A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia

To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia

Start Date22 Dec 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

NCT06894212

/ RecruitingPhase 3

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Start Date28 Feb 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT05848700

/ CompletedPhase 1

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate SEP-363856 Physical Dependence in Adult Subjects With Schizophrenia

A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.

Start Date21 Jun 2023

Sponsor / Collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

100 Clinical Results associated with Ulotaront

100 Translational Medicine associated with Ulotaront

100 Patents (Medical) associated with Ulotaront

Literatures (Medical) associated with Ulotaront

01 Oct 2025·BIOLOGICAL PSYCHIATRY

The trace amine-associated receptor 1 regulates presynaptic dopamine function: evidence from preclinical studies and a phase 1b trial in patients with schizophrenia

Article

Author: Koblan, Kenneth ; Rabiner, Eugenii A ; Dedic, Nina ; Rutigliano, Grazia ; Lopes, Emanuel F ; Milanovic, Snezana ; Vano, Luke J ; Hopkins, Seth C ; Nordio, Giovanna ; Natesan, Sridhar ; Howes, Oliver D ; McCutcheon, Robert A ; Petty, Alice E ; Withers, Dominic J ; Cragg, Stephanie J ; Wells, Lisa ; Veronese, Mattia ; Kaar, Stephen J

BACKGROUND:

Schizophrenia remains a leading cause of disability globally. Elevated striatal dopamine synthesis capacity is a hallmark of its pathophysiology, but it is unknown whether this can be reduced and whether such reductions lead to symptom improvement. Trace amine-associated receptor 1 (TAAR1) may regulate dopaminergic function, and ulotaront (SEP-363856), a TAAR1 agonist, offers a potential novel treatment strategy.

METHODS:

We conducted combined translational preclinical and clinical test of mechanism studies. Preclinical work involved TAAR1 knockout (KO) and wild-type mice (n = 27), as well as ex vivo striatal brain slices. In a phase I open-label trial, 22 patients with symptomatic schizophrenia (mean age = 32.5 years; 72.7% male) received 14 days of adjunctive ulotaront treatment. Dopamine synthesis capacity (K_i) was measured using [18F]-DOPA PET in animals and humans. Dopamine release in brain slices was assessed using fast-scan cyclic voltammetry.

RESULTS:

TAAR1-KO mice showed significantly higher striatal K_i than wild-type controls (p < 0.05). Ulotaront reduced evoked dopamine release in brain slices after single (p < 0.0005) and repeated (p < 0.005) stimulation. In patients, ulotaront significantly reduced striatal K_i (p < 0.01), particularly in the putamen. Reductions in K_i correlated with improvements in positive symptoms (r = 0.5, p < 0.05), but not with changes in negative or total symptoms. The most common adverse events were somnolence and dizziness.

CONCLUSIONS:

TAAR1 regulates dopamine synthesis and release. Adjunctive ulotaront reduces presynaptic dopamine function and psychotic symptoms in schizophrenia. These findings support TAAR1 as a promising target for treating antipsychotic non-responsive schizophrenia and other dopaminergic disorders.

01 Sep 2025·MOLECULAR PHARMACOLOGY

Trace amine–associated receptor 1 agonists differentially regulate dopamine transporter function

Article

Author: Shi, Xiao ; Abbas, Atheir I ; Huey, Julia K ; Janowsky, Aaron ; Schutzer, William E

Trace amine-associated receptor 1 (TAAR1) is a G protein-coupled receptor stimulated by trace amines and amphetamine-like psychostimulants. The TAAR1 agonists RO5166017 and RO5256390 have antidepressant- and anxiolytic-like effects in preclinical models, and the TAAR1/partial 5HT_1A agonist ulotaront has been evaluated for its clinical utility as an antipsychotic. Early clinical investigations of ulotaront for treating psychosis in schizophrenia yielded positive endpoints. However, results from phase III clinical trials showed that ulotaront had the same efficacy as placebo. One concern arising from these results is that investigational TAAR1 agonists could be diverse in the mechanisms by which they influence dopamine homeostasis. Thus, we evaluated the pharmacology of TAAR1 agonists RO5166017, RO5256390, and ulotaront at the dopamine transporter (DAT) and TAAR1 to test our hypothesis that there would be differences among agonists in their effects on DAT. We found that RO5166017 and RO5256390 directly bind DAT and inhibit dopamine uptake, while ulotaront did not. In cultured cells and rodent synaptosomes, pretreatment with ulotaront and RO5256390 reduced dopamine uptake by approximately half, while RO5166017 pretreatment increased dopamine uptake by a similar magnitude. In cells, the effects of TAAR1 agonist pretreatment on dopamine uptake were TAAR1-dependent. RO5166017, but not RO5256390 or ulotaront, increased amphetamine-induced dopamine efflux in a TAAR1-dependent manner. Surface biotinylation experiments indicated that RO5166017 pretreatment increased cell-surface DAT by approximately 15% via a TAAR1-dependent mechanism. These findings demonstrate clinically relevant differences in the effects of 3 TAAR1 agonists on DAT. SIGNIFICANCE STATEMENT: This study evaluated the direct and heterologous TAAR1-dependent effects of the TAAR1 agonists RO5166017, RO5256390, and ulotaront at DAT. All 3 affected DAT transport and/or trafficking, with each exhibiting a unique profile of direct and heterologous effects, some of which were TAAR1-dependent. These issues should be considered with therapeutic design and clinical use of TAAR1 agonists.

