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SkQ1 Vehicle Solution
SkQ1 Vehicle Solution is a Mitochondrially-targeted antioxidant Small molecule drug developed by Mitotech, SA. It is currently in Phase 3 development for Dry age-related macular degeneration, Atrial fibrillation for stroke prevention. Also known as: Vehicle for SkQ1.
SkQ1 is a mitochondrially-targeted antioxidant that aims to delay the onset of age-related diseases.
SkQ1 Vehicle Solution is being studied as a treatment for Dry Eye Syndrome and Keratoconjunctivitis Sicca in a Phase 3 clinical trial. The study, NCT04206020, is a randomized, double-masked, placebo-controlled trial sponsored by Mitotech, SA.
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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 | SkQ1 Vehicle Solution |
|---|---|
| Also known as | Vehicle for SkQ1 |
| Sponsor | Mitotech, SA |
| Drug class | Mitochondrially-targeted antioxidant |
| Target | Mitochondrial targeting sequence |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology, Cardiology |
| Phase | Phase 3 |
Mechanism of action
SkQ1 works by accumulating in the mitochondria, where it can neutralize reactive oxygen species and reduce oxidative stress. This is thought to help delay the onset of age-related diseases by protecting cells from damage. By doing so, SkQ1 may help to improve overall healthspan and potentially treat age-related conditions.
Approved indications
- Dry age-related macular degeneration
- Atrial fibrillation for stroke prevention
Common side effects
- Increased intraocular pressure
- Cardiac arrhythmias
Key clinical trials
- Study of SkQ1 as Treatment for Dry-eye Syndrome (PHASE3)
- Vehicle-Controlled 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:
- SkQ1 Vehicle Solution CI brief — competitive landscape report
- SkQ1 Vehicle Solution updates RSS · CI watch RSS
- Mitotech, SA portfolio CI
Frequently asked questions about SkQ1 Vehicle Solution
What is SkQ1 Vehicle Solution?
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What drug class is SkQ1 Vehicle Solution in?
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Related
- Drug class: All Mitochondrially-targeted antioxidant drugs
- Target: All drugs targeting Mitochondrial targeting sequence
- Manufacturer: Mitotech, SA — full pipeline
- Therapeutic area: All drugs in Ophthalmology, Cardiology
- Indication: Drugs for Dry age-related macular degeneration
- Indication: Drugs for Atrial fibrillation for stroke prevention
- Also known as: Vehicle for SkQ1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing