Axsome Therapeutics acquires global rights to balipodect, a PDE10A inhibitor, from Takeda Pharmaceutical Company, targeting Schizophrenia and Tourette syndrome, with Phase 3 plans in 2026.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Axsome Therapeutics has expanded its neuroscience pipeline through an asset purchase agreement with Takeda Pharmaceutical Company, securing exclusive global rights to TAK-063 (balipodect), a novel oral phosphodiesterase 10A (PDE10A) inhibitor. The company plans to advance the candidate for the treatment of Schizophrenia and Tourette syndrome, with Phase 3 trial-enabling activities in schizophrenia expected to begin in 2026.
Balipodect represents a potential first-in-class approach targeting PDE10A, an enzyme expressed in medium spiny neurons of the striatum. By modulating intracellular signaling pathways downstream of dopamine D1 and D2 receptors, the therapy aims to address multiple symptom domains associated with neuropsychiatric disorders.
The candidate has already completed a 164-patient Phase 2 proof-of-concept study in schizophrenia and has demonstrated a favorable safety and tolerability profile across clinical studies involving more than 360 participants. Balipodect has not shown increases in glucose or prolactin levels in studies to date, suggesting a differentiated safety profile compared with traditional antipsychotics.
Under the terms of the agreement, Axsome gains worldwide development, manufacturing, and commercialization rights. Takeda will receive an upfront payment and remains eligible for development, regulatory, and commercial milestone payments for the first two indications, along with royalties on future global net sales.
Herriot Tabuteau, MD, Chief Executive Officer of Axsome said that adding balipodect strengthens the company’s neuroscience pipeline, highlighting its potential first-in-class mechanism for multiple neuropsychiatric disorders. He emphasized Axsome’s readiness to advance development in schizophrenia and Tourette syndrome, noting the drug could enhance their portfolio of differentiated brain health treatments.
Schizophrenia remains a highly burdensome condition, affecting approximately 3.7 million individuals in the United States alone. It is characterized by positive symptoms such as hallucinations and delusions, negative symptoms including social withdrawal and reduced emotional expression, and cognitive impairment. Despite available treatments, significant unmet need persists, particularly for therapies addressing the full spectrum of symptoms with improved safety.
With the addition of balipodect, Axsome continues to build a differentiated CNS portfolio focused on novel mechanisms, aiming to improve outcomes across complex neuropsychiatric disorders.
Reference
Axsome Therapeutics Acquires Selective PDE10A Inhibitor Balipodect for the Treatment of Schizophrenia and Other Neuropsychiatric Conditions, 01 April 2026, Axsome Therapeutics Acquires Selective PDE10A Inhibitor Balipodect for the Treatment of Schizophrenia and Other Neuropsychiatric Conditions | Axsome Therapeutics, Inc.
About the Writer
Chikkula Pavan Kumar, Pharm.D is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.
