Tisento Therapeutics

What Tisento Therapeutics does

Tisento Therapeutics is a privately held, clinical-stage biotechnology company founded in 2023 and headquartered in Cambridge, Massachusetts. The company is developing novel small-molecule medicines for serious diseases with significant unmet medical need, with its initial focus on MELAS (Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke-like Episodes), a rare, progressive, and fatal mitochondrial disorder with no approved disease-modifying treatments.

The company's lead asset, zagociguat, is a first-in-class, once-daily, oral, brain-penetrant soluble guanylate cyclase (sGC) stimulator. It works by modulating the nitric oxide-cyclic guanosine monophosphate (NO-sGC-cGMP) signaling pathway, which is dysregulated in mitochondrial disease, with the goal of restoring mitochondrial energy production and physiological function. Zagociguat demonstrated a favorable safety profile, CNS exposure, and improvements in neuronal function, mitochondrial biomarkers (FGF-21, GDF-15), and cerebral blood flow in an 8-patient Phase 2a study. The global Phase 2b PRIZM study (~43 participants, 6 countries) completed enrollment in January 2026 with top-line data expected in Q4 2026. A second asset, CY3018 (a CNS-targeted sGC stimulator), is in IND-enabling studies. The company also sponsors the MELAS interview study published in the Journal of Patient-Reported Outcomes to inform patient-centric endpoint design.

Tisento is pre-revenue and entirely funded by an $81 million Series A closed in July 2023 with lead investors Venrock and Sanofi Ventures. Its go-to-market motion is sales-led through physician-driven clinical trial recruitment at mitochondrial disease centers of excellence, supplemented by patient advocacy partnerships with MitoAction and UMDF. Future revenue, contingent on approval, would derive from specialty pharmaceutical product sales, licensing, or partnership arrangements for zagociguat in MELAS and broader mitochondrial indications.

Name

Tisento Therapeutics

Legal name

Tisento Therapeutics, Inc.

Website

https://tisentotx.com

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

11–50 employees

Short description

Tisento Therapeutics is a clinical-stage biotechnology company developing zagociguat, a first-in-class brain-penetrant sGC stimulator, as a potential treatment for MELAS and other rare mitochondrial diseases.

Ownership category

akta.pro rank

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Pre-Revenue / Research Stage: Tisento Therapeutics is a privately held, clinical-stage biotechnology company. It has no commercialized products and generates no product revenue. The company is funded entirely through venture capital (Series A financing of $81 million). The company acquired zagociguat and CY3018 from Cyclerion Therapeutics in exchange for $10.4 million cash, 10% equity in Tisento, and anti-dilution protection through $100M post-money valuation. Once zagociguat completes clinical development and receives regulatory approval, potential revenue streams would include product sales (specialty pharmaceutical), licensing, or partnerships.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Tisento Therapeutics is a clinical-stage biotechnology company developing zagociguat, an oral, once-daily, first-in-class, brain-penetrant soluble guanylate cyclase (sGC) stimulator, as an investigational treatment for MELAS (Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke-like Episodes) and other genetic mitochondrial diseases. The company is advancing zagociguat through the global Phase 2b PRIZM clinical study and holds a second pipeline asset, CY3018, a CNS-targeted sGC stimulator in IND-enabling studies acquired from Cyclerion Therapeutics.

Product overview

Tisento Therapeutics is a clinical-stage biotechnology company developing novel medicines for diseases with significant unmet medical needs, beginning with MELAS (Mitochondrial Encephalomyopathy with Lactic Acidosis and Stroke-like Episodes) and other genetic mitochondrial diseases. The company's lead product is zagociguat, a once-daily oral first-in-class brain-penetrant sGC stimulator currently in Phase 2b clinical development (PRIZM study) for the treatment of MELAS. The pipeline also includes CY3018, a CNS-targeted sGC stimulator in IND-enabling studies. The company was founded in 2023 with an $81 million Series A financing and assets acquired from Cyclerion Therapeutics.

Differentiator

Problem solved

Functional benefit

Products and services

• Zagociguat Investigational once-daily, oral, first-in-class brain-penetrant soluble guanylate cyclase (sGC) stimulator that targets the nitric oxide-cyclic guanosine monophosphate (NO-sGC-cGMP) pathway to restore mitochondrial energy production and address both CNS and peripheral symptoms of MELAS and other genetic mitochondrial diseases. In Phase 2a, it showed favorable safety, CNS exposure, and improvements in neuronal function, mitochondrial biomarkers (FGF-21, GDF-15), and cerebral blood flow (BOLD MRI). It is currently being evaluated in the Phase 2b PRIZM study.
• CY3018 CNS-targeted soluble guanylate cyclase (sGC) stimulator in IND-enabling studies, acquired from Cyclerion Therapeutics. Part of Tisento's pipeline for serious diseases with unmet medical need.
• PRIZM Phase 2b Clinical Study Global Phase 2b randomized, placebo-controlled, crossover clinical study evaluating once-daily oral zagociguat 15 mg or 30 mg versus placebo for 12 weeks in approximately 44 adults and adolescents (ages 12+) with genetically and phenotypically defined MELAS. Primary endpoints include fatigue and cognitive function. Conducted at mitochondrial disease centers of excellence in the U.S., Italy, Germany, U.K., Australia, and Canada.
• PRIZM Open-Label Extension Study Open-label extension study (NCT06961344) providing long-term access to zagociguat for MELAS patients who completed the Phase 2b PRIZM study, evaluating long-term safety and tolerability for up to two years.