01 Sep 2025·INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY

Trajectory of efficacy and safety across ulotaront dose levels in schizophrenia: a systematic review and dose–response meta-analysis

Review

Author: Liang, Chih-Sung ; Hung, Kuo-Chuan ; Solmi, Marco ; Chen, Yang-Chieh Brian ; Correll, Christoph U ; Hsu, Yu-Chia ; Hung, Tzu-Yen ; Tu, Yu-Kang ; Tseng, Ping-Tao ; Hsu, Chih-Wei

Abstract:

Background:

Ulotaront is an experimental antipsychotic for schizophrenia, but its optimal dose is unclear. This study aimed to evaluate dose–response relationships for efficacy and safety in people with schizophrenia.

Methods:

A systematic review of four databases (until January 22, 2025; INPLASY202510091) identified randomized clinical trials assessing ulotaront. Outcomes included efficacy, measured by changes in the Positive and Negative Syndrome Scale (PANSS) total score (primary outcome), positive and negative subdomains, and the Clinical Global Impression Scale-Severity, and safety, assessed by all-cause dropout (co-primary outcome, dropout due to adverse event, serious, non-serious, and specific adverse events). We employed one-stage dose–response meta-analysis (random-effects model) calculating standardized mean differences (SMDs) and risk ratios (RRs) with 95% confidence intervals (CIs).

Results:

Analysis of three randomized clinical trials (n = 1144) indicated that the 100 mg dose of ulotaront provided the greatest improvement in PANSS total score (standardized mean difference = −0.23 [95% CI: −0.43, −0.02]), PANSS positive symptom score (−0.30 [−0.70, 0.10]), and PANSS negative symptom score (−0.28 [−0.48, −0.08]). However, Clinical Global Impression Scale-Severity scores did not exhibit a clear dose–response relationship. Regarding safety, all-cause dropout (RR at 100 mg = 1.10 [95% CI: 0.57, 2.12]), adverse event-related dropout, serious, non-serious, and most specific adverse events showed no significant dose–response relationship. The risk of anxiety-related adverse events was significantly higher than placebo at 50 and 75 mg doses (RR at 75 mg = 2.06 [95% CI: 1.11, 3.80]).

Conclusion:

Ulotaront 100 mg appears greatest efficacy with favorable safety for acute schizophrenia. However, effect sizes were small, and higher ulotaront doses should be tested.Significance Statement Ulotaront is a new medication being tested for treating schizophrenia. Unlike most existing antipsychotic drugs that block dopamine receptors in the brain, ulotaront works through a different mechanism by activating trace amine-associated receptor 1 and serotonin 1A receptors. These novel targets may help reduce both hallucinations and negative symptoms like social withdrawal and lack of motivation, with fewer side effects. In this study, we analyzed data from several clinical trials to understand how different doses of ulotaront affect patients. We found that higher doses—especially around 100 mg—can improve schizophrenia symptoms without increasing safety concerns. These findings are important because they suggest that ulotaront may offer a new and safer treatment option for people with schizophrenia, and they help guide doctors toward the most effective dose.

News (Medical) associated with Ulotaront

26 Aug 2024

·www.prnewswire.com

Schizophrenia Market: RISVAN's Approval Has Sparked a Competitive Race Among Pharmaceutical Companies | DelveInsight

