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

Antiseizure Medications that Did Not Reach the Epilepsy Market: An Assessment of Factors Contributing to Their Failed Clinical Development Over the Last Three Decades. (PubMed, Drugs) - "Compounds whose development was terminated include atimepazole, beprodone, cannabidivarin, carabersat, conantokin-G, dezinamide, elpetrigine, flunarizine, fluorofelbamate, ICA-105665, isovaleramide, JNJ-40411813, losigamone, naluzotan, padsevonil, pitolisant, ralitoline, remacemide, safinamide, soretolide, talampanel, tonabersat, T2000, T2007, valnoctamide, valrocemide, VX-765, zandatrigine, zuranolone, and 534U87. In some instances, failure to pursue an epilepsy indication could be explained by prioritization of development for other neurological or psychiatric conditions. This may reflect the perception of the drug market for common epilepsies being relatively crowded, and only attractive for compounds with outstanding safety or efficacy advantages over existing medications."

Journal • Review • CNS Disorders • Epilepsy • Psychiatry

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