SEP-363856

01/01/2022 - "MDS provides important insights into the molecular basis of binding site interactions of SEP-363856 with TAAR1 and the 5HT1A receptor, which will be beneficial for understanding the pharmacological uniqueness of SEP-363856 and for the design of novel drug candidates for these newly targeted receptors in the treatment of schizophrenia and related disorders."
12/01/2022 - "Phase 2 clinical data for ulotaront in patients with acutely exacerbated schizophrenia are promising regarding the potential improvement in positive, negative, and depressive symptoms. "
01/01/2021 - "Only one agent, SEP-363856, has progressed to randomised clinical trials in humans; however further, larger studies with SEP-363856 are required to clarify its suitability as a new treatment for schizophrenia spectrum disorders. "
12/07/2021 - "Ulotaront, the first TAAR1 agonist to progress to randomized controlled clinical trials, has demonstrated efficacy in the treatment of schizophrenia, while another, ralmitaront, is currently being evaluated in clinical trials in schizophrenia. "
04/14/2022 - "SEP-363856 is a novel psychotropic agent which is under phase III clinical trials for schizophrenia treatment. "

08/01/2023 - "Ulotaront improved Scales for Outcomes in Parkinson Disease Sleep Scale - Daytime Sleepiness scores (p = 0.022). "
08/01/2023 - "This Class II study was an exploratory pilot study that was underpowered to detect a statistically significant difference between ulotaront and placebo in the treatment of patients with Parkinson disease psychosis without worsening motor function."
08/01/2023 - "In this exploratory, flexibly dosed study, ulotaront was evaluated for the treatment of Parkinson disease psychosis (PDP). "
07/13/2023 - "Clinical studies evaluating the potential efficacy of ulotaront in Parkinson's disease psychosis, generalized anxiety disorder, and major depressive disorder have also been started. "
08/01/2023 - "Ulotaront, a Trace Amine-Associated Receptor 1/Serotonin 5-HT1A Agonist, in Patients With Parkinson Disease Psychosis: A Pilot Study."

01/01/2021 - "TAAR1 and 5-HT1a agonists such as SEP-363856 may be a treatment option for psychosis. "
08/01/2023 - "This Class II study was an exploratory pilot study that was underpowered to detect a statistically significant difference between ulotaront and placebo in the treatment of patients with Parkinson disease psychosis without worsening motor function."
08/01/2023 - "In this exploratory, flexibly dosed study, ulotaront was evaluated for the treatment of Parkinson disease psychosis (PDP). "
12/03/2020 - "We may be hopeful that antipsychotics with a novel mechanism of action are investigated, but only the future will learn whether SEP-363856 will have true added value to improve the life of patients suffering from psychotic disorders."
07/13/2023 - "Clinical studies evaluating the potential efficacy of ulotaront in Parkinson's disease psychosis, generalized anxiety disorder, and major depressive disorder have also been started. "

07/13/2023 - "Clinical studies evaluating the potential efficacy of ulotaront in Parkinson's disease psychosis, generalized anxiety disorder, and major depressive disorder have also been started. "

01/01/2023 - "Although cataplexy events decreased from the overall mean baseline during the 2-week treatment period, neither dose of ulotaront statistically separated from placebo (p = 0.76, 25 mg; p = 0.82, 50 mg), and no significant improvement in patient and clinician measures of sleepiness from baseline to end of the 2-week treatment period occurred in any treatment group. "
01/01/2023 - "A multicenter, double-blind, placebo-controlled, randomized, Phase 1b crossover trial comparing two doses of ulotaront with placebo in the treatment of narcolepsy-cataplexy."
01/01/2023 - "The effect of ulotaront on suppression of REM did not demonstrate a statistical or clinically meaningful effect in narcolepsy-cataplexy. "
01/01/2023 - "In a multicenter, double-blind, placebo-controlled, randomized, 3-way crossover study, ulotaront was evaluated in 16 adults with narcolepsy-cataplexy. "
01/01/2023 - "We assessed acute and sustained treatments of ulotaront on REM sleep and symptoms of cataplexy and alertness in subjects with narcolepsy-cataplexy. "