The Phase I study success could lead to further studies in patients with schizophrenia and other psychosis-related conditions. Credit: Marina Demidiuk/Shutterstock.

NeuShen Therapeutics has dosed the first healthy volunteer in Australia, marking the start of a Phase I first-in-human clinical trial of NS-136 for schizophrenia treatment.

NS-136 is a new selective M4 receptor-positive allosteric modulator (M4 PAM) intended for the treatment of schizophrenia along with other psychosis-associated conditions.

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Claimed to offer potential benefits in alleviating negative symptoms and cognitive impairment, M4 PAM has the potential to treat psychosis in Alzheimer’s or Parkinson’s disease.

Developed from NeuShen’s small molecule R&D platform, NS-136 has shown efficacy against both positive and negative symptoms of schizophrenia in preclinical animal models.

The Phase I double-blind, placebo-controlled trial is designed to assess the safety and tolerability of NS-136 in healthy participants.

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The trial’s success could lead to further studies in patients with schizophrenia and other psychosis-related conditions.

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Earlier, NeuShen filed an investigational new drug (IND) application with China’s National Medical Products Administration (NMPA).

NeuShen Therapeutics founder and CEO Dr Joan Shen said: “NS-136 was discovered and developed internally by utilising our profound CNS expertise and advanced AI technology.

“It holds great potential to offer innovative therapies for not only schizophrenia but also a spectrum of cognitive and mood disorders.”

In March 2024, the Center for Drug Evaluation (CDE) of the NMPA approved NeuShen’s IND application for its pipeline product NS-041.