A total of 161 patients were randomized to enter one of three active (low, medium or high dose) treatment arms or placebo. The primary endpoint was the Montgomery Asberg Depression Rating Scale (MADRS) total score. In the study, the overall difference observed between the drug-treated and placebo-treated groups was not statistically significant, however, in a pre-specified subgroup analysis of bipolar 1 patients, an efficacy signal was observed. ABBV-932 was generally safe and well-tolerated across all doses studied. The safety profile of ABBV-932 was generally similar to placebo, including rates of extrapyramidal side effects, demonstrating the potential for a more favorable tolerability profile compared to cariprazine, an original drug discovered also by Richter and being commercialized in various indications, including bipolar 1 depression in the US. The evaluation of potential next steps to continue development of ABBV-932 (RGH-932) in bipolar 1 depression is ongoing.

ABBV-932 (RGH-932) is also being investigated in generalized anxiety disorder in a Phase II study.

About the Study

This was a randomized double-blind, placebo-controlled, fixed-dose group study that evaluated the efficacy, safety and tolerability of once-daily dosed ABBV-932 (RGH-932) in patients with bipolar depression. Following a washout period, a total of 161 patients between ages 18 and 65 years old were randomized to receive ABBV-932 (RGH-932) at one of three dose levels or placebo. The primary endpoint was defined as a change from baseline to Week 6 in the MADRS total score compared to placebo treatment. 

About ABBV-932 (RGH-932)

ABBV-932 (RGH-932), discovered by researchers at Gedeon Richter, is an investigational drug being co-developed for the treatment of certain neuropsychiatric disorders by AbbVie and Gedeon Richter.

About Richter

Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.8bn and sales of EUR 2.3bn in 2025, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com

For further information:

Investors:        Róbert Réthy, CFA                                                                +36 20 342 2555 

Media:               Zsuzsa Beke                                                                           +36 20 916 4507