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Low Dose - SkQ1
Low Dose - SkQ1 is a Mitochondria-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. Also known as: Visomitin.
SkQ1 is a mitochondria-targeted antioxidant that accumulates in mitochondria to neutralize reactive oxygen species and protect against oxidative damage.
SkQ1 is being studied as a potential treatment for Keratoconjunctivitis Sicca and Dry Eye Syndrome in a clinical trial. The study is comparing the safety and efficacy of a low dose 0.155µg/mL SkQ1 ophthalmic solution to a high dose 1.55µg/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 | Low Dose - SkQ1 |
|---|---|
| Also known as | Visomitin |
| Sponsor | Mitotech, SA |
| Drug class | Mitochondria-targeted antioxidant |
| Target | Mitochondrial reactive oxygen species (ROS) |
| 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 antioxidant to scavenge reactive oxygen species (ROS) and reduce oxidative stress, thereby protecting mitochondrial function and cellular viability. This mechanism is intended to slow age-related degeneration and improve outcomes in conditions characterized by mitochondrial dysfunction.
Approved indications
- Age-related macular degeneration (AMD)
- Dry eye disease
Common side effects
- Ocular irritation
- Conjunctival hyperemia
- Visual disturbances
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:
- Low Dose - SkQ1 CI brief — competitive landscape report
- Low Dose - SkQ1 updates RSS · CI watch RSS
- Mitotech, SA portfolio CI
Frequently asked questions about Low Dose - SkQ1
What is Low Dose - SkQ1?
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Who makes Low Dose - SkQ1?
Is Low Dose - SkQ1 also known as anything else?
What drug class is Low Dose - SkQ1 in?
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What does Low Dose - SkQ1 target?
Related
- Drug class: All Mitochondria-targeted antioxidant drugs
- Target: All drugs targeting Mitochondrial reactive oxygen species (ROS)
- 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
- Also known as: Visomitin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing