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A Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Individuals With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)

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Trial Profile

A Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Individuals With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 03 Sep 2024

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At a glance

  • Drugs Zagociguat (Primary)
  • Indications Lactic acidosis; Mitochondrial encephalomyopathies; Stroke
  • Focus Adverse reactions
  • Sponsors Tisento Therapeutics

    • Most Recent Events

    • 31 Jul 2023 According to Cyclerion Therapeutics media release, Tisento is launching with an $81 million Series A financing to support its development of the Phase 2 soluble guanylate cyclase (sGC) stimulator zagociguat in MELAS
    • 27 Mar 2023 According to a Cyclerion Therapeutics media release, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to zagociguat (previously CY6463) for the treatment of mitochondrial diseases.
    • 22 Mar 2023 According to a Cyclerion Therapeutics media release, company recently filed a request with FDA for Orphan Drug Designation and manufactured drug product to support this trial.

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