zolankalner (NS-041) / NeuShen Therap - LARVOL DELTA

A First-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of NS-041, a Novel KCNQ2/3 Activator, in Healthy Subjects (NS041HV101) (AES 2025) - "NS-041, a next-generation KCNQ2/3 activator, demonstrates enhanced potency, selectivity, and pharmacokinetic (PK) properties compared to first-generation agent retigabine. NS-041 demonstrated favorable safety and tolerability up to 45 mg (single-dose) and 35 mg (multiple-dose), with PK properties suitable for once-daily administration without titration. A Phase 2 proof-of-concept study is currently underway in patients with focal-onset seizures as adjunctive therapy."

Clinical • First-in-human • Late-breaking abstract • P1 data • PK/PD data • CNS Disorders • Depression • Epilepsy • Major Depressive Disorder • Mood Disorders • Ophthalmology • Psychiatry

A first-in-human study to assess the safety, tolerability, and pharmacokinetics of NS-041, a novel KCNQ2/3 activator, in healthy subjects (NS041HV101) [WITHDRAWN] (Neuroscience 2025) - "NS-041, a next-generation KCNQ2/3 activator, demonstrates enhanced potency, selectivity, and pharmacokinetic (PK) properties compared to first-generation agent retigabine. NS-041 demonstrated favorable safety and tolerability up to 45 mg (single-dose) and 35 mg (multiple-dose), with PK properties suitable for once-daily administration without titration. A Phase 2 proof-of-concept study is currently underway in patients with focal-onset seizures as adjunctive therapy."

Clinical • First-in-human • P1 data • PK/PD data • CNS Disorders • Depression • Epilepsy • Major Depressive Disorder • Mood Disorders • Psychiatry