Overview
Oil extracted from olives . Consists primarily of the glycerides of the fatty acids linoleic, oleic and palmitic. Used as a source of fatty acids in total parenteral nutrition and as an additive in some cosmetic products .
Indication
For use in adults as a source of calories and fatty acids in total parenteral nutrition . Sometimes used as an additive in cosmetic products.
Associated Conditions
No associated conditions information available.
Research Report
An Expert Report on Olive Oil (DB09567) as a Biopharmaceutical Agent and Therapeutic Modality
Executive Summary
Olive Oil (DB09567), a substance long recognized for its culinary and traditional medicinal value, has emerged as a significant agent within the modern pharmaceutical and biotechnology landscape. This report provides a comprehensive scientific and clinical analysis of olive oil, elucidating its multifaceted role that extends far beyond basic nutrition. Classified by DrugBank as a "Biotech" product, its identity in contemporary medicine is defined by two primary functions: first, as an Active Pharmaceutical Ingredient (API) in parenteral nutrition emulsions, providing essential calories and fatty acids to vulnerable patient populations; and second, as a critical, high-purity excipient and raw material that enables the formulation and manufacture of advanced therapeutics, including sensitive biologic drugs and sustainable vaccine adjuvants.
The pharmacological profile of olive oil is uniquely dualistic. Its major lipid components, predominantly glycerides of oleic acid, provide metabolic energy. However, its therapeutic potency is largely derived from a complex mixture of minor bioactive constituents, including the potent anti-inflammatory phenol oleocanthal, which exhibits a mechanism of action similar to ibuprofen, and a broad array of other polyphenols like hydroxytyrosol and oleuropein that confer significant antioxidant and immunomodulatory effects. This synergistic interplay of components underpins the extensive clinical evidence supporting its use.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/09/18 | Phase 4 | Completed | |||
2020/06/04 | Phase 2 | Active, not recruiting | |||
2019/08/09 | Phase 1 | UNKNOWN | |||
2017/05/11 | Phase 4 | Completed | General University Hospital, Prague | ||
2016/05/03 | Phase 3 | Completed | Carola Pfeiffer-Mosesson | ||
2015/06/22 | Phase 4 | Terminated | |||
2014/07/10 | Phase 2 | Completed | |||
2013/12/12 | Phase 3 | Completed | |||
2013/09/17 | Phase 4 | Completed | Johane Allard | ||
2013/05/10 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-820 | INTRAVENOUS | 5 g in 100 mL | 8/15/2025 | |
| Baxter Healthcare Corporation | 0338-9540 | INTRAVENOUS | 16 g in 100 mL | 7/24/2024 | |
| BIOCARE PLUS INTERNATIONAL LIMITED | 85522-001 | TOPICAL | 0.47 g in 1 g | 4/9/2025 |
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 |
|---|---|---|---|---|---|
| SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION | SIN16135P | INJECTION, EMULSION | 7.2g/1000ml | 3/24/2021 | |
| SmofKabiven Emulsion for Infusion | SIN14286P | INJECTION, EMULSION | 50g /1000ml | 1/8/2013 | |
| SmofKabiven Electrolyte Free Emulsion for Infusion | SIN14292P | INJECTION, EMULSION | 50g /1000ml | 1/16/2013 | |
| SmofKabiven Peripheral Emulsion for Infusion | SIN14287P | INJECTION, EMULSION | 50g /1000ml | 1/8/2013 | |
| SMOFlipid 20% | SIN13246P | INJECTION, EMULSION | 50g per 1000ml | 4/12/2007 | |
| SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION | SIN16136P | INJECTION, EMULSION | 7.2g/1000ml | 3/24/2021 |
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 |
|---|---|---|---|---|---|
| OLIMEL N9E EMULSION FOR INFUSION | N/A | N/A | N/A | 10/24/2013 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OLIMEL 5.7% E | baxter corporation | 02352532 | Emulsion - Intravenous | 32 G / L | 1/19/2011 |
| OLIMEL 7.6% E | baxter corporation | 02477955 | Emulsion - Intravenous | 28 G / L | 10/25/2018 |
| OLIMEL 5.7% | baxter corporation | 02352540 | Emulsion - Intravenous | 32 G / L | 3/1/2011 |
| OLIMEL 4.4% | baxter corporation | 02352524 | Emulsion - Intravenous | 32 G / L | 9/29/2011 |
| HEM-RELIEF ONT | nature's way of canada ltd. | 00656259 | Ointment - Topical | 1.8 % | 12/31/1985 |
| SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE | fresenius kabi canada ltd | 02501775 | Emulsion - Intravenous | 0.72 G / 100 ML | 7/9/2021 |
| SMOFKABIVEN PERIPHERAL | fresenius kabi canada ltd | 02456206 | Emulsion - Intravenous | 700 MG / 100 ML | 2/14/2017 |
| OLIMEL 3.3% E | baxter corporation | 02352508 | Emulsion - Intravenous | 32 G / L | N/A |
| SMOFKABIVEN | fresenius kabi canada ltd | 02440695 | Emulsion - Intravenous | 0.95 G / 100 ML | 9/15/2015 |
| X-ITCH ONT | nature's way of canada ltd. | 00656240 | Ointment - Topical | 1.8 % | 12/31/1986 |
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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