Mitotech

What Mitotech does

Mitotech is a clinical-stage biotechnology company founded in 2009 as a spinoff from Moscow State University's bioengineering department, based on Professor Vladimir Skulachev's pioneering research on mitochondria-targeted antioxidants. The company develops small-molecule drugs centered on its lead compound SkQ1 (a cardiolipin peroxidation inhibitor and ferroptosis inhibitor) that accumulates within mitochondria due to its charged nature, allowing it to address oxidative stress and restore mitochondrial function at extremely low concentrations. Mitotech's core products include Visomitin (an ophthalmic formulation of SkQ1, commercially available in Russia since 2012 for dry eye syndrome, with approximately 1 million units sold) and Plastomitin (a systemic oral formulation in development for metabolic and neurodegenerative indications).

The company operates across multiple therapeutic areas including ophthalmology (dry eye disease, Leber's Hereditary Optic Neuropathy, glaucoma, dry AMD, uveitis), metabolic disorders (obesity, MASH), and neurodegenerative diseases (Friedreich's Ataxia, Multiple Sclerosis, Alzheimer's, Parkinson's). Mitotech has completed two Phase 3 trials in the U.S. for dry eye disease (VISTA-1 with ~450 patients and VISTA-2 with 610 patients) and received FDA Orphan Drug Designation for Visomitin in LHON in December 2021.

Mitotech's business model combines modest Russian consumer-product sales (Visomitin) with a partnership-driven co-development structure. Through an agreement finalized in October 2022, Essex Bio-Technology (HKG: 1061) holds exclusive worldwide rights to develop, manufacture, and sell SkQ1-based therapeutics in ophthalmology, providing approximately $17 million for late-stage clinical development. Mitotech retains rights to non-ophthalmology indications. The company employs 1-10 people (six executives) across Luxembourg, London, and Moscow origins, and operates with minimal fixed infrastructure, relying on CROs (notably Ora, Inc.), academic collaborations (Doheny Eye Institute at UCLA, Stockholm University, Mount Sinai), and its strategic partner for development and commercialization.

Name

Mitotech

Legal name

Mitotech Ltd

Website

https://mitotechpharma.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

Mitotech is a clinical-stage biotechnology company developing mitochondria-targeted small-molecule drugs (SkQ1 platform) for ophthalmology, metabolic, and neurodegenerative diseases, with one approved product (Visomitin) sold in Russia and US Phase 3 trials partnered with Essex Bio-Technology.

Ownership category

akta.pro rank

Product category

Ophthalmic Pharmaceuticals

NAICS

Ophthalmic Goods Manufacturing (339115)

SIC

Medicinal Chemicals & Botanical Products (2833)

akta.pro primary industry

Ophthalmology Pharmaceuticals (HLAIAAAL)

akta.pro secondary industries

Ophthalmology Specialty Pharmaceuticals (HLAIACAK), Rare Ophthalmology Disorder Therapies (HLAIAIAK)

Keywords

• Mitochondria-targeted therapeutics
• Ophthalmic pharmaceuticals
• Cardiolipin inhibitors
• Ferroptosis inhibitors
• Rare disease therapeutics

Headquarters

HQ city

Luxembourg

HQ country

Luxembourg

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pharmaceutical Product Sales (Visomitin): Visomitin, the ophthalmic formulation of SkQ1, is already commercialized in Russia since 2012 for dry eye syndrome. Approximately 1 million units have been sold in the Russian market. This represents early commercial revenue from an approved product.
2. Partnership and Licensing Revenue (Essex Bio-Technology): Essex Bio-Technology provides funding for late-stage clinical development (~17M for first Phase 3 study) and holds exclusive rights to SkQ1 in ophthalmology globally. Mitotech receives development funding and potentially milestone payments and royalties.
3. Future Pipeline Product Revenue: Multiple pipeline candidates in development including SkQ1 oral formulation for obesity, MASH, Friedreich's Ataxia, Multiple Sclerosis, and other indications. Preclinical and clinical stage programs targeting significant unmet medical needs in metabolic and neurodegenerative disorders.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Mitotech develops mitochondria-targeted small molecule drugs centered on its lead compound SkQ1, a cardiolipin peroxidation inhibitor and ferroptosis inhibitor. Its ophthalmic formulation Visomitin is commercially marketed in Russia for dry eye syndrome, while additional ophthalmology indications (LHON, glaucoma, dry AMD, uveitis) and systemic indications (obesity, MASH, Friedreich's Ataxia, Multiple Sclerosis) are in clinical and preclinical development through the systemic oral formulation Plastomitin.

