The approval of the International Nonproprietary Name (INN) provides a globally recognized identifier for the drug, which functions by modulating large-conductance calcium-activated potassium (BK) channels. By targeting these channels, the therapy aims to correct the synaptic dysfunctions and cortical hyperexcitability that drive the core cognitive, behavioral, and sensory symptoms of Fragile X syndrome. Dr. Stella Sarraf, CEO and founder of Spinogenix, noted that the designation reflects the program's maturation as the company prepares for the CLARITY Phase 2b/3 registrational trial.
In section Releases
Spinogenix Secures WHO Approval for Codabakalner as SPG601 Name
The World Health Organization has officially designated the investigational therapy SPG601 as codabakalner, a key regulatory milestone for the first-in-class drug. Developed by Los Angeles-based Spinogenix, the oral treatment is currently entering Phase 2b/3 testing as a potential breakthrough for Fragile X syndrome, the leading inherited cause of intellectual disability.
Chief Medical Advisor Dr. Craig Erickson is set to present the new name and provide trial updates at the upcoming NFXF International Fragile X Conference in Louisville. Codabakalner has already secured Orphan Drug and Fast Track designations from the FDA, along with orphan medicinal product status in the European Union. Beyond this program, Spinogenix continues to explore its broader pipeline of synaptic regenerative therapeutics, including the small molecule Tazbentetol, which targets synaptic loss in conditions such as ALS and Alzheimer’s disease.
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