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About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Not yet reported

zagociguat

Company
Tisento Therapeutics
Mechanism
Mechanism not yet reported
Route
Route not yet reported
Recruiting trials
None currently listed

Efficacy results: Not yet reported

No recruiting studies currently listed

See all studies for this drug

Data source: ClinicalTrials.gov · trial data as of Oct 7, 2026

Trial details
  • Completed NCT NCT03856827

    A Study of IW-6463 in Healthy Volunteers

    Not yet reported Tisento Therapeutics 110 participants Est. completion 2019-10-22 1 site Stand-alone
    Other conditions: Other
    View official trial listing →
  • Terminated NCT NCT04240158

    IW-6463 Safety Study in Healthy Elderly Subjects

    Not yet reported Tisento Therapeutics 24 participants Est. completion 2020-05-22 1 site Stand-alone
    Other conditions: Other
    View official trial listing →
  • Terminated NCT NCT04475549

    Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)

    Not yet reported Tisento Therapeutics 8 participants Est. completion 2022-01-23 5 sites Stand-alone
    Other conditions: MELAS
    View official trial listing →
  • Terminated NCT NCT04798989

    A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology

    Not yet reported Tisento Therapeutics 12 participants Est. completion 2022-11-28 5 sites Stand-alone
    Other conditions: Alzheimer's Disease With Vascular Pathology
    View official trial listing →
  • Completed NCT NCT04972227

    Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia

    Not yet reported Tisento Therapeutics 48 participants Est. completion 2022-04-18 2 sites Stand-alone
    Other conditions: Schizophrenia
    View official trial listing →
  • Completed NCT NCT06402123

    A Phase 2b Study of Zagociguat in Patients With MELAS

    Not yet reported Tisento Therapeutics 43 participants Est. completion 2026-06-29 20 sites Stand-alone
    Cardiovascular disease
    View official trial listing →
  • Active, not recruiting NCT NCT06961344

    An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)

    Not yet reported Tisento Therapeutics 44 participants Est. completion 2028-07 16 sites Stand-alone
    Cardiovascular disease
    View official trial listing →
Efficacy history

Not yet reported.

Safety

Not yet reported.

Sources

Also known as: zagociguat, zagociguat 15mg, IW-6463, CY6463, zagociguat 30mg

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.