The recent approval of Rovi Pharmaceuticals Laboratories' OKEDI/RISVAN (risperidone ISM) has spiked the competition among the other pharmaceutical companies that are developing novel therapies to improve the treatment landscape. RISVAN has the potential to become a blockbuster drug. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- Schizophrenia is a severe mental illness affecting about 1% of Americans, cognitive functions, emotional responses, decision-making, and social interaction. Onset typically occurs in late teens to early 20s for men and late 20s to early 30s for women. Currently, as per the WHO, the vast majority of schizophrenia patients around the world are not receiving mental health care. Approximately 50% of people in mental hospitals have a schizophrenia diagnosis, and only 31.3% of people with psychosis receive specialist mental health care. As per DelveInsight analysis, in 2023 the total diagnosed prevalent cases of schizophrenia in the 7MM were found to be approximately 4 million cases out of which the US accounted for nearly 1.5 million cases. It is anticipated that these numbers will rise by 2034 due to several factors, including population growth, improved diagnostic techniques, increased awareness, and reduced stigma around mental health issues prompting more individuals to seek diagnosis, and potentially, environmental stressors contributing to a higher occurrence of the disorder. Schizophrenia treatment involves a blend of medication, psychological counseling, and social support. However, nearly one-third of patients do not respond sufficiently to standard treatments. Relapses, characterized by psychotic symptoms and functional impairments, are significant. Schizophrenia treatment mainly consists of antipsychotic medications that target dopamine neurotransmitters. Second-generation medications are favored because they lower the risk of severe side effects. Long-acting injectable antipsychotics can enhance adherence and improve treatment outcomes. High-dose regimens of specific medications may be advantageous for patients with severe, treatment-resistant schizophrenia. Additionally, hospitalization and electroconvulsive therapy might be necessary for patients who do not respond to medication therapy or during severe episodes. First-generation antipsychotics like chlorpromazine, fluphenazine, haloperidol, and perphenazine are effective in treating positive symptoms such as hallucinations and delusions but do not alleviate negative symptoms or cognitive impairments. Second-generation antipsychotics, including REXULTI/RXULTI (brexpiprazole), CAPLYTA (lumateperone), LATUDA (lurasidone hydrochloride), SAPHRIS (asenapine), ABILIFY MYCITE (aripiprazole tablets with sensor), VRAYLAR/REAGILA (cariprazine), SECUADO (asenapine), INVEGA SUSTENNA/TRINZA/HAYFERA (paliperidone palmitate), ARISTADA/ARISTADA INITIO (aripiprazole lauroxil), PERSERIS (risperidone), FANAPT (iloperidone), and LYBALVI (olanzapine and samidorphan), were developed to address both positive and negative symptoms, as well as cognitive symptoms. Although these medications typically have fewer extrapyramidal side effects, they can cause weight gain, sexual dysfunction, and other metabolic disorders. Additionally, elderly patients using FGAs and SGAs are at an increased risk of developing pneumonia. Learn more about the FDA-approved schizophrenia drugs @ Drugs for Schizophrenia Treatment REXULTI (brexpiprazole) is an oral tablet available in strengths from 0.25 mg to 4 mg, containing various inactive ingredients. While its exact mechanism of action is not fully understood, it work as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors and as an antagonist at serotonin 5-HT2A receptors. REXULTI was first approved in the US in July 2015 for use in adults with MDD and schizophrenia. In January 2022, it received FDA approval for pediatric patients aged 13–17. The EMA approved it in July 2018, and Japan approved it in tablet form in January 2018 and as an oral-disintegrating dose in August 2021. Generic versions of REXULTI have now been approved, which may affect its market presence. Janssen Pharmaceutical's INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA (paliperidone palmitate) is an SGA agent that seems to act as a D2 partial agonist and a 5-HT-2A receptor antagonist. INVEGA SUSTENNA is administered monthly, INVEGA TRINZA every three months, and INVEGA HAFYERA twice yearly. Paliperidone is a benzisoxazole derivative. In the EU and Japan, INVEGA SUSTENNA is marketed as XEPLION. In the EU, INVEGA TRINZA is sold as TREVICTA, and in Japan as XEPLION TRI. INVEGA HAFYERA is a long-acting injectable treatment administered in the upper buttocks every six months, providing continuous treatment and symptom control over this period. Additionally, the recent approval of RISVAN (Risperidone ISM) has intensified the competition in the schizophrenia treatment space. Risperidone ISM is a long-acting injectable antipsychotic created and patented by ROVI for treating schizophrenia in adults. From the first injection, it delivers immediate and sustained plasma drug levels without the need for loading doses or additional oral risperidone. This approval is based on the positive outcomes of the pivotal PRISMA-3 study, which assessed the efficacy and safety of Risperidone ISM in patients with schizophrenia. The study's findings demonstrate that the two doses tested (75 mg and 100 mg administered once monthly) successfully met the predetermined primary and secondary efficacy endpoints for treating patients with moderate to severe schizophrenia symptoms. Furthermore, OKEDI (risperidone ISM) was launched in Germany, the UK, and Spain in 2022. The approval was based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of risperidone ISM in schizophrenia patients. As per the estimates by Delveinsight analysts, this drug has blockbuster potential in the schizophrenia market with medium-fast uptake. To know more about schizophrenia treatment options, visit @ New Treatment for Schizophrenia The schizophrenia market is crowded with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include Boehringer Ingelheim's Iclepertin (BI-425809), Sumitomo Pharma/Otsuka's Ulotaront (SEP-363856), Reviva Pharmaceuticals' Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma's Roluperidone (MIN-101/MT-210), Karuna Therapeutics (Bristol Myers Squibb)/Royalty Pharma's KarXT (xanomeline-trospium), ACADIA Pharmaceuticals' NUPLAZID (pimavanserin), Teva Pharmaceutical/MedinCell/Royalty Pharma's Olanzapine LAI (mdc-TJK/TV-44749), Neurocrine Biosciences/Mitsubishi Tanabe Pharma's Valbenazine (NBI-98854), Lyndra Therapeutics' LYN-005 (long-acting oral risperidone), Newron Pharmaceuticals' Evenamide (NW-3509), Luye Pharma's LY03010 (ER paliperidone palmitate), and others. Discover which therapies are expected