ReviewEuropean archives of psychiatry and clinical neuroscience2023
Ulotaront: review of preliminary evidence for the efficacy and safety of a TAAR1 agonist in schizophrenia.
Review in European archives of psychiatry and clinical neuroscience, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Depressive disorders: systematic review of approved psychiatric medications (2009-April 2025) and pipeline phase 3 medications.BMC psychiatry · 2025Pooled it
- Trajectory of efficacy and safety across ulotaront dose levels in schizophrenia: a systematic review and dose-response meta-analysis.The international journal of neuropsychopharmacology · 2025Pooled it
- Novel pharmaceutical treatment approaches for schizophrenia: a systematic literature review.European journal of clinical pharmacology · 2025Pooled it
- Trace amine-associated receptor 1 (TAAR1) agonism for psychosis: a living systematic review and meta-analysis of human and non-human data.Wellcome open research · 2024Pooled it
- The Economic Impact of Cumulative Metabolic Comorbidity Burden in Schizophrenia: A Claims-Based Analysis of Medical Costs in the United States.Neurology and therapy · 2026Article
- Xanomeline-Trospium Validates Muscarinic Agonism as an Effective Non-Dopaminergic Treatment for Schizophrenia.International journal of molecular sciences · 2026Review
- Towards Mechanism-Informed Treatments for Mental Health.Journal of neurochemistry · 2026Review
- The Changing Concept in the History of Schizophrenia.Brain sciences · 2026Review
- New Pharmacological Treatment Approaches for Schizophrenia: Navigating the Post-iclepertin Landscape.CNS drugs · 2026Review
- Neurosyphilis and Parkinsonism: Overlapping Pathophysiology and Emerging Therapeutic Insights.Current neurovascular research · 2026Review
- TAAR1-mediated pathways regulating nigrostriatal function and the discovery and pharmacological characterization of a novel TAAR1 agonist, Selutaront.Frontiers in pharmacology · 2026Article
- New Insights into Complex PTSD Treatment: Focus on TAAR1 Agonists.Biomedicines · 2025Article
- Distinct structural deficits in treatment-resistant schizophrenia and their putative neurotransmitter basis: a source-based morphometry analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025Article
- Effect of lurasidone plus sulpiride on treatment efficacy, psychiatric manifestations, and quality of life among patients with schizophrenia.World journal of psychiatry · 2025Article
- Blood‑brain barrier dysfunction in schizophrenia: Mechanisms and implications (Review).International journal of molecular medicine · 2025Review
- Trace Amine-associated Receptors (TAARs): Candidate Targets in the Treatment of Bipolar Disorders.Actas espanolas de psiquiatria · 2025Review
- New pharmacological approaches in the treatment of schizophrenia.Pharmacological reports : PR · 2025Review
- Olfactory GPCRs through the lens of structural bioinformatics.Chemical senses · 2025Review
- Schizophrenia management: Systematic review of current medications and Phase-3 agents (2008-2024).Neuroscience applied · 2025Review
- Aryl Hydrocarbon Receptor Establishes a Delicate Balance between the Level of the Trace Amine Tryptamine and Monoamine Oxidase Activity in the Brain and Periphery in Health and Conditions such as Neurodegenerative, Neurodevelopmental, and Psychiatric Disorders.Current neuropharmacology · 2025Review
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Ulotaront is a trace amine-associated receptor 1 (TAAR1) agonist in Phase 3 clinical development for the treatment of schizophrenia. Ulotaront was discovered through a unique, target-agnostic approach optimized to identify drug candidates lacking D2 and 5-HT2A receptor antagonism, while demonstrating an antipsychotic-like phenotypic profile in vivo. The mechanism of action (MOA) of ulotaront is thought to be mediated by agonism at TAAR1 and serotonin 5-HT1A receptors. Ulotaront has completed two Phase 2 trials (4-week acute study and 26-week open-label extension) which led to Breakthrough Therapy Designation from the US Food and Drug Administration for the treatment of schizophrenia. In the double-blind, placebo-controlled, acute study, ulotaront was associated with significant (p < 0.001) improvement in Positive and Negative Syndrome Scale (PANSS) total score (effect size [ES]: 0.45), with improvements vs. placebo also observed across secondary endpoints. Post-hoc analyses of the acute trial revealed additional evidence to support the effect of ulotaront on negative symptoms. In the 4-week study, ulotaront was well-tolerated, with an incidence of adverse events (AEs) numerically lower compared to placebo (45.8% vs. 50.4%; with a number needed to harm [NNH] for individual ulotaront AEs all > 40). The open-label extension demonstrated further improvement across schizophrenia symptoms and confirmed the tolerability of ulotaront, with a 6-month completion rate of 67%. Based on current data, ulotaront shows potential to be a first-in-class TAAR1 agonist for the treatment of schizophrenia with a safety and efficacy profile distinct from current antipsychotics.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.