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Ulotaront

Alternative Names: ulotaront, sep-363856, sep363856, sep 363856
Latest Update: 2025-04-15
Latest Update Note: Clinical Trial Update

Product Description

For schizophrenia and parkinson's disease psychosis (Sourced from: https://www.sumitomo-pharma.com/rd/clinical/pipeline.html)

Mechanisms of Action: 5-HT1A Agonist,TAAR1 Agonist

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Otsuka
Company Location: NEW YORK NY 10271
Company CEO:
Additional Commercial Interests: Sunovion

Clinical Description

Map of Global Clinical Trials for Ulotaront

Countries in Clinic: Bulgaria, China, Colombia, Croatia, Czech Republic, Estonia, Finland, Germany, Hungary, Japan, Latvia, Malaysia, Philippines, Poland, Russia, Serbia, Slovakia, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States

Active Clinical Trial Count: 22

Highest Development Phases

Phase 3: Depressive Disorder, Major|Generalized anxiety disorder|Schizophrenia

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
NCT06894212

P3

Recruiting

Schizophrenia

2028-04-06

SEP361-226

P3

Recruiting

Generalized anxiety disorder

2026-02-08

NCT05593029

P3

Recruiting

Depressive Disorder, Major

2026-02-01

jRCT2071210003

P3

Recruiting

Schizophrenia

2025-09-30

Recent News Events

Date

Type

Title

05/06/2024

PubMed

 Advancements in Non-Dopaminergic Treatments for Schizophrenia: A Systematic Review of Pipeline Developments.

04/23/2024

PubMed

 The trace amine-associated receptor 1 agonists - non-dopaminergic antipsychotics or covert modulators of D2 receptors?

04/23/2024

PubMed

 Beyond dopamine: Novel strategies for schizophrenia treatment.

09/25/2023

News Article

 Generalized Anxiety Disorder Pipeline, Clinical Trials Assessment, and FDA Approvals 2023 (Updated)

07/10/2023

News Article

 Sumitomo Pharma America Launches as New Combined Organization with Expanded Scale, Resources & Capabilities

04/26/2023

News Article

 Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder

04/06/2023

News Article

 PsychoGenics Launches eCube, a New AI-Enabled Platform for Drug Discovery

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