Product overview

Mitotech is a clinical-stage biotechnology company developing mitochondria-targeted therapies centered on its lead compound SkQ1. The company markets Visomitin (ophthalmic SkQ1 formulation) in Russia for dry eye syndrome, while advancing SkQ1 through multiple clinical programs including Phase 3 trials for dry eye disease in the U.S. (VISTA program) and developing the systemic formulation Plastomitin for metabolic and neurodegenerative disorders. The product portfolio consists of the core SkQ1 molecule platform with multiple delivery formulations targeting different therapeutic areas.

Differentiator

Problem solved

Functional benefit

Products and services

• Visomitin Visomitin is an ophthalmic (eye drop) formulation of SkQ1, a mitochondria-targeted antioxidant and cardiolipin peroxidation inhibitor. It is approved and marketed in Russia for the treatment of dry eye syndrome since 2012, and is also being developed for other ophthalmic indications including Leber's Hereditary Optic Neuropathy (LHON), glaucoma, dry AMD, and uveitis. The product is targeted at patients with ocular surface and optic nerve conditions linked to mitochondrial dysfunction and oxidative stress.
• Plastomitin Plastomitin is the systemic (oral) formulation of SkQ1, designed for non-ophthalmic indications such as neurodegenerative and metabolic diseases including obesity, MASH, Friedreich's Ataxia, and Multiple Sclerosis. It represents Mitotech's expansion beyond ophthalmology into systemic treatments targeting mitochondrial dysfunction.
• SkQ1 SkQ1 is Mitotech's lead compound, an orally bioavailable small-molecule cardiolipin peroxidation inhibitor that targets mitochondrial dysfunction and inhibits ferroptosis. It is being developed for multiple therapeutic areas including ophthalmology (dry eye, glaucoma, LHON, dry AMD, uveitis), metabolic disorders (obesity, MASH), and neurodegenerative diseases (Friedreich's Ataxia, Multiple Sclerosis). SkQ1 is the foundational technology underlying both Visomitin and Plastomitin formulations.

Quantifiable outcome

• 27% body weight reduction in large non-rodent HFD animal model after two months of SkQ1 treatment
• +8 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Essex Bio-Technology (including Essex Bio-Investment)coreStrategic or Co-development Partner · 13 October 2022Major strategic partnership where Essex Bio-Technology secured exclusive worldwide rights to develop, manufacture and sell SkQ1-based therapeutic products in ophthalmology. Essex is providing approximately $17 million in funding for late-stage clinical development. Essex is a Hong Kong-listed bio-pharmaceutical company (HKG: 1061) with established ophthalmology commercial infrastructure in China (43 regional sales offices, 10,710+ hospitals). Mitotech retains rights for non-ophthalmology indications.
• Ora, Inc.coreImplementation/ SI/ Consulting PartnerOra is the world's leading independent full-service ophthalmic CRO that conducted Mitotech's VISTA-1 and VISTA-2 clinical trials. Ora provides clinical development support including regulatory strategy, manufacturing guidance, and preclinical services. Over 40 years of experience with 45+ FDA approvals. Offices in the U.S., Europe, Australia, and Asia.
• Doheny Eye Institute at UCLAminorStrategic or Co-development PartnerMitotech planned to start a Phase 2 clinical study with Visomitin in LHON in 2022 in collaboration with the LHON clinic at the Doheny Eye Institute at UCLA. Collaboration for clinical development of Visomitin for Leber's Hereditary Optic Neuropathy.
• Stockholm University (Wenner-Gren Institute)minorStrategic or Co-development PartnerCollaboration with Stockholm University's Wenner-Gren Institute led by Dr. Barbara Cannon and Dr. Jan Nedergaard on anti-aging research. Study demonstrated that SkQ1 increased longevity of mtDNA mutator mice by 16% median lifespan increase (p<0.005). Published in Aging journal February 2017.
• Mount Sinai School of Medicine (Dr. Yi Wei)minorStrategic or Co-development PartnerCollaborative research with Dr. Yi Wei at Icahn School of Medicine at Mount Sinai demonstrating anti-inflammatory effect of SkQ1 in conjunctival epithelial cells. Mount Sinai researchers also presented positive results of corneal wound healing study involving SkQ1 at ARVO 2016.

