AbbVie's Small Molecule Drug ABBV-932 Receives IND Approval in China for Bipolar Disorder Treatment

Today (April 29), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China,AbbVie's Class 1 new drug ABBV-932 capsule has been approved for clinical trials and is proposed for development.Treatment of Bipolar Disorder (for the treatment of depressive episodes in bipolar disorder). Public information shows,ABBV-932 is a small molecule new drug, a selective D3 dopamine receptor modulator., by AbbVie andGedeon RichterCo-developed. This product is being developed as a monotherapy for bipolar disorder and generalized anxiety disorder. This is the first time the product has been approved for an IND in China.

Screenshot source: CDE official website

Bipolar disorder (also known as bipolar affective disorder) refers to a category of mood disorders that include both manic or hypomanic episodes and depressive episodes. The D3 receptor is primarily distributed in the limbic brain regions (such as the nucleus accumbens and prefrontal cortex), and its overactivation or dysfunction may be associated with the manic and depressive symptoms of bipolar disorder.The mechanism of D3 dopamine receptor modulators in treating bipolar disorder may involve regulating the function of the mesolimbic dopamine pathway, impacting emotional stability and the reward system.Studies have shown that D3 receptor antagonists can modulate dopaminergic neurotransmission, reduce excessive dopamine release during manic episodes, and improve low dopamine function during depressive episodes.

ABBV-932 is a DRD2 and DRD3 dopamine receptor modulator.In October 2024, AbbVie announcedGree PharmaReach a new discovery, co-development, and licensing agreement to advance potential new targets for the treatment of neuropsychiatric disorders. This collaboration includes the discovery of ABBV-932 for the treatment of bipolar depressive episodes and generalized anxiety disorder.

According toClinicalTrialsAccording to the official website, AbbVie is currently conducting two Phase II clinical trials for ABBV-932, respectively.For Generalized Anxiety Disorder, Bipolar I Disorder/Bipolar II Disorder Depressive Episodes. The approval of this product for clinical use in China means that it is about to undergo clinical research in China.

[2] AbbVie Official Website. Fromhttps://www.abbvie.com/science/pipeline.html

[3]AbbVie and Gedeon Richter Announce New Collaboration for the Discovery and Development of Novel Targets for Neuropsychiatric Conditions. Retrieved Oct 24，2024, From https://www.gedeonrichter.com/-/media/sites/hq/documents/investors/announcements/2024/20241024_bus_cns_abbvie/abbvie-gedeon-richter-neuro-collab-expansion_24oct2024_en.pdf?rev=74b5194dadef461dbdb555e22d3dc72f&hash=367CCB52B51853FF0E49457C7B4A4119