- Ulotaront - Wikipedia
- Ulotaront: review of preliminary evidence for the efficacy and …
- Sumitomo Pharma and Otsuka Announce Topline Results from …
- Safety and effectiveness of ulotaront (SEP-363856) in ... - Nature
- Disappointing Results for Ulotaront in Two Phase 3 …
- TAAR1 agonist ulotaront modulates striatal and hippocampal
- Ulotaront: A TAAR1 Agonist for the Treatment of Schizophrenia
- Unlocking the Therapeutic Potential of Ulotaront as a Trace …
- Why the TAAR1 agonist ulotaront holds promise for schizophrenia
- Ulotaront: a TAAR1/5-HT1A agonist in clinical development for the ...
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Ulotaront (INNTooltip International Nonproprietary Name; developmental codes SEP-363856, SEP-856) is an investigational antipsychotic that is undergoing clinical trials for the treatment of schizophrenia and Parkinson's disease psychosis. The medication was discovered in collaboration between PsychoGenics Inc. and Sunovion Pharmaceuticals (which was subsequently merged into Sumitomo Pharma) using PsychoGenics' behavior and AI-based phenotypic drug discovery platform, SmartCube.
Ulotaront is in phase III clinical trial for schizophrenia, phase II/III for generalised anxiety disorder and major depressive disorder and discontinued for narcolepsy and psychotic disorders.
Research has shown that ulotaront results in a greater reduction from baseline in the PANSS total score than placebo. Treatment with ulotaront, as compared with placebo, was also associated with an improvement in sleep quality. Ulotaront was awarded a Breakthrough Therapy designation due to its increased efficacy and greatly reduced side effects compared to current treatments.
Adverse effects
The adverse effect profile of ulotaront differs from that of other antipsychotics because its mechanism of action does not involve antagonism of dopamine receptors in the brain, which is responsible for the drug-induced movement disorders (like akathisia) that may occur with those agents. Some adverse events reported in preliminary clinical trials are somnolence, agitation, nausea, diarrhea, and dyspepsia.
Pharmacology
= Pharmacodynamics
=The mechanism of action of ulotaront in the treatment of schizophrenia is unclear. However, it is thought to be an agonist at the trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors. This mechanism of action is unique among available antipsychotics, which generally antagonize dopamine receptors (especially dopamine D2 receptor).
Ulotaront is a full agonist of the human TAAR1 with an EC50Tooltip half-maximal effective concentration of 140 nM and an EmaxTooltip maximal efficacy of 101.3%. It is also a partial agonist of the serotonin 5-HT1A receptor (EC50 = 2,300 nM; Emax = 74.7%) and of the serotonin 5-HT1D receptor (EC50 = 262 nM; Emax = 57.1%). Conversely, its activities at various other targets, such as various other serotonin receptors as well as adrenergic and dopamine receptors, are much less potent.
Ulotaront decreases basal locomotor activity in rodents and this effect was absent in TAAR1 knockout mice. It prevented the hyperlocomotion induced by the NMDA receptor antagonist phencyclidine (PCP). Conversely, ulotaront did not affect dextroamphetamine-induced hyperlocomotion. Similarly, it did not reverse apomorphine-induced climbing behavior.
= Pharmacokinetics
=The precise pharmacokinetic profile of ulotaront has not been reported, though the developer has suggested that the pharmacokinetic data supports once daily dosing.
Research
As of 2018, Sunovion, the maker of another antipsychotic called lurasidone (Latuda), is conducting clinical trials on ulotaront in partnership with the preclinical research company PsychoGenics. The U.S. Food and Drug Administration has granted ulotaront the breakthrough therapy designation. In addition to schizophrenia, ulotaront is also being studied for the treatment of psychosis associated with Parkinson's disease.
The Brief Negative Symptom Scale (BNSS) has been used to assess the effect of Ulotaront on the negative symptoms of schizophrenia.