to grab major schizophrenia market share @ Schizophrenia Market Report Iclepertin (BI 425809) is an investigational drug and a glycine transporter 1 (GlyT1) inhibitor aimed at addressing the brain biology related to cognitive symptoms in schizophrenia (CIAS). Abnormalities in glutamatergic signaling downstream of neuronal NMDA receptors contribute to cognitive impairment in this condition. Enhancing NMDA receptor function could potentially improve synaptic plasticity and cognition. Glycine, an essential NMDA receptor co-agonist, is modulated by glycine transporters GlyT-1 and GlyT-2, which are located in presynaptic and astrocyte membranes. These transporters regulate glycine levels by taking it up into nerve terminals and adjacent glial cells, affecting synaptic cleft glycine concentration. By inhibiting these transporters, BI 425809 aims to increase glycine levels, thereby modulating NMDA receptor function. Administered orally, this potent and selective GlyT1 inhibitor is also under investigation for Alzheimer's disease. However, early 2020 Phase II trial results did not support its continued development for this indication, and the focus has now shifted to schizophrenia, with multiple Phase III trials currently underway. Since schizophrenia, patients frequently ignore certain symptoms, such as cognitive impairment. Therefore, if approved, BI-425809 will be the first approved pharmacotherapy for the treatment of CIAS. Ulotaront (SEP-363856), developed by Sumitomo Pharma and Otsuka Pharmaceuticals, is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity. It is a small-molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Sunovion discovered Ulotaront in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Ulotaront is currently in late-stage development for schizophrenia and generalized anxiety disorder (GAD) in Japan and as an adjunctive treatment for major depressive disorder, schizophrenia, and GAD in the US. Top-line results from Phase III DIAMOND 1 and DIAMOND 2 trials in schizophrenia have been released, but the Phase III DIAMOND 3 trial in the US has been halted. Sumitomo Pharma has also stopped a Phase III trial for schizophrenia in Japan and another Phase II/III trial in China, Japan, Taiwan, and the Philippines, citing business strategy reasons. Despite this, two Phase III trials are still ongoing. Recently, Otsuka and Sumitomo revised their licensing agreement, excluding SEP-4199 and SEP-378614. Under this revision, Otsuka gained exclusive rights from SMPA to develop, manufacture, and commercialize ulotaront worldwide. If Otsuka successfully develops and commercializes ulotaront, they will pay up to 30 million USD (approximately 4.5 billion yen) in milestones, along with royalties based on sales, without any upfront payment. Starting January 2024, Otsuka will cover the full cost of studies conducted by both Sumitomo Pharma Group and Otsuka, except for certain studies. KarXT (xanomeline–trospium) is an oral modulator targeting muscarinic receptors found in both the central nervous system (CNS) and various peripheral tissues. This proprietary product combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS. As a dual M1/M4 muscarinic acetylcholine receptor agonist, KarXT aims to improve the positive, negative, and cognitive symptoms of schizophrenia. The US FDA has accepted Karuna Therapeutics' NDA for KarXT for adult schizophrenia treatment, with a PDUFA date of September 26, 2024. Additionally, KarXT is undergoing multiple Phase III trials as an adjunctive treatment with standard-of-care agents for schizophrenia and is being evaluated for psychosis treatment in Alzheimer's disease patients. Following Bristol Myers Squibb's acquisition of Karuna Therapeutics, Karuna is now a wholly-owned subsidiary of BMS. At the Annual Congress of the Schizophrenia International Research Society (SIRS) in April 2024 in Italy, BMS presented promising results from the latest interim analysis of the Phase III EMERGENT-4 open-label extension trial, showing KarXT's efficacy in reducing symptoms in adults with schizophrenia. BMS plans to continue discussions with the US FDA and will release more data from the EMERGENT program later this year. Discover more about drugs for schizophrenia in development @ Schizophrenia Clinical Trials The anticipated launch of these emerging therapies for schizophrenia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the schizophrenia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for schizophrenia is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Schizophrenia market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Schizophrenia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the schizophrenia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The schizophrenia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Schizophrenia Total Diagnosed Prevalent Cases of Schizophrenia Gender-specific Diagnosed Prevalent Cases of Schizophrenia Severity-specific Diagnosed Prevalent Cases of Schizophrenia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM schizophrenia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this schizophrenia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the schizophrenia market. Also, stay abreast of the mitigating factors to improve your market position in the schizophrenia therapeutic space. Related Reports Schizophrenia Pipeline Schizophrenia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Otsuka Pharmaceutical Development & Commercialization, Inc., Gedeon Richter Ltd., Lyndra Therapeutics, Neurocrine Bioscience, Takeda Pharmaceutical Company, Memory Pharmaceuticals, Hoffmann-La Roche, Neurocrine Biosciences, Boehringer Ingelheim, Meiji Seika Pharma Co., Ltd., SK Life Science, Inc., Alkermes, Inc. , Solvay Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, SyneuRx International (Taiwan) Corp, BioXcel Therapeutics Inc, Cognitive Research Corporation, Amarex Clinical Research, Forum Pharmaceuticals Inc, Amneal Pharmaceuticals, LLC, Recognify Life Sciences, Accutest Research Laboratories (I) Pvt. Ltd., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Janssen, LP, Delpor, Inc., Jiangsu Hansoh Pharmaceutical, Cerevel Therapeutics, LLC, Zogenix, Inc., Luye Pharma, Reviva Pharmaceuticals, Alkermes, Inc., Karuna Therapeutics, Autifony Therapeutics, Neumora Therapeutics, Adex Therapeutics, among others. Schizophrenia Epidemiology Forecast Schizophrenia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and schizophrenia epidemiology trends. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Bipolar Depression Market Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bipolar depression companies, including Intra-Cellular Therapies, Sunovion Pharmaceuticals, COMPASS Pathways, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2Clinical ResultDrug ApprovalLicense out/in