Scale indicators6 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• Ocular Therapeutix: Clinical-stage ophthalmology biotech developing sustained-release drug delivery platforms for dry eye, glaucoma, and rare eye diseases including Dextenza. Comparable given similar size, ophthalmology focus, late-stage clinical assets, and reliance on partnership-driven commercialization.
• Aldeyra Therapeutics: Clinical-stage ophthalmology biotech developing reproxalap for dry eye disease and other inflammatory ocular conditions. Closely comparable to Mitotech as a late-stage dry eye biotech with novel mechanism of action seeking to disrupt the DED treatment paradigm.
• Stealth BioTherapeutics: Clinical-stage biotech developing mitochondria-targeted therapeutics including elamipretide for mitochondrial diseases. Most directly comparable peer to Mitotech given shared focus on cardiolipin-protective, mitochondria-targeted small molecules addressing rare mitochondrial disorders.
• Akero Therapeutics: Clinical-stage biotech developing efruxifermin (FGF21 analog) for MASH. Comparable given Mitotech's parallel MASH development with a differentiated mechanism (mitochondrial ferroptosis inhibition vs FGF21 agonism), representing a competing MASH pipeline asset class.
• GenSight Biologics: French clinical-stage biotech developing gene therapies for rare mitochondrial ophthalmic diseases including Lumevoq for LHON. Directly comparable to Mitotech's LHON program given shared focus on addressing inherited mitochondrial vision loss.
• Nicox: European ophthalmology specialty company developing novel therapeutics for glaucoma and dry eye disease, including NCX 470 (NO-donating prostaglandin analog) and NCX 4251. Comparable as a focused ophthalmology biotech with late-stage assets and partnership-driven commercialization model.
• Kala Bio: Clinical-stage ophthalmology biotech developing KPI-012 (a regenerative mesenchymal stem cell secretome) for persistent corneal epithelial defects and rare ocular surface diseases. Comparable given similar size, clinical-stage ophthalmology focus, and pursuit of orphan/rare eye indications.
• Madrigal Pharmaceuticals: Clinical-stage biopharma that developed Rezdiffra, the first FDA-approved therapy for MASH. Comparable given Mitotech's parallel MASH preclinical program targeting liver triglyceride reduction and fibrosis improvement with a different mechanism (mitochondrial vs THR-beta).
• Santhera Pharmaceuticals: Swiss specialty pharma developing and commercializing Raxone (idebenone) for LHON and other mitochondrial disease indications. Directly comparable given LHON focus and rare mitochondrial disease pipeline, representing Mitotech's closest approved competitor in the LHON space.

Broad incumbents

• Bausch + Lomb: Major global ophthalmology company commercializing Miebo (perfluorohexyloctane) and Xiidra (lifitegrast) for dry eye disease. Comparable as the dominant incumbent against which Mitotech's SkQ1 will compete commercially, with established payer relationships and physician adoption in DED.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/mitotech-llc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mitotech