Balipodect, an oral selective phosphodiesterase 10A inhibitor originally developed by Takeda Pharmaceutical (NYSE: TAK) as TAK-063, has changed hands in an asset purchase agreement that gives Axsome Therapeutics (NASDAQ: AXSM) exclusive worldwide commercial, development, and manufacturing rights. The Axsome balipodect acquisition, announced April 1, 2026, adds a clinical-stage small molecule to Axsome's CNS portfolio, with initial development planned for schizophrenia and Tourette syndrome. Balipodect completed a 164-patient proof-of-concept Phase II trial in schizophrenia in July 2016, and has been evaluated in more than 360 individuals across clinical studies to date. Axsome said it intends to begin Phase III trial-enabling activities for the schizophrenia indication in 2026.
Takeda received an undisclosed upfront payment at signing and is eligible for development, regulatory, and commercial milestone payments tied to the first two indications, plus royalties on potential global net sales. The specific amounts were not disclosed.
Deal context
PDE10A is an enzyme expressed selectively in medium spiny neurons of the striatum, a region central to dopaminergic signaling implicated in psychotic and movement disorders. Balipodect inhibits PDE10A, which according to the company regulates cyclic AMP and cyclic GMP levels downstream of dopamine D1 and D2 receptor signaling in those neurons. Published preclinical characterization of TAK-063 describes antipsychotic-like activity in rodent models and a profile of balanced activation of direct and indirect striatal pathways. In clinical studies, balipodect did not increase glucose or prolactin levels, a metabolic profile the company attributes to the striatal selectivity of PDE10A expression and the molecule's action downstream of dopamine receptors. Axsome describes balipodect as a potentially first-in-class selective PDE10A inhibitor, though PDE10A inhibition as a mechanism has been explored by other companies, including Pfizer, whose PDE10A program did not advance to approval.
Schizophrenia affects approximately 3.7 million people in the United States and is characterized by positive symptoms such as hallucinations and delusions, negative symptoms including social withdrawal and diminished motivation, and cognitive deficits. Current approved therapies primarily act through dopamine D2 receptor antagonism or partial agonism, and the negative and cognitive symptom domains remain areas of unmet need. Balipodect's mechanism, acting downstream of D1 and D2 receptors rather than directly blocking them, is mechanistically distinct from approved antipsychotics.
Spot something wrong? Report an issue with this article