naluzotan (PRX-00023) / National Institutes of Health, Sawai Pharma - LARVOL DELTA

Serotonin and Focal Epilepsy: A Therapeutic Role? (AAN 2022) - P2 | "Several anti-seizure drugs, including carbamazepine, may block 5HT reuptake...Fenfluramine, a drug recently approved for Dravet’s Syndrome but not focal epilepsy, increases 5HT synaptic availability by disrupting 5HT vesicular storage. Design/ We performed a pilot trial of PRX-00023 (Nalutozan), a high affinity 5HT1A agonist , in patients with focal epilepsy that showed promise in trials for anxiety and depression (Investigator initiated IND 110522; NCT01281956)...Subjects on benzodiazepines, phenobarbital, or phenytoin were excluded... Our two small pilot trials do not provide any suggestion that 5HT1A agonists have a treatment role in focal epilepsy."

CNS Disorders • Depression • Epilepsy • Immunology • Mood Disorders • Psychiatry • DRD2

PRX-00023 Therapy in Localization-Related Epilepsy (clinicaltrials.gov) - P2; N=12; Enrolling by invitation; Sponsor: National Institute of Neurological Disorders and Stroke (NINDS); Trial primary completion date: Aug 2017 ➔ Mar 2018

Trial primary completion date • Biosimilar • CNS Disorders • Epilepsy

PRX-00023 Therapy in Localization-Related Epilepsy (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: National Institute of Neurological Disorders and Stroke (NINDS); Enrolling by invitation ➔ Recruiting

Enrollment status • Biosimilar • Epilepsy