Trial reportDrug design, development and therapy2026
Intramuscular Generic Injection (QLG2072) versus Haloperidol in Chinese Patients with Acute Agitation: A Phase 3 Multicenter, Randomized, Double-Blind, Active-Controlled Trial.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05803642 (A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.
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29 authors.
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Abstract
Introduction: 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. Methods: 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. Results: 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%). Discussion: 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. Trial Registration: ClinicalTrials.gov: NCT05803642.
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