2026-04-17T03:49:58Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/130422025-10-24T10:23:11Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Gisbert, Laura
author
Xaus , Jordi
author
Gutierrez Bezon, Sonia
author
Arévalo, M. Isabel
author
Ferrer Vinardel, Marc
author
Richarte, Vanesa
author
Ramos-Quiroga, Josep Antoni
2025-10-24T10:23:11Z
2025-10-24T10:23:11Z
2025-05-06T13:07:25Z2025-05-06T13:07:25Z2025-05
http://hdl.handle.net/11351/13042
Aggression; Attention‐deficit/hyperactivity disorder; Borderline personality disorderAgresión; Trastorno por déficit de atención e hiperactividad; Trastorno límite de la personalidadAgressivitat; Trastorn per dèficit d'atenció i hiperactivitat; Trastorn límit de la personalitatAim
Vafidemstat is a brain-penetrant, orally bioavailable, small molecule irreversible inhibitor of the histone lysine-specific demethylase KDM1A (also known as LSD1), which corrects memory deficits and behavior alterations including aggression and social interaction deficits in preclinical models.
Methods
Here, we report the results of REIMAGINE, a phase IIa, single-center, open-label, one-arm basket trial that evaluated the safety and efficacy of vafidemstat on aggression in adult patients with borderline personality disorder (BPD), attention-deficit/hyperactivity disorder (ADHD), and autistic spectrum disorder (ASD). Participants received 1.2 mg/day of vafidemstat for 8 weeks.
Results
Vafidemstat was shown to be safe and well tolerated, and no drug-related clinically significant adverse events were observed. Furthermore, all neuropsychiatric scales assessed showed notable efficacy signals, whether assessing agitation/aggression (Clinical Global Impression for Severity [CGI-S] and Clinical Global Impression for Improvement [CGI-I] and Neuropsychiatric Inventory [NPI] questionnaire for Agitation-Aggression [NPI-AA]), overall patient functioning (total NPI), or disease-specific features (Attention-Deficit/Hyperactivity Disorder Rating Scale [ADHD-RS] and Borderline Personality Disorder Checklist [BPDCL]). Statistically significant improvements were observed in the aggregated data (all participants) and for each of the three disease groups independently. Changes were evident within the first 2 weeks of treatment.
Conclusion
In summary, the REIMAGINE study supports that vafidemstat is safe, well tolerated, and causes a significant and consistent reduction in agitation/aggression and nonaggression features in BPD, ADHD, and ASD. These data support continuing the development of vafidemstat as a new treatment option for these psychiatric disorders.This study was funded by Oryzon Genomics, S.A.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
Agressivitat
Trastorn límit de la personalitat - Tractament
Trastorn per dèficit d'atenció amb hiperactivitat - Tractament
Trastorns de l'espectre autista - Tractament
Enzims - Inhibidors - Ús terapèutic
PSYCHIATRY AND PSYCHOLOGY::Behavior and Behavior Mechanisms::Behavior::Behavioral Symptoms::Aggression
PSYCHIATRY AND PSYCHOLOGY::Mental Disorders::Personality Disorders::Borderline Personality Disorder
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors
Other subheadings::Other subheadings::/therapeutic use
PSYCHIATRY AND PSYCHOLOGY::Mental Disorders::Neurodevelopmental Disorders::Child Development Disorders, Pervasive::Autism Spectrum Disorder
PSYCHIATRY AND PSYCHOLOGY::Mental Disorders::Neurodevelopmental Disorders::Attention Deficit and Disruptive Behavior Disorders::Attention Deficit Disorder with Hyperactivity
PSIQUIATRÍA Y PSICOLOGÍA::conducta y mecanismos de la conducta::conducta::síntomas conductuales::agresión
PSIQUIATRÍA Y PSICOLOGÍA::trastornos mentales::trastornos de la personalidad::trastorno de personalidad limítrofe
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos
Otros calificadores::Otros calificadores::/uso terapéutico
PSIQUIATRÍA Y PSICOLOGÍA::trastornos mentales::trastornos del desarrollo neurológico::trastornos generalizados del desarrollo del niño::trastorno del espectro del autismo
PSIQUIATRÍA Y PSICOLOGÍA::trastornos mentales::trastornos del desarrollo neurológico::trastornos conductuales disruptivos y déficit de atención::trastornos de déficit de atención con hiperactividad
REIMAGINE: A central nervous system basket trial showing safety and efficacy of vafidemstat on aggression in different psychiatric disorders
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion