CSPC drug for depression cleared for US clinical trials

CSPC Pharmaceutical Group Limited announced that its selective 5-HT2A receptor agonist, SYH2056 tablets, has secured approval from the U.S. Food and Drug Administration to commence clinical trials in the U.S. This Class 1 new chemical drug also received clinical trial approval in China in November 2025.

The product is designed to treat major depressive disorder by activating the 5-HT2A receptor, aiming for rapid onset and long-lasting effects without hallucination risk. Preclinical studies indicate the drug's potential to promote neural remodeling and demonstrated strong antidepressant activity while minimizing the risk of hallucination associated with this target.

The group highlights SYH2056's favorable pharmacokinetic characteristics and safety, positioning it as a potential "best-in-class" antidepressant, addressing a significant unmet clinical demand. Multiple patent applications for the product have been submitted both domestically and internationally.