Quantifiable outcome

• In Phase 2a study (8 MELAS patients, 29-day treatment): excellent safety profile, CNS exposure confirmed, improvements in neuronal function, mitochondrial function (FGF-21, GDF-15 biomarkers), and cerebral blood flow (BOLD MRI)
• +2 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Five partnerships are on record, tiered core and minor.

• Cyclerion TherapeuticscoreStrategic or Co-development Partner · 31 July 2023Tisento acquired zagociguat and CY3018 (CNS-targeted sGC stimulator in IND-enabling studies) from Cyclerion Therapeutics in a strategic asset purchase transaction. Cyclerion received 10% equity ownership in Tisento with anti-dilution protection through $100 million post-money valuation, the right to purchase additional Tisento equity in the future, an $8 million upfront cash payment, and reimbursement for certain employee and development expenses totaling $10.4 million combined. Peter Hecht (CEO) also invested $5 million in Cyclerion in conjunction with the deal. Cyclerion shareholders benefit from future Tisento value creation without further financial or operational obligations.
• MitoActioncoreStrategic or Co-development PartnerMitoAction is a patient advocacy organization for mitochondrial disease. Tisento is sponsoring the first externally led Patient-Focused Drug Development (EL-PFDD) meeting dedicated to MELAS on February 10, 2026, which MitoAction is leading and hosting. Kira Mann (CEO of MitoAction) has publicly endorsed the company's patient-centric approach. Tisento also supported MitoAction's MELAS storytelling video series.
• United Mitochondrial Disease Foundation (UMDF)coreStrategic or Co-development PartnerUMDF is a patient advocacy organization for mitochondrial diseases. Philip Yeske (Science and Alliance Officer at UMDF) has publicly supported Tisento's MELAS interview study. Tisento presented at UMDF Mito Med conferences and Bench to Bedside events. UMDF series 'Our MELAS Stories' is featured on Tisento's website.
• Reagan-Udall Foundation for the FDAminorStrategic or Co-development PartnerThe Reagan-Udall Foundation for the FDA hosted a public workshop on Primary Mitochondrial Diseases (May 22, 2025) in collaboration with the FDA. Tisento's Chad Glasser presented the company's approach to developing zagociguat for MELAS at this workshop.
• VeraSafeminorOthersVeraSafe serves as Tisento's Data Protection Officer (DPO), EU Representative, and UK Representative for GDPR compliance purposes. Contact details provided in the Privacy Notice.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Stealth BioTherapeutics: Clinical-stage biotech developing therapies for mitochondrial diseases, including MELAS. Directly comparable as a rare mitochondrial disease drug developer with an asset in MELAS clinical development.
• Cyclerion Therapeutics: Originating developer of zagociguat and CY3018 before divesting the assets to Tisento. Most directly comparable because it developed the same sGC stimulator chemistry and CNS-focused pipeline strategy.
• Modis Therapeutics (Zogenix/UCB): Developed omaveloxolone (now approved as Skyclarys for Friedreich's ataxia) and had programs in mitochondrial disease including MELAS. Comparable as a rare mitochondrial disease therapeutic developer that reached late-stage clinical trials.
• Pretzel Therapeutics: Well-funded biotech developing therapies for mitochondrial diseases affecting neurological and muscular function. Directly comparable as a venture-backed mitochondrial disease drug developer with a similar stage and therapeutic focus.
• Khondrion: Clinical-stage biotech developing small-molecule therapies for primary mitochondrial diseases, including MELAS-related programs. Comparable as a rare mitochondrial disease drug developer targeting the same patient population.
• Abliva: Swedish clinical-stage biotech developing therapies for primary mitochondrial diseases. Comparable as a rare mitochondrial disease drug developer with similar regulatory pathways (EMA/FDA) and patient advocacy engagement.

Broad incumbents

• Bayer: Markets Adempas (riociguat), the only approved sGC stimulator. Comparable as the established player in sGC pharmacology, demonstrating commercial validation of the mechanism Tisento is exploiting in mitochondrial disease.
• Astellas Pharma: Acquired Mitobridge to build a mitochondrial disease franchise and has active rare disease programs. Comparable as a large pharmaceutical company with strategic interest in the same mitochondrial disease therapeutic space.
• Ultragenyx Pharmaceutical: Commercial-stage rare disease biotech with multiple approved therapies and active programs in metabolic/mitochondrial disorders. Comparable as an established rare-disease commercial model Tisento would likely need to partner with or emulate.
• Sanofi: Sanofi Ventures is already on Tisento's board, and Sanofi has a rare disease and specialty care franchise (e.g., Genzyme). Comparable as a strategic investor/acquirer with the rare disease commercial infrastructure Tisento would need for MELAS commercialization.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/tisentotx
• Facebookfacebook.com/tisentotx
• LinkedInlinkedin.com/company/tisentotx

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Funding overview

Funding rounds2 records

Investors6 records

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 Tisento Therapeutics