SUMMARY  

• After CAPLYTA dosing, the absolute bioavailability of lumateperone is about 4.4%. Peak plasma concentration (C_max) of lumateperone is reached approximately 1-2 hours after CAPLYTA dosing.¹ 
  • Ingestion of a high-fat meal with CAPLYTA lowered lumateperone mean C_max by 33% and increased mean area under the concentration vs time curve (AUC) by 9%. Median time to maximum plasma concentration (T_max) was delayed about 1 hour (from 1 hour at fasted state to 2 hours in the presence of food). 
• Following once daily oral administration of CAPLYTA, lumateperone steady state is reached in about 5 days.¹ 
• Lumateperone steady-state exposure is approximately dose-proportional in the range of 3.5 mg to 56 mg (0.08 to 1.3 times the approved recommended daily dosage).¹ 
• A large inter-subject variability in lumateperone pharmacokinetic (PK) parameters was observed, with coefficients of variation for C_max and AUC ranging from 68% to 97% at steady state.¹  

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) conducted on 13 October 2025 did not identify any relevant citations pertaining to this topic.