27 Mar 2024

·synapse.patsnap.com

Bristol Myers Squibb Invests $1.4 Billion in Layout for Schizophrenia Treatment Candidate Drugs

On March 18th, Bristol Myers Squibb (BMS) announced that it had completed the acquisition of Karuna Therapeutics, a move that will further strengthen its investment portfolio in the field of neuroscience. With the acquisition finalized, Karuna Therapeutics has ceased trading on the NASDAQ Global Select Market and is now a wholly-owned subsidiary of Bristol Myers Squibb. At the end of December last year, BMS and Karuna jointly announced that the parties had reached a definitive merger agreement. According to the terms of the agreement, Bristol Myers Squibb will acquire all outstanding shares of Karuna at a cash price of $330.00 per share, with a total equity value of approximately $14 billion. After deducting the estimated cash acquired, the net transaction value is approximately $12.7 billion. Karuna is a biopharmaceutical company focused on the discovery, development, and delivery of innovative treatments that change the lives of patients with psychiatric and neurological disorders. Its lead product in development, KarXT (xanomeline-trospium), is an antipsychotic drug with a novel mechanism of action that offers unique efficacy and safety. The New Drug Application (NDA) for KarXT for the treatment of adult schizophrenia submitted by Karuna has been accepted for review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date set for September 26, 2024. KarXT is also undergoing registrational trials exploring its potential as an adjunctive therapy to existing standard-of-care medications for schizophrenia and for the treatment of psychosis in Alzheimer's disease patients. Regarding SchizophreniaSchizophrenia is a chronic, severe, and debilitating mental disorder. When schizophrenia is active, symptoms can include delusions, hallucinations, disorganized speech, thought disorders, and a lack of motivation. There are 20 million people worldwide who suffer from schizophrenia. With treatment, most symptoms of schizophrenia can greatly improve, and the possibility of relapse can be reduced. The impact of schizophrenia is equivalent in males and females, but males may develop the disease earlier. The prevalence rate is similar worldwide. Compared to the general population, people with schizophrenia are more likely to die prematurely, mainly due to a higher prevalence of diseases such as heart disease and diabetes. The complexity of schizophrenia may help explain why there are misconceptions about the disorder. Schizophrenia does not mean a split personality or multiple personalities. Most people with schizophrenia are not more dangerous or violent than the general public. Although limited mental health resources in the community can lead to homelessness and frequent hospitalizations for individuals with schizophrenia, the belief that individuals with schizophrenia end up homeless or in hospitals is a misconception. Karuna TherapeuticsKaruna Therapeutics was established in Boston, the mecca of global biotechnology companies. Its parent company Puretech Health is revered as a respected industry leader within the Boston biotech community, founded by Daphne Zohar, who is also the founder and CEO of Puretech Health. Ms. Daphne Zohar, founder of Puretech Health, has been recognized as one of the top innovators under 35 by MIT Technology Review. She was chosen as one of the 28 top female leaders globally by BioWorld, named one of the "Top 15 Innovators" in the Boston area by The Boston Globe, recognized as a woman to watch by the Boston Business Journal, and MedCity News acknowledged her as one of the most influential women in healthcare innovation and on Twitter. Another founding figure of Puretech Health is Robert Langer, the company's key strategist working behind the scenes. He is a distinguished professor at MIT and a member of all three national academies. He has published more than 1,400 research papers and holds over 1,300 issued and pending patents worldwide. His patents have been licensed or sublicensed to more than 350 pharmaceutical, chemical, biotechnology, and medical device companies. He is a world-renowned expert in the field of biomedical engineering. Robert Langer has been successful in transforming scientific discoveries and research findings in the laboratory into real-world therapeutic methods, diagnostic reagents, devices, and medicines. According to the official website of PureTech Health, the company's vision is "Giving Life to Science." PureTech Health transforms scientific and technological advancements into practical clinical applications by creating companies. PureTech Health has incubated several subsidiaries, aiming to develop new drugs in various different directions. Among them, Karuna's mission is to advance transformative medications for patients with psychiatric and neurological disorders. In May 2012, Karuna signed an exclusive licensing agreement with Eli Lilly. Under the terms of this agreement, Eli Lilly transferred to Karuna all rights related to certain patents, regulatory documents, data records, and materials associated with Xanomeline. Karuna obtained the authority to sublicense or otherwise transfer rights related to the licensing agreement with Eli Lilly and is obliged to make commercially reasonable efforts to develop, produce, and commercialize any dosage form of Xanomeline, as well as to seek and maintain regulatory approval for human use. This collaboration resulted in the most significant R&D pipeline for