A Phase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Individuals With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
Latest Information Update: 21 Nov 2023
At a glance
- Drugs Zagociguat (Primary)
- Indications Lactic acidosis; Mitochondrial encephalomyopathies; Stroke
- Focus Adverse reactions
- Sponsors Tisento Therapeutics
- 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.