MedPath

Olive oil

Generic Name
Olive oil
Brand Names
Clinoleic, Clinolipid, Olimel, Periolimel
Drug Type
Biotech
CAS Number
8001-25-0
Unique Ingredient Identifier
6UYK2W1W1E

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

Published: Aug 26, 2025

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.

Continue reading the full research report

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

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL
180546
Medicine
A
1/9/2012
OLICLINOMEL N4-550 E 1000 mL IV emulsion for infusion with electrolytes bag
136599
Medicine
A
9/4/2007
OLICLINOMEL N4-550 E 2500 mL IV emulsion for infusion with electrolytes bag
141396
Medicine
A
9/4/2007
OLIMEL N5-860E Emulsion for intravenous infusion
197417
Medicine
A
8/9/2013
Olimel N12-640 emulsion for intravenous infusion bag.
303755
Medicine
A
7/1/2019
Zinzino BalanceOil+ Orange Lemon Mint Flavour
380401
Medicine
A
12/8/2021
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 2500 mL biofine bag
329619
Medicine
A
8/27/2020
SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 2463 mL
180550
Medicine
A
1/9/2012
SMOFKABIVEN ELECTROLYTE FREE amino acids 5.1% / lipids 3.8% / glucose 12.7% emulsion for intravenous infusion bag 986 mL
173891
Medicine
A
1/9/2012
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 1400 mL biofine bag
329617
Medicine
A
8/27/2020

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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