Karuna: KarXT (Karuna-Xanomeline-Trospium), intended for the treatment of psychosis-related symptoms in patients with schizophrenia and Alzheimer's disease. Looking back at 2018, it was a pivotal year for Karuna Therapeutics. In mid-June, Karuna received an $8 million Wellcome Trust Award grant from the Wellcome Trust to advance its key pipeline, KarXT (Karuna-Xanomeline-Trospium), in Phase 2 clinical trials for the treatment of schizophrenia. This represented additional funding following the initial $3.8 million awarded by the Wellcome Trust to Karuna for Phase 1 clinical research of KarXT (Karuna-Xanomeline-Trospium). KarXT (Karuna-Xanomeline-Trospium) is a combination formulation comprising Trospium Chloride and Xanomeline, which works as an agonist of the muscarinic M1 and M4 receptors and as an antagonist of peripheral muscarinic receptors with restrictive properties. Karuna initiated a Phase 1 clinical study of KarXT for the treatment of schizophrenia in 2016, which was completed in mid-2017. In August, Karuna announced the completion of its Series A financing round, raising $42 million, led by ARCH Venture Partners. Among the investors in this round was an individual investor, the founder of publicly traded company SAGE Therapeutics, Steven Paul. Subsequently, Karuna announced the appointment of Steven Paul as the company's new CEO. Steven Paul possesses extensive experience in the research and development of central nervous system (CNS) drugs. He worked at Eli Lilly for 17 years, where he held several key leadership roles, including the President of Lilly Research Laboratories. At Eli Lilly, he was responsible for the company's overall R&D efforts and helped oversee the development of CNS drugs such as Zyprexa® and Cymbalta®. Most critically, he led the clinical development research of the xanomeline project at Eli Lilly for the treatment of Alzheimer's disease and obtained clinical evidence of xanomeline's antipsychotic and pro-cognitive properties. Between 2018 and 2022, Steven Paul led the rapid growth and transformation of Karuna. Karuna's Drug PipelineAccording to the latest corporate presentation by Karuna, KarXT is the company's most important research and development pipeline. In three 5-week clinical studies (EMERGENT-1/2/3), patients with schizophrenia experienced clinically meaningful improvements in symptoms. Data on patients' positive symptoms, negative symptoms, and secondary endpoints were all highly significant. The company has submitted a marketing application in the third quarter of 2023 and will continue to complete multiple long-term studies on the safety and tolerability over the next two years. Clinical trials for KarXT in the treatment of Alzheimer’s disease are also set to commence. Additionally, in February 2023, the company entered into a global exclusive licensing agreement with Goldfinch Bio for the research of TRPC4/5 candidate products. Under this agreement, Karuna will obtain the global exclusive rights to develop, manufacture, and commercialize multiple TRPC4/5 candidates, including the lead clinical-stage candidate GFB-887. Goldfinch Bio will receive an upfront payment of $15 million and up to $520 million in potential milestone payments, as well as royalties on each TRPC4/5 candidate product. Karuna will share details of the development plan for GFB-887 in the treatment of mood and anxiety disorders in the second half of 2023. Other Representative Schizophrenia Candidate DrugBrilaroxazine is a novel multimodal partial agonist for 5-HT1A, 5-HT2A, D2, D3, D4 receptors, and an antagonist for 5-HT2B, 5-HT2C, 5-HT7R, developed by Reviva Pharmaceuticals. In 2017, Reviva Pharmaceuticals published preclinical study results about Brilaroxazine as an atypical antipsychotic, indicating that Brilaroxazine could improve declarative memory and psychotic symptoms in a mouse model of schizophrenia. Furthermore, the drug also has the potential to treat idiopathic pulmonary fibrosis and pulmonary arterial hypertension. On October 30th, Reviva Pharmaceuticals announced that the global pivotal Phase 3 RECOVER trial for its investigational drug Brilaroxazine achieved positive preliminary results. Compared to placebo, a 50 mg dose of Brilaroxazine resulted in a reduction of 10.1 points in the PANSS total score (a scale that measures positive and negative syndromes of schizophrenia) at week 4, with significant statistical and clinical relevance. In terms of safety, after 4 weeks of treatment, no drug-related serious adverse events (SAEs) were observed, no treatment-emergent SAEs (TESAEs) were seen, and no significant safety concerns for Brilaroxazine were reported. Roluperidone (MIN-101) is a clinical-stage small molecule drug developed by Minerva Neurosciences that acts as a dual antagonist of the 5-HT2A receptor and sigma2 receptor. On May 10th, Minerva Neurosciences announced that the New Drug Application for Roluperidone for the treatment of negative symptoms in patients with schizophrenia has been submitted for FDA review. Ulotaront is a dual agonist of the 5-HT1A receptor and Trace Amine-Associated Receptor 1 (TAAR1), originally developed by Sumitomo Pharma, and is currently being investigated as an adjunctive therapy for the treatment of schizophrenia, generalized anxiety disorder, and major depressive disorder. On July 31st, Sumitomo Pharma announced on their official website that their antipsychotic clinical candidate drug, Ulotaront (SEP-363856), did not meet the primary endpoints in two recent Phase 3 clinical studies (DIAMOND 1 and DIAMOND 2).

