AbbVie’s Schizophrenia Drug Emraclidine Misses Key Goal In Phase 2 Trials But Shows Safety

AbbVie announced that its Phase 2 EMPOWER-1 and EMPOWER-2 trials for emraclidine did not meet the primary goal of showing a statistically significant improvement on the Positive and Negative Syndrome Scale (PANSS) at six weeks compared to the placebo.

Emraclidine is an oral, once-daily monotherapy intended for adults with schizophrenia experiencing acute psychotic symptoms.

"While disappointed with the results, we continue analysing the data to determine the next steps. We would like to extend our gratitude to the study participants, their loved ones, and our network of clinical investigative sites for their participation in these trials. We are confident that our innovative pipeline will continue to bring meaningful therapies to patients, and we remain committed to finding better treatments for people living with psychiatric and neurological disorders,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.

The EMPOWER trials indicated that emraclidine was generally well-tolerated, with a safety profile similar to that observed in the Phase 1b study. The most frequent side effects reported in the EMPOWER-1 and EMPOWER-2 trials included headache with rates of 9.4% and 10.8% for placebo and ranging from 13.0% to 14.6% across different doses of emraclidine along with dry mouth, and dyspepsia. 

AbbVie continues to prioritise neuroscience research. Through its acquisition of Cerevel, the company has expanded its neuroscience pipeline, adding several clinical and preclinical candidates that align with its existing portfolio of treatments in psychiatry, migraine, and Parkinson’s disease.