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Tablets

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA, Taiwan
Comments
Indication: Alzheimer's disease — targeting neuroinflammation in early-to-moderate AD Clinical stage: Phase 2 — approved by Taiwan FDA (TFDA) September 2023; Phase 2 trial ongoing Modality: Small molecule (selective, brain-penetrant CSF-1R inhibitor) Mechanism / Target: Selective inhibitor of colony stimulating factor 1 receptor (CSF-1R) with good blood-brain barrier penetration; specifically suppresses activated microglia by blocking CSF-1R-driven microglial proliferation and pro-inflammatory activation; reduces neuroinflammation-related gene expression (TREM2, Iba1) while preserving normal microglial surveillance function Route / form: Oral tablet/capsule Differentiation: First brain-penetrant CSF-1R inhibitor targeting neuroinflammation in Alzheimer's — a mechanism entirely distinct from amyloid/tau approaches;
Manufacturer #39349
Clinical-stage biotech developing Rx precision immunotherapies for Alzheimer's disease and vitiligo through innovative immune-targeting mechanisms. International team spanning Asia and North America advances a biologic pipeline through clinical development stages. Focused on immune mechanism-based approaches for underserved neurodegenerative and autoimmune conditions.

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