27 Mar 2024

·synapse.patsnap.com

Sumitomo Pharma Renews Collaborative Development Agreement with Otsuka Pharmaceutical for Multiple Psychiatric Disorder Treatments

On March 15th, Sumitomo Dainippon Pharma Co., Ltd., and its U.S. subsidiary, Sumitomo Pharma America, Inc. (SMPA), announced that they have amended the global collaboration and commercialization agreement originally signed with Sumitomo Dainippon Pharma, SMPA, and Otsuka Pharmaceutical Co., Ltd., on September 30, 2021, concerning the joint development of four investigational compounds in the fields of psychiatry and neurology, including ulotaront, SEP-380135, SEP-4199, and SEP-378614 (hereinafter referred to as "the Amendment Agreement"). It is reported that SEP-4199 and SEP-378614 from the original collaboration agreement will no longer be included in the scope of this Amendment Agreement. SMPA has granted Otsuka Pharmaceutical exclusive global rights to develop, produce, and market ulotaront and SEP-380135 for all indications. SMPA is entitled to receive milestone payments of up to 30 million U.S. dollars (approximately 45 billion Japanese yen) related to the development progress of ulotaront and SEP-380135 from Otsuka Pharmaceutical, as well as royalties based on Otsuka Pharmaceutical's sales revenue. Sumitomo Pharma and SMPA have been collaborating with Otsuka Pharmaceutical in the development of novel candidate compounds including ulotaront in the priority areas of psychiatry and neurology. However, given the current situation, the likelihood of these compounds generating revenue during the Mid-Term Business Plan period for fiscal 2027 (FY2023-FY2027) poses significant challenges. In light of this, the Sumitomo Pharma Group has reassessed its priority development products and has decided to focus its efforts on the development of projects in the fields of oncology and regenerative medicine/cell therapy, which are expected to come to market during the Mid-Term Business Plan period for fiscal 2027. Consequently, Sumitomo Pharma Group has transferred the development responsibilities for the aforementioned ulotaront and SEP-380135 to Otsuka Pharmaceutical. At the same time, Sumitomo Pharma Group is evaluating further development strategies for SEP-4199 and SEP-378614. Ulotaront is an agonist associated with Trace Amine-Associated Receptor 1 (TAAR1) and exhibits agonist activity at the 5-HT1A receptor. Currently, ulotaront is in the development phase for the treatment of schizophrenia, as an adjunctive treatment for major depressive disorder (MDD), and for generalized anxiety disorder (GAD). In May 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Ulotaront for the treatment of schizophrenia, making it the first and only TAAR1 agonist to enter Phase III clinical trials for schizophrenia. Additionally, Ulotaront is the first TAAR1 agonist to progress to Phase II/III clinical trials as an adjunctive treatment for Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD). However, on July 31, 2023, Sumitomo Pharma announced on its official website that its antipsychotic clinical candidate Ulotaront (SEP-363856) failed to meet the primary endpoints in two recent Phase III clinical studies (DIAMOND 1 and DIAMOND 2). In April 2020, the team at Sunovion, the U.S. subsidiary of Sumitomo Pharmaceuticals, published the results of a Phase 2 clinical study on the oral small molecule SEP-363856 for the treatment of schizophrenia in The New England Journal of Medicine online. The study conducted a randomized controlled trial to evaluate the efficacy and safety of SEP-363856 in adult patients with an acute exacerbation of schizophrenia. Patients were randomly assigned in a 1:1 ratio to receive SEP-363856 treatment (either 50 mg or 75 mg) or placebo once daily for a duration of 4 weeks. The primary endpoint was the change in the total score on the Positive and Negative Syndrome Scale (PANSS; range 30 to 210, with higher scores indicating more severe psychotic symptoms) from baseline to week 4. A total of 120 patients were assigned to the SEP-363856 group, and 125 patients were allocated to the placebo group. At baseline, the mean total score on the Positive and Negative Syndrome Scale (PANSS) was 101.4 for the SEP-363856 group and 99.7 for the placebo group. The mean change at week 4 was -17.2 for the SEP-363856 group and -9.7 for the placebo group. The reductions in the Clinical Global Impressions - Severity (CGI-S) and the Brief Negative Symptom Scale (BNSS) scores at week 4 were consistent with the primary outcome in terms of direction of improvement. The adverse reactions of SEP-363856 include somnolence and gastrointestinal symptoms; a case of sudden cardiac death occurred in the SEP-363856 group. The incidence of extrapyramidal symptoms in the trial group, as well as changes in blood lipid levels, glycated hemoglobin, and prolactin levels, was similar. In 2021, the Sunovion team published an article in the journal Schizophrenia, reporting on the safety and efficacy of SEP-363856 in the treatment of schizophrenia (results from a 6-month open-label extension study). According to the study report, this 26-week open-label extension study was designed to evaluate the safety and efficacy of Ulotaront (25/50/75 mg/day) in patients who completed the initial 4-week study. The results showed that after 26 weeks of extended treatment, the mean change in the observed PANSS total score compared to the open-label baseline was -22.6. The long-term treatment with the TAAR1 agonist Ulotaront had a relatively high completion rate, characterized by the absence of extrapyramidal related adverse reactions, a lower incidence of weight and metabolic adverse reactions, and no effect on prolactin levels. It is reported that the Phase III clinical trial results jointly announced by Sumitomo Pharmaceuticals and Otsuka are multicenter, randomized, double-blind, parallel-group, fixed-dose studies. The DIAMOND 1 study evaluated the efficacy, safety, and tolerability of ulotaront (50 mg/day and 75 mg/day) compared to placebo; while DIAMOND 2 assessed the efficacy, safety, and tolerability of ulotaront (75 mg/day and 100 mg/day) compared to placebo. In the DIAMOND 1 study, over time, the Positive and Negative Syndrome Scale (PANSS) total scores for all three treatment groups decreased. However, at the primary endpoint of change from baseline in PANSS total score at week 6, the ulotaront treatment groups did not show superiority to the placebo group (patients treated with ulotaront at doses of 50 mg/day and 75 mg/day had changes of -16.9 and -19.6, respectively, compared to -19.3 in the placebo group). In the DIAMOND 2 study, the 75 mg/day and 100 mg/day ulotaront treatment groups did not show statistically significant improvement over placebo at the primary endpoint. At week 6, the least squares (LS) mean changes for patients treated with 75 mg/day and 100 mg/day ulotaront were -16.4 and -18.1, respectively, compared to -14.3 for the placebo group. In both DIAMOND 1 and DIAMOND 2 studies, a substantial placebo effect was observed which may have masked the therapeutic effect of the molecule. SEP-380135 is an orally-administered small molecule drug targeting the central nervous system, jointly developed by SMPA and PsychoGenics, and is currently in Phase I clinical trials in the United States. The discovery of this drug was made possible by the in vivo phenotypic SmartCube® platform and its associated artificial intelligence algorithms. SmartCube® is a proprietary state-of-the-art automated testing platform by PsychoGenics that uses custom hardware to guide mice through a series of challenges, extracting profound behavioral and physiological insights through integrated computer vision and artificial intelligence (AI) technology. Compared to traditional behavioral testing methods, the SmartCube® system boasts the following advantages: ·High Automation: Using precise hardware devices, SmartCube® can automatically guide mice to participate in a variety of experimental challenges, reducing the errors associated with human interference and enhancing experiment efficiency and accuracy. ·Real-time Behavior Monitoring: Employing advanced computer vision technology, it captures and precisely identifies the mice's behavior in real-time, providing researchers with a wealth of behavioral data. ·AI Data Analysis: The built-in artificial intelligence algorithms are capable of deep learning and intelligent analysis on the vast amount of behavioral data collected, revealing behavioral patterns and physiological correlations that traditional methods may fail to detect. ·Multidimensional Assessment: Beyond basic behavioral parameters, SmartCube® also synchronously acquires physiological indicators, enabling comprehensive and multi-level evaluations. ·High Throughput Capacity: Compared to manual operation, SmartCube® can process large quantities of experimental samples more rapidly and efficiently, accelerating the process of drug screening and disease model research. PsychoGenics has identified thousands of active behavioral compounds through the screening of various compound libraries, which can serve as starting points for new drug discovery projects. Typically, the discovery process begins with the search for "hits" that possess desired characteristics and other specific features. For instance, a project might focus on finding compounds with antidepressant features similar to certain psychedelic compounds but without activity on the 5HT2a receptor. In preclinical studies, SEP-380135 has demonstrated a broad range of in vivo activity, preliminarily indicating its effectiveness against a variety of behavioral and psychological symptoms of dementia, including, but not limited to, agitation/aggression, psychomotor hyperactivity, and depressive symptoms. This suggests that SEP-380135 has the potential to be one of the effective medications for treating multiple complex symptoms associated with dementia, offering new possibilities for further improving the quality of life of patients with dementia. SEP-4199 is a small molecule compound that functions as a dual antagonist targeting 5-HT receptors and D2 receptors. It is currently undergoing phase 3 clinical trials for the treatment of bipolar I disorder, major depressive disorder, and severe depression. SEP-378614 is a small molecule compound jointly developed by Sumitomo and PsychoGenics, which is currently undergoing phase 1 clinical trials for the treatment of major depressive disorder.

