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Tocofersolan and tocopherol alpha
Tocofersolan and tocopherol alpha is a Antioxidant Small molecule drug developed by Hospices Civils de Lyon. It is currently in Phase 3 development for Prevention of oxidative stress.
Tocofersolan and tocopherol alpha work together to provide antioxidant properties.
Tocofersolan is a small molecule with the synonym E307, used in various interventions such as VisuXL and Lagricel PF. It has been studied in conditions including Short Bowel Syndrome, Vitamin E Deficiency, Dry Eye Syndromes, Diabetic Retinopathy, and Oxidative Stress, with one study specifically examining its use in preventing or treating refractive Vitamin E Deficiency in infants and children.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Tocofersolan and tocopherol alpha |
|---|---|
| Sponsor | Hospices Civils de Lyon |
| Drug class | Antioxidant |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Tocofersolan is a form of vitamin E that helps protect cells from damage caused by free radicals. Tocopherol alpha is another form of vitamin E that has antioxidant properties, which helps to neutralize free radicals and protect cells from damage.
Approved indications
- Prevention of oxidative stress
Common side effects
Key clinical trials
- Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention (PHASE3)
- Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy (PHASE2)
- Use of Tocofersolan (Vedrop®) to Prevent or Treat Refractive Vitamin E Deficiency in Infants and Children (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tocofersolan and tocopherol alpha CI brief — competitive landscape report
- Tocofersolan and tocopherol alpha updates RSS · CI watch RSS
- Hospices Civils de Lyon portfolio CI
Frequently asked questions about Tocofersolan and tocopherol alpha
What is Tocofersolan and tocopherol alpha?
How does Tocofersolan and tocopherol alpha work?
What is Tocofersolan and tocopherol alpha used for?
Who makes Tocofersolan and tocopherol alpha?
What drug class is Tocofersolan and tocopherol alpha in?
What development phase is Tocofersolan and tocopherol alpha in?
Related
- Drug class: All Antioxidant drugs
- Manufacturer: Hospices Civils de Lyon — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Prevention of oxidative stress
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing