COMPANY

Tisento Therapeutics

HQ: Cambridge, MA source · tisentotx.com ↗

Location: Cambridge, MA · source · Oct 14, 2026

Profile checked Oct 10, 2026

Keywords: Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome) Other Alzheimer's Disease With Vascular Pathology Schizophrenia CY6463 IW-6463 zagociguat

7Trials (company is sponsor)

Timeline

Aug 18, 2025 Trial start Phase 2: An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM) source ↗
Sep 10, 2024 Trial start 2: A Phase 2b Study of Zagociguat in Patients With MELAS source ↗
Nov 2, 2021 Trial start Phase 2: A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology source ↗
Sep 10, 2021 Trial start Phase 1: Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia source ↗
Nov 13, 2020 Trial start 2: Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS) source ↗
Jan 6, 2020 Trial start Phase 1: IW-6463 Safety Study in Healthy Elderly Subjects source ↗
Feb 6, 2019 Trial start Phase 1: A Study of IW-6463 in Healthy Volunteers source ↗

Upcoming milestones

2028-07 (ESTIMATED) · Phase 2 · An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM) · NCT06961344

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 7

Record	Title	Phase	Status	Start	Primary completion
NCT06402123	A Phase 2b Study of Zagociguat in Patients With MELAS	2	Completed	Sep 10, 2024	Jun 29, 2026 (actual)
NCT06961344	An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)	Phase 2	Active, not recruiting	Aug 18, 2025	2028-07 (estimated)
NCT04798989	A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology	Phase 2	Terminated	Nov 2, 2021	Nov 28, 2022 (actual)
NCT04475549	Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)	2	Terminated	Nov 13, 2020	Jan 23, 2022 (actual)
NCT03856827	A Study of IW-6463 in Healthy Volunteers	Phase 1	Completed	Feb 6, 2019	Oct 22, 2019 (actual)
NCT04240158	IW-6463 Safety Study in Healthy Elderly Subjects	Phase 1	Terminated	Jan 6, 2020	May 22, 2020 (actual)
NCT04972227	Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia	Phase 1	Completed	Sep 10, 2021	Apr 18, 2022 (actual)