Clinical Trials

Visomitin (SKQ1) has been evaluated in several clinical trials sponsored by Mitotech, SA, to assess its therapeutic efficacy and safety in inflammatory ocular surface disorders. These studies encompass Phase II and Phase III evaluations focusing on Keratoconjunctivitis Sicca and Dry Eye Syndrome. All of these clinical trials have achieved completed recruitment status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04206020 COMPLETED
Dry Eye Syndrome
Mitotech, SA
 2019-12-20 PHASE3
NCT03764735 COMPLETED
Dry Eye Syndrome
Mitotech, SA
 2018-12-06 PHASE3
NCT02121301 COMPLETED
Keratoconjunctivitis Sicca
Mitotech, SA
 2014-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2022-01-19)

Check the Visomitin (SKQ1) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Visomitin (SKQ1) functions as a mitochondria-targeted antioxidant that selectively accumulates within the inner mitochondrial membrane to neutralize reactive oxygen species and mitigate cell-damaging oxidative events. By attenuating mitochondrial oxidative stress and inhibiting downstream inflammatory cascades, Visomitin protects ocular surface cells, providing therapeutic relevance for treating dry eye syndrome and related corneal injuries.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.