laviclidine (NS-136) / NeuShen Therap - LARVOL DELTA

NeuShen Therapeutics has raised more than $80 million in a series B that will help it advance its pipeline of small molecules for central nervous system (CNS) disorders, including a selective M4 receptor modulator… (Firstwordpharma Press Release) - "The Shanghai- and Boston-based biotech's assets include NS-136 (laviclidine), a highly selective M4 positive allosteric modulator in Phase II for acute schizophrenia in China. The programme is also moving into Alzheimer's disease agitation, with Phase II studies cleared to start in China and the US; enrollment is expected to begin shortly."

Financing • New P2 trial • Alzheimer's Disease • CNS Disorders • Schizophrenia

A Phase I Study of NS-079 in Healthy Participants (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: NeuShen Therapeutics

New P1 trial

A first-in-human (FIH) study to assess the safety, tolerability, and pharmacokinetics of NS-136, a novel M4 muscarinic receptor (mAChR) positive allosteric modulator (PAM), in healthy subjects both in Australia and China (NS136HV101) [WITHDRAWN] (Neuroscience 2025) - "NS-136 demonstrated favorable safety and tolerability up to 100 mg, with PK properties suitable for once-daily administration without titration. No major ethnic differences between Australian and Chinese population observed, which supports multi-regional studies in phase 2 or beyond. A Phase 2a proof-of-concept study is under planning in patients with schizophrenia."

Clinical • First-in-human • P1 data • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia • DRD2

Preclinical characterization of M4 muscarinic receptor positive allosteric modulator NS-136 (Neuroscience 2025) - "Additionally, in the Sprague-Dawley rat catalepsy model, NS-136 did not induce extrapyramidal symptoms, indicating a low risk of motor side effects.NS-136 also demonstrated strong brain penetration, as evidenced by high Kp, uu and brain-to-plasma (B/P) ratios across multiple species. These findings suggest efficient central nervous system (CNS) exposure, which may contribute to enhanced therapeutic efficacy in CNS disorders.In summary, NS-136 is a potent and selective M4 PAM with a promising preclinical safety and pharmacokinetic profile, supporting its potential as a next-generation antipsychotic therapy."

Preclinical • CNS Disorders • Psychiatry • Schizophrenia • DRD2

First-into-human Study of NS-136 in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: NeuShen Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

NeuShen Therapeutics Initiates First-in-Human Trial of NS-136, a Novel Selective M4 Receptor Positive Allosteric Modulator for the Treatment of Schizophrenia (PRNewswire) - "NeuShen Therapeutics...announced the dosing of the first healthy volunteer in Australia in the Phase I first-in-human clinical trial of NS-136, a novel selective M4 receptor positive allosteric modulator (M4 PAM) designed for the treatment of schizophrenia and other conditions associated with psychosis."

Trial status • CNS Disorders • Schizophrenia

First-into-human Study of NS-136 in Healthy Subjects (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: NeuShen Therapeutics

New P1 trial