Intramuscular Generic Injection (QLG2072) versus Haloperidol in Chinese Patients with Acute Agitation: A Phase 3...

This multicenter, randomized, double-blind, phase 3 trial aimed to assess the efficacy and safety of generic olanzapine injection (QLG2072) in managing acute agitation associated with schizophrenia/bipolar I disorder in Chinese patients.

Patients with acute agitation associated with schizophrenia/bipolar I disorder were randomly (1:1) assigned to receive 1-3 intramuscular (IM) injections within a 24-hour treatment period, with either QLG2072 (10 mg per injection) or haloperidol (7.5 mg per injection). The primary endpoint was the change in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score from baseline to 2 hours post-injection, assessed against a pre-specified non-inferiority margin of 2.0 for QLG2072 versus haloperidol.

A total of 318 participants were randomized; 159 and 158 were included in the olanzapine and haloperidol FAS groups, respectively. At 2 h post-injection, the adjusted mean reductions in PANSS-EC scores were -9.37 (95% confidence interval [CI]: -10.02 to -8.72) for QLG2072 versus -9.40 (95% CI: -10.04 to -8.75) for IM haloperidol with a between-group difference of 0.03 (95% CI: -0.88 to 0.93), establishing non-inferiority of QLG2072 to IM haloperidol, as the upper limit of the 95% CI fell below the predefined margin. Consistent with the primary endpoint, comparable efficacy was observed across multiple secondary efficacy measures, including response rate and the Clinical Global Impression-Improvement scores. The overall incidence of treatment-emergent adverse events was comparable between the treatment groups. However, QLG2072 was associated with a numerically lower incidence of extrapyramidal symptoms compared to haloperidol (10.1% vs 27.2%).

QLG2072 demonstrated non-inferiority to haloperidol in acute agitation management, with comparable efficacy and favorable neurological tolerability. These findings support its clinical application in Chinese psychiatric populations.

ClinicalTrials.gov: NCT05803642.