Clinical Programs

The core technology behind Mitotech products is based on a novel class of small molecules – mitochondria addressed  cardiolipin peroxidation inhibitors. Mitotech is developing several drug formulations of SkQ1 covering a variety of therapeutic areas and methods of administration. The most advanced SkQ1-based drug product in Mitotech’s pipeline is Visomitin™ which reached Phase III stage in the U.S. for Dry Eye Disease. Visomitin™ already received marketing approval for Dry Eye Disease in Russia. Multifactorial nature of Dry Eye made this indication a perfect target for SkQ1 as its mechanism of action addresses tissue degeneration, oxidative stress of the tear and inflammation at the same time. Clinical studies demonstrated effect of Visomitin™ on corneal staining, tear quality and a range of symptoms of this disease.

Other indications in Mitotech’s pipeline include other ophthalmic (LHON, dry AMD, uveitis and more), neurodegenerative, cardiovascular and metabolic disorders and are at earlier stages of clinical development.

US

Drug/Indication
 
Pre-clinical
Phase 1
Phase 2
Phase 3

Visomitin™ (SkQ1 eye drops)

Dry Eye
Dry Eye
Phase III initiated
Uveitis
Uveitis
Phase II ready
Dry AMD
Dry AMD
Phase II ready

Plastomitin™ (SkQ1 pill)

Multiple Sclerosis
Multiple Sclerosis
Phase I ready
Acute Kidney Injury
Acute Kidney Injury
Phase I ready
Barth Syndrome
Phase I ready

Russia

Drug/Indication
 
Pre-clinical
Phase 1
Phase 2
Phase 3

Visomitin™ (SkQ1 eye drops)

Dry Eye
Dry Eye
Marketing approval received
Dry Eye
LHON
Phase II completed
Dry AMD
Pre-clinical Completed

Plastomitin™ (SkQ1 pill)

Neurodegeneration
Phase II ready

Mitotech is committed to adding therapeutic indications that are important for millions of patients worldwide as well as rare genetic disorders to its development pipeline to make sure SkQ1 technology realizes its full pharmaceutical potential.