AbbVie Revamps Strategy for Emraclidine After Schizophrenia Trial Setback

AbbVie, a leading pharmaceutical company, is recalibrating its approach to the development of emraclidine following disappointing results in Phase II trials for schizophrenia. The company is now exploring alternative applications for the drug while reporting strong financial performance across other areas of its portfolio.

Emraclidine's New Direction

After emraclidine failed to meet its primary endpoint in the EMPOWER Phase II trials for schizophrenia, AbbVie is pivoting its strategy. The drug, initially positioned as a potential monotherapy, will now be advanced as an adjunct treatment in combination with existing therapies for schizophrenia.

Robert Michael, CEO of AbbVie, stated, "We still see opportunity in adjunctive schizophrenia as well as neurodegenerative psychosis, and we haven't completely given up on the monotherapy opportunity either, but that's a more heavily risk adjusted opportunity now."

The company plans to conduct a multiple ascending dose study this year, with data expected in early 2026. If higher doses show improved efficacy, AbbVie may reconsider emraclidine as a monotherapy for schizophrenia.

Expanding Therapeutic Horizons

Despite the setback in schizophrenia, AbbVie sees potential for emraclidine in other neurological disorders. Roopal Thakkar, AbbVie's executive vice president of research and development and chief scientific officer, outlined plans to explore the drug's efficacy in Alzheimer's and Parkinson's-related psychosis.

"When assessing sites beyond those with high placebo response, a clear efficacy signal was observed, albeit more modest than reported in PhaseIb," Thakkar explained. "Therefore, we see a path forward as an adjunct to atypicals in schizophrenia and as a monotherapy in psychosis related to Alzheimer's and Parkinson's."

The company is currently conducting dose-ranging studies for these indications, with Phase II trials planned for 2026.

Financial Performance and Portfolio Strength

Despite the $3.5 billion impairment charge related to emraclidine, AbbVie reported strong financial results for the fourth quarter and full year of 2024. The company's revenue reached $56.334 billion for the year, a 3.7% increase from the previous year.

Key drivers of growth included Skyrizi and Rinvoq, which generated $11.718 billion and $5.971 billion in global sales, respectively. The neuroscience portfolio also performed well, collecting about $9 billion, a 16.6% increase over the prior year.

While Humira sales continued to decline due to biosimilar competition, earning just under $9 billion for the full year, the overall financial outlook remains positive. AbbVie's earnings per share (EPS) for the fourth quarter hit $2.16, surpassing analyst estimates of $2.06.