The 8-week open-label Phase 4 trial enrolled 105 adults with schizophrenia on stable atypical antipsychotics to evaluate two cross-titration strategies to Cobenfy monotherapy at a target dose of 125/30 mg BID. Participants underwent either a 4-week or 2-week taper of their prior therapy while up-titrating Cobenfy over two weeks, with all-cause discontinuation as the primary endpoint.

Mean Positive and Negative Syndrome Scale (PANSS) scores fell by 4.2 points in the slower 4-week taper group and by 3.1 points in the faster 2-week taper group over 8 weeks. Clinical Global Impression-Severity (CGI-S) scores improved by 0.2 points across both arms, and Personal and Social Performance (PSP) scores increased by 1.1 and 0.7 points in the slower and faster taper groups, respectively.

Treatment-emergent adverse events occurred in 49% of participants, none serious, with early discontinuations due to AEs in 1.9% of the slower group and 3.8% of the faster group. No patients discontinued due to lack of efficacy, and no new safety signals emerged compared to previous trials.

Stable symptom control regardless of taper speed and low discontinuation rates provide actionable guidance for clinicians considering switching adult patients with schizophrenia to Cobenfy, highlighting its potential as a differentiated therapeutic option.