In July 2023, the pharmaceutical company behind the drug announced that the drug had failed to outperform placebo in the treatment of acutely psychotic patients with schizophrenia, as measured by the PANSS.
See also
List of investigational antipsychotics § Monoamine receptor modulators
Ralmitaront
References
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ulotaront
Sep-363856 | C9H13NOS | CID 89532783 - PubChem
Ulotaront is a TAAR1 agonist with 5-HT1A agonist activity for the ...
Discovery and characterization of ulotaront. A Ulotaront discovery ...
Discovery and characterization of ulotaront. A Ulotaront discovery ...
Discovery and characterization of ulotaront. A Ulotaront discovery ...
Discovery and characterization of ulotaront. A Ulotaront discovery ...
Chemical structure of ulotaront | Download Scientific Diagram
Saw this in an med article about Ulotaront - Medications ...
A lot of benefits of taking【Ulotaront】: A new antipsychotic drug ...
Clinical trials evaluating Ulotaront (SEP-363856). | Download ...
Ulotaront (SEP-363856) Effective for Negative Symptoms - News ...
ulotaront
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Ulotaront - Wikipedia
Ulotaront (INN Tooltip International Nonproprietary Name; [1] developmental codes SEP-363856, SEP-856) is an investigational antipsychotic that is undergoing clinical trials for the treatment of schizophrenia and Parkinson's disease psychosis.
Ulotaront: review of preliminary evidence for the efficacy and …
Ulotaront is a trace amine-associated receptor 1 (TAAR1) agonist with additional agonism at 5-HT1A receptors currently in Phase III clinical development for the treatment of schizophrenia.
Sumitomo Pharma and Otsuka Announce Topline Results from …
Jul 31, 2023 · Ulotaront is the first and only TAAR1 agonist to enter into Phase 3 clinical studies in people living with schizophrenia. It’s also the first TAAR1 agonist to enter into Phase 2/3 clinical studies in GAD, and as an adjunctive therapy in MDD.
Safety and effectiveness of ulotaront (SEP-363856) in ... - Nature
Dec 9, 2021 · Ulotaront, a trace amine-associated receptor 1 (TAAR1) and serotonin 5-HT1A receptors agonist, has demonstrated efficacy in the treatment of patients with an acute exacerbation of schizophrenia...
Disappointing Results for Ulotaront in Two Phase 3 …
Aug 1, 2023 · Ulotaront was not found to significantly benefit patients with schizophrenia more than placebo in two phase 3 studies, according to Sumitomo Pharma and Otsuka Pharmaceutical.
TAAR1 agonist ulotaront modulates striatal and hippocampal
Dec 19, 2023 · Ulotaront (SEP-363856), which is currently in Phase III clinical development, was the first TAAR1 agonist to demonstrate efficacy in a randomized, double-blind, placebo-controlled Phase II...
Ulotaront: A TAAR1 Agonist for the Treatment of Schizophrenia
Ulotaront has demonstrated efficacy in the treatment of symptoms of an exacerbation of schizophrenia in a large randomized, double-blind placebo-controlled clinical trial, with continued improvement in a 6-month open-label extension study.
Unlocking the Therapeutic Potential of Ulotaront as a Trace …
Ulotaront is an agonist of trace amine-associated receptor 1 and serotonin 5-HT1A receptors, but can modulate dopamine neurotransmission indirectly. In 2019, the United States Food and Drug Administration granted Breakthrough Therapy Designation for …
Why the TAAR1 agonist ulotaront holds promise for schizophrenia
Nov 22, 2022 · Ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist in Phase 3 clinical development, could prove to be a breakthrough therapy in treating schizophrenia.
Ulotaront: a TAAR1/5-HT1A agonist in clinical development for the ...
Ulotaront is a novel trace-amine-associated receptor-1 (TAAR1) agonist with serotonin-1A receptor agonist activity, and without postsynaptic D2-receptor antagonism. Phase 2 clinical data for ulotaront in patients with acutely exacerbated schizophrenia are promising regarding the potential improvement in positive, negative, and depressive symptoms.