Codabakalner is a First-in-Class Investigational Therapy Entering Phase 2b/3 Development for Fragile X Syndrome

LOS ANGELES, July 16, 2026 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering novel therapeutics that have the potential to restore synapses to improve the lives of patients worldwide, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization has approved "codabakalner" as the non-proprietary name for the Company's investigational therapy, SPG601.

Codabakalner is a first-in-class, oral investigational therapy being developed for the treatment of Fragile X syndrome (FXS), the leading inherited cause of intellectual disability and a known genetic cause of autism. The therapy is designed to positively modulate large-conductance calcium-activated potassium (BK) channels to correct specific synaptic dysfunctions that underlie many of the core cognitive, behavioral, and sensory symptoms associated with FXS.

"Approval of the non-proprietary name codabakalner marks another important milestone in the advancement of our Fragile X syndrome program," said Dr. Stella Sarraf, CEO and Founder of Spinogenix. "As we prepare for the CLARITY Phase 2b/3 trial, establishing a globally recognized non-proprietary name reflects the maturity of the program and our commitment to bringing this first-in-class therapy to patients living with Fragile X syndrome. We are focused on advancing codabakalner as a potential treatment capable of addressing the underlying synaptic dysfunction that drives many of the core symptoms of this devastating condition."

Spinogenix is a proud sponsor of this year's NFXF International Fragile X Conference in Louisville, KY, where Chief Medical Advisor, Craig Erickson, MD, will be presenting to share the new INN, codabakalner. Dr. Erickson will also share updates regarding CLARITY, Spinogenix's Phase 2b/3 trial evaluating the efficacy, safety, and tolerability of codabakalner in male patients with FXS.

Commonly referred to as a generic name, each International Nonproprietary Name (INN) is a unique name assigned by the World Health Organization to identify pharmaceutical substances and active pharmaceutical ingredients. A globally recognized non-proprietary name facilitates the clear identification, safe prescribing, and consistent communication of medicines throughout their development and eventual clinical use.

About Codabakalner

Codabakalner (SPG601) is an oral investigational medication being developed to treat FXS by mitigating key underlying abnormalities in synaptic function and neural excitability. FXS involves a reduction in the activity of large conductance, calcium-activated potassium (BK) channels, which contributes to synaptic dysfunction, cortical hyperexcitability, and multiple symptoms of FXS. Codabakalner, a novel small molecule, is the first positive modulator of BK channels to be clinically evaluated in FXS patients in a Phase 2a study and demonstrated the potential to improve cognitive, emotional, and sensory symptoms by boosting BK channel activity. Codabakalner has received both Orphan Drug designation and Fast Track designation from the FDA for FXS, as well as orphan medicinal product designation from the EMA. Plans for the CLARITY registrational-directed Phase 2b/3 trial have been agreed to with the FDA.

About Spinogenix

Current treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction.

Spinogenix is developing two novel therapeutics: Tazbentetol (SPG302), which is designed to trigger neurons to produce new glutamatergic synapses and restore cognitive, motor, and other functions in ALS, Alzheimer's disease, schizophrenia and other diseases; and codabakalner (SPG601), which is designed to work at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS) that underlie many core symptoms. The company has received FDA and EMA Orphan Drug Designations for ALS as well as FDA Orphan Drug and Fast Track designations for FXS. More information on Spinogenix can be found at www.spinogenix.com or follow us on LinkedIn.

Media Contact

Daniel Davis
FINN Partners for Spinogenix
daniel.davis@finnpartners.com

Investor Relations 

Sasha Damouni Ellis
Spinogenix, Inc.
ir@spinogenix.com 

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SOURCE Spinogenix