellular fractions, including nerve terminals, microsomes, synaptic vesicles, and synaptosomal plasma membranes .
Indication
Used as a high-docosahexaenoic acid (DHA) oral supplement.
Associated Conditions
- Fredrickson classification type IV Hyperlipidemia
- Fredrickson type IIb hyperlipidemia
- Type III hyperlipidaemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/10 | Early Phase 1 | Not yet recruiting | |||
2019/05/29 | Phase 3 | Recruiting | Sherief Abd-Elsalam | ||
2018/08/03 | Phase 2 | Completed | |||
2018/01/18 | Phase 1 | Withdrawn | |||
2016/11/25 | Phase 2 | UNKNOWN | |||
2016/02/24 | Phase 2 | Completed | |||
2015/11/16 | Phase 4 | UNKNOWN | National Institute of Malariology, Parasitology and Entomology, Vietnam | ||
2015/11/13 | Phase 3 | UNKNOWN | |||
2015/08/07 | Early Phase 1 | Completed | Carol Fabian, MD | ||
2015/07/01 | Phase 3 | Completed | Susan Carlson, PhD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MISSION PHARMACAL COMPANY | 0178-0812 | ORAL | 250 mg in 1 1 | 5/3/2010 | |
| Exeltis USA, Inc. | 0642-7473 | ORAL | 200 mg in 1 1 | 2/14/2023 | |
| Avion Pharmaceuticals, LLC | 75854-313 | ORAL | 300 mg in 1 1 | 1/7/2021 | |
| Avion Pharmaceuticals, LLC | 75854-312 | ORAL | 300 mg in 1 1 | 1/7/2021 | |
| Acella Pharmaceuticals, LLC | 42192-321 | ORAL | 300 mg in 1 1 | 1/5/2018 | |
| Avion Pharmaceuticals, LLC | 75854-309 | ORAL | 400 mg in 1 1 | 1/7/2021 | |
| Acella Pharmaceuticals, LLC | 42192-343 | ORAL | 250 mg in 1 1 | 9/11/2018 | |
| MISSION PHARMACAL COMPANY | 0178-0799 | ORAL | 250 mg in 1 1 | 6/3/2011 | |
| PBM Pharmaceuticals, Inc | 66213-543 | ORAL | 250 mg in 1 1 | 2/6/2013 | |
| Acella Pharmaceuticals, LLC | 42192-301 | ORAL | 350 mg in 1 1 | 10/11/2023 |
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 |
|---|---|---|---|---|---|
| KANGPAI MAXEPA natural fish oil 1.2g capsule bulk | 54114 | Kangpai International Pty Ltd | Medicine | A | 11/21/1995 |
| DANES MAXEPA/EVENING PRIMROSE OIL capsule | 50728 | Danes Pty Ltd | Medicine | A | 11/3/1994 |
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