Last reviewed 2026-05-14 · How we verify

Hydroxytyrosol plus Vitamin E

Bambino Gesù Hospital and Research Institute · Phase 3 active Small molecule

Hydroxytyrosol plus Vitamin E is a Antioxidant combination Small molecule drug developed by Bambino Gesù Hospital and Research Institute. It is currently in Phase 3 development for Neurological disorders associated with oxidative stress (specific indication under investigation in Phase 3). Also known as: Hydroxytyrosol, alpha-tocopherol.

Hydroxytyrosol and Vitamin E work synergistically as antioxidants to reduce oxidative stress and inflammation.

Hydroxytyrosol and Vitamin E work synergistically as antioxidants to reduce oxidative stress and inflammation. Used for Neurological disorders associated with oxidative stress (specific indication under investigation in Phase 3).

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Hydroxytyrosol plus Vitamin E
Also known as	Hydroxytyrosol, alpha-tocopherol
Sponsor	Bambino Gesù Hospital and Research Institute
Drug class	Antioxidant combination
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 3

Mechanism of action

Hydroxytyrosol, a polyphenol from olive oil, and Vitamin E (tocopherol) are both potent antioxidants that scavenge free radicals and reduce lipid peroxidation. Together, they may provide complementary neuroprotective and anti-inflammatory effects, potentially protecting against oxidative damage in neurological conditions.

Approved indications

Neurological disorders associated with oxidative stress (specific indication under investigation in Phase 3)

Common side effects

Gastrointestinal disturbances
Headache
Mild allergic reactions

Key clinical trials

Hydroxytyrosol and Vitamin E in Pediatric NASH (PHASE3)

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:

Hydroxytyrosol plus Vitamin E CI brief — competitive landscape report
Hydroxytyrosol plus Vitamin E updates RSS · CI watch RSS
Bambino Gesù Hospital and Research Institute portfolio CI

Frequently asked questions about Hydroxytyrosol plus Vitamin E

What is Hydroxytyrosol plus Vitamin E?

Hydroxytyrosol plus Vitamin E is a Antioxidant combination drug developed by Bambino Gesù Hospital and Research Institute, indicated for Neurological disorders associated with oxidative stress (specific indication under investigation in Phase 3).

How does Hydroxytyrosol plus Vitamin E work?

Hydroxytyrosol and Vitamin E work synergistically as antioxidants to reduce oxidative stress and inflammation.

What is Hydroxytyrosol plus Vitamin E used for?

Hydroxytyrosol plus Vitamin E is indicated for Neurological disorders associated with oxidative stress (specific indication under investigation in Phase 3).

Who makes Hydroxytyrosol plus Vitamin E?

Hydroxytyrosol plus Vitamin E is developed by Bambino Gesù Hospital and Research Institute (see full Bambino Gesù Hospital and Research Institute pipeline at /company/bambino-ges-hospital-and-research-institute).

Is Hydroxytyrosol plus Vitamin E also known as anything else?

Hydroxytyrosol plus Vitamin E is also known as Hydroxytyrosol, alpha-tocopherol.

What drug class is Hydroxytyrosol plus Vitamin E in?

Hydroxytyrosol plus Vitamin E belongs to the Antioxidant combination class. See all Antioxidant combination drugs at /class/antioxidant-combination.

What development phase is Hydroxytyrosol plus Vitamin E in?

Hydroxytyrosol plus Vitamin E is in Phase 3.

What are the side effects of Hydroxytyrosol plus Vitamin E?

Common side effects of Hydroxytyrosol plus Vitamin E include Gastrointestinal disturbances, Headache, Mild allergic reactions.

Drug class: All Antioxidant combination drugs
Manufacturer: Bambino Gesù Hospital and Research Institute — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Neurological disorders associated with oxidative stress (specific indication under investigation in Phase 3)
Also known as: Hydroxytyrosol, alpha-tocopherol

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing