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
Research Report
Tocopherol (Vitamin E): A Comprehensive Pharmacological and Clinical Review
Executive Summary
Tocopherol, a term that collectively describes a family of eight related lipophilic compounds, is a cornerstone of human nutrition, with alpha-(α)-tocopherol recognized as the most biologically active and preferentially utilized form. Functioning primarily as an essential, chain-breaking antioxidant, Tocopherol is integral to protecting cellular membranes from the deleterious effects of lipid peroxidation. This report provides a comprehensive examination of Tocopherol, exploring its multifaceted identity as both a vital nutrient and a widely investigated pharmacological agent.
The central paradox of Tocopherol lies in the significant disparity between its undisputed physiological necessity and the largely disappointing, and at times concerning, outcomes of high-dose supplementation in large-scale clinical trials. At a molecular level, the biological activity and pharmacokinetic fate of Tocopherol are critically dictated by its stereochemistry. The naturally occurring RRR-α-tocopherol isomer exhibits significantly greater bioavailability and retention than the synthetic all-racemic mixture, a difference governed by the selective action of the hepatic α-tocopherol transfer protein (α-TTP). This protein acts as a sophisticated gatekeeper, ensuring the systemic circulation of the most potent form while triaging others for metabolic degradation.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/06 | Phase 2 | 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 | |
| H2-Pharma, LLC | 61269-162 | ORAL | 3.35 mg in 1 mL | 9/15/2025 | |
| H2-Pharma, LLC | 61269-163 | ORAL | 3.35 mg in 1 mL | 9/15/2025 | |
| 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 |
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 |
|---|---|---|---|---|---|
| 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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