MedPath

Tocopherol

Generic Name
Tocopherol
Drug Type
Small Molecule
CAS Number
1406-66-2
Unique Ingredient Identifier
R0ZB2556P8

Overview

Tocopherol exists in four different forms designated as α, β, δ, and γ. They present strong antioxidant activities, and it is determined as the major form of vitamin E. Tocopherol, as a group, is composed of soluble phenolic compounds that consist of a chromanol ring and a 16-carbon phytyl chain. The classification of the tocopherol molecules is designated depending on the number and position of the methyl substituent in the chromanol ring. The different types of tocopherol can be presented trimethylated, dimethylated or methylated in the positions 5-, 7- and 8-. When the carbons at position 5- and 7- are not methylated, they can function as electrophilic centers that can trap reactive oxygen and nitrogen species. Tocopherols can be found in the diet as part of vegetable oil such as corn, soybean, sesame, and cottonseed. It is currently under the list of substances generally recognized as safe (GRAS) in the FDA for the use of human consumption.

Indication

Tocopherol can be used as a dietary supplement for patients with a deficit of vitamin E; this is mainly prescribed in the alpha form. Vitamin E deficiency is rare, and it is primarily found in premature babies of very low birth weight, patients with fat malabsorption or patients with abetalipoproteinemia. Tocopherol, due to its antioxidant properties, is studied for its use in prevention or treatment in different complex diseases such as cancer, atherosclerosis, cardiovascular diseases, and age-related macular degeneration.

Associated Conditions

  • Vitamin E Deficiency

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/06
Phase 2
Not yet recruiting
2024/07/10
Phase 2
Recruiting
2024/05/10
Not Applicable
Completed
2023/04/14
Phase 4
Completed
2022/04/27
Phase 3
UNKNOWN
2021/08/23
Phase 3
UNKNOWN
Mahmoud Ramadan mohamed Elkazzaz
2020/04/24
Phase 4
Completed
2018/02/23
Phase 2
Completed
2017/02/02
Phase 3
ENROLLING_BY_INVITATION
2016/09/22
Phase 2
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
BonGeo Pharmaceuticals, Inc.
52796-174
ORAL
20 [iU] in 1 1
2/2/2024
Novian Pharmaceuticals
83146-003
ORAL
30 mg in 1 1
10/6/2023
Everett Laboratories, Inc.
0642-0092
ORAL
10 [iU] in 1 1
4/18/2012
Everett Laboratories, Inc.
0642-0070
ORAL
9 mg in 1 1
9/1/2021
Guangdong Miaolian Cosmetics Co., Ltd.
84507-036
TOPICAL
0.438 mg in 100 g
3/31/2025
Nephro-Tech, Inc.
59528-1988
ORAL
35 [iU] in 1 1
7/14/2021
Mission Pharmacal Company
0178-0796
ORAL
30 [iU] in 1 1
8/13/2025
Exeltis USA, Inc.
0642-0079
ORAL
30 [iU] in 1 1
12/31/2022
BonGeo Pharmaceuticals, Inc.
52796-173
ORAL
20 [iU] in 1 1
2/1/2024
BonGeo Pharmaceuticals, Inc.
52796-177
ORAL
20 [iU] in 1 1
2/1/2024

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

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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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

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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