Cobenfy for Treatment of Schizophrenia Now Approved in China

A New Drug Application for Cobenfy (xanomeline-trospium) has been approved by China’s National Medical Products Administration (NMPA), Zai Labs announced today.¹ The NMPA approved the medication for treatment of schizophrenia in adults.

The approval was supported by data from a phase 1 pharmacokinetics study in China, a phase 3 study in China, and 3 global EMERGENT studies. The phase 3 study in China was a multicenter, 2-part study with a 5 week double-blind, randomized, placebo-controlled phase and a 12 week open-label extension phase.² The study evaluated efficacy and safety of xanomeline-trospium in acutely psychotic hospitalized adult subjects with schizophrenia (as defined by the DSM-5). Over 200 patients in China were enrolled in the phase 3 study, and it ran from 2023 to 2024. The 3 EMERGENT trials confirmed that Cobenfy is efficacious and well-tolerated in patients with schizophrenia who are experiencing acute psychosis. EMERGENT-3, the most recent of these global trials, was a phase 3 double-blind, randomized, placebo-controlled trial of 256 patients with schizophrenia.³ Results showed that Cobenfy was associated with a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale total scores compared with placebo.

“We are pleased to receive NMPA approval for Cobenfy marking a groundbreaking milestone for schizophrenia care in China,” said Rafael G. Amado, MD, president, head of global research and development at Zai Lab, in a press release.¹ “With its broad symptom improvement and unique safety profile, Cobenfy has the potential to redefine how schizophrenia can be managed, and we look forward to bringing this transformative therapy to patients as soon as possible,” he added.

Earlier this year, the Chinese Medical Association released the China Schizophrenia Prevention and Treatment Guidelines for 2025, which included Cobenfy as a novel treatment. These guidelines were the first national-level guidance to include Cobenfy for treatment of schizophrenia. Cobenfy is also the first schizophrenia treatment with a novel mechanism of action to be approved in over 70 years.

“Cobenfy represents the first truly new therapeutic approach for schizophrenia in decades,” noted Gang Wang, MD, dean of Beijing Anding Hospital, Capital Medical University and the leading principal investigator for the Phase 3 China study.¹ Wang highlighted that “Cobenfy has demonstrated comprehensive improvement across positive, negative and cognitive symptoms, while avoiding many of the adverse effects commonly associated with traditional antipsychotics, including weight gain, hyperprolactinemia, and a problematic movement disorder called extrapyramidal symptoms, offering a meaningful new option for patients.”

Cobenfy is a combination of an M1/M4-preferring muscarinic acetylcholine receptor agonist and a muscarinic acetylcholine receptor antagonist. The xanomeline stimulates muscarinic receptors implicated in psychiatric conditions like schizophrenia, which is a differing mechanism of action than traditional targeting of dopamine or serotonin. Trospium then acts peripherally to mitigate peripheral cholinergic adverse events related to xanomeline.

Psychiatric Times will be featuring Cobenfy in our January issue, with special coverage of the drug’s muscarinic mechanism of action and how it is faring 1 year after approval in the US.

References

1. Zai Lab announces approval of Cobenfy (xonomeline and trospium chloride) in China, a first-in-class therapy for schizophrenia. Press release. December 23, 2025. Accessed December 23, 2025. https://www.businesswire.com/news/home/20251223179134/en/Zai-Lab-Announces-Approval-of-COBENFY-xanomeline-and-trospium-chloride-in-China-a-First-in-Class-Therapy-for-Schizophrenia

2. A study to assess the efficacy and safety of KarXT in acutely psychotic hospitalized Chinese adult subjects with DSM-5 schizophrenia (UNITE-001). ClinicalTrials.gov. 2025. Accessed December 23, 2025. https://clinicaltrials.gov/study/NCT05919823

3. Kaul I, Sawchak S, Walling DP, et al. Efficacy and safety of xanomeline-trospium chloride in schizophrenia. JAMA Psychiatry. 2024;81(8):749-756.