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High dose - SkQ1
High dose - SkQ1 is a Mitochondrial-targeted antioxidant Small molecule drug developed by Mitotech, SA. It is currently in Phase 3 development for Age-related macular degeneration (AMD), Dry eye disease, Other age-related ocular conditions. Also known as: Visomitin.
SkQ1 is a mitochondrial-targeted antioxidant that accumulates in mitochondria to neutralize reactive oxygen species and protect against oxidative damage.
High dose SkQ1 is being studied in a clinical trial for the treatment of Keratoconjunctivitis Sicca and Dry Eye Syndrome. The trial is comparing the safety and efficacy of a high dose 1.55µg/mL SkQ1 ophthalmic solution to a low dose 0.155µg/mL SkQ1 ophthalmic solution and a placebo solution.
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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).
| 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 | High dose - SkQ1 |
|---|---|
| Also known as | Visomitin |
| Sponsor | Mitotech, SA |
| Drug class | Mitochondrial-targeted antioxidant |
| Target | Mitochondrial electron transport chain / reactive oxygen species |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology; Age-related degenerative diseases |
| Phase | Phase 3 |
Mechanism of action
SkQ1 (plastoquinone derivative) is designed to cross cell membranes and concentrate in mitochondria due to its lipophilic cationic structure. Once localized to mitochondria, it acts as an electron acceptor and antioxidant, reducing mitochondrial oxidative stress and preventing cellular damage from reactive oxygen species. This mechanism is intended to slow age-related degeneration and protect against conditions driven by mitochondrial dysfunction.
Approved indications
- Age-related macular degeneration (AMD)
- Dry eye disease
- Other age-related ocular conditions
Common side effects
- Local ocular irritation
- Conjunctival hyperemia
- Eye discomfort
Key clinical trials
- Study of SkQ1 as Treatment for Dry-eye Syndrome (PHASE3)
- A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES) (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:
- High dose - SkQ1 CI brief — competitive landscape report
- High dose - SkQ1 updates RSS · CI watch RSS
- Mitotech, SA portfolio CI
Frequently asked questions about High dose - SkQ1
What is High dose - SkQ1?
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Is High dose - SkQ1 also known as anything else?
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Related
- Drug class: All Mitochondrial-targeted antioxidant drugs
- Target: All drugs targeting Mitochondrial electron transport chain / reactive oxygen species
- Manufacturer: Mitotech, SA — full pipeline
- Therapeutic area: All drugs in Ophthalmology; Age-related degenerative diseases
- Indication: Drugs for Age-related macular degeneration (AMD)
- Indication: Drugs for Dry eye disease
- Indication: Drugs for Other age-related ocular conditions
- Also known as: Visomitin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing