OV4071 / Ovid Therapeutics - LARVOL DELTA

Phase 1 Randomised, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of OV4071 in Healthy Participants (ANZCTR) - P1 | N=88 | Recruiting | Sponsor: Ovid Therapeutics Australia Pty Ltd | Not yet recruiting ➔ Recruiting | Initiation date: May 2026

Enrollment open • Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

Activation of KCC2 as a novel strategy for potential treatment of psychosis (APA 2026) - "For validation, compounds were tested in murine models of psychosis using the psychotomimetics phencyclidine phosphate (PCP) and MK801... The SmartCube® revealed that OV350 has a signature robustly similar to atypical antipsychotics such as risperidone and clozapine... This study suggests that KCC2 activators can potentially treat psychotic symptoms through a novel mechanism of action. In addition to the suppression of psychotomimetic-induced hyperlocomotion with both OV350 and OV4071, lack of motor disturbance and alterations of the resting state qEEG pattern with OV350, together suggest that these compounds may target mechanisms distinct from those of current antipsychotics and represent a meaningful advance in the development of safer and more effective treatments for psychotic disorders, warranting further study. This study was supported by Ovid Therapeutics, Inc."

CNS Disorders • Metabolic Disorders • Psychiatry

A Food Effect Open-Label, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OV4071 in Healthy Male and Female Participants. (ANZCTR) - P1 | N=8 | Not yet recruiting | Sponsor: Ovid Therapeutics Australia Pty Ltd

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase 1 Randomised, Double-Blind, Placebo-Controlled Study Assessing the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of OV4071 in Healthy Participants (ANZCTR) - P1 | N=88 | Not yet recruiting | Sponsor: Ovid Therapeutics Australia Pty Ltd

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Ovid Therapeutics Reports Business Updates and Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "...Anticipated milestones include: results for OV329 biomarker and safety data (Q3 2025); initiation of a Phase 2a patient study for OV329 in drug resistant epilepsies (Q1 2026); results from a first-in-human safety and exploratory biomarker study with OV350, our first KCC2 direct activator (Q4 2025); and initiation of human trials for the first oral KCC2 direct activator, OV4071 (Q2 2026)."

Biomarker • Clinical data • New P2a trial • New trial • Epilepsy