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.

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.

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

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.