100 Deals associated with Ulotaront

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KEGG	Wiki	ATC	Drug Bank
-	Ulotaront	-	DB15665

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized anxiety disorder	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Generalized anxiety disorder	Phase 3	Japan	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Generalized anxiety disorder	Phase 3	Bulgaria	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Generalized anxiety disorder	Phase 3	Estonia	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Generalized anxiety disorder	Phase 3	Finland	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Generalized anxiety disorder	Phase 3	Slovakia	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Generalized anxiety disorder	Phase 3	Spain	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Generalized anxiety disorder	Phase 3	Sweden	Otsuka Pharmaceutical Development & Commercialization, Inc.	08 Mar 2023
Depressive Disorder, Major	Phase 3	United States	Sumitomo Pharma America, Inc.	09 Nov 2022
Schizophrenia	Phase 3	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	11 Sep 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04115319 (CTgov)	Phase 3	Schizophrenia	305	SEP-363856 (SEP-363856 50 to 100 mg/Day)	vpgveiypop = wdmuabpyit pefasouwla (uzvlfhfpcs, jujivwofjk - kzpxfqxlql) View more	-	31 Dec 2025
				Quetiapine XR (Quetiapine XR 400 to 800 mg/Day)	vpgveiypop = xmaeseqnzj pefasouwla (uzvlfhfpcs, inwvucaywg - cwgywngnau) View more
NCT05628103 (CTgov)	Phase 3	Schizophrenia	101	SEP-363856	kpplqtgszf = nolfqciwxc lslsxfrrhm (lkerzienbh, tmqcpuotlr - lmugnvvdbf) View more	-	12 Nov 2025
NCT05741528 (CTgov)	Phase 3	Schizophrenia	75	SEP-363856	eiitebibpv = osjvdkveif cawaumyrkf (kuidfpziyk, hvwebonsfd - hkedrjtpzh) View more	-	12 Nov 2025
NCT04038957 (CTgov)	Phase 1	Schizophrenia	22	SEP-363856	zztodvmpai(higodsuwrh) = nforoxpgjr qoshperbfw (jbqlkvlnyz, 0.00157) View more	-	25 Nov 2024
NCT05402111 (Pubmed)	Phase 1	Schizophrenia	27	Ulotaront	guwpwpknbc(rrzzsltjbl) = xezoyqldap thjntxjdaa (rqwrcioxsf )	Positive	01 Mar 2024
				PA	guwpwpknbc(rrzzsltjbl) = wmfxrnclty thjntxjdaa (rqwrcioxsf )
DIAMOND 1 (Corporate Publications) Manual	Phase 3	Schizophrenia	435	Ulotaront 50 mg/day	yqicdvhwse(lrjtvpckxg) = fijqeameyk byhafqcols (gultamdpvg )	Negative	31 Jul 2023
				Ulotaront 75 mg/day	yqicdvhwse(lrjtvpckxg) = gwuyehrmbj byhafqcols (gultamdpvg )
DIAMOND 2 (Corporate Publications) Manual	Phase 3	Schizophrenia	464	Ulotaront 75 mg/day	aairlprezi(mgguhevjmf) = fexhofvaus ptlreaqdfc (irivpipnad )	Negative	01 Jul 2023
				Ulotaront 100 mg/day	aairlprezi(mgguhevjmf) = bowwaookto ptlreaqdfc (irivpipnad )
NCT02969369 (CTgov)	Phase 2	Parkinson Disease	39	SEP-363856	tbqltnbflp(qwlgukawrz) = cakakhczyo sdkghhxviy (kfccxqyrpz, qvkmyjdvlm - gbhsiznvft) View more	-	05 Jun 2023
NCT02970929 (CTgov)	Phase 2	Schizophrenia	157	SEP-363856	wtcbvainrs = caudvbbasq bitywkpdsq (galrviwxex, crbexdlwja - wvctymkgfi) View more	-	09 Feb 2022
NCT02969382 (CTgov)	Phase 2	Schizophrenia	245	Placebo - Cap (Placebo)	jxbpgailvh(qxaznpbwwy) = teegvfmicw eapttnqdya (hxlkjwrmfw, 1.61) View more	-	22 Sep 2021
				SEP-363856 (SEP-363856)	jxbpgailvh(qxaznpbwwy) = rpbhfozchu eapttnqdya (hxlkjwrmfw, 1.66) View more

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