Zai Lab Announces Acceptance of KarXT NDA for Schizophrenia Treatment
Saturday, January 18, 2025
Zai Lab has announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for KarXT, a treatment for schizophrenia in adults.
Schizophrenia is a chronic mental health condition that affects how individuals think, feel, and behave. It is characterised by positive symptoms (e.g., hallucinations and delusions), negative symptoms (e.g., social withdrawal), and cognitive impairments.
These symptoms often impact daily functioning, with many patients facing difficulties in employment and independent living.
Schizophrenia affects over 8 million people in China, many of whom face challenges due to limited treatment options and adverse side effects associated with current therapies.
KarXT combines xanomeline, a muscarinic acetylcholine receptor agonist, and trospium chloride, a muscarinic receptor antagonist, targeting pathways associated with psychiatric conditions. This approach differs from existing antipsychotics, which typically focus on dopamine or serotonin receptors.
KarXT, a novel treatment, has shown promising results in clinical trials, offering significant symptom reduction with a tolerable safety profile. If approved, it may provide a much-needed alternative for patients.
The NDA submission is backed by data from a Phase 1 China Pharmacokinetics (PK) study, a Phase 3 China study (ZL-2701-001), and the global EMERGENT clinical programme. The Phase 3 China study achieved its primary goal, demonstrating a notable reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo.
It also met all key secondary efficacy endpoints, including improvements in specific symptom scores and global severity assessments. No unexpected safety concerns were identified, and the most common side effects included nausea, dizziness, and diarrhoea, consistent with earlier studies.
Globally, KarXT has also shown positive outcomes in the Phase 3 EMERGENT-2 and EMERGENT-3 trials, which confirmed its effectiveness and safety in reducing schizophrenia symptoms.
Zai Lab holds the exclusive licence to develop, produce, and market KarXT in Greater China, following an agreement with Karuna Therapeutics, now part of Bristol Myers Squibb.
Source: zailaboratory.com
