WHO Approves 'Tazbentetol' as International Name for Spinogenix's First-in-Class Synaptic Regenerative Therapy
核心洞察
The World Health Organization's International Nonproprietary Names Expert Committee approved 'tazbentetol (搜索)' as the non-proprietary name for Spinogenix (搜索)'s investigational synaptic regenerative therapy SPG302.
Tazbentetol (搜索) represents a first-in-class oral therapy designed to restore synaptic function and potentially reverse cognitive, motor, respiratory and sensory function declines in neurodegenerative diseases.
The therapy is currently being evaluated in Phase 2 clinical trials for Alzheimer's disease, ALS, and schizophrenia, with topline results expected this week.
Spinogenix (搜索), Inc. announced that the World Health Organization's International Nonproprietary Names (INN) Expert Committee has approved 'tazbentetol (搜索)' as the non-proprietary name for the company's synaptic regenerative therapy SPG302. The approval represents a significant regulatory milestone for the first-in-class oral investigational therapy being developed to restore synaptic function in multiple neurodegenerative and psychiatric conditions.
First-in-Class Synaptic Regenerative Approach
Tazbentetol (搜索) is positioned as a first-in-class therapeutic with the unique potential to restore synapses, the critical connections between neurons that enable cognitive function, movement control, and sensory processing. Unlike current treatments for neurodegenerative conditions that primarily focus on slowing disease progression or minimizing symptoms, tazbentetol's synaptic regenerative activity has the potential to reverse declines in cognitive, motor, respiratory, and sensory function.
The therapy works by triggering neurons to produce new glutamatergic synapses, offering a paradigm-shifting approach to treating diseases characterized by synaptic degeneration and dysfunction. This mechanism represents a departure from conventional therapeutic strategies and positions tazbentetol (搜索) as a potentially restorative treatment option.
Clinical Development Program
Tazbentetol (搜索) is currently being evaluated across three major disease indications through separate clinical trials. The therapy is under investigation for Alzheimer's disease (NCT06427668), ALS (NCT05882695), and schizophrenia (NCT06442462). The company has achieved significant regulatory recognition, with tazbentetol receiving Orphan Drug Designation from both the FDA and European Medicines Agency for ALS treatment.
Dr. Stella Sarraf, Chief Executive Officer and Founder of Spinogenix (搜索), emphasized the significance of the INN approval, stating, "Approval of the non-proprietary name tazbentetol (搜索) is an important milestone in the development and potential future commercialization of our synaptic regenerative therapies." She noted that the timing coincides with planned announcements of topline results from the Phase 2a study in Alzheimer's disease at the CTAD conference and ALS results at the MNDA conference this week.
Upcoming Data Readouts
The company is preparing to release critical Phase 2a data for both Alzheimer's disease and ALS indications, with results expected to be presented at major medical conferences this week. Additionally, Spinogenix (搜索) is approaching completion of enrollment for its ongoing Phase 2 clinical trial in schizophrenia, marking progress across its multi-indication development strategy.
Broader Pipeline Development
Beyond tazbentetol (搜索), Spinogenix (搜索) is developing SPG601, a second therapeutic that works at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS). The company has received FDA Orphan Drug and Fast Track designations for FXS, demonstrating regulatory support for its synaptic corrective approach.
The INN approval provides tazbentetol (搜索) with a unique, globally recognized identifier essential for future commercialization. Each INN serves as a standardized name used worldwide to ensure clear identification, safe prescription, and proper dispensing of pharmaceutical substances to patients.