Global pharma major Bristol Myers Squibb has announced encouraging results from a Phase 4 trial evaluating the safety, tolerability, and symptom stability of Cobenfy (xanomeline and trospium chloride) in adults with schizophrenia switching from an oral atypical antipsychotic.

 

Over 8 weeks, patients remained stable, with mean PANSS scores staying below baseline and no new safety signals observed, regardless of whether the switch was conducted over two or four weeks. The findings, presented at the 2026 Annual Congress of the Schizophrenia International Research Society in Florence, Italy, offer crucial guidance for clinicians managing treatment transitions.

 

“While transitioning patients is common in schizophrenia, clinicians have historically had limited data to help guide these decisions, especially for differentiated treatments like Cobenfy,” said David Walling, principal investigator and chief clinical officer at Cenexel – CNS. 

 

“The data presented today provide much-needed insight into what happens during a switch to Cobenfy, notably that patients remained stable through 8 weeks of treatment regardless of a slower or faster cross-titration, which will help healthcare professionals make informed treatment decisions for adults living with schizophrenia.”

 

The open-label trial involved 105 adults with schizophrenia who were on a stable dose of an oral atypical antipsychotic for at least six weeks. Patients underwent either a faster 2-week or slower 4-week taper of their existing medication while titrating up to the target Cobenfy dose of 125/30 mg BID.

 

“Cobenfy represents a fundamentally different approach to treating schizophrenia as the first novel mechanism in decades, and physicians are naturally curious as to how they can switch and transition adult patients with schizophrenia to this innovative medication,” said Harald Hampel, senior vice president, worldwide head of neuroscience, global medical affairs, at Bristol Myers Squibb. 

 

“We carefully designed this trial with the scientific rigor and curiosity in mind, knowing that treatment decisions are not made lightly, and patient benefit, safety and stability is our ultimate goal.”