PDE10A Inhibition in Schizophrenia: A Randomised, Placebo-Controlled Phase 2 Study of Alofropodect (CPL'36) in Patients Experiencing Acute Schizophrenia.
CNS DrugsJul 31, 2026 (epub)
Maciej Wieczorek, Napoleon Waszkiewicz, Ewa Gromniak-Haniecka et al.
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In 30 seconds
This phase 2, randomized, double-blind, placebo-controlled trial evaluated the efficacy of alofropodect, a PDE10A inhibitor, in 189 hospitalized patients with acute schizophrenia. The study found significant improvements in the PANSS positive subscale at week 4, with alofropodect 20 mg showing a reduction of -3.70 and 40 mg showing -6.35 compared to placebo, both statistically significant.
Key findings
- Alofropodect 20 mg reduced PANSS positive subscale by -3.70 compared to placebo (p < 0.001).
- Alofropodect 40 mg reduced PANSS positive subscale by -6.35 compared to placebo (p = 0.001).
- Clinical response was observed in 42.3% of patients receiving 40 mg alofropodect at week 4.
- Alofropodect was well tolerated with low rates of serious adverse events.
Why it matters
The findings suggest that alofropodect may provide a new therapeutic option for managing acute schizophrenia symptoms, potentially improving patient outcomes. Its favorable safety profile also